Wednesday, July 8, 2026

Drug profile · INN

afatinib dimaleate

afatinib dimaleate (GILOTRIF) is a epidermal growth factor receptor erbb1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 0
News articles 0
Drug details — afatinib dimaleate
US status
approved
Class
Route
ORAL
Patents
0
Programs
0
Data quality
0.84

Quick answer

afatinib dimaleate (GILOTRIF) is a epidermal growth factor receptor erbb1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN afatinib dimaleate
Brand GILOTRIF
Mechanism Epidermal growth factor receptor erbB1 inhibitor
Target Epidermal growth factor receptor
Route ORAL
Formulation TABLET

Mechanism of action

Epidermal growth factor receptor erbB1 inhibitor

Primary target: Epidermal growth factor receptor

Approval history

Authority Status Date
FDA approved

Related & competitor drugs

  1. erlotinib hydrochloride Epidermal growth factor receptor erbB1 inhibitor
  2. lapatinib ditosylate Receptor protein-tyrosine kinase erbB-2 inhibitor
  3. mobocertinib Antineoplastic and immunomodulating agents (L01)
  4. mobocertinib succinate Epidermal growth factor receptor erbB1 inhibitor
  5. neratinib maleate Receptor protein-tyrosine kinase erbB-2 inhibitor
  6. amivantamab-vmjw Epidermal growth factor receptor erbB1 inhibitor

Frequently asked questions

What is afatinib dimaleate?

afatinib dimaleate (GILOTRIF) is a epidermal growth factor receptor erbb1 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for afatinib dimaleate?

GILOTRIF is a marketed brand name for afatinib dimaleate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of afatinib dimaleate?

afatinib dimaleate 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.