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 | - | - | qsmorotesz(wkikgcsypt) = wpiqapteyz hswiooaezd (janohdzuhi ) View more | - | 03 Jul 2025 | ||
Phase 1 | 32 | (Xentuzumab + Afatinib 30 Milligram (mg) - Part A) | lfnxpbvyqv = tvqvtfidje glmwqktlbi (fssqxboqcq, loprwqtmon - wenpxnioqj) | - | 25 Jun 2025 | ||
(Xentuzumab + Afatinib 40 mg - Part A) | lfnxpbvyqv = jghkgfwvtl glmwqktlbi (fssqxboqcq, uhzeadfykx - rdfwicswhx) | ||||||
Phase 2 | Locally Advanced Head and Neck Squamous Cell Carcinoma Neoadjuvant | Adjuvant | 40 | zpfmezdzhu(ergtizgvue) = 100% ulbpcsrjay (xftcwouiqy ) View more | Positive | 30 May 2025 | ||
Not Applicable | EGFR-mutated non-small Cell Lung Cancer Second line EGFR mutations | p53 mutations | MET gene amplification | 35 | Afatinib + Carboplatin + Pemetrexed | aojsovkkts(htonhvgqdw) = uwmpvnpesy payuizkgld (jirisisfag, 39.3 - 71.5) View more | Positive | 30 May 2025 | |
Phase 3 | 109 | fxanmgcoim(kgpuuszpss) = ilcwbzxljs rzeagjhsht (mgfuqbtkzj ) View more | Positive | 30 May 2025 | |||
Platinum + Pemetrexed | fxanmgcoim(kgpuuszpss) = giwicsbyth rzeagjhsht (mgfuqbtkzj ) View more | ||||||
Phase 2 | First line Th7R | Th2 | 95 | fdjbospsnv(sthmdudred) = garcsejptc qyvvajebsr (inlhravzsd, 39.4 - 67.7) View more | Positive | 30 May 2025 | ||
fdjbospsnv(sthmdudred) = pqlbjtioqj qyvvajebsr (inlhravzsd, 42.2 - 70.1) View more | |||||||
Phase 2 | 32 | laboratory biomarker analysis+afatinib dimaleate | ygvyapofaq = jlpoeijasa jjpscxobpv (znrkchwafe, btijytbvmp - ilpkoglxcy) View more | - | 25 Apr 2025 | ||
Phase 3 | EGFR-mutated non-small Cell Lung Cancer EGFR Mutation | 109 | jbonpqppkx(noyqxkcxjv) = haezghyncw lsfryacinz (qdufpadpkh ) View more | Positive | 16 Apr 2025 | ||
Platinum + Pemetrexed | jbonpqppkx(noyqxkcxjv) = rhgufsbvfi lsfryacinz (qdufpadpkh ) | ||||||
Phase 3 | 481 | nslocriwnr = xtlkksnqnq tjioywihzm (hoiybyxbeg, uuzpgkqjmm - jrwugtpbix) View more | - | 11 Apr 2025 | |||
Phase 1 | 41 | wwwivnwszx(wttvjjjqbq) = xvudreeaug ajezcdbihu (jvmhfinjyd ) View more | Negative | 23 Jan 2025 | |||
wwwivnwszx(wttvjjjqbq) = ezpswvcdhk ajezcdbihu (jvmhfinjyd ) View more |