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Drug

Voclosporin

Approved · EMA
Emerging researchLate-stage development

Also known as Lupkynis.

RxNorm2475166ChEMBLCHEMBL5314379UNII2PN063X6B1
1
Research papers
2
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

PRESERVE: A Multi-Center Phase 4 Study of the Efficacy and Safety of LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab at Inducing Rapid Renal Response in Patients With Lupus Nephritis

Clinical trial2026-06-12Results expected Q1 2029 · ClinicalTrials.gov

Safety and EfficacY of CombinatioN Belimumab and Voclosporin in the TrEatment of PRoliferative Forms of Lupus Glomerulopathy: Synergy Trial

Clinical trial2025-11-06Results expected Q1 2027 · ClinicalTrials.gov

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Clinical trial2025-07-04Terminated · ClinicalTrials.gov

A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Clinical trial2025-07-03Terminated · ClinicalTrials.gov

A Phase 2, Double-Blind, Placebo-Controlled Trial of Mycophenolate Mofetil Alone or With Voclosporin for Systemic Lupus: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment (DIVERT) (ALE10)

Clinical trial2024-07-11Terminated · ClinicalTrials.gov

A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients

Clinical trial2023-03-27Results posted · ClinicalTrials.gov

A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg Twice Daily) With Placebo in Achieving Renal Response in Subjects With Active Lupus Nephritis

Clinical trial2023-03-27Results posted · ClinicalTrials.gov

A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Voclosporin (23.7 mg Twice Daily) With Placebo in Subjects With Lupus Nephritis

Clinical trial2022-12-14Results posted · ClinicalTrials.gov

An Open-Label Study Evaluating Anti-Viral Effects of Voclosporin in SARS-CoV-2 Positive Kidney Transplant Recipients - the VOCOVID Study

Clinical trial2022-10-25Completed · ClinicalTrials.gov

Approval: Lupkynis (EMA)

Regulatory2022-09-15EMA

A Single Center, Open Label, Phase 1 Drug-Drug Interaction Study to Investigate the Effects of Voclosporin on the Pharmacokinetics of Simvastatin in Healthy Volunteers

Clinical trial2022-04-05Completed · ClinicalTrials.gov

The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation.

Research2011-09-22American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Voclosporin
Aliases & brands
Lupkynis
RxNorm CUI
2475166
ChEMBL ID
CHEMBL5314379
UNII
2PN063X6B1
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-09-15
Latest approval
2022-09-15
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-09-15Approval
Approval: Lupkynis (EMA)
Indication: Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus… Show full indication

Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

18 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
18
registered trials across all phases
LATEST COMPLETION 2022
2
Active studies
2
Recruiting
10
Late-stage (III+)
11
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 18
Phase 12Phase 26Phase 38Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

PRESERVE: A Multi-Center Phase 4 Study of the Efficacy and Safety of LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab at Inducing Rapid Renal Response in Patients With Lupus Nephritis

RecruitingPH IVAurinia Pharmaceuticals Inc.n=1502029

Safety and EfficacY of CombinatioN Belimumab and Voclosporin in the TrEatment of PRoliferative Forms of Lupus Glomerulopathy: Synergy Trial

RecruitingPH IVNephroNet, Inc.n=302027

An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

TerminatedPH IIIAurinia Pharmaceuticals Inc.n=42025

A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

TerminatedPH IIIAurinia Pharmaceuticals Inc.n=92025

A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Voclosporin (23.7 mg Twice Daily) With Placebo in Subjects With Lupus Nephritis

CompletedPH IIIAurinia Pharmaceuticals Inc.n=2162021

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Open-Label Study Evaluating Anti-Viral Effects of Voclosporin in SARS-CoV-2 Positive Kidney Transplant Recipients - the VOCOVID Study

CompletedPH IILeiden University Medical Centern=202022

A Single Center, Open Label, Phase 1 Drug-Drug Interaction Study to Investigate the Effects of Voclosporin on the Pharmacokinetics of Simvastatin in Healthy Volunteers

CompletedPH IAurinia Pharmaceuticals Inc.n=242022

A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Voclosporin (23.7 mg Twice Daily) With Placebo in Subjects With Lupus Nephritis

CompletedPH IIIAurinia Pharmaceuticals Inc.n=2162021

A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg Twice Daily) With Placebo in Achieving Renal Response in Subjects With Active Lupus Nephritis

CompletedPH IIIAurinia Pharmaceuticals Inc.n=3582019

An Exploratory Study Assessing the Short Term Predictors of Remission of Voclosporin 23.7mg Twice Daily (BID) in Combination With Standard of Care in Patients With Active Lupus Nephritis

CompletedPH IIAurinia Pharmaceuticals Inc.n=102017

A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg BID, or 39.5 mg BID) With Placebo in Achieving Remission in Patients With Active Lupus Nephritis

CompletedPH IIAurinia Pharmaceuticals Inc.n=2652017

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation.

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2011 · 64 cites
Recent papers

The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation.

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2011 · 64 cites
Major research themes2
Kidney Transplantation1Postoperative Complications1
Journals, researchers & institutions
Top journals
  • American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons1
Leading researchers
  • Busque S1
  • Cantarovich M1
  • Gaber AO1
  • Gaston R1
  • Huizinga RB1
  • Ling S1
  • Mayo PR1
  • Meier-Kriesche HU1
Leading institutions
free-text, unnormalised
  • Stanford University School of Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.