Wednesday, July 8, 2026

Drug profile · INN

cetuximab

cetuximab (ERBITUX) is a epidermal growth factor receptor erbb1 inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01FE01
US status approved
Patents linked 0
Pipeline programs 46
News articles 0
Drug details — cetuximab
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INTRAVENOUS
Patents
0
Programs
46
Data quality
0.84

Quick answer

cetuximab (ERBITUX) is a epidermal growth factor receptor erbb1 inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN cetuximab
Brand ERBITUX
Mechanism Epidermal growth factor receptor erbB1 inhibitor
Target Epidermal growth factor receptor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INTRAVENOUS
Formulation VIAL
ATC code L01FE01

Mechanism of action

Epidermal growth factor receptor erbB1 inhibitor

Primary target: Epidermal growth factor receptor

Approval history

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

Pipeline programs

  1. 61186372COR3001 Phase 3 · Janssen-Cilag International N.V · KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left
  2. 61186372COR3002 Phase 3 · Janssen-Cilag International N.V · KRAS/NRAS and BRAF Wildtype Recurrent, Unresectable or Metas
  3. AV-299-23-301 Phase 3 · Anaxis Pharma · Head and Neck Squamous Cell Carcinoma (HNSCC)
  4. C4221015 Phase 3 · First Biotech (Australia) · Colorectal cancer (BRAF V600E-mutant mCRC)
  5. CETUXIMAB Phase 3 · Disc Medicine · oral squamous cell carcinoma
  6. Cetuximab Phase 3 · Amgen · Metastatic Colorectal Cancer
  7. D7310C00001 Phase 3 · AstraZeneca · Patients With Recurrent or Metastatic Squamous Cell Carcinom
  8. MK-1084-012 Phase 3 · MSD Merck Sharp · KRAS G12C-mutant, Locally Advanced Unresectable or Metastati

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 cetuximab?

cetuximab (ERBITUX) is a epidermal growth factor receptor erbb1 inhibitor. Associated with Merck KGaA, Darmstadt, Germany. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for cetuximab?

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

What is the US approval status of cetuximab?

cetuximab 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.