Last update 09 Sep 2026

Erlotinib Hydrochloride

Overview

Basic Info

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
Drug Highest PhaseApproved
First Approval Date
United States (18 Nov 2004),
RegulationOrphan Drug (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC22H24ClN3O4
InChIKeyGTTBEUCJPZQMDZ-UHFFFAOYSA-N
CAS Registry183319-69-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaPhase 3
United States
06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaPhase 3
Japan
06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaPhase 3
Canada
06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaPhase 3
France
06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaPhase 3
Germany
06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaPhase 3
Greece
06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaPhase 3
Hong Kong
06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaPhase 3
Italy
06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaPhase 3
Romania
06 May 2015
EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaPhase 3
South Korea
06 May 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
19
cyxjbeujvr(uydzmfuimv) = muotdwdhzb acyudwosqf (rktiqmhphb )
Positive
12 Sep 2026
yljjctpkxu(rgvadgdpod) = vnrtfbljku tpwprozuey (gixpobiwzu )
Not Applicable
RIT1-A77G | ARID1A | RIT1-M90I ...
3
cdzpxmhxin(znnutcomsw) = fekuhbvxnk ujtkfjgpyy (mrlrtppxdg )
Negative
12 Sep 2026
(RIT1 amplified LUAD with bone metastasis)
cdzpxmhxin(znnutcomsw) = sdzeutkcrw ujtkfjgpyy (mrlrtppxdg )
Phase 2
Non-Small Cell Lung Cancer
Neoadjuvant
EGFR-Mutant
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 )
Positive
25 Jun 2026
Phase 3
422
Ultra-low-dose immunotherapy plus oral metronomic chemotherapy
nifyepxtjm(gkuqzrshdi) = sslikevqbg jmdydfhzre (ywgkmlmalh )
Positive
29 May 2026
nifyepxtjm(gkuqzrshdi) = zaahtgpbng jmdydfhzre (ywgkmlmalh )
Phase 3
Non-Small Cell Lung Cancer
Adjuvant
EGFR mutation
390
hzpmptwsjj(gmvdkjibnl) = wgsfsezhxc ojjchhzswl (mmndhsaxba )
Negative
29 May 2026
Placebo/Observation
hzpmptwsjj(gmvdkjibnl) = iyarlcrkdw ojjchhzswl (mmndhsaxba )
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)
-
15 May 2026
(Erlotinib)
wrblvfdsgc = tncbufbbtb ireatmepha (mggreixsyc, ixwwynggrs - dalomckxhh)
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)
-
15 Apr 2026
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