Wednesday, July 8, 2026

Drug profile · INN

belimumab

belimumab (BENLYSTA) is a tumor necrosis factor ligand superfamily member 13b inhibitor. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved PMDA: approved Antineoplastic and immunomodulating agents (L04) L04AG04
US status approved
Patents linked 0
Pipeline programs 9
News articles 0
Drug details — belimumab
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
INJECTION
Patents
0
Programs
9
Data quality
0.84

Quick answer

belimumab (BENLYSTA) is a tumor necrosis factor ligand superfamily member 13b inhibitor. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN belimumab
Brand BENLYSTA
Mechanism Tumor necrosis factor ligand superfamily member 13B inhibitor
Target Tumor necrosis factor ligand superfamily member 13B
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route INJECTION
Formulation INJECTABLE
ATC code L04AG04

Mechanism of action

Tumor necrosis factor ligand superfamily member 13B inhibitor

Primary target: Tumor necrosis factor ligand superfamily member 13B

Approval history

Authority Status Date
FDA approved
EMA approved
PMDA approved

Pipeline programs

  1. 218224 Phase 3 · GSK Glaxo Smith · systemic sclerosis associated interstitial lung disease
  2. 221672 Phase 3 · GSK Glaxo Smith · Lung Diseases, Interstitial
  3. APHP201098 Phase 3 · PARItec · Adult patients with persistent or chronic immune thrombocyto
  4. Benlysta 200 mg solution for injection in pre-filled pen. Phase 3 · GSK Glaxo Smith · connective tissue diseases
  5. 114055 Phase 2 · GSK Glaxo Smith · Systemic Lupus Erythematosus
  6. 200908 Phase 2 · GSK Glaxo Smith · Systemic Lupus Erythematosus
  7. APHP180351 Phase 2 · PARItec · Cryoglobulinemia vasculitis
  8. CYTB323J12201 Phase 2 · Novartis India · Active, refractory systemic lupus erythematosus (SLE), and

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)

Frequently asked questions

What is belimumab?

belimumab (BENLYSTA) is a tumor necrosis factor ligand superfamily member 13b inhibitor. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for belimumab?

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

What is the US approval status of belimumab?

belimumab 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.