NDAORALCAPSULEPriority Review
Approved
Jan 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
16
Data completeness
6/8 — Strong
Priority Review
LUPKYNIS (voclosporin) by Aurinia Pharmaceuticals is calcineurin inhibitors [moa]. First approved in 2021.
Drug data last refreshed 9h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUPKYNIS (voclosporin) is an oral calcineurin inhibitor immunosuppressant approved in January 2021 for lupus nephritis. It works by inhibiting calcineurin-dependent T-cell activation, reducing pathogenic immune responses in kidney disease. This represents the first FDA approval specifically for lupus nephritis in over a decade.
$0.020BPart D
Peak11.3 years to LOEProduct is in peak commercial phase with modest $20M spending on ~1,676 claims, suggesting a niche specialty indication with limited but established market penetration and stable team footprint.
Mechanism of Action
Calcineurin Inhibitors
Pharmacologic Class:
Calcineurin Inhibitor Immunosuppressant
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
Started Apr 2026
150 enrolled
Lupus Nephritis
LUPKYNIS Drug-use Results Survey
Started Sep 2025
400 enrolled
Lupus Nephritis
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
Started Mar 2024
4 enrolled
Adolescent Lupus NephritisPediatric Lupus Nephritis
Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
Started Oct 2023
9 enrolled
Adolescent Lupus NephritisPediatric Lupus Nephritis
A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US
Started Apr 2022
229 enrolled
Lupus Nephritis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.