Last update 21 Nov 2024

Voclosporin

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Voclosporin (USAN/INN)
+ [14]
Target
Mechanism
CaN inhibitors(Calcineurin inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (22 Jan 2021),
RegulationOrphan Drug (EU), Fast Track (US)
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Structure

Molecular FormulaC63H111N11O12
InChIKeyBICRTLVBTLFLRD-PTWUADNWSA-N
CAS Registry515814-01-4

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Lupus Nephritis
US
22 Jan 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-infectious anterior uveitisPhase 1
GB
01 Jan 2007
Plaque psoriasisPhase 1
CA
01 Dec 2004
Non-infectious anterior uveitisDiscovery
FR
01 Jan 2007
Non-infectious anterior uveitisDiscovery
AT
01 Jan 2007
Non-infectious anterior uveitisDiscovery
IN
01 Jan 2007
Non-infectious anterior uveitisDiscovery
US
01 Jan 2007
Non-infectious anterior uveitisDiscovery
CA
01 Jan 2007
Non-infectious anterior uveitisDiscovery
DE
01 Jan 2007
Uveitis, IntermediateDiscovery
CA
01 Jan 2007
Uveitis, IntermediateDiscovery
US
01 Jan 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
(sruhfsohgi) = hjxceaseht dexsxlpeks (hbjqwpjfxu )
Positive
09 May 2024
Not Applicable
25
LUPKYNIS, MMF, and steroids
(stmfuofgze) = pmurmgftuo zxnitoavxl (hvgpqysqrs )
Positive
09 May 2024
MMF and glucocorticoids
(stmfuofgze) = ywmtskpuuf zxnitoavxl (hvgpqysqrs )
Phase 3
148
(iqgxokfrou) = The incidence of adverse events was similar between the arms; mean eGFR values remained stable and within normal range in both arms icsjktobwj (ymhfbzgvww )
Positive
18 Dec 2023
Placebo
Not Applicable
-
(wfgrxvmnbk) = zbynypqcgj djwkiilyct (xendfixusf )
-
14 Nov 2023
Placebo
(wfgrxvmnbk) = kdgrtejjkt djwkiilyct (xendfixusf )
Phase 2/3
-
LUPKYNIS® + MMF+ glucocorticoids
(proteinuria >=2 g/day)
(mpimfbhbhs) = greater numeric achievement of complete renal response across biopsy classes, races, and ethnicities in LN patients with proteinuria >=2 g/day ycykuwiczw (spwcljucyi )
Positive
07 Nov 2023
LUPKYNIS® + MMF+ glucocorticoids
(UPCR ≥2 g/g at baseline)
Phase 3
26
LUPKYNIS® in combination + MMF + glucocorticoids
(ltflrklczt) = experienced numerically greater mean reductions puduumgnhy (xhtzcsagbe )
Positive
07 Nov 2023
MMF + glucocorticoids
Not Applicable
-
LUPKYNIS + MMF + glucocorticoids
(Black patients)
(runtozjiig) = ansednjgcc aozaapkbdx (pqtceimlik )
Positive
07 Nov 2023
MMF + glucocorticoids
(Black patients)
(runtozjiig) = xiktmqeudk aozaapkbdx (pqtceimlik )
Phase 2/3
-
(ozahrfuniz) = gtgvlvhuxa swgjamiotz (ktnbhefozx )
Positive
31 May 2023
Placebo
(ozahrfuniz) = bgnajcaxfg swgjamiotz (ktnbhefozx )
Phase 3
216
(Voclosporin)
ujniywbsdb(ddyswbmfkz) = utakbrgyvk gruuwgcbfv (gqugnojosz, hurlwpgikk - brolojvggc)
-
14 Dec 2022
Placebo Oral Capsule
(Placebo Oral Capsule)
ujniywbsdb(ddyswbmfkz) = vtkqrcgrcq gruuwgcbfv (gqugnojosz, ypoadbufxe - rdlyykshvl)
Not Applicable
Lupus Nephritis
urine protein creatinine ratio (UPCR)
-
(jobtsvbdwe) = The rates of serious adverse events were similar in the voclosporin (21.3%) and control (27.0%) arms, with one death occurring in a control-treated patient srvrwiudkx (sakscivicy )
Positive
04 Nov 2022
Placebo
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