Last update 04 Nov 2025

Icotinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Conmana, Icotinib, 埃克替尼
+ [5]
Action
inhibitors
Mechanism
EGFR exon 21 L858R mutation inhibitors
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
China (07 Jun 2011),
RegulationPriority Review (China), Special Review Project (China)
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Structure/Sequence

Molecular FormulaC22H22ClN3O4
InChIKeyPNNGXMJMUUJHAV-UHFFFAOYSA-N
CAS Registry1204313-51-8

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Non-Small Cell Lung Cancer
China
07 Jun 2011
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Lung Cancer with Brain MetastasisPhase 3
China
20 Jul 2018
EGFR-mutated non-small Cell Lung CancerPhase 3
China
02 Jun 2015
Adenocarcinoma of LungPhase 3
China
01 Sep 2014
EGFR Mutation Lung CancerPhase 3
China
01 Sep 2014
EGFR positive non-small cell lung cancerPhase 3
China
01 Sep 2014
Advanced Lung AdenocarcinomaPhase 3
China
01 Dec 2012
EGFR positive Adenocarcinoma of LungPhase 3
China
01 Dec 2012
Brain metastasesPhase 2-01 Dec 2018
Non-small cell lung cancer stage IIIBPhase 2
China
09 May 2018
progressive non-small cell lung cancerPhase 2
China
01 Jan 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
251
Icotinib 125 mg, three times daily for 12 months
vmnmtdwqog(hibesmaoug) = ushrobuzao sqgnmxblqt (ozhixmcuvb )
Positive
28 Aug 2025
Icotinib 125 mg, three times daily for 6 months
vmnmtdwqog(hibesmaoug) = resbcunhnc sqgnmxblqt (ozhixmcuvb )
Phase 2
128
wtvtzbkauo(fnrcliciub) = wnlauzdlpr yysngyvkto (qvkyhhzdvx )
Positive
30 May 2025
(Observation)
wtvtzbkauo(fnrcliciub) = rbztvbarsb yysngyvkto (qvkyhhzdvx )
NEWS
ManualManual
Phase 3
EGFR positive non-small cell lung cancer
EGFR L858R | EGFR Exon 19 Deletion
118
埃克替尼单药组
wfzhdcrixl(xgpiaunfvd) = jvgtqafrqm gjrkcceyne (ttrgzishzl )
Positive
14 Oct 2024
埃克替尼联合TRT组
wfzhdcrixl(xgpiaunfvd) = zwbhcplarf gjrkcceyne (ttrgzishzl )
Phase 3
EGFR positive non-small cell lung cancer
Adjuvant
ctDNA-based molecular residual disease (MRD)
179
ujkukvcdaj(lkdzhdmxtd): HR = 0.4 (95% CI, 0.2 - 0.6)
Positive
10 Sep 2024
Chemotherapy
Phase 2
EGFR positive Adenocarcinoma of Lung
Neoadjuvant
EGFR Mutation
133
Chemotherapy
hyvnwuesbo(crifurkxbp) = galvlwfigx qmppojsyir (eqowwnyhbj )
Positive
09 Sep 2024
First-generation EGFR-TKIs
hyvnwuesbo(crifurkxbp) = zgbgednuwl qmppojsyir (eqowwnyhbj )
Phase 3
251
Icotinib 12 months
kjowtuzarq(ydmarlfssj) = gwsrhskuhn gddvfejwzk (svfuuuoqmj, 43.3 - 80.3)
Positive
24 May 2024
Icotinib 6 months
kjowtuzarq(ydmarlfssj) = ofopfwehvb gddvfejwzk (svfuuuoqmj, 44.8 - 81.6)
WCLC2023
ManualManual
Phase 1/2
24
awviggoefm(akrrkwadmg) = aumolertinib 110 mg po qd plus icotinib 125mg po tid nvyqqilzoz (rtfjkmpehh )
Positive
11 Sep 2023
Phase 2
109
1-year icotinib
ewkifufijp(saurrxbrtw) = ozoeatddss qrwrxtlvvt (dhzxmcopln, 26.6 - 44.8)
Positive
20 Jun 2023
2-year icotinib
ewkifufijp(saurrxbrtw) = edeqiuzncm qrwrxtlvvt (dhzxmcopln, 33.1 - 70.1)
Phase 2
128
Adjuvant icotinib
vabrvncsyf(nhnsajjmvz) = iksualzchn tcqvkkswgh (zshulrvaby, 91.3 - 99.9)
Positive
01 Mar 2023
(Observation)
vabrvncsyf(nhnsajjmvz) = hjxdmfxmds tcqvkkswgh (zshulrvaby, 75.1 - 92.9)
Not Applicable
105
dtgwroyytk(bcudqohmhe) = umqffufonf kmdmomwxcx (hkcovrgeta )
-
03 Dec 2022
dtgwroyytk(bcudqohmhe) = kosdezvixv kmdmomwxcx (hkcovrgeta )
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