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IndexedBuilt automatically from public databases on 2026-09-30. Not yet hand-reviewed by PLOBT.How this works →

Voclosporin

FDA approved · Rx

Calcineurin inhibitor immunosuppressant

Also known as: Lupkynis, ISAtx-247, ISA-247, ISA247, LX211, Voclosporine, R 1524

Evidence score
91/ 100
Strong evidence

Strong, human-grade evidence

  • Regulatory standing. FDA-approved prescription medicine
  • Human trials. Backed by controlled human studies
  • Registered human trials. 28 registered studies on ClinicalTrials.gov, most advanced Phase 4
  • 2 cited sources. Includes primary / regulatory sources

Computed with the same four public criteria as every profile. The human-evidence grade on an indexed profile is set automatically and may change when it is hand-reviewed. It is not a safety score, not a purity rating, and not medical advice, and not a claim that this compound treats, cures, or prevents any condition.

What it is

Voclosporin, sold as Lupkynis, is a cyclic peptide related to cyclosporine that suppresses the immune system. It blocks calcineurin, an enzyme that T cells need to activate, which reduces immune-driven inflammation, and it is also thought to help stabilize the filtering cells of the kidney.

What the evidence shows

Automatic summaryHuman trials

It is FDA approved for use with background immunosuppressive therapy in adults with active lupus nephritis, supported by randomized trials among 28 registered human studies reaching Phase 4. Its use outside that indication is not established, and like other calcineurin inhibitors it carries known risks such as infection, kidney effects, and raised blood pressure.

Key facts

Molecular formula
C63H111N11O12
Molecular weight
1214.6 g/mol
FDA approval
Confirmed on openFDA

Registered human trials

Live from ClinicalTrials.gov, refreshed daily.

28registered studies
Phase 4most advanced phase
16completed (sample)
5recruiting (sample)

Study of ISA247 (Voclosporin) in De Novo Renal Transplantation

Phase 2CompletedNCT00270634

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

Phase 3TerminatedNCT05962788

Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation

Phase 3WithdrawnNCT01586845

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

Phase 1CompletedNCT05306379

Published literature

Live from Europe PMC. This is how much has been published, not how much is proven in humans.

203papers referencing Voclosporin

EULAR recommendations for the management of systemic lupus erythematosus: 2023 update.

Ann Rheum Dis2024

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

Lancet2021

Systemic Lupus Erythematosus: A Review.

JAMA2024

Systemic lupus erythematosus.

Lancet2024

Sources

Risks, side effects and study doses are only published on hand-reviewed profiles. Want this one reviewed, or spotted something wrong? Tell us.