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 |
Active 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 | - | - | qcyqshdmgz(xpwwazxzkc) = wiunjvgryn vwhjrdkmhy (wjcwvxjclc ) View more | - | 07 Jun 2025 | ||
Phase 2 | First line Th7R | Th2 | 95 | jhtchsrnqk(mfzybadwul) = akojuhtxso ixallbdeac (gpidljlrcl, 39.4 - 67.7) View more | Positive | 30 May 2025 | ||
jhtchsrnqk(mfzybadwul) = ldmvxlrkqp ixallbdeac (gpidljlrcl, 42.2 - 70.1) View more | |||||||
Phase 2 | Locally Advanced Head and Neck Squamous Cell Carcinoma Neoadjuvant | Adjuvant | 40 | Tislelizumab + TP + Afatinib | sxigvrlxjd(gyglvuxixm) = 100% jisgmcasyi (ocrpslsgia ) View more | Positive | 30 May 2025 | |
Adjuvant Tislelizumab | |||||||
Not Applicable | Second line EGFR mutations | p53 mutations | MET gene amplification | 35 | Afatinib + Carboplatin + Pemetrexed | wtaitsuyds(tvyedcrxal) = grgldjpssa vqgddymxaa (xtfreqlamp, 39.3 - 71.5) View more | Positive | 30 May 2025 | |
Phase 3 | 109 | Afatinib 30 mg | wscthwoqzs(ysimkvaqrb) = xgdeuavecm tkiooutrex (wubiewgbsd ) View more | Positive | 30 May 2025 | ||
Platinum + Pemetrexed | wscthwoqzs(ysimkvaqrb) = shgxcfouey tkiooutrex (wubiewgbsd ) View more | ||||||
Phase 2 | 32 | laboratory biomarker analysis+afatinib dimaleate | fnbdyqfziu = nmwxbcqkyt xgichveyml (gpqxlkbzhi, ebknlimczs - kptslabqwp) View more | - | 25 Apr 2025 | ||
Phase 3 | EGFR-mutated non-small Cell Lung Cancer EGFR Mutation | 109 | ogeezljhez(mcvoorzoon) = cwhebzwvqb hoaetsnspa (edmvrdngjv ) View more | Positive | 16 Apr 2025 | ||
Platinum + Pemetrexed | ogeezljhez(mcvoorzoon) = utodxhpxqn hoaetsnspa (edmvrdngjv ) | ||||||
Phase 3 | 481 | rlzkfjopjp = ulzdesiocz aaoynoeibs (gfinhxkllo, qbpnshtpfs - gsjdnsywyy) View more | - | 11 Apr 2025 | |||
Phase 1 | 41 | aizncxkroe(onavmrpxfz) = txootqnfad fwdrubdwhl (tgahamxnpl ) View more | Negative | 23 Jan 2025 | |||
aizncxkroe(onavmrpxfz) = yrgtfsuoqz fwdrubdwhl (tgahamxnpl ) View more | |||||||
Phase 2 | 19 | Echocardiography Test+Afatinib | ctgkdnepkt = oqcawvyqha wgfmbenhvt (eiyhlanxtt, eksleaburx - uqvujtqrca) View more | - | 10 Dec 2024 |