Voclosporin

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C63H111N11O12
Molecular Weight	1214.6244
Optical Activity	UNSPECIFIED
Defined Stereocenters	12 / 12
E/Z Centers	1
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

[H][C@@]1([C@H](O)[C@H](C)C\C=C\C=C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C(=O)[C@H](CC)NC1=O)C(C)C

InChI

InChIKey=BICRTLVBTLFLRD-PTWUADNWSA-N

InChI=1S/C63H111N11O12/c1-25-27-28-29-41(15)53(76)52-57(80)66-44(26-2)59(82)68(18)34-49(75)69(19)45(30-35(3)4)56(79)67-50(39(11)12)62(85)70(20)46(31-36(5)6)55(78)64-42(16)54(77)65-43(17)58(81)71(21)47(32-37(7)8)60(83)72(22)48(33-38(9)10)61(84)73(23)51(40(13)14)63(86)74(52)24/h25,27-28,35-48,50-53,76H,1,26,29-34H2,2-24H3,(H,64,78)(H,65,77)(H,66,80)(H,67,79)/b28-27+/t41-,42+,43-,44+,45+,46+,47+,48+,50+,51+,52+,53-/m1/s1

HIDE SMILES / InChI

Molecular Formula	C63H111N11O12
Molecular Weight	1214.6244
Charge	0
Count

Stereochemistry	ABSOLUTE
Additional Stereochemistry	No
Defined Stereocenters	12 / 12
E/Z Centers	1
Optical Activity	UNSPECIFIED

Description
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213006s000lbl.pdf|https://pubmed.ncbi.nlm.nih.gov/33788181

Voclosporin (Lupkynis™) is an oral calcineurin inhibitor immunosuppressant that is being developed by Aurinia Pharmaceuticals. Voclosporin is an analogue of cyclosporine with a modification at the amino acid-1 position. The drug has been designed to show improved potency against calcineurin inhibition and better metabolic stability than cyclosporine. Although the exact mechanism of voclosporin is not yet clear, it inhibits calcineurin, thereby blocking lymphocyte proliferation and T-cell mediated immune responses, as well as increasing podocyte integrity in the kidney. In January 2021, based on positive results from the pivotal phases II and III trials, oral voclosporin received its first approval in the USA for use in combination with a background immunosuppressive therapy regimen for adults with active lupus nephritis. Voclosporin is also being explored for the novel coronavirus disease 2019 (COVID-19) in kidney transplant recipients. Clinical evaluation of voclosporin for plaque psoriasis, coronary artery restenosis and rheumatoid arthritis has been discontinued and no recent development for prevention of renal transplant rejection has been identified since 2015.

CNS Activity

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Serine/threonine protein phosphatase 2B catalytic subunit, alpha isoform 1 Target ID: CHEMBL4445 Sources: https://pubmed.ncbi.nlm.nih.gov/21245533	Inhibitor 8504		15.8 null [IC50]
Peptidyl-prolyl cis-trans isomerase A 1 Target ID: P62937\|\|\|Q9BTY9 Gene ID: 5478.0 Gene Symbol: PPIA Target Organism: Homo sapiens (Human) Sources: https://pubmed.ncbi.nlm.nih.gov/21245533	Inhibitor 8504		15.0 nM [Kd]

Conditions

Condition	Modality	Targets	Highest Phase	Product
Lupus nephritis 7 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213716s000lbl.pdf	Primary		Approved 8583	Lupkynis Approved Use Indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis Launch Date 2021

C_max

Value	Dose	Analyte	Population
48.6 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	0.25 mg/kg single, oral dose: 0.25 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
117.9 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	0.5 mg/kg single, oral dose: 0.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
496.2 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	1 mg/kg single, oral dose: 1 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
705.2 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	1.5 mg/kg single, oral dose: 1.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
43.4 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.25 mg/kg 2 times / day multiple, oral dose: 0.25 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
190.8 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.5 mg/kg 2 times / day multiple, oral dose: 0.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
607.2 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1 mg/kg 2 times / day multiple, oral dose: 1 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
843.9 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1.5 mg/kg 2 times / day multiple, oral dose: 1.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
32 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	0.25 mg/kg single, oral dose: 0.25 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
77 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	0.5 mg/kg single, oral dose: 0.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
459 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	1.5 mg/kg single, oral dose: 1.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
874.9 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	3 mg/kg single, oral dose: 3 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
955.5 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	4.5 mg/kg single, oral dose: 4.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
46.6 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.25 mg/kg single, oral dose: 0.25 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
130 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.5 mg/kg single, oral dose: 0.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
314 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1 mg/kg single, oral dose: 1 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
441 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1.5 mg/kg single, oral dose: 1.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
70.3 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.25 mg/kg 2 times / day multiple, oral dose: 0.25 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
160 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.5 mg/kg 2 times / day multiple, oral dose: 0.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
416 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1 mg/kg 2 times / day multiple, oral dose: 1 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
619 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1.5 mg/kg 2 times / day multiple, oral dose: 1.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

AUC

Value	Dose	Analyte	Population
195.8 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	0.25 mg/kg single, oral dose: 0.25 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
468.3 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	0.5 mg/kg single, oral dose: 0.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
2191.6 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	1 mg/kg single, oral dose: 1 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
3098.5 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	1.5 mg/kg single, oral dose: 1.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
207.8 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.25 mg/kg 2 times / day multiple, oral dose: 0.25 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
804.6 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.5 mg/kg 2 times / day multiple, oral dose: 0.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
2880.2 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1 mg/kg 2 times / day multiple, oral dose: 1 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
4567.7 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1.5 mg/kg 2 times / day multiple, oral dose: 1.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
142.9 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	0.25 mg/kg single, oral dose: 0.25 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
354.4 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	0.5 mg/kg single, oral dose: 0.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
2166.5 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	1.5 mg/kg single, oral dose: 1.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
5079.6 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	3 mg/kg single, oral dose: 3 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
7693.6 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	4.5 mg/kg single, oral dose: 4.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
199 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.25 mg/kg single, oral dose: 0.25 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
492 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.5 mg/kg single, oral dose: 0.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1260 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1 mg/kg single, oral dose: 1 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1780 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1.5 mg/kg single, oral dose: 1.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
591 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.25 mg/kg 2 times / day multiple, oral dose: 0.25 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1480 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.5 mg/kg 2 times / day multiple, oral dose: 0.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
4180 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1 mg/kg 2 times / day multiple, oral dose: 1 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
8080 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1.5 mg/kg 2 times / day multiple, oral dose: 1.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

T_1/2

Value	Dose	Analyte	Population
30 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=94	steady-state, oral	VOCLOSPORIN plasma	Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN
6.9 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	0.25 mg/kg single, oral dose: 0.25 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
8.5 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	0.5 mg/kg single, oral dose: 0.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
11.9 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	1 mg/kg single, oral dose: 1 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
12.5 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281	1.5 mg/kg single, oral dose: 1.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
30.2 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.25 mg/kg 2 times / day multiple, oral dose: 0.25 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
33.2 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.5 mg/kg 2 times / day multiple, oral dose: 0.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
31.4 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1 mg/kg 2 times / day multiple, oral dose: 1 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
36.8 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=281 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1.5 mg/kg 2 times / day multiple, oral dose: 1.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
5.7 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	0.25 mg/kg single, oral dose: 0.25 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
7.9 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	0.5 mg/kg single, oral dose: 0.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
14.3 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	1.5 mg/kg single, oral dose: 1.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
17.4 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	3 mg/kg single, oral dose: 3 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
42.3 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=282	4.5 mg/kg single, oral dose: 4.5 mg/kg route of administration: Oral experiment type: SINGLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
27.1 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.25 mg/kg 2 times / day multiple, oral dose: 0.25 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
29.6 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	0.5 mg/kg 2 times / day multiple, oral dose: 0.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
29.9 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1 mg/kg 2 times / day multiple, oral dose: 1 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
30.6 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=293	1.5 mg/kg 2 times / day multiple, oral dose: 1.5 mg/kg route of administration: Oral experiment type: MULTIPLE co-administered:	VOCLOSPORIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

F_unbound

Value	Dose	Co-administered	Analyte	Population
3.03% OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=48 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=50			VOCLOSPORIN plasma	Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN

Doses

Dose	Population	Adverse events
1.5 mg/kg 2 times / day steady, oral Highest studied dose Dose: 1.5 mg/kg, 2 times / day Route: oral Route: steady Dose: 1.5 mg/kg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf	healthy, ADULT Health Status: healthy Age Group: ADULT Sex: unknown Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf	Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf
39.5 mg 2 times / day steady, oral Highest studied dose Dose: 39.5 mg, 2 times / day Route: oral Route: steady Dose: 39.5 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf	unhealthy Health Status: unhealthy Sex: unknown Food Status: UNKNOWN Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf	Disc. AE: Sepsis, Pulmonary embolism... AEs leading to discontinuation/dose reduction: Sepsis (1 patient) Pulmonary embolism (1 patient) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf
4.5 mg/kg single, oral Highest studied dose Dose: 4.5 mg/kg Route: oral Route: single Dose: 4.5 mg/kg Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf	healthy Health Status: healthy Sex: unknown Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf	Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf
23.7 mg 2 times / day steady, oral Recommended Dose: 23.7 mg, 2 times / day Route: oral Route: steady Dose: 23.7 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf	unhealthy Health Status: unhealthy Sex: unknown Food Status: UNKNOWN Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf	Disc. AE: renal toxicity, decreased eGFR... AEs leading to discontinuation/dose reduction: renal toxicity, decreased eGFR (4%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf

AEs

AE	Significance	Dose	Population
Pulmonary embolism	1 patient Disc. AE	39.5 mg 2 times / day steady, oral Highest studied dose Dose: 39.5 mg, 2 times / day Route: oral Route: steady Dose: 39.5 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf	unhealthy Health Status: unhealthy Sex: unknown Food Status: UNKNOWN Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf
Sepsis	1 patient Disc. AE	39.5 mg 2 times / day steady, oral Highest studied dose Dose: 39.5 mg, 2 times / day Route: oral Route: steady Dose: 39.5 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf	unhealthy Health Status: unhealthy Sex: unknown Food Status: UNKNOWN Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf
renal toxicity, decreased eGFR	4% Disc. AE	23.7 mg 2 times / day steady, oral Recommended Dose: 23.7 mg, 2 times / day Route: oral Route: steady Dose: 23.7 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf	unhealthy Health Status: unhealthy Sex: unknown Food Status: UNKNOWN Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000RiskR.pdf

Overview

CYP3A4	CYP2C9	CYP2D6	hERG
substrate 1946 inhibitor 2252 inducer 1087	inhibitor 2438	inhibitor 2507 substrate 1388	inhibitor 2217

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
CYP3A5 136 BCRP 910 OATP1B1 1079 CYP2C19 2057 OATP1B3 961 CYP1A2 2153 CYP2C8 1057 CYP2B6 926 P-gp 1741	CYP2B6 776 CYP3A5 446 BCRP 697 CYP2C19 1119 OATP1B1 503 P-gp 2052 OATP1B3 435	CYP2B6 669 CYP3A5 92 CYP1A2 832

Drug as perpetrator

Target	Modality	Activity	Clinical evidence
CYP2B6 1160	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no [IC50 >9.9 uM]
CYP2C19 2141	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no [IC50 >9.9 uM]
CYP2C8 1117	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no [IC50 >9.9 uM]
CYP2C9 2497	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no [IC50 >9.9 uM]
CYP2D6 2546	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no [IC50 >9.9 uM]
CYP1A2 2333	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no
CYP1A2 2333	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no
CYP2B6 1160	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no
CYP3A4 2633	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no
CYP3A5 201	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no
P-gp 1932	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=48 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=109 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 48 \| 109 \| 289	weak	yes (co-administration study) Comment: Voclosporin BID increased digoxin (multiple doses) AUC24 and Cmax by 1.25-fold and 1.51-fold Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=48 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=109 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 48 \| 109 \| 289
OATP1B3 970	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=278 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 278 \| 289	yes [IC50 0.24 uM]
OATP1B1 1095	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=90 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 90 \| 93 \| 109 \| 278 \| 289	yes [IC50 0.49 uM]
BCRP 985	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=278 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 278 \| 289	yes [Inhibition 10 uM]
CYP3A5 201	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=48 Page: 48 \| 278 \| 289	yes [Ki 1.1 uM]
CYP3A4 2633	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=48 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=109 Page: 48 \| 109 \| 278 \| 289	yes [Ki 1.1 uM]	no (co-administration study) Comment: Voclosporin BID decreased midazolam (single dose) Cmax by 11% and increased AUCinf by 2% Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=48 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=109 Page: 48 \| 109 \| 278 \| 289

Drug as victim

Target	Modality	Activity	Clinical evidence
CYP3A5 446	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=48 Page: 48 \| 289	major
CYP3A4 1946	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=48 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=99 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=109 Page: 48 \| 93 \| 99 \| 109 \| 289	major	yes (co-administration study) Comment: Ketoconazole increased AUC and Cmax by 18.55-fold and 6.45-fold, Verapamil increased AUC and Cmax by 2.71-fold and 2.08-fold, rifampicin decreased AUC and Cmax by 87% and 68% Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=48 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=99 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=109 Page: 48 \| 93 \| 99 \| 109 \| 289
BCRP 697	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=278 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 278 \| 289	no
CYP2C19 1119	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no
CYP2D6 1388	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	no
OATP1B1 503	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=278 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 278 \| 289	no
OATP1B3 435	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=278 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 278 \| 289	no
CYP2B6 776	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 289.0	yes
P-gp 2052	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=48 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=289 Page: 48 \| 289	yes

Tox targets

Target	Modality	Activity	Metabolite	Clinical evidence
hERG 2263	inhibitor 2237 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=46 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213716Orig1s000MultidisciplineR.pdf#page=366 Page: 46 \| 366

PubMed

Title	Date	PubMed
Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin.	2014-06	24330024

Sample Use Guides

In Vivo Use Guide

Recommended starting dose: 23.7 mg orally, twice a day. Lupkynis must be swallowed whole on an empty stomach. Administer consistently as close to a 12-hour schedule as possible, and with at least 8 hours between doses.

Route of Administration: Oral

In Vitro Use Guide

Using a human lymphocyte proliferation assay it was shown that the IC50 for voclosporin to inhibit calcineurin activity was 15.8±10.2 ng/ml.

Substance Class	Chemical Created by `admin` on `Mon Mar 31 18:06:37 GMT 2025` Edited by `admin` on `Mon Mar 31 18:06:37 GMT 2025`
Record UNII	2PN063X6B1
Record Status	`FAILED`
Record Version

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Name

Type

Language

LUPKYNIS

Preferred Name

English

Voclosporin

Official Name

English

VOCLOSPORIN [MART.]

Common Name

English

VOCLOSPORIN [MI]

Common Name

English

ISA-247

Code

English

CYCLO(L-ALANYL-D-ALANYL-N-METHYL-L-LEUCYL-N-METHYL-L-LEUCYL-N-METHYL-L-VALYL- ((2S,3R,4R,6E)-3-HYDROXY-4-METHYL-2-(METHYLAMINO)NONA-6,8-DIENOYL)-(2S)-2- AMINOBUTANOYL-N-METHYLGLYCYL-N-METHYL-L-LEUCYL-L-VALYL-N-METHYL-L-LEUCYL)

Common Name

English

Voclosporin [WHO-DD]

Common Name

English

voclosporin [INN]

Common Name

English

LX211

Code

English

CYCLOSPORIN A, 6-((2S,3R,4R,6E)-3-HYDROXY-4-METHYL-2-(METHYLAMINO)-6,8- NONADIENOIC ACID)-

Common Name

English

VOCLOSPORIN [USAN]

Common Name

English

LX-211

Code

English

VOCLOSPORIN [ORANGE BOOK]

Common Name

English

ISA247

Code

English

ISATX247

Code

English

CYCLO (((E,Z)-(2S,3R,4R)-3-HYDROXY-4-METHYL-2-(METHYLAMINO)NONA-6,8-DIENOYL)-L-2-AMINOBYTYRL-N-METHYL-GLYCYL-N-METHYL-L-LEUCYL-L-VALYL-N-METHYL-L-LEUCYL-L-ALANYL-D-ALANYL-N-METHYL-L-LEUCYL-N-METHYL-L-LEUCYL-N-METHYL-L-VALYL)

Common Name

English

ISATX-247

Code

English

Classification Tree Code System Code

EU-Orphan Drug

EU/3/12/1085