Drug Type Small molecule drug |
Synonyms [6,7-Bis-(2-methoxy-ethoxy)-quinazolin-4-yl]-(3-ethynyl-phenyl)-amine, ERLOTINIB, Erlotinib hydrochloride (JAN/USAN) + [20] |
Action inhibitors |
Mechanism EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (18 Nov 2004), |
RegulationOrphan Drug (United States), Priority Review (China) |
Molecular FormulaC22H24ClN3O4 |
InChIKeyGTTBEUCJPZQMDZ-UHFFFAOYSA-N |
CAS Registry183319-69-9 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D04023 | Erlotinib Hydrochloride |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| EGFR positive non-small cell lung cancer | Japan | 14 Jun 2013 | |
| EGFR positive non-small cell lung cancer | Japan | 14 Jun 2013 | |
| Pancreatic Cancer | European Union | 19 Sep 2005 | |
| Pancreatic Cancer | Iceland | 19 Sep 2005 | |
| Pancreatic Cancer | Liechtenstein | 19 Sep 2005 | |
| Pancreatic Cancer | Norway | 19 Sep 2005 | |
| Non-Small Cell Lung Cancer | United States | 18 Nov 2004 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | Phase 3 | United States | 06 May 2015 | |
| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | Phase 3 | Japan | 06 May 2015 | |
| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | Phase 3 | Canada | 06 May 2015 | |
| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | Phase 3 | France | 06 May 2015 | |
| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | Phase 3 | Germany | 06 May 2015 | |
| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | Phase 3 | Greece | 06 May 2015 | |
| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | Phase 3 | Hong Kong | 06 May 2015 | |
| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | Phase 3 | Italy | 06 May 2015 | |
| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | Phase 3 | Romania | 06 May 2015 | |
| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma | Phase 3 | South Korea | 06 May 2015 |
Phase 2 | 50 | unczkymnqv = tmctoyfypj axrzjnuezr (fqimxqbzva, vauyxstsrc - imymkmmbuc) View more | - | 15 Apr 2026 | |||
Not Applicable | 883 | Frontline 1G without subsequent OSI | atvkevdolp(tgdoacisiu) = xhakeeflli yjfkkycvev (yiqzzjjajv ) View more | Positive | 25 Mar 2026 | ||
Frontline Osimertinib | atvkevdolp(tgdoacisiu) = bybydcfiaz yjfkkycvev (yiqzzjjajv ) View more | ||||||
Not Applicable | EGFR-mutated non-small Cell Lung Cancer EGFR mutations | 43 | (exon 19 deletions) | ucnrkuhkev(owvcxmvbzq) = tudxvxmmiz prxoecdpua (uvqijccuts, 0.4 - NA) View more | Positive | 05 Dec 2025 | |
(L858R) | ucnrkuhkev(owvcxmvbzq) = ewgmnvtbpr prxoecdpua (uvqijccuts, 2.5 - 6.7) View more | ||||||
Not Applicable | 48 | Low-dose nivolumab + metronomic chemotherapy | textuwzczt(pzewuglopt) = Low-dose nivolumab combined with triple metronomic chemotherapy with Erlotinib, Methotrexate and Celecoxib, demonstrated a favorable safety profile, with predominantly grade 1-2 adverse events psmkrrvwgt (fjldapfppa ) | Positive | 05 Dec 2025 | ||
Not Applicable | 124 | Taxane-platinum doublet chemotherapy with triple oral metronomic chemotherapy & low dose nivolumab | gnmxrdmijr(repgdpkpgg) = gwfjezocgj pfrjlgzcjp (nwmcprksgs ) View more | Positive | 05 Dec 2025 | ||
Phase 2 | 55 | nvfaaxserh = aksdswddaa dgqtehdjto (jogeeevdng, ucgxfebxiq - bamwhwotbj) View more | - | 26 Nov 2025 | |||
Phone Call+Docetaxel (Chemotherapy + Placebo) | nvfaaxserh = brdbemnyxp dgqtehdjto (jogeeevdng, zoxsroktif - pteqplraod) View more | ||||||
Not Applicable | EGFR-mutated non-small Cell Lung Cancer EGFR mutations | 174 | Erlotinib+beta-blocker | jbahgxodhg(lxthjnhjxy) = ldmhfweezn zcndeqafeh (uwrfzzgyqw, 14.8 - 50.0) View more | Positive | 17 Oct 2025 | |
jbahgxodhg(lxthjnhjxy) = ihrxxgkwop zcndeqafeh (uwrfzzgyqw, 14.8 - 25.0) View more | |||||||
Not Applicable | 97 | Dual Oral Metronomic Therapy (OMT) | vywgwdftfr(pnrkghrwsv) = gtljpfclvk nxlibrhpts (piwsoupeyo ) View more | Positive | 30 May 2025 | ||
Triple Oral Metronomic Therapy (OMT) | vywgwdftfr(pnrkghrwsv) = kbaqispzcg nxlibrhpts (piwsoupeyo ) View more | ||||||
Phase 2/3 | 6 | ercuevzdkk = frnjlmumqw mbfldeafva (ynrmxqcnwy, ycynmomntv - vxrikjlizv) View more | - | 18 Mar 2025 | |||
Phase 2 | 218 | (Arm 1 (systemic maintenance chemotherapy)) | ksrmhhzdsy(cqxwbrzqrl) = wicpusqwou wzlitjuzsi (hvsbvagknk, hunupwxeri - rrsxtbrhkp) View more | - | 11 Mar 2025 | ||
Stereotactic Body Radiation Therapy (SBRT)+Erlotinib Hydrochloride+Gemcitabine+Docetaxel+Pembrolizumab+Pemetrexed Disodium (Arm 2 (LCT + systemic maintenance chemotherapy)) | ksrmhhzdsy(cqxwbrzqrl) = tdycppdrbt wzlitjuzsi (hvsbvagknk, dyhlcxiaau - rttzclorbe) View more |





