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, HER2 Inhibitor, HER4 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
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: None
Company: Boehringer Ingelheim
Company Location: Europe
Company Founding Year: 1885
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, China, Czech Republic, Greece, Hungary, Israel, Italy, Japan, Netherlands, Poland, Portugal, Russia, Spain, United Kingdom, United States
Active Clinical Trial Count: 12
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Non-Small-Cell Lung Cancer
Phase 2: Abnormalities, Multiple|COVID-19|Chordoma|Head and Neck Cancer|Hodgkin Lymphoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Multiple Myeloma|Severe Acute Respiratory Syndrome|Squamous Cell Carcinoma|Vision, Low
Phase 1: Cholangiocarcinoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06302621 |
NCT06302621 | P1 |
Recruiting |
Cholangiocarcinoma |
2027-12-01 |
50% |
2025-09-05 |
Primary Endpoints |
NCT05070403 |
MCC-20731 | P2 |
Active, not recruiting |
Squamous Cell Carcinoma |
2027-02-01 |
43% |
2026-07-03 |
Primary Endpoints |
NCT03083678 |
NCT03083678 | P2 |
Completed |
Chordoma |
2025-01-31 |
2025-02-14 |
Primary Endpoints|Treatments|Trial Status |
|
NCT02979977 |
NCT02979977 | P2 |
Completed |
Head and Neck Cancer |
2025-01-18 |
2026-02-05 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
ACTRN12621000704897p |
2006-7041-83/hah | P2 |
Not yet recruiting |
Severe Acute Respiratory Syndrome|COVID-19 |
2022-06-27 |
|||
jRCT2061230111 |
jRCT2061230111 | P3 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2028-09-30 |
|||
NCT02925234 |
DRUP | P2 |
Recruiting |
Abnormalities, Multiple|Lymphoma, B-Cell|Vision, Low|Hodgkin Lymphoma|Multiple Myeloma|Lymphoma, Non-Hodgkin |
2027-09-01 |
2024-01-25 |
Primary Endpoints |
|
CTR20201697 |
CTR20201697 | P1 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
None |
2025-06-22 |
Treatments |
|
2025-522151-26-00 |
FURMO-006 | P3 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2030-12-31 |
|||
2017-000086-74 |
2017-000086-74 | P2 |
Completed |
Head and Neck Cancer|Squamous Cell Carcinoma |
2024-11-12 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2020-003025-37 |
combination | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
None |
2022-03-13 |
Treatments |
|
NCT01853826 |
NCT01853826 | P3 |
Completed |
Non-Small-Cell Lung Cancer |
2024-03-06 |
2025-04-12 |
Primary Completion Date|Primary Endpoints|Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
12/22/2025 |
News Article |
ArriVent Announces First Patient Dosed in Global Pivotal Phase 3 ALPACCA Trial Evaluating Firmonertinib for First-Line Treatment of EGFR PACC Mutant Non-Small Cell Lung Cancer |
|
09/30/2025 |
News Article |
YD Bio Limited Reports Unaudited Half Year 2025 Financial Results |
|
06/17/2025 |
News Article |
Lung Cancer Research Foundation Announces Request for Proposals Focused on Curing EGFR Mutant Lung Cancers |
|
06/10/2025 |
News Article |
Study Shows That Existing Drug Class May Help Patients with Skin Cancer That Resists Standard Treatments |