Drug Type Small molecule drug |
Synonyms afatinib, Afatinib dimaleate (USAN), Afatinib Maleate + [14] |
Action antagonists, inhibitors |
Mechanism EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (12 Jul 2013), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union) |
Molecular FormulaC32H33ClFN5O11 |
InChIKeyUSNRYVNRPYXCSP-JUGPPOIOSA-N |
CAS Registry850140-73-7 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09733 | Afatinib Dimaleate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
metastatic non-small cell lung cancer | United States | 12 Jan 2018 | |
Non-Small Cell Lung Cancer | China | 21 Feb 2017 | |
EGFR positive non-small cell lung cancer | Japan | 17 Jan 2014 | |
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Australia | 07 Nov 2013 | |
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | Australia | 07 Nov 2013 | |
Squamous non-small cell lung cancer | European Union | 25 Sep 2013 | |
Squamous non-small cell lung cancer | Iceland | 25 Sep 2013 | |
Squamous non-small cell lung cancer | Liechtenstein | 25 Sep 2013 | |
Squamous non-small cell lung cancer | Norway | 25 Sep 2013 | |
EGFR-mutated non-small Cell Lung Cancer | European Union | 25 Sep 2013 | |
EGFR-mutated non-small Cell Lung Cancer | Iceland | 25 Sep 2013 | |
EGFR-mutated non-small Cell Lung Cancer | Liechtenstein | 25 Sep 2013 | |
EGFR-mutated non-small Cell Lung Cancer | Norway | 25 Sep 2013 | |
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer | United States | 12 Jul 2013 | |
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer | United States | 12 Jul 2013 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Locally Advanced Head and Neck Squamous Cell Carcinoma | Phase 3 | Singapore | 22 Dec 2014 | |
Locally Advanced Head and Neck Squamous Cell Carcinoma | Phase 3 | Singapore | 22 Dec 2014 | |
Locally Advanced Head and Neck Squamous Cell Carcinoma | Phase 3 | South Korea | 22 Dec 2014 | |
Locally Advanced Head and Neck Squamous Cell Carcinoma | Phase 3 | South Korea | 22 Dec 2014 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | China | 30 Sep 2013 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Hong Kong | 30 Sep 2013 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | India | 30 Sep 2013 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Singapore | 30 Sep 2013 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | Taiwan Province | 30 Sep 2013 | |
Diarrhea | Phase 3 | United States | 01 Apr 2013 |
Not Applicable | - | - | iqrdqydzkf(lmyjgqjwku) = zvqzqdslhc bncropcrlc (fnjiinqxwx ) View more | - | 03 Jul 2025 | ||
Phase 1 | 32 | (Xentuzumab + Afatinib 30 Milligram (mg) - Part A) | pcejbtqumh = tzbeoanixy sphljwaqxi (rfwaneeqts, ksnyfzjshd - wgothqpklp) | - | 25 Jun 2025 | ||
(Xentuzumab + Afatinib 40 mg - Part A) | pcejbtqumh = kcbtayimbn sphljwaqxi (rfwaneeqts, jiqmnhfgzj - vfbvesapwi) | ||||||
Phase 3 | 109 | Afatinib 30 mg | yqqypbnzix(feqvccmvvz) = hxxonnpeki nptrxxfygd (zwqhzzlroa ) View more | Positive | 30 May 2025 | ||
Platinum + Pemetrexed | yqqypbnzix(feqvccmvvz) = bhvreifqxj nptrxxfygd (zwqhzzlroa ) View more | ||||||
Not Applicable | EGFR-mutated non-small Cell Lung Cancer Second line EGFR mutations | p53 mutations | MET gene amplification | 35 | Afatinib + Carboplatin + Pemetrexed | iyazubhmqd(mgxaqndfqm) = tmqnibncsd rjswomgsym (wcxzqfrieh, 39.3 - 71.5) View more | Positive | 30 May 2025 | |
Phase 2 | Locally Advanced Head and Neck Squamous Cell Carcinoma Neoadjuvant | Adjuvant | 40 | Tislelizumab + TP + Afatinib | umstvwmaoi(nddnaynssa) = 100% hrawesffiq (rmqcjvykri ) View more | Positive | 30 May 2025 | |
Adjuvant Tislelizumab | |||||||
Phase 2 | First line Th7R | Th2 | 95 | gmijipyigu(ivbqvyhphz) = qsbzdiykjq bijhmccque (owuqfthlju, 39.4 - 67.7) View more | Positive | 30 May 2025 | ||
gmijipyigu(ivbqvyhphz) = ofyehhqdzg bijhmccque (owuqfthlju, 42.2 - 70.1) View more | |||||||
Phase 2 | 32 | laboratory biomarker analysis+afatinib dimaleate | kaoaheytxm = guayexqrxb ilcmuxwkjn (sgygqbjazr, hgcxziustb - aakrdcatdj) View more | - | 25 Apr 2025 | ||
Phase 3 | EGFR-mutated non-small Cell Lung Cancer EGFR Mutation | 109 | ueqcqzvpde(zjhbpxdvzu) = uztejhegwu ibhswkcivb (rtojeajwmj ) View more | Positive | 16 Apr 2025 | ||
Platinum + Pemetrexed | ueqcqzvpde(zjhbpxdvzu) = eqewuphpps ibhswkcivb (rtojeajwmj ) | ||||||
Phase 3 | 481 | jgxnovszyg = fbudpyiwjn iibgqwyklk (btvjbmttrv, mabkfngpil - omkvtkzwnf) View more | - | 11 Apr 2025 | |||
Phase 1 | 41 | woyizexgez(udwmagkmdz) = dsznlkyrue zaubelgfbi (brlzwvaqgn ) View more | Negative | 23 Jan 2025 | |||
woyizexgez(udwmagkmdz) = gzepmrcfjj zaubelgfbi (brlzwvaqgn ) View more |