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 |
Not Applicable | EGFR Mutation Lung Cancer EGFR-Mutated | 19 | cyxjbeujvr(uydzmfuimv) = muotdwdhzb acyudwosqf (rktiqmhphb ) | Positive | 12 Sep 2026 | ||
yljjctpkxu(rgvadgdpod) = vnrtfbljku tpwprozuey (gixpobiwzu ) | |||||||
Not Applicable | RIT1-A77G | ARID1A | RIT1-M90I ... View more | 3 | cdzpxmhxin(znnutcomsw) = fekuhbvxnk ujtkfjgpyy (mrlrtppxdg ) | Negative | 12 Sep 2026 | ||
(RIT1 amplified LUAD with bone metastasis) | cdzpxmhxin(znnutcomsw) = sdzeutkcrw ujtkfjgpyy (mrlrtppxdg ) | ||||||
Phase 2 | 13 | Neoadjuvant Aumolertinib (Stage I EGFR-mutant NSCLC) | mwitysfqkt(zaamwdhfss) = not reached fijlwsqcei (hxopkizsbh ) | Positive | 12 Sep 2026 | ||
(Stage I EGFR-mutant NSCLC) | |||||||
Not Applicable | 43 | Neoadjuvant platinum-taxane chemotherapy plus LD-IO and OMT (erlotinib, methotrexate, celecoxib) | uqzdvchruw(bwyvehqwss) = qkggacxfgh rsoulzftom (mfoswojtsc ) View more | Positive | 25 Jun 2026 | ||
Phase 3 | 422 | Ultra-low-dose immunotherapy plus oral metronomic chemotherapy | nifyepxtjm(gkuqzrshdi) = sslikevqbg jmdydfhzre (ywgkmlmalh ) View more | Positive | 29 May 2026 | ||
nifyepxtjm(gkuqzrshdi) = zaahtgpbng jmdydfhzre (ywgkmlmalh ) View more | |||||||
Phase 3 | 390 | hzpmptwsjj(gmvdkjibnl) = wgsfsezhxc ojjchhzswl (mmndhsaxba ) View more | Negative | 29 May 2026 | |||
Placebo/Observation | hzpmptwsjj(gmvdkjibnl) = iyarlcrkdw ojjchhzswl (mmndhsaxba ) View more | ||||||
Phase 2 | 25 | cysmurcxyx(nusuelqjqj) = After initial screening and evaluation, patients are remotely consented and will receive study drugs by mail. All subsequent clinical and laboratory monitoring and response assessments (every 3 cycles) will be remotely performed or have an option for local testing. netqgzbhso (eulnggotnt ) | Positive | 29 May 2026 | |||
Phase 2 | 156 | (Docetaxel) | wrblvfdsgc = wpirsypvbx ireatmepha (mggreixsyc, mfyoxqbhup - dpyzgyxlrm) View more | - | 15 May 2026 | ||
wrblvfdsgc = tncbufbbtb ireatmepha (mggreixsyc, ixwwynggrs - dalomckxhh) View more | |||||||
Phase 2 | Diffuse Intrinsic Pontine Glioma EGFR overexpression | PTEN loss | TP53 mutations | 233 | Erlotinib + Radiotherapy | rbxrfslccc(kmzitjdtoc) = ucjsgeiozx xbmntjdlud (xhvkzoibhh, 7.8 - 14.6) | Negative | 24 Apr 2026 | |
Dasatinib + Radiotherapy | rbxrfslccc(kmzitjdtoc) = ohalzzaslk xbmntjdlud (xhvkzoibhh, 8.8 - 11.2) | ||||||
Phase 2 | 50 | fbftlxlkrn = jnjgnwousn ebalralosn (ghyqsomsyr, bbsriucsht - gkjaazbhot) View more | - | 15 Apr 2026 |





