MARIBAVIR

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C15H19Cl2N3O4
Molecular Weight	376.235
Optical Activity	( - )
Defined Stereocenters	4 / 4
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

CC(C)NC1=NC2=C(C=C(Cl)C(Cl)=C2)N1[C@H]3O[C@@H](CO)[C@H](O)[C@@H]3O

InChI

InChIKey=KJFBVJALEQWJBS-XUXIUFHCSA-N

InChI=1S/C15H19Cl2N3O4/c1-6(2)18-15-19-9-3-7(16)8(17)4-10(9)20(15)14-13(23)12(22)11(5-21)24-14/h3-4,6,11-14,21-23H,5H2,1-2H3,(H,18,19)/t11-,12-,13-,14-/m0/s1

HIDE SMILES / InChI

Molecular Formula	C15H19Cl2N3O4
Molecular Weight	376.235
Charge	0
Count

Stereochemistry	ABSOLUTE
Additional Stereochemistry	No
Defined Stereocenters	4 / 4
E/Z Centers	0
Optical Activity	UNSPECIFIED

Description
Sources: https://www.ncbi.nlm.nih.gov/pubmed/20881959 | http://www.fiercebiotech.com/biotech/viropharma-terminates-maribavir-trial-after-failure | https://www.ncbi.nlm.nih.gov/pubmed/19759127

Maribavir (previously known as 1263W94) is a novel benzimidazole riboside compound. This drug was in phase III of clinical trial for the prevention of cytomegalovirus (CMV) infections in transplant patients, sponsored by ViroPharma. However, drug failed to demonstrate a higher efficacy rate than the placebo. Maribavir has activity against cytomegalovirus and Epstein-Barr virus (EBV), but not against other human herpesviruses. Maribavir’s mechanism of action is unique and is complex compared to the currently approved antivirals for CMV. Maribavir inhibits the viral UL97 kinase rather than the viral DNA polymerase. The UL97 kinase is important for viral DNA elongation, DNA packaging, and nuclear egress of encapsidated viral DNA. In addition, maribavir inhibits the EBV DNA polymerase processivity factor (BMRF1), reduces the level of certain EBV glycoproteins, and inhibits viral transcription. However, future work will be designed to address the interaction of MBV and BGLF4 and to evaluate the mechanisms through which maribavir downregulates viral transcripts. BGLF4 belongs to the family of conserved herpesvirus PKs, which includes HCMV UL97, HSV UL13, and HSV US3. Maribavir does need to be phosphorylated for its activity.

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Serine/threonine protein kinase UL97 1 Target ID: P16788\|\|\|Q91B49 Gene ID: NA Gene Symbol: UL97 Target Organism: Human cytomegalovirus (strain AD169) (HHV-5) (Human herpesvirus 5) Sources: https://www.ncbi.nlm.nih.gov/pubmed/12121906/	Inhibitor 8504

Conditions

Condition	Modality	Targets	Highest Phase	Product
Cytomegalovirus infection 6 Sources: https://clinicaltrials.gov/ct2/show/NCT00411645	Preventing		Phase III 665	Unknown Approved Use Unknown

C_max

Value	Dose	Analyte	Population
17.2 μg/mL DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215596lbl.pdf3page=10	400 mg 2 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
2.66 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
3.32 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
7.45 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
16.68 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
26.39 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	800 mg single, oral dose: 800 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
48.81 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	1600 mg single, oral dose: 1600 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
3.783 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	100 mg 3 times / day multiple, oral dose: 100 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
4.371 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	100 mg 3 times / day multiple, oral dose: 100 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
8.154 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	200 mg 3 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
6.999 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	200 mg 3 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
18.102 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	400 mg 3 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
19.189 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	400 mg 3 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
30.551 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	600 mg 2 times / day multiple, oral dose: 600 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
33.499 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	600 mg 2 times / day multiple, oral dose: 600 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
35.366 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	900 mg 2 times / day multiple, oral dose: 900 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
43.532 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	900 mg 2 times / day multiple, oral dose: 900 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
34.005 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	1200 mg 2 times / day multiple, oral dose: 1200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
43.905 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	1200 mg 2 times / day multiple, oral dose: 1200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
11.4 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=167	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED
15.9 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=167	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
20.98 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=172	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
21.88 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=172	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
20.34 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=172	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
12.72 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=175	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
9.45 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=175	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED

AUC

Value	Dose	Analyte	Population
128 μg × h/mL DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215596lbl.pdf3page=10	400 mg 2 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
10.77 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
16.31 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
34.16 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
97.8 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
183.05 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	800 mg single, oral dose: 800 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
436.75 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	1600 mg single, oral dose: 1600 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
12.79 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	100 mg 3 times / day multiple, oral dose: 100 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
17.2 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	100 mg 3 times / day multiple, oral dose: 100 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
28.79 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	200 mg 3 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
26.73 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	200 mg 3 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
55.49 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	400 mg 3 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
77.42 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	400 mg 3 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
122.01 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	600 mg 2 times / day multiple, oral dose: 600 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
126.76 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	600 mg 2 times / day multiple, oral dose: 600 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
154.82 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	900 mg 2 times / day multiple, oral dose: 900 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
229.92 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	900 mg 2 times / day multiple, oral dose: 900 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
206.05 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	1200 mg 2 times / day multiple, oral dose: 1200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
249 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	1200 mg 2 times / day multiple, oral dose: 1200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
85.6 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=167	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FED
99 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=167	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
138.3 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=172	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
127.6 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=172	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
122.6 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=172	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
78.6 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=175	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
62.3 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=175	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED

T_1/2

Value	Dose	Analyte	Population
4.32 h DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215596lbl.pdf3page=10	400 mg 2 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
3.28 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
3.01 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
3.64 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
3.91 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	400 mg single, oral dose: 400 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
4.04 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	800 mg single, oral dose: 800 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
4.8 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=161	1600 mg single, oral dose: 1600 mg route of administration: Oral experiment type: SINGLE co-administered:	MARIBAVIR plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
5.07 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	100 mg 3 times / day multiple, oral dose: 100 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
5.67 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	100 mg 3 times / day multiple, oral dose: 100 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
4.55 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	200 mg 3 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
3.78 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	200 mg 3 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
5.86 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	400 mg 3 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
5.37 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	400 mg 3 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
5.23 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	600 mg 2 times / day multiple, oral dose: 600 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
6.1 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	600 mg 2 times / day multiple, oral dose: 600 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
5.04 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	900 mg 2 times / day multiple, oral dose: 900 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
4.73 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	900 mg 2 times / day multiple, oral dose: 900 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
6.39 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	1200 mg 2 times / day multiple, oral dose: 1200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN
5.83 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=163	1200 mg 2 times / day multiple, oral dose: 1200 mg route of administration: Oral experiment type: MULTIPLE co-administered:	MARIBAVIR plasma	Homo sapiens population: UNHEALTHY age: ADULT sex: MALE food status: UNKNOWN

F_unbound

Value	Dose	Co-administered	Analyte	Population
2% DRUG LABEL https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215596lbl.pdf3page=10			MARIBAVIR plasma	Homo sapiens
2% OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215596Orig1s000IntegratedR.pdf#page=170			MARIBAVIR plasma	Homo sapiens population: UNKNOWN age: ADULT sex: FEMALE / MALE food status: UNKNOWN

Doses

Dose	Population	Adverse events
1200 mg 2 times / day steady-state, oral Highest studied dose Dose: 1200 mg, 2 times / day Route: oral Route: steady-state Dose: 1200 mg, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/30329038/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/30329038/	Disc. AE: death... Other AEs: Dysgeusia, Nausea... AEs leading to discontinuation/dose reduction: death (grade 5, 10 patients) Other AEs: Dysgeusia (29 patients) Nausea (14 patients) Vomiting (11 patient) Diarrhea (10 patients) Fatigue (7 patients) Anemia (10 patients) Peripheral edema (6 patients) Headache (6 patients) Renal impairment (9 patients) Depression (1 pt) Sources: https://pubmed.ncbi.nlm.nih.gov/30329038/
400 mg single, oral Studied dose Dose: 400 mg Route: oral Route: single Dose: 400 mg Sources: https://pubmed.ncbi.nlm.nih.gov/18316526/	healthy, ADULT Health Status: healthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/18316526/	Other AEs: Dysgeusia... Other AEs: Dysgeusia (9 patients) Sources: https://pubmed.ncbi.nlm.nih.gov/18316526/
400 mg single, oral Studied dose Dose: 400 mg Route: oral Route: single Dose: 400 mg Sources: https://pubmed.ncbi.nlm.nih.gov/18316526/	healthy, ADULT Health Status: healthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/18316526/	Other AEs: Dysgeusia, Headache... Other AEs: Dysgeusia (7 patients) Headache (2 patients) Vomiting (1 pt) Sources: https://pubmed.ncbi.nlm.nih.gov/18316526/
400 mg 2 times / day steady-state, oral Studied dose Dose: 400 mg, 2 times / day Route: oral Route: steady-state Dose: 400 mg, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/30329038/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/30329038/	Disc. AE: death... Other AEs: Dysgeusia, Nausea... AEs leading to discontinuation/dose reduction: death (grade 5, 10 patients) Other AEs: Dysgeusia (24 patients) Nausea (15 patients) Vomiting (11 patient) Diarrhea (5 patients) Fatigue (8 patients) Anemia (7 patients) Peripheral edema (11 patient) Headache (9 patients) Renal impairment (3 patients) Depression (2 patients) Sources: https://pubmed.ncbi.nlm.nih.gov/30329038/
800 mg 2 times / day steady-state, oral Studied dose Dose: 800 mg, 2 times / day Route: oral Route: steady-state Dose: 800 mg, 2 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/30329038/	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Food Status: UNKNOWN Sources: https://pubmed.ncbi.nlm.nih.gov/30329038/	Disc. AE: death... Other AEs: Dysgeusia, Nausea... AEs leading to discontinuation/dose reduction: death (grade 5, 12 patients) Other AEs: Dysgeusia (25 patients) Nausea (12 patients) Vomiting (13 patients) Diarrhea (13 patients) Fatigue (10 patients) Anemia (7 patients) Peripheral edema (6 patients) Headache (4 patients) Renal impairment (7 patients) Depression (8 patients) Sources: https://pubmed.ncbi.nlm.nih.gov/30329038/

AEs

PubMed

Title	Date	PubMed
In vitro activity and mechanism of action of methylenecyclopropane analogs of nucleosides against herpesvirus replication.	2005-03	15728900
Inhibition of human cytomegalovirus replication by benzimidazole nucleosides involves three distinct mechanisms.	2004-10	15388453
Effects of maribavir and selected indolocarbazoles on Epstein-Barr virus protein kinase BGLF4 and on viral lytic replication.	2004-05	15105156
Activities of benzimidazole D- and L-ribonucleosides in animal models of cytomegalovirus infections.	2004-05	15105130
Mechanism of action of the ribopyranoside benzimidazole GW275175X against human cytomegalovirus.	2004-05	15105116
In vitro activities of benzimidazole D- and L-ribonucleosides against herpesviruses.	2003-07	12821466
Interactions of 1263W94 with other antiviral agents in inhibition of human cytomegalovirus replication.	2003-04	12654696
Interactions among antiviral drugs acting late in the replication cycle of human cytomegalovirus.	2002-10	12323400
Potent and selective inhibition of human cytomegalovirus replication by 1263W94, a benzimidazole L-riboside with a unique mode of action.	2002-08	12121906
A novel nonnucleoside inhibitor specifically targets cytomegalovirus DNA maturation via the UL89 and UL56 gene products.	2001-10	11533171
Synthesis and antiviral evaluation of halogenated beta-D- and -L-erythrofuranosylbenzimidazoles.	2000-06-15	10882374
Synthesis and evaluation of a series of 2'-deoxy analogues of the antiviral agent 5,6-dichloro-2-isopropylamino-1-(beta-L-ribofuranosyl)-1H-benzimidazole (1263W94).	2000-04-25	10772705
Human cytomegalovirus: challenges, opportunities and new drug development.	1999-09	10574177
Inhibition of Epstein-Barr virus replication by a benzimidazole L-riboside: novel antiviral mechanism of 5, 6-dichloro-2-(isopropylamino)-1-beta-L-ribofuranosyl-1H-benzimidazole.	1999-09	10438815
Development of novel benzimidazole riboside compounds for treatment of cytomegalovirus disease.	1999	10549385

Patents

Sample Use Guides

In Vivo Use Guide

100 mg twice daily for up to 12 weeks

Route of Administration: Oral

In Vitro Use Guide

Maribavir (MBV) may be linked to indirect effects on the transcription of Epstein-Barr virus (EBV) genes through the interaction of BGLF4 with multiple viral proteins. It was examined the effects of MBV and acyclovir (ACV) on the expression of the early (EA-D) and the late (gp125 and gp350) viral proteins by immunofluorescence staining. EA-D was detected in the nucleus, while both gp125 and gp350 were detected in the cytoplasm. MBV (20 μM) reduced the number of cells expressing EA-D by about 50% and almost eliminated the expression of gp125 and gp350 . It was revealed the potent inhibitory effect of MBV on the phosphorylation of EA-D during lytic infection and the lack of such an effect produced by ACV. Both drugs inhibited the expression of the two late viral glycoproteins, but MBV had a considerably greater effect, probably due to its greater antiviral potency.

Substance Class	Chemical Created by `admin` on `Wed Apr 02 09:43:34 GMT 2025` Edited by `admin` on `Wed Apr 02 09:43:34 GMT 2025`
Record UNII	PTB4X93HE1
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

MARIBAVIR

Official Name

English

LIVTENCITY

Preferred Name

English

maribavir [INN]

Common Name

English

1H-BENZIMIDAZOL-2-AMINE, 5,6-DICHLORO-N-(1-METHYLETHYL)-1-.BETA.-L-RIBOFURANOSYL-

Systematic Name

English

1263-W-94

Code

English

MARIBAVIR [USAN]

Common Name

English

5,6-DICHLORO-N-(1-METHYLETHYL)-1-.BETA.-L-RIBOFURANOSYL-1H-BENZIMIDAZOL-2-AMINE

Common Name

English

Maribavir [WHO-DD]

Common Name

English

BW-1263W94

Code

English

5,6-DICHLORO-2-(ISOPROPYLAMINO)-1-.BETA.-L-RIBOFURANOSYLBENZIMIDAZOLE

Common Name

English

1263W94

Code

English

GW-257406X

Code

English

Classification Tree Code System Code

WHO-VATC

QJ05AX10