NDAORALCAPSULEPriority Review
Approved
Jan 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
15
Data completeness
7/8 — Comprehensive
Priority Review
LUPKYNIS (voclosporin) by Aurinia Pharmaceuticals is calcineurin inhibitors [moa]. Approved for lupus nephritis. First approved in 2021.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUPKYNIS (voclosporin) is an oral calcineurin inhibitor immunosuppressant approved by the FDA on January 22, 2021, for the treatment of lupus nephritis. As a selective calcineurin inhibitor, it works by suppressing T-cell activation and cytokine production to reduce kidney inflammation in lupus patients. The drug represents an important addition to the lupus nephritis treatment arsenal, offering an oral alternative to intravenous immunosuppressive therapies historically used in this indication.
$0.0BPart D
11.6 years to LOEMechanism of Action
Calcineurin Inhibitors
Pharmacologic Class:
Calcineurin Inhibitor Immunosuppressant
Indications (1)
Clinical Trials (15)
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
Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin
Started Jan 2022
24 enrolled
Drug-drug Interaction
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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.