Voclosporin (Lupkynis)

Peptide

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.

Quick Answer

What it is

Voclosporin is a novel cyclic peptide calcineurin inhibitor for lupus nephritis. FDA-approved January 2021.

Key findings

Grade A: Complete Renal Response (Lupus Nephritis)
Grade A: Response in High Proteinuria (Lupus Nephritis)
Grade A: Long-term Efficacy and Safety (Lupus Nephritis)

Safety

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.

⚠️ Research Notice

This peptide information is for educational and research purposes only. Peptides may not be FDA-approved for human use and may only be legally available for research purposes. Consult qualified healthcare professionals before considering any peptide compounds.

ℹ️ Quick Facts: Voclosporin (Lupkynis)

Quick Facts: Voclosporin (Lupkynis)

Best Evidence:Grade A
Conditions Studied:1
Research Outcomes:9
Grade A Findings:5
Grade B Findings:3
Key Effect:Lupus Nephritis

1 conditions · 9 outcomes

Detailed Outcomes

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.

large↑Improves

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.

large↑Improves

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.

moderate↓Worsens

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.

moderate↑Worsens

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.

moderate↑Worsens