Wednesday, July 8, 2026

Drug profile · INN

infliximab

infliximab (INFLECTRA) is a tnf-alpha inhibitor. Associated with Pfizer Australia Pty Ltd. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L04) L04AB02
US status approved
Patents linked 0
Pipeline programs 63
News articles 1
Drug details — infliximab
US status
approved
Class
Antineoplastic and immunomodulating agents (L04)
Route
Patents
0
Programs
63
Data quality
0.83

Quick answer

infliximab (INFLECTRA) is a tnf-alpha inhibitor. Associated with Pfizer Australia Pty Ltd. Current US regulatory status: approved.

Key facts

INN infliximab
Brand INFLECTRA
Mechanism TNF-alpha inhibitor
Target Tumor necrosis factor
Therapeutic class Antineoplastic and immunomodulating agents (L04)
Formulation VIAL
ATC code L04AB02

Mechanism of action

TNF-alpha inhibitor

Primary target: Tumor necrosis factor

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Recent coverage

Pipeline programs

  1. 20200041 Phase 3 · Amgen · Extensive stage small cell lung cancer (ES-SCLC)
  2. 20240178 Phase 3 · Amgen · Extensive stage small cell lung cancer (ES-SCLC).
  3. ABP 206 Phase 3 · Amgen · Melanoma
  4. CT-P13 3.11 Phase 3 · Celltrion Healthcare Australia · Rheumatoid arthritis
  5. D419JC00001(POTOMAC) Phase 3 · AstraZeneca · Non-muscle invasive bladder cancer
  6. D5086C00001 Phase 3 · AstraZeneca · MET-driven, unresectable and locally advanced or metastatic
  7. D533BC00001 Phase 3 · AstraZeneca · Advanced or Metastatic Non-Small Cell Lung Cancer
  8. D6185C00001 Phase 3 · AstraZeneca · Patients with non-small cell lung cancer (NSCLC).

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 infliximab?

infliximab (INFLECTRA) is a tnf-alpha inhibitor. Associated with Pfizer Australia Pty Ltd. Current US regulatory status: approved.

What is the brand name for infliximab?

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

What is the US approval status of infliximab?

infliximab 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.