Wednesday, July 8, 2026

Drug profile · INN

golimumab

golimumab (SIMPONI) is a tnf-alpha inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L04) L04AB06
US status approved
Patents linked 0
Pipeline programs 6
News articles 1
Drug details — golimumab
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
INJECTION
Patents
0
Programs
6
Data quality
0.84

Quick answer

golimumab (SIMPONI) is a tnf-alpha inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN golimumab
Brand SIMPONI
Mechanism TNF-alpha inhibitor
Target Tumor necrosis factor
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Route INJECTION
Formulation INJECTABLE
ATC code L04AB06

Mechanism of action

TNF-alpha inhibitor

Primary target: Tumor necrosis factor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Recent coverage

Pipeline programs

  1. CNTO148UCO3003 Phase 3 · Janssen-Cilag Pty · Ulcerative Colitis
  2. Golimumab 1 mg per kg Phase 3 · Janssen Cilag International · Colitis, Ulcerative
  3. 78934804CRD2001 Phase 2 · Janssen-Cilag International N.V · Moderately to Severely Active Crohn's Disease
  4. 78934804UCO2001 Phase 2 · Janssen-Cilag International N.V · Moderately to Severely Active Ulcerative Colitis
  5. PRIMERA001 Approved · Disc Medicine · Rheumatoid arthritis according to 2010 criteria
  6. Re-JIA Approved · Istituto Gentili Italia · Juvenile idiopathic arthritis

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. adalimumab-aqvh TNF-alpha inhibitor
  3. anagrelide Antineoplastic and immunomodulating agents (L01)
  4. apremilast Antineoplastic and immunomodulating agents (L04)
  5. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  6. axitinib Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is golimumab?

golimumab (SIMPONI) is a tnf-alpha inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for golimumab?

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

What is the US approval status of golimumab?

golimumab 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.