Product Description
Afatinib is an orally bioavailable anilino-quinazoline derivative and inhibitor of the receptor tyrosine kinase (RTK) epidermal growth factor receptor (ErbB; EGFR) family, with antineoplastic activity. Upon administration, afatinib selectively and irreversibly binds to and inhibits the epidermal growth factor receptors 1 (ErbB1; EGFR), 2 (ErbB2; HER2), and 4 (ErbB4; HER4), and certain EGFR mutants, including those caused by EGFR exon 19 deletion mutations or exon 21 (L858R) mutations. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Afatinib)
Mechanisms of Action: EGFR Inhibitor,ERBB2 Inhibitor,ERBB4 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Lung Cancer | Non-Small-Cell Lung Cancer | Oncology Solid Tumor Unspecified | Oncology Unspecified
Known Adverse Events: Dermatitis | Stomatitis | Pruritus | Paronychia | Diarrhea
Company: Boehringer Ingelheim
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Canada, China, Germany, Japan, Netherlands, United Kingdom, United States
Active Clinical Trial Count: 14
Highest Development Phases
Phase 3: Non-Small-Cell Lung Cancer
Phase 2: COVID-19|Chordoma|Esophageal Cancer|Gastrointestinal Cancer|Head and Neck Cancer|Lung Cancer|Mucinous Adenocarcinoma|Pancreatic Cancer|Severe Acute Respiratory Syndrome|Signet Ring Cell Carcinoma|Squamous Cell Carcinoma
Phase 1: Cholangiocarcinoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2061230111 | P3 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2028-09-30 |
|
| MCC-20731 | P2 |
Recruiting |
Squamous Cell Carcinoma |
2025-10-01 |
|
| KY2019-610 | P2 |
Not yet recruiting |
Chordoma |
2025-06-30 |
|
| NCT06302621 | P1 |
Recruiting |
Cholangiocarcinoma |
2024-12-01 |