LUPKYNIS (voclosporin)
Lupkynis helps adult patients with active lupus nephritis, a condition where lupus causes inflammation in the kidneys. It is used in combination with other immunosuppressive medications to manage the disease. This medication is specifically for adults, though it is not recommended for use alongside cyclophosphamide.
How LUPKYNIS Works
This drug works by inhibiting calcineurin, which prevents the activation of T-cells and the production of inflammatory cytokines. It also helps stabilize the internal structure of podocytes in the kidneys, which helps maintain the integrity of the glomeruli.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-01-22
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- CAPSULE
LUPKYNIS Approval History
What LUPKYNIS Treats
1 indicationsLUPKYNIS is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Lupus Nephritis
LUPKYNIS Boxed Warning
MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 , 5.2 )]. WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2...
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 , 5.2 )]. WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. Increased risk for developing serious infections and malignancies with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death. ( 5.1 , 5.2 )
LUPKYNIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LUPKYNIS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LUPKYNIS treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LUPKYNIS
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05962788 VOCAL-EXT | AUR-VCS-2020-04 | Ph 3 | terminated | Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis |
| NCT05288855 VOCAL | AUR-VCS-2020-03 | Ph 3 | terminated | Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis |
| NCT07225387 SYNERGY | NephroNet-24-009 | Ph 4 | recruiting | Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial |
| NCT05306873 DIVERT results posted | DAIT ALE10 | Ph 2 | terminated | Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus |
| NCT04701528 VOCOVID | NL73762.058.20 | Ph 2 | completed | Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients |
| NCT03021499 AURORA results posted | AUR-VCS-2016-01 | Ph 3 | completed | Aurinia Renal Response in Active Lupus With Voclosporin |
| NCT03597464 AURORA 2 results posted | AUR-VCS-2016-02 | Ph 3 | completed | Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin |
| NCT05306379 Statin-DDI | AUR-VCS-2021-02 | Ph 1 | completed | Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin |
| NCT03598036 AURONA™ results posted | AUR-VCS-2017-03 | Ph 2 | terminated | Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis |
| NCT02949973 AURION results posted | AUR-VCS-2014-01 | Ph 2 | completed | Aurinia Early Urinary Protein Reduction Predicts Response |
| NCT02949999 | AUR-VCS-2015-J01 | Ph 1 | completed | Voclosporin in Healthy Japanese Volunteers |
| NCT01586845 INSPIRE | ISA10-12 | Ph 3 | withdrawn | Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LUPKYNIS FDA Label Details
Indications & Usage
FDA Label (PDF)LUPKYNIS is indicated for the treatment of Lupus Nephritis.
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 , 5.2 )]. WARNING: MALIGNANCIES AND SERIOUS INFECTIONS See full presc...
LUPKYNIS Patents & Exclusivity
Patents (3 active)
Exclusivity
Pro Intelligence Preview
Deep insights for LUPKYNIS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 3 active patents
Trial Analysis
- • 12 total trials
- • Stage: Declining
Competitive Landscape
- • 2 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment