Vericiguat

Details

Stereochemistry	ACHIRAL
Molecular Formula	C19H16F2N8O2
Molecular Weight	426.3795
Optical Activity	NONE
Defined Stereocenters	0 / 0
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

COC(=O)NC1=C(N)N=C(N=C1N)C2=NN(CC3=CC=CC=C3F)C4=NC=C(F)C=C24

InChI

InChIKey=QZFHIXARHDBPBY-UHFFFAOYSA-N

InChI=1S/C19H16F2N8O2/c1-31-19(30)25-14-15(22)26-17(27-16(14)23)13-11-6-10(20)7-24-18(11)29(28-13)8-9-4-2-3-5-12(9)21/h2-7H,8H2,1H3,(H,25,30)(H4,22,23,26,27)

HIDE SMILES / InChI

Molecular Formula	C19H16F2N8O2
Molecular Weight	426.3795
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Description
Sources: https://www.ncbi.nlm.nih.gov/pubmed/28557445 | http://www.chemdiv.com/pivotal-phase-iii-study-started-vericiguat-patients-chronic-heart-failure/ | http://www.prnewswire.com/news-releases/data-on-vericiguat-investigational-heart-failure-medicine-to-be-presented-as-late-breaking-clinical-trial-at-the-2015-american-heart-association-aha-scientific-sessions-300174024.html

Vericiguat, discovered at Bayer, is the first soluble guanylate cyclase (sGC) stimulator. Vericiguat is currently being studied in a Phase III clinical program for the treatment of heart failure with reduced ejection fraction (HFrEF).

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Soluble guanylate cyclase 36 Target ID: CHEMBL2111348 Sources: https://www.ncbi.nlm.nih.gov/pubmed/28557445	Activator 1447		1005.0 nM [EC50]

Conditions

Condition	Modality	Targets	Highest Phase	Product
Heart Failure 7 Sources: https://clinicaltrials.gov/ct2/show/NCT02861534	Primary		Phase III 665	Unknown Approved Use Unknown

C_max

Value	Dose	Analyte	Population
350 μg/L OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214377Orig1s000IntegratedR.pdf#page=223	10 mg 1 times / day steady-state, oral dose: 10 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FED
41 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	1.25 mg single, oral dose: 1.25 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
106 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
176 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
115 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
72 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
129 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
279 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
202 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
274 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=41	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
195 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=41	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
61.8 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	1.25 mg 1 times / day multiple, oral dose: 1.25 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
236 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
324 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	7.5 mg 1 times / day multiple, oral dose: 7.5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
365 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	10 mg 1 times / day multiple, oral dose: 10 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
46.4 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=120	1.25 mg 1 times / day multiple, oral dose: 1.25 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
161 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=120	5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
242 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=120	7.5 mg 1 times / day multiple, oral dose: 7.5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
285 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=120	10 mg 1 times / day multiple, oral dose: 10 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
89.2 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	1.25 mg 1 times / day steady-state, oral dose: 1.25 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
289 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	5 mg 1 times / day steady-state, oral dose: 5 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
407 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	7.5 mg 1 times / day steady-state, oral dose: 7.5 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
472 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	10 mg 1 times / day steady-state, oral dose: 10 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
17.2 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	0.5 mg single, oral dose: 0.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
39.3 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	1 mg single, oral dose: 1 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
82.7 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
158 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
194 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
259 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	7.5 mg single, oral dose: 7.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
285 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
430 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	15 mg single, oral dose: 15 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
38.5 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	1.25 mg 1 times / day multiple, oral dose: 1.25 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
114 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
200 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	10 mg 1 times / day multiple, oral dose: 10 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
136 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	5 mg 2 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
51.4 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	1.25 mg 1 times / day multiple, oral dose: 1.25 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
185 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
310 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	10 mg 1 times / day multiple, oral dose: 10 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
312 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	5 mg 2 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
83.1 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED
76.2 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
92.7 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
91.4 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
66.6 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=37 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K109_1.pdf#page=72	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
69.5 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=37 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K109_1.pdf#page=72	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
68.7 μg/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=37 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K109_1.pdf#page=72	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED

AUC

Value	Dose	Analyte	Population
6680 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214377Orig1s000IntegratedR.pdf#page=223	10 mg 1 times / day steady-state, oral dose: 10 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FED
754 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	1.25 mg single, oral dose: 1.25 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
2300 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
3260 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
2730 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
1360 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
2520 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
5480 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
3890 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
5600 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=41	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
3890 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=41	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
703 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	1.25 mg 1 times / day multiple, oral dose: 1.25 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
2540 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
3230 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	7.5 mg 1 times / day multiple, oral dose: 7.5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
4410 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	10 mg 1 times / day multiple, oral dose: 10 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
666 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=120	1.25 mg 1 times / day multiple, oral dose: 1.25 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
2370 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=120	5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
3300 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=120	7.5 mg 1 times / day multiple, oral dose: 7.5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
4340 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=120	10 mg 1 times / day multiple, oral dose: 10 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
1170 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	1.25 mg 1 times / day steady-state, oral dose: 1.25 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
3670 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	5 mg 1 times / day steady-state, oral dose: 5 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
4810 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	7.5 mg 1 times / day steady-state, oral dose: 7.5 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
6170 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	10 mg 1 times / day steady-state, oral dose: 10 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
273 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	0.5 mg single, oral dose: 0.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
618 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	1 mg single, oral dose: 1 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
1450 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
2900 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
2500 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
4460 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	7.5 mg single, oral dose: 7.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
4940 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
7900 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	15 mg single, oral dose: 15 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
423 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	1.25 mg 1 times / day multiple, oral dose: 1.25 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
1370 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
2240 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	10 mg 1 times / day multiple, oral dose: 10 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
951 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	5 mg 2 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
656 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	1.25 mg 1 times / day multiple, oral dose: 1.25 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
2230 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
3840 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	10 mg 1 times / day multiple, oral dose: 10 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
2600 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	5 mg 2 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
1330 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED
1390 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
2200 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
2940 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
1550 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=37 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K109_1.pdf#page=72	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
1780 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=37 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K109_1.pdf#page=72	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
1250 μg × h/L OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=37 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K109_1.pdf#page=72	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED

T_1/2

Value	Dose	Analyte	Population
20 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214377Orig1s000IntegratedR.pdf#page=223	10 mg 1 times / day steady-state, oral dose: 10 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: FED
18.8 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	1.25 mg single, oral dose: 1.25 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
20.4 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
21.4 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
18.9 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=30 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=17	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: HIGH-FAT
18.5 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
18.1 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
17.6 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
18.2 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=40	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
18 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=41	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FED
18.9 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=31 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=41	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
22.3 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	1.25 mg 1 times / day multiple, oral dose: 1.25 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
21.1 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
17.9 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	7.5 mg 1 times / day multiple, oral dose: 7.5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
18.3 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=119	10 mg 1 times / day multiple, oral dose: 10 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
27 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	1.25 mg 1 times / day steady-state, oral dose: 1.25 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
23.5 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	5 mg 1 times / day steady-state, oral dose: 5 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
22.1 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	7.5 mg 1 times / day steady-state, oral dose: 7.5 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
20.7 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=34 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=121	10 mg 1 times / day steady-state, oral dose: 10 mg route of administration: Oral experiment type: STEADY-STATE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
17.2 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	0.5 mg single, oral dose: 0.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
19.4 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	1 mg single, oral dose: 1 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
19.4 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
19.8 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
14.5 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	5 mg single, oral dose: 5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
19.8 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	7.5 mg single, oral dose: 7.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
20.7 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	10 mg single, oral dose: 10 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
17.2 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=67	15 mg single, oral dose: 15 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
25.7 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	1.25 mg 1 times / day multiple, oral dose: 1.25 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
24.7 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	5 mg 1 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
19.9 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	10 mg 1 times / day multiple, oral dose: 10 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
20.7 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=35 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K108_1.pdf#page=89	5 mg 2 times / day multiple, oral dose: 5 mg route of administration: Oral experiment type: MULTIPLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
20.7 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED
17.1 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
32.1 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
36.9 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=36	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
19.8 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=37 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K109_1.pdf#page=72	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
23.7 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=37 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K109_1.pdf#page=72	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FED
20.2 h OTHER GOV'T https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_A100_1.pdf#page=37 \| https://www.pmda.go.jp/drugs/2021/P20210602001/630004000_30300AMX00275_K109_1.pdf#page=72	2.5 mg single, oral dose: 2.5 mg route of administration: Oral experiment type: SINGLE co-administered:	VERICIGUAT plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED

F_unbound

Value	Dose	Co-administered	Analyte	Population
2% OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214377Orig1s000IntegratedR.pdf#page=223			VERICIGUAT plasma	Homo sapiens

Doses

Dose	Population	Adverse events
10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214377s000lbl.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: FED Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214377s000lbl.pdf	Disc. AE: Embryo-fetal toxicity... AEs leading to discontinuation/dose reduction: Embryo-fetal toxicity Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214377s000lbl.pdf
10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/26547357/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/26547357/	Other AEs: Hypotension, Syncope... Other AEs: Hypotension (15.4%) Syncope (4.4%) Sources: https://pubmed.ncbi.nlm.nih.gov/26547357/

AEs

AE	Significance	Dose	Population
Embryo-fetal toxicity	Disc. AE	10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214377s000lbl.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: FED Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214377s000lbl.pdf
Hypotension	15.4%	10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/26547357/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/26547357/
Syncope	4.4%	10 mg 1 times / day multiple, oral Recommended Dose: 10 mg, 1 times / day Route: oral Route: multiple Dose: 10 mg, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/26547357/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/26547357/

PubMed

Title	Date	PubMed

Patents

Sample Use Guides

In Vivo Use Guide

Starting dose of 2.5 mg taken orally once daily with food, on a background of standard of care. Dose will be uptitrated to 5 mg and to 10 mg.

Route of Administration: Oral

In Vitro Use Guide

Studies on the in vitro effects of Vericiguat on highly purified sGC (soluble guanylate cyclase) revealed that Vericiguat (0.01 uM to 100 uM) stimulates recombinant sGC concentration dependently, by 1.7-fold to 57.6-fold.

Substance Class	Chemical Created by `admin` on `Mon Mar 31 21:44:51 GMT 2025` Edited by `admin` on `Mon Mar 31 21:44:51 GMT 2025`
Record UNII	LV66ADM269
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

Vericiguat [INN]

Preferred Name

English

Vericiguat

Official Name

English

Methyl N-[4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]carbamate

Systematic Name

English

Methyl (4,6-diamino-2-(5-fluoro-1-((2-fluorophenyl)methyl)-1H-pyrazolo(3,4-b)pyridin-3-yl(pyrimidin-5-yl)carbamate

Systematic Name

English

Methyl [4,6-diamino-2-[5-fluoro-1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]pyrimidin-5-yl]carbamate

Systematic Name

English

BAY-1021189

Code

English

Vericiguat [JAN]

Common Name

English

Carbamic acid, N-[4,6-diamino-2-[5-fluoro-1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]-, methyl ester

Systematic Name

English

Vericiguat [ORANGE BOOK]

Common Name

English

Verquvo

Brand Name

English

Vericiguat [WHO-DD]

Common Name

English

MK-1242

Code

English

Vericiguat [USAN]

Common Name

English

Classification Tree Code System Code

NCI_THESAURUS

C29707