Wednesday, July 8, 2026

Drug profile · INN

voclosporin

voclosporin (LUVENIQ) is a serine/threonine protein phosphatase 2b catalytic subunit, alpha isoform inhibitor. Associated with Aurinia Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved Antineoplastic and immunomodulating agents (L04) L04AD03
US status approved
Patents linked 3
Pipeline programs 12
News articles 0
Drug details — voclosporin
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
ORAL
Patents
3
Programs
12
Data quality
0.89

Quick answer

voclosporin (LUVENIQ) is a serine/threonine protein phosphatase 2b catalytic subunit, alpha isoform inhibitor. Associated with Aurinia Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN voclosporin
Brand LUVENIQ
Mechanism Serine/threonine protein phosphatase 2B catalytic subunit, alpha isoform inhibitor
Target Protein phosphatase 3 catalytic subunit alpha
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route ORAL
Formulation CAPSULE
ATC code L04AD03

Mechanism of action

Serine/threonine protein phosphatase 2B catalytic subunit, alpha isoform inhibitor

Primary target: Protein phosphatase 3 catalytic subunit alpha

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved

Pipeline programs

  1. 0.05% Voclosporin Ophthalmic Solution (VOS) Phase 3 · Aurinia Pharmaceuticals · Dry Eye Syndrome
  2. Voclosporin Phase 3 · Aurinia Pharmaceuticals · Lupus Nephritis
  3. Voclosporin Phase 3 · Aurinia Pharmaceuticals · Adolescent Lupus Nephritis
  4. voclosporin Phase 3 · Aurinia Pharmaceuticals · Psoriasis
  5. voclosporin Phase 3 · Aurinia Pharmaceuticals · Renal Transplantation
  6. CYTB323J12201 Phase 2 · Novartis India · Active, refractory systemic lupus erythematosus (SLE), and
  7. Voclosporin Phase 2 · Aurinia Pharmaceuticals · Covid19
  8. Voclosporin Phase 2 · Aurinia Pharmaceuticals · Focal Segmental Glomerulosclerosis

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 11622991

    Protocol for treatment of lupus nephritis

    Expires Mon Apr 06 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 10286036

    Protocol for treatment of lupus nephritis

    Expires Mon May 09 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 7332472

    Cyclosporine analogue mixtures and their use as immunomodulating agents

    Expires Mon Feb 14 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is voclosporin?

voclosporin (LUVENIQ) is a serine/threonine protein phosphatase 2b catalytic subunit, alpha isoform inhibitor. Associated with Aurinia Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for voclosporin?

LUVENIQ is a marketed brand name for voclosporin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of voclosporin?

voclosporin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.