Voclosporin
A modified cyclosporine approved for the kidney inflammation of lupus
Voclosporin is cyclosporine with one amino acid changed, which makes its blood levels more predictable. Approved as Lupkynis in 2021, it is taken twice daily with mycophenolate and corticosteroids for active lupus nephritis.
What is it?
Voclosporin is a calcineurin inhibitor built on cyclosporine, with a modification to one amino acid that changes how it binds calcineurin and gives more consistent exposure. It was first tested in psoriasis and kidney transplantation, then developed for lupus nephritis, the kidney inflammation that affects many people with lupus.
In the phase 3 AURORA 1 trial, 41% of patients on voclosporin reached a complete kidney response at one year, against 23% on placebo, both groups also taking mycophenolate and low-dose steroids. The phase 2 AURA-LV trial showed a similar benefit but more deaths in the low-dose group; AURORA 2 followed patients for two further years without new safety signals.
FDA approved it as Lupkynis on January 22, 2021. The label carries a boxed warning for cancers and serious infections, and warns of kidney toxicity, high blood pressure, nerve effects, high potassium and QT prolongation. Strong CYP3A4 inhibitors raise its levels sharply.
At a Glance
Every value in this table is printed from the Grey Peptides dataset, the same record the compound explorer and comparison tool read, so the three can never disagree.
Educational information, not medical advice. The doses on this page come from approved labels, published studies and, where no study exists, amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
Half-Life: How Much Remains
The dataset records a half-life of mean terminal half-life about 30 hours (24.9 to 36.5) for Voclosporin. After each half-life, half of what was in the circulation is gone, so about 3% remains after five. Real clearance varies with the person, the dose, the route and kidney or liver function; this is arithmetic on a published figure, not a dosing tool.
Published Research
The studies behind voclosporin, from their PubMed abstracts.
AURORA 1: phase 3 in lupus nephritis
In 357 patients, complete renal response at week 52 was reached by 41% on voclosporin against 23% on placebo (odds ratio 2.65), both with mycophenolate and steroids; serious adverse events occurred in 21% of each group.
AURA-LV: phase 2
In 265 patients, complete remission at 24 weeks was 32.6% on low-dose and 27.3% on high-dose voclosporin against 19.3% on placebo; there were more serious adverse events on voclosporin and more deaths in the low-dose group (11.2%, against 1.1% on placebo).
AURORA 2: two more years
In 216 patients continuing treatment, 86.1% completed the study with no unexpected safety signals; decreased kidney function and high blood pressure were reported more often on voclosporin, but mean eGFR stayed in the normal range and stable.
PROMISE: kidney transplantation
In 334 low-risk kidney transplant recipients, biopsy-proven acute rejection rates on three voclosporin exposure levels (10.7%, 9.1% and 2.3%) were noninferior to tacrolimus over six months.
Phase 3 in plaque psoriasis
At week 12, PASI 75 was reached by 16%, 25% and 47% of patients on three doses of voclosporin against 4% on placebo, with mild to moderate falls in kidney filtration in a few patients on the higher doses.
Drug interactions
Ketoconazole raised voclosporin exposure 18-fold and verapamil 2.7-fold, and rifampin cut it sharply; the authors concluded that strong CYP3A inhibitors and inducers should be considered contraindicated.
Side Effects & Contraindications
Reported Side Effects
From the studies above.
Contraindications & Cautions
Warnings from the Lupkynis label (DailyMed, effective August 25, 2026).
Legal Status
Voclosporin is an approved prescription drug in the US.
Frequently Asked Questions
?What is Lupkynis used for?
Active lupus nephritis in adults, the kidney inflammation caused by lupus, taken with mycophenolate and corticosteroids.
?How is voclosporin different from cyclosporine?
It is cyclosporine with one amino acid modified, which changes how it binds calcineurin and makes blood levels more predictable. It is approved only for lupus nephritis.
?How well does it work?
In the phase 3 AURORA 1 trial, 41% of patients reached a complete kidney response at one year on voclosporin, against 23% on placebo, with both groups on background treatment.
References
- [fda] US FDA, Drugs@FDA (openFDA): LUPKYNIS, NDA 213716 (January 22, 2021). Read October 3, 2026.
- [fda-pi] FDA. Lupkynis (voclosporin) US prescribing information (DailyMed set 9f489295-1156-52c7-5fd0-5c4c52f9b813, effective August 25, 2026). Read October 3, 2026.
- [clinical-trial] Rovin BH, et al. "Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial." Lancet, 2021;397(10289):2070-2080. PMID: 33971155.
- [clinical-trial] Rovin BH, et al. "A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis." Kidney Int, 2019;95(1):219-231. PMID: 30420324.
- [clinical-trial] Saxena A, et al. "Safety and Efficacy of Long-Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial." Arthritis Rheumatol, 2024;76(1):59-67. PMID: 37466424.
- [clinical-trial] Busque S, et al. "The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation." Am J Transplant, 2011;11(12):2675-84. PMID: 21943027.
- [clinical-trial] Papp K, et al. "Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study." Lancet, 2008;371(9621):1337-42. PMID: 18424323.
- [pubmed] Ling SY, et al. "Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin." Br J Clin Pharmacol, 2014;77(6):1039-50. PMID: 24330024.
Sources & Citations
Studies were read from their PubMed records; regulatory sources are listed below, read October 3, 2026.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Consult a licensed healthcare provider before making health decisions.