How is voclosporin different from older calcineurin inhibitors?

It has a more predictable pharmacokinetic profile, so it is given at a fixed oral dose twice daily without the routine blood trough-level monitoring required for ciclosporin or tacrolimus.

Does voclosporin affect kidney function and blood pressure?

Yes; it can cause dose-dependent reductions in kidney function and raise blood pressure, glucose and potassium, so eGFR and these parameters are monitored during treatment.

Can it be taken with other medicines freely?

No; it is metabolised by CYP3A4, is contraindicated with strong CYP3A4 inhibitors, and needs dose adjustment with moderate inhibitors, so all medicines should be reviewed by the prescriber.

EMA-approvedaka Lupkynis

Voclosporin — Complete Research Guide (2026)

Q: What does the boxed warning cover?

As a calcineurin-inhibitor immunosuppressant, it carries the class boxed warning for increased risk of serious infections and of malignancy, including lymphoma.

Last updated 2026-06-30

TL;DR

Voclosporin (also known as Lupkynis) is a peptide catalogued under Cyclic & Antimicrobial (Cyclosporin analog). It is described as: Calcineurin. Documented context: Lupus nephritis. Neutral reference entry; EU status: EU-approved prescription medicine.

What is Voclosporin?

Voclosporin (Lupkynis) is a next-generation oral calcineurin inhibitor structurally related to ciclosporin.

It was FDA-approved in 2021 and is EMA-approved, in combination with mycophenolate mofetil, for adults with active lupus nephritis.

Its approval is supported by the phase 2 AURA-LV and pivotal phase 3 AURORA 1 randomised trials, with three-year safety and efficacy from the AURORA 2 continuation study.

How does Voclosporin work?

Voclosporin binds cyclophilin to inhibit calcineurin, blocking NFAT-mediated T-cell activation and interleukin-2 transcription and thereby dampening the autoimmune response.

It is also thought to stabilise podocytes in the kidney, contributing to reduced proteinuria beyond immunosuppression alone.

What does the research say about Voclosporin?

Added to mycophenolate and low-dose steroids, voclosporin significantly increased the rate of complete renal response at week 52 in active lupus nephritis (AURORA 1). ^[1]
In the phase 2 AURA-LV dose-ranging trial, low-dose voclosporin raised complete remission rates versus placebo when added to standard therapy. ^[2]
Over three years in AURORA 2, voclosporin maintained renal treatment effect with stable eGFR and no new safety signals. ^[3]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

[1] Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial — Rovin BH et al., Lancet 2021. (Randomised placebo-controlled phase 3 trial (AURORA 1))
[2] 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 — Rovin BH et al., Kidney International 2019. (Randomised placebo-controlled phase 2 trial (AURA-LV))
[3] Safety and Efficacy of Long-Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial — Saxena A et al., Arthritis and Rheumatology 2024. (Randomised controlled continuation trial (AURORA 2))
[4] Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis — Arriens C et al., Arthritis Care and Research (Hoboken) 2023. (Integrated pooled analysis of clinical trials)
[5] Voclosporin: Unique Chemistry, Pharmacology and Toxicity Profile, and Possible Options for Implementation into the Management of Lupus Nephritis — Kale A et al., Cells 2023. (Narrative pharmacology review)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

Dosing is context-only: voclosporin is a fixed-dose oral capsule taken twice daily that, unlike older calcineurin inhibitors, does not require routine blood trough-level monitoring, and it is always combined with mycophenolate and glucocorticoids.

It is prescribed and monitored by nephrology or rheumatology specialists with eGFR-guided dose reduction, and is not a self-administered or research-use compound.

Side effects & safety profile

As a calcineurin inhibitor, voclosporin carries the class boxed warning for increased risk of serious infections and of malignancy (including lymphoma) arising from immunosuppression.

Dose-dependent nephrotoxicity is a key concern, so eGFR is monitored and the dose reduced for declines; it can also raise blood pressure, glucose and potassium.

It is a CYP3A4 substrate with important drug interactions - contraindicated with strong CYP3A4 inhibitors - and dose adjustment is needed with moderate inhibitors.

Stacking & combinations

Voclosporin is used only as part of a defined triple regimen (with mycophenolate mofetil and glucocorticoids) under specialist care, not as a discretionary stack component.

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Frequently asked questions

It is approved, in combination with mycophenolate mofetil and glucocorticoids, for adults with active lupus nephritis.

References

[1] Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial — Rovin BH et al., Lancet 2021. PMID: 33971155. View sourceStudy: Randomised placebo-controlled phase 3 trial (AURORA 1)Voclosporin added to standard therapy significantly increased complete renal response at 52 weeks in lupus nephritis.
[2] 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 — Rovin BH et al., Kidney International 2019. PMID: 30420324. View sourceStudy: Randomised placebo-controlled phase 2 trial (AURA-LV)Low-dose voclosporin increased complete remission rates versus placebo when added to mycophenolate and steroids.
[3] Safety and Efficacy of Long-Term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial — Saxena A et al., Arthritis and Rheumatology 2024. PMID: 37466424. View sourceStudy: Randomised controlled continuation trial (AURORA 2)Three years of voclosporin maintained renal benefit with stable eGFR and no new safety signals.
[4] Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis — Arriens C et al., Arthritis Care and Research (Hoboken) 2023. PMID: 36039949. View sourceStudy: Integrated pooled analysis of clinical trialsPooled AURA-LV and AURORA data confirm consistent renal efficacy and a manageable safety profile for voclosporin.
[5] Voclosporin: Unique Chemistry, Pharmacology and Toxicity Profile, and Possible Options for Implementation into the Management of Lupus Nephritis — Kale A et al., Cells 2023. PMID: 37887284. View sourceStudy: Narrative pharmacology reviewReviews voclosporin's distinct chemistry, calcineurin-inhibitor pharmacology, and role in lupus nephritis management.

This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.