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Peptide

Voclosporin (Lupkynis)

Voclosporin is a novel cyclic peptide calcineurin inhibitor for lupus nephritis. FDA-approved January 2021. First oral therapy approved for active lupus nephritis. Phase 3 AURORA 1 (n=357): Complete renal response 40.8% vs 22.5% placebo at 52 weeks (OR 2.7, P<0.001). UPCR ≤0.5 achieved by 45.3% vs 23.0%. AURORA 2 extension: Safety and efficacy maintained at 3 years. Cyclosporine analogue with consistent PK profile - no therapeutic drug monitoring required. SAFETY: Hypertension, nephrotoxicity (monitor eGFR), serious infections. Use with MMF and low-dose steroids.

Research notice. This page is for education and research. Peptides may not be FDA-approved for human use and may only be legally available for research. Talk to a qualified clinician before considering any peptide.

Best evidence
Grade A
Conditions studied
1
Outcomes
9
Graded outcomes
5301

Evidence by condition

  • Strong
  • Moderate
  • Limited
  • Very limited

1 condition, plus general outcomes

Lupus Nephritis

Lupus Nephritis: outcomes studied for Voclosporin (Lupkynis)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Long-term Efficacy and Safety

AURORA 2 extension (n=216): 86.1% completed 3-year study. Treatment well-tolerated with no unexpected safety signals. Sustained efficacy over long-term follow-up. No new safety concerns identified.

Improves (the measure goes up)Moderate effect17 studies

Studies that measured long-term efficacy and safety

and 7 more in the citations list

Complete Renal Response

AURORA 1 Phase 3 (n=357): Complete renal response at 52 weeks 40.8% voclosporin vs 22.5% placebo (OR 2.7; 95% CI 1.6-4.3; P<0.001). Added to MMF + low-dose steroids. UPCR ≤0.5 mg/mg: 45.3% vs 23.0% (OR 3.1). Clinically and statistically superior.

Improves (the measure goes up)Large effect16 studies

Studies that measured complete renal response

and 6 more in the citations list

Response in High Proteinuria

Subgroup with UPCR ≥3 g/g (n=148): Complete renal response 34% voclosporin vs 11% control at 12 months (OR 4.43; 95% CI 1.78->9.99; P=0.001). Greater benefit in patients with higher baseline proteinuria.

Improves (the measure goes up)Large effect16 studies

Studies that measured response in high proteinuria

and 6 more in the citations list

Hypertension Risk

SAFETY: New-onset or worsening hypertension common with calcineurin inhibitors. Blood pressure monitoring required. Consider antihypertensive therapy. May require dose adjustment or discontinuation if uncontrolled.

Worsens (the measure goes up)Moderate effect16 studies

Studies that measured hypertension risk

and 6 more in the citations list

Nephrotoxicity Risk

SAFETY: Acute and chronic nephrotoxicity possible. Monitor eGFR regularly. Reduce dose if eGFR decreases. AURA-LV Phase 2: Higher adverse events including deaths in low-dose group (11.2% vs 2.3% high-dose vs 1.1% placebo) - led to dose selection refinement.

Worsens (the measure goes up)Moderate effect16 studies

Studies that measured nephrotoxicity risk

and 6 more in the citations list

General

General: outcomes studied for Voclosporin (Lupkynis)
GradeOutcomeEffectSizeStudiesPeopleStudies list
Safety/Tolerability

13 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect19 studies

Studies that measured safety/tolerability

and 9 more in the citations list

Kidney Function

8 human trials support this finding. Human clinical trial data available.

Improves (the measure goes up)Moderate effect16 studies

Studies that measured kidney function

and 6 more in the citations list

Immune Function

8 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes up)Moderate effect16 studies

Studies that measured immune function

and 6 more in the citations list

Blood Glucose Control

2 human trials and systematic reviews support this finding. Evidence includes systematic reviews/meta-analyses. Human clinical trial data available.

Improves (the measure goes down)Small effect10 studies

Studies that measured blood glucose control

Key findings

  • Long-term Efficacy and SafetyLupus NephritisImproves (the measure goes up)
  • Complete Renal ResponseLupus NephritisImproves (the measure goes up)
  • Response in High ProteinuriaLupus NephritisImproves (the measure goes up)

Safety notes in the studies

  • AURA-LV Phase 2: Higher adverse events including deaths in low-dose group (11.2% vs 2.3% high-dose vs 1.1% placebo) - led to dose selection refinement.

Studies cited

42 studies from PubMed

  1. Clinical adverse events to voclosporin: a real-world drug safety study based on the FDA Adverse Event Reporting System.Clinical and experimental rheumatology, 2026 · PMID 40737084
  2. Recent advances in immunosuppressive therapy for lupus nephritis.Immunological medicine, 2026 · PMID 41498488
  3. The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin.Frontiers in nephrology, 2025 · PMID 40166657
  4. Effect of Long-Term Voclosporin Treatment on Renal Histology in Patients With Active Lupus Nephritis With Repeat Renal Biopsies.Arthritis & rheumatology (Hoboken, N.J.), 2025 · PMID 40317902
  5. Voclosporin Nephrotoxicity: A Myth Debunked?Arthritis & rheumatology (Hoboken, N.J.), 2025 · PMID 40317997
  6. Voclosporin Overdose-Induced Peroxisomal Structural Changes and AKI Are Prevented by Renal Indole Detoxifier, INMT.Journal of the American Society of Nephrology : JASN, 2025 · PMID 40397512
  7. Post-marketing safety surveillance of voclosporin: an observational, pharmacovigilance study leveraging faers database study on the safety of voclosporin.Frontiers in pharmacology, 2025 · PMID 40458795
  8. Phase IV safety evaluation of voclosporin in lupus nephritis patients using the FAERS database for a 42-month period (2021 - 2024).International journal of clinical pharmacology and therapeutics, 2025 · PMID 40888213
  9. Calcineurin Inhibitors: Current Role, Toxicity Management, and Future Frontiers in Immunosuppression.Molecular neurobiology, 2025 · PMID 41361657
  10. Novel therapies in SLE treatment: A literature review.Advances in clinical and experimental medicine : official organ Wroclaw Medical University, 2025 · PMID 39817571
  11. Voclosporin: A comprehensive review of its role as a novel calcineurin inhibitor in the management of systemic lupus erythematosus.Medicine, 2025 · PMID 40550096
  12. Efficacy and safety of Belimumab, Rituximab and Voclosporin in the treatment of lupus nephritis based on registered clinical trials: A systematic review and network meta-analysis.Lupus, 2025 · PMID 40911722
  13. "A Change Is Gonna Come" to Treatment of Lupus Nephritis: A Review.American journal of kidney diseases : the official journal of the National Kidney Foundation, 2025 · PMID 41238160
  14. Safety and efficacy of long-term voclosporin treatment for lupus nephritis in the phase 3 AURORA 2 clinical trialArthritis Rheumatol, 2024 · PMID 37466424
  15. Efficacy of voclosporin in proliferative lupus nephritis with high levels of proteinuriaClin J Am Soc Nephrol, 2024 · PMID 38110196
  16. Calcineurin inhibitor effects on kidney electrolyte handling and blood pressure: tacrolimus versus voclosporin.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2024 · PMID 38777623
  17. Efficacy and safety of biologics, multitarget therapy, and standard therapy for lupus nephritis: a systematic review and network meta-analysis.Renal failure, 2024 · PMID 39212247
  18. The Role of Sodium-Glucose Co-Transporter-2 (SGLT-2) Inhibitors in Treating Lupus Nephritis: A Systematic Review.Cureus, 2024 · PMID 39835073
  19. Comparison of a voclosporin-based triple immunosuppressive therapy to high-dose glucocorticoid-based immunosuppressive therapy: a propensity analysis of the AURA-LV and AURORA 1 studies and ALMS.Lupus science & medicine, 2024 · PMID 39521453
  20. Systemic calcineurin inhibitors tacrolimus and voclosporin: A review of off-label dermatologic uses.Journal of the American Academy of Dermatology, 2024 · PMID 37307993
  21. Treatment With Voclosporin and Anifrolumab in a Patient With Lupus Nephritis and Refractory Discoid Lupus Erythematosus: A Case Report and Literature Review.Cureus, 2024 · PMID 38559540
  22. Systemic Lupus Erythematosus: A Review.JAMA, 2024 · PMID 38587826
  23. Management of systemic lupus erythematosus: a systematic literature review informing the 2023 update of the EULAR recommendations.Annals of the rheumatic diseases, 2024 · PMID 38777375
  24. Navigating Lupus Nephritis: A Comprehensive Review of the Current Treatment Trends.Cureus, 2024 · PMID 39610592
  25. Update on the efficacy and safety profile of voclosporin: an integrated analysis of clinical trials in lupus nephritisArthritis Care Res (Hoboken), 2023 · PMID 36039949
  26. Voclosporin and the Antiviral Effect Against SARS-CoV-2 in Immunocompromised Kidney Patients.Kidney international reports, 2023 · PMID 38106593
  27. A network meta-analysis of randomized controlled trials comparing the effectiveness and safety of voclosporin or tacrolimus plus mycophenolate mofetil as induction treatment for lupus nephritis.Zeitschrift fur Rheumatologie, 2023 · PMID 34545430
  28. Voclosporin: Unique Chemistry, Pharmacology and Toxicity Profile, and Possible Options for Implementation into the Management of Lupus Nephritis.Cells, 2023 · PMID 37887284
  29. Efficacy and safety of immunosuppressive agents for adults with lupus nephritis: a systematic review and network meta-analysis.Frontiers in immunology, 2023 · PMID 37901212
  30. Recent advances in immunotherapies for lupus nephritis.Pediatric nephrology (Berlin, Germany), 2023 · PMID 35778517
  31. The efficacy of immunosuppressive drugs induction therapy for lupus nephritis: a systematic review and network meta-analysis.Renal failure, 2023 · PMID 38087473
  32. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trialLancet, 2021 · PMID 33971155
  33. Voclosporin (Lupkynis) for lupus nephritisMed Lett Drugs Ther, 2021 · PMID 34544103
  34. Voclosporin: first approvalDrugs, 2021 · PMID 34676807
  35. Journal Club: Efficacy and Safety of Voclosporin Versus Placebo for Lupus Nephritis (AURORA 1): A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Phase 3 Trial.ACR open rheumatology, 2021 · PMID 34463434
  36. Transplantation and immunosuppression: a review of novel transplant-related immunosuppressant drugs.Immunopharmacology and immunotoxicology, 2021 · PMID 34415233
  37. Pharmacokinetic Disposition Difference Between Cyclosporine and Voclosporin Drives Their Distinct Efficacy and Safety Profiles in Clinical Studies.Clinical pharmacology : advances and applications, 2020 · PMID 32669879
  38. Differential Effects of Voclosporin and Tacrolimus on Insulin Secretion From Human Islets.Endocrinology, 2020 · PMID 32894758
  39. 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 nephritisKidney Int, 2019 · PMID 30420324
  40. An evaluation of voclosporin for the treatment of lupus nephritisExpert Opin Pharmacother, 2018 · PMID 30207816
  41. Population PKPD of voclosporin in renal allograft patients.Journal of clinical pharmacology, 2014 · PMID 24243422
  42. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment.Journal of clinical pharmacology, 2013 · PMID 23996158