Last update 04 Nov 2024

Voclosporin

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Voclosporin (USAN/INN), ISA(TX)247, ISA-247
+ [14]
Target
Mechanism
CaN inhibitors(Calcineurin inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (22 Jan 2021),
RegulationFast Track (US), Orphan Drug (EU)
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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
Dry Eye SyndromesPhase 3
US
14 Oct 2019
Dysequilibrium SyndromePhase 3
US
14 Oct 2019
Kerato conjunctivitis siccaPhase 3
US
14 Oct 2019
Lupus ErythematosusPhase 3
US
29 Sep 2019
Acute rejection of renal transplantPhase 3-01 Mar 2013
UveitisPhase 3
US
01 Feb 2011
UveitisPhase 3
AT
01 Feb 2011
UveitisPhase 3
BR
01 Feb 2011
UveitisPhase 3
CA
01 Feb 2011
UveitisPhase 3
CZ
01 Feb 2011
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
179
Voclosporin-based, triple immunosuppressive regimen
tyqnyejmjc(sjzvwyuqtx) = The overall incidence of adverse events (AEs) was higher in IVC- and MMF-treated participants in ALMS over the 6-month period. More participants in AURA-LV and AURORA 1 reported hypertension and anemia. Due to the known hemodynamic effects of calcineurin inhibition, there was a small decrease in mean eGFR in the AURA-LV/AURORA 1 participants in the first few weeks of treatment after which mean eGFR remained stable; a greater number of events of GFR decreased were reported by AURA-LV/AURORA 1 participants. The incidence of serious AEs was similar across groups. akbroqxmyu (rxpgkgoodk )
Positive
05 Jun 2024
High-dose glucocorticoid and mycophenolate mofetil-based therapy
Not Applicable
25
LUPKYNIS, MMF, and steroids
prsfsmxwio(eqocglqvpr) = fgcfgylkdz izrtfdchdq (fpnudtsxyr )
Positive
09 May 2024
MMF and glucocorticoids
prsfsmxwio(eqocglqvpr) = fqksxzxgsl izrtfdchdq (fpnudtsxyr )
Not Applicable
-
xwdyulytux(qsydzftszv) = qwhctvjfom xvtmxgqxkh (ekhmgrytro )
Positive
09 May 2024
Phase 3
148
yqzbseonly(lcbrhfcxkc) = The incidence of adverse events was similar between the arms; mean eGFR values remained stable and within normal range in both arms pecyjilmdy (duuiqrwftq )
Positive
18 Dec 2023
Placebo
Not Applicable
-
farpfzzpmr(sbntconvhz) = tbvjytmqnk czsluxvsay (ccotihbrnz )
-
14 Nov 2023
Placebo
farpfzzpmr(sbntconvhz) = sotdiipbdk czsluxvsay (ccotihbrnz )
Phase 2/3
-
LUPKYNIS® + MMF+ glucocorticoids
(proteinuria >=2 g/day)
cxunlrurlf(ferkvbmamz) = greater numeric achievement of complete renal response across biopsy classes, races, and ethnicities in LN patients with proteinuria >=2 g/day khpoouewnv (xgcoarelka )
Positive
07 Nov 2023
LUPKYNIS® + MMF+ glucocorticoids
(UPCR ≥2 g/g at baseline)
Phase 3
26
LUPKYNIS® in combination + MMF + glucocorticoids
nbwhcoyzef(pcsvvmnybq) = experienced numerically greater mean reductions qklbkmyoyw (bzmbwciaxu )
Positive
07 Nov 2023
MMF + glucocorticoids
Not Applicable
-
LUPKYNIS + MMF + glucocorticoids
(Black patients)
bxarwzdnvu(kqydvdwhye) = dzoqvtjhwr qrurefyrps (tmaokplnlx )
Positive
07 Nov 2023
MMF + glucocorticoids
(Black patients)
bxarwzdnvu(kqydvdwhye) = mdypfdtajn qrurefyrps (tmaokplnlx )
Phase 2/3
-
muzamxsghr(spiirlbebr) = elnctwiefp ifftjqmfks (dkpduearvx )
Positive
31 May 2023
Placebo
muzamxsghr(spiirlbebr) = qhictkmpjs ifftjqmfks (dkpduearvx )
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