Voclosporin History and Updates

76 events · 2005 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: July 17, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-15Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Voclosporin since 2005, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (6)

2025

Results postedVoclosporin: Phase 2 Systemic Lupus trial shows fewer treatment failures· Sep 9, 2025
Primary completionVoclosporin Phase 3 Trial for Pediatric Lupus Nephritis Terminated· Jul 4, 2025
Primary completionVoclosporin Phase 3 Trial in Pediatric Lupus Nephritis Terminated· Jul 3, 2025

2022

Pivotal publicationVoclosporin AURORA 1 Trial Results Published for Lupus Nephritis· Jan 1, 2022

2011

Pivotal publicationVoclosporin AURORA Study Publication for Lupus Nephritis· Jan 1, 2011

2008

Pivotal publicationVoclosporin Phase III Study Shows Efficacy in Plaque Psoriasis· Jan 1, 2008

Upcoming & expected milestones

Primary completionJan 31, 2027· ClinicalTrials.gov

Phase 4 primary completion: NCT07225387

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

Primary completionJun 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06406205

A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis

Primary completionMar 2, 2029· ClinicalTrials.gov

Phase 4 primary completion: NCT07611214

PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

Primary completionJun 30, 2031· ClinicalTrials.gov

Primary completion: NCT07053891

LUPKYNIS Drug-use Results Survey

Past events

2026

Trial registeredMay 28, 2026· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07611214

PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis

2025

Trial registeredNov 6, 2025· ClinicalTrials.gov

Phase 4 trial registered on ClinicalTrials.gov: NCT07225387

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

FDA approval (supplemental)Oct 8, 2025· FDA

FDA approved supplemental application for Lupkynis (voclosporin) — Labeling (NDA 213716 S-8)

Sponsor: AURINIA. Class: Labeling.

Trial startedSep 17, 2025· ClinicalTrials.gov

Trial started: NCT07053891

LUPKYNIS Drug-use Results Survey

Results postedSep 9, 2025· ClinicalTrials.gov

Trial results posted: NCT05306873

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

Trial registeredJul 8, 2025· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT07053891

LUPKYNIS Drug-use Results Survey

Primary completionJul 4, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05962788

Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis

Primary completionJul 3, 2025· ClinicalTrials.gov

Phase 3 primary completion: NCT05288855

Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Primary completionJan 31, 2025· ClinicalTrials.gov

Primary completion: NCT05337124

A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US

2024

Trial startedOct 1, 2024· ClinicalTrials.gov

Phase 4 trial started: NCT07225387

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

Primary completionJun 13, 2024· ClinicalTrials.gov

Phase 2 primary completion: NCT05306873

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

Trial registeredMay 9, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06406205

A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis

FDA approval (supplemental)Apr 29, 2024· FDA

FDA approved supplemental application for Lupkynis (voclosporin) — Efficacy (NDA 213716 S-4)

Sponsor: AURINIA. Class: Efficacy.

Trial startedMar 28, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT05962788

Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis

2023

Trial startedDec 25, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT06406205

A Study of QLG1074 Combined With Background Therapy in Subjects With Active Lupus Nephritis

Trial startedOct 10, 2023· ClinicalTrials.gov

Phase 3 trial started: NCT05288855

Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Trial registeredJul 27, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05962788

Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis

Results postedMar 27, 2023· ClinicalTrials.gov

Trial results posted: NCT00244842

Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis

2022

Results postedDec 14, 2022· ClinicalTrials.gov

Trial results posted: NCT03597464

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

Trial startedNov 30, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05306873

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

Trial registeredApr 20, 2022· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT05337124

A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US

Primary completionApr 5, 2022· ClinicalTrials.gov

Phase 1 primary completion: NCT05306379

Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin

Trial startedApr 5, 2022· ClinicalTrials.gov

Trial started: NCT05337124

A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US

Trial registeredApr 1, 2022· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05306379

Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin

Trial registeredApr 1, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05306873

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

Primary completionMar 25, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT04701528

Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients

Trial registeredMar 21, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05288855

Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Trial startedJan 24, 2022· ClinicalTrials.gov

Phase 1 trial started: NCT05306379

Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin

Pivotal publicationJan 1, 2022· PubMed

Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. (Lancet)

AURORA — Aurinia Renal Response in Active Lupus With Voclosporin

2021

Results postedDec 10, 2021· ClinicalTrials.gov

Trial results posted: NCT04147650

Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome

Primary completionOct 7, 2021· ClinicalTrials.gov

Phase 3 primary completion: NCT03597464

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

Results postedSep 16, 2021· ClinicalTrials.gov

Trial results posted: NCT03598036

Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis

Results postedJul 8, 2021· ClinicalTrials.gov

Trial results posted: NCT03597139

Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

Results postedJun 16, 2021· ClinicalTrials.gov

Trial results posted: NCT03021499

Aurinia Renal Response in Active Lupus With Voclosporin

Results postedMay 18, 2021· ClinicalTrials.gov

Trial results posted: NCT02141672

AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

Results postedMar 19, 2021· ClinicalTrials.gov

Trial results posted: NCT02949973

Aurinia Early Urinary Protein Reduction Predicts Response

FDA approvalJan 22, 2021· FDA

FDA approved Lupkynis (voclosporin) (NDA 213716)

Sponsor: AURINIA. Class: Type 1 - New Molecular Entity.

Trial registeredJan 8, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04701528

Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients

2020

Trial startedNov 15, 2020· ClinicalTrials.gov

Phase 2 trial started: NCT04701528

Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients

Primary completionSep 17, 2020· ClinicalTrials.gov

Phase 2/Phase 3 primary completion: NCT04147650

Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome

Primary completionMay 19, 2020· ClinicalTrials.gov

Phase 2 primary completion: NCT03598036

Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis

2019

Trial registeredNov 1, 2019· ClinicalTrials.gov

Phase 2/Phase 3 trial registered on ClinicalTrials.gov: NCT04147650

Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome

Trial startedOct 14, 2019· ClinicalTrials.gov

Phase 2/Phase 3 trial started: NCT04147650

Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome

Trial startedSep 29, 2019· ClinicalTrials.gov

Phase 3 trial started: NCT03597464

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

Primary completionSep 24, 2019· ClinicalTrials.gov

Phase 3 primary completion: NCT03021499

Aurinia Renal Response in Active Lupus With Voclosporin

2018

Primary completionNov 9, 2018· ClinicalTrials.gov

Phase 2 primary completion: NCT03597139

Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

Trial startedAug 13, 2018· ClinicalTrials.gov

Phase 2 trial started: NCT03597139

Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

Trial registeredJul 26, 2018· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03598036

Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis

Trial registeredJul 24, 2018· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT03597139

Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

Trial registeredJul 24, 2018· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03597464

Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

Trial startedJun 21, 2018· ClinicalTrials.gov

Phase 2 trial started: NCT03598036

Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis

2017

Trial startedMay 17, 2017· ClinicalTrials.gov

Phase 3 trial started: NCT03021499

Aurinia Renal Response in Active Lupus With Voclosporin

Trial registeredJan 16, 2017· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT03021499

Aurinia Renal Response in Active Lupus With Voclosporin

2016

Primary completionDec 31, 2016· ClinicalTrials.gov

Phase 1 primary completion: NCT02949999

Voclosporin in Healthy Japanese Volunteers

Primary completionDec 31, 2016· ClinicalTrials.gov

Phase 2 primary completion: NCT02949973

Aurinia Early Urinary Protein Reduction Predicts Response

Trial registeredOct 31, 2016· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT02949999

Voclosporin in Healthy Japanese Volunteers

Trial startedOct 31, 2016· ClinicalTrials.gov

Phase 1 trial started: NCT02949999

Voclosporin in Healthy Japanese Volunteers

Trial registeredOct 31, 2016· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT02949973

Aurinia Early Urinary Protein Reduction Predicts Response

Primary completionJul 31, 2016· ClinicalTrials.gov

Phase 2 primary completion: NCT02141672

AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

2015

Primary completionDec 31, 2015· ClinicalTrials.gov

Phase 3 primary completion: NCT01586845

Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation

Trial startedJun 30, 2015· ClinicalTrials.gov

Phase 2 trial started: NCT02949973

Aurinia Early Urinary Protein Reduction Predicts Response

2014

Trial startedJun 30, 2014· ClinicalTrials.gov

Phase 2 trial started: NCT02141672

AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

Trial registeredMay 19, 2014· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT02141672

AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

2013

Trial startedMar 31, 2013· ClinicalTrials.gov

Phase 3 trial started: NCT01586845

Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation

Results postedFeb 12, 2013· ClinicalTrials.gov

Trial results posted: NCT00270634

Study of ISA247 (Voclosporin) in De Novo Renal Transplantation

2012

Trial registeredApr 27, 2012· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT01586845

Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation

2011

Pivotal publicationJan 1, 2011· PubMed

Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. (N Engl J Med)

AURORA — Aurinia Renal Response in Active Lupus With Voclosporin

2010

Trial registeredNov 8, 2010· ClinicalTrials.gov

Trial registered on ClinicalTrials.gov: NCT01236287

Special Access for the Use of Voclosporin for Kidney Transplantation

2009

Primary completionJul 31, 2009· ClinicalTrials.gov

Phase 2 primary completion: NCT00270634

Study of ISA247 (Voclosporin) in De Novo Renal Transplantation

Primary completionMar 31, 2009· ClinicalTrials.gov

Phase 1 primary completion: NCT00851734

A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label

2008

Pivotal publicationJan 1, 2008· PubMed

Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study. (Lancet)

SPIRIT — Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis

2005

Primary completionOct 31, 2005· ClinicalTrials.gov

Phase 3 primary completion: NCT00244842

Randomized Placebo-controlled Study of ISA247 in Plaque Psoriasis

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.