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lupkynis

Generic: voclosporin

lupkynis: developed by 1 company · 2 clinical trials tracked · 1 FDA decision.

lupkynis evidence translation

What we can confirm

1 FDA record · 2 tracked trials

What it means

Source-backed records connect lupkynis to AUPH; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could lupkynis → AUPH affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Lupus Nephritis

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
Aurinia Pharmaceuticals Inc. (AUPH)
Lupus Nephritis
Phase 4
Clinical Trials (2)

PRESERVE: A Multi-Center Phase 4 Study of the Efficacy and Safety of LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab at Inducing Rapid Renal Response in Patients With Lupus Nephritis

NCT07611214·Phase 4·AUPH
Recruiting

Primary endpoint: To assess the efficacy of LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response: Proportion of patients with complete renal response at 24 weeks

Interventionalopen150 targetStarted 2026-04Completion 2029-0327 sites · United StatesAurinia Pharmaceuticals Inc.

A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US

NCT05337124·AUPH
Completed

Primary endpoint: LUPKYNIS utilization patterns

Observational229 enrolledStarted 2022-04Completion 2025-011 site · United StatesAurinia Pharmaceuticals Inc.
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen [see Clinical Studies ( 14 )] for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation. LUPKYNIS is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive th(AUPH)FDA ↗
NDA213716Type 1 - New Molecular EntityPriorityOralCapsule

Frequently asked questions

Who is developing lupkynis?

lupkynis is being developed by Aurinia Pharmaceuticals Inc..

How many clinical trials involve lupkynis?

BioSniper tracks 2 clinical trials involving lupkynis.

What is lupkynis's latest FDA decision?

The most recent tracked FDA decision for lupkynis is Approval for 1 INDICATIONS AND USAGE LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen [see Clinical Studies ( 14 )] for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation. LUPKYNIS is a calcineurin-inhibitor immunosuppressant indicated in combination with a background immunosuppressive th, dated January 22, 2021.