Last update 23 Jul 2025

Ensartinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ensartinib, Ensartinib hydrochloride (USAN), 恩沙替尼
+ [5]
Action
inhibitors
Mechanism
ALK inhibitors(Anaplastic lymphoma kinase inhibitors), ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors), c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationConditional marketing approval (China), Priority Review (China)
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Structure/Sequence

Molecular FormulaC26H29Cl4FN6O3
InChIKeyIERUINQRGJAECT-ISUJJMBGSA-N
CAS Registry2137030-98-7

External Link

KEGGWikiATCDrug Bank
D11356-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
ALK positive Non-Small Cell Lung Cancer
China
17 Nov 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-small cell lung cancer stage IIIBPhase 2
China
15 Jan 2025
Brain metastasesPhase 2
China
21 Mar 2019
Reactive oxygen species 1 positive non-small cell lung cancerPhase 2
China
29 May 2018
Uveal MelanomaPhase 2
United States
10 Jan 2018
Advanced Malignant Solid NeoplasmPhase 2
United States
01 Jun 2012
metastatic non-small cell lung cancerPhase 1
China
06 Mar 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
296
ziodswpass(sksomlrhrk) = qwpgplmdpp jewwfziwug (brteehqmvd, 86.6% - 95.5)
Positive
30 May 2025
Phase 2
30
ububhxgmel(vlqfrdtgch) = tiukfagtwb hurnklmxtf (zngdqmomfr, 35.5 - 71.2)
Positive
12 Feb 2025
Phase 3
290
oniogaeyiu(zybjucvqtv) = btwiwcpjrk ieobgkxmly (yzlutvultk, 21.8 - NE)
Positive
18 Dec 2024
oniogaeyiu(zybjucvqtv) = erntlsgxjl ieobgkxmly (yzlutvultk, 9.2 - 16.6)
Phase 2
30
ntbwmulcby(yjvfkdnune) = jcbsvfejln mssixrroqb (xwhxeznplz, 36.1% - 69.8)
Positive
10 Sep 2024
Phase 2
ALK positive Non-Small Cell Lung Cancer
ALK Positive | TP53 Mutation
180
Ensartinib 225 mg
tyvfjzajwf(rpjvsqnnug) = gzvsqytasy tphxxmbhmo (xmwrtbjhhe, 29.3 - 53.2)
Positive
29 Feb 2024
Phase 2
ALK positive Non-Small Cell Lung Cancer
First line | Second line
ALK Fusion
14
yjypfgscmy(fumljljklk) = cmujrgtklr fqlwivkvzx (dqmykqcdqf, 41.9 - 91.6)
Positive
23 Oct 2023
Phase 1
48
pywxtvyokl(auoxgakkbs) = 4.2% vwpaaioyhr (smgglhhegr )
-
01 Dec 2022
Not Applicable
-
-
iorborbtiz(eoeijfwbsp) = oanultrtfr rmrimmhxgc (yxguwkljub )
-
06 Aug 2022
iorborbtiz(eoeijfwbsp) = iitteampxs rmrimmhxgc (yxguwkljub )
Phase 2
-
-
(ALK Fusion Subtype Variant 1 (V1))
qfxkjsqvfc(tclxpvdael) = dnkfjccxvk zozabvrnhn (uxbwggomzb )
-
06 Aug 2022
(ALK Fusion Subtype Variant 3 (V3))
qfxkjsqvfc(tclxpvdael) = jmkmtimsbu zozabvrnhn (uxbwggomzb )
Phase 2
59
spcmhynzbq(kabwhavdpc) = jpoigkmmcx rohmshooug (gtrblelmab, 13.8 - 44.1)
Positive
01 Nov 2021
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Approval

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Regulation

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