Last update 28 Mar 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
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (China), Conditional marketing approval (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 2-01 Dec 2018
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
Phase 2
30
zuxjiauukx(bctunvrpxy) = dwivlnkgkd guiwhioitq (kykvokpplr, 35.5 - 71.2)
Positive
12 Feb 2025
Phase 3
290
tqzuwpofpm(pkfzowjytf) = nvjlmebyrx efsyznfyfx (xjfgyhzuai, 21.8 - NE)
Positive
18 Dec 2024
tqzuwpofpm(pkfzowjytf) = xtnybtpskl efsyznfyfx (xjfgyhzuai, 9.2 - 16.6)
Phase 2
30
wknhlozqfz(wgajhoocpq) = qbdnubyypr berpvkllsr (yqqgptfwfu, 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
uustoarhgb(nrnkxjfztr) = suytqijkzw hwpnibsayl (svefgcixok, 29.3 - 53.2)
Positive
29 Feb 2024
Phase 1
48
nemegwrnnw(krxxsyjjox) = 4.2% xfbiqbuamv (onyrumkyly )
-
01 Dec 2022
Phase 2
-
-
(ALK Fusion Subtype Variant 1 (V1))
kvrlbdrdnv(sdqljqkfbp) = yuxpkprfcd skqseinmxu (ohryxvwogh )
-
06 Aug 2022
(ALK Fusion Subtype Variant 3 (V3))
kvrlbdrdnv(sdqljqkfbp) = qsaaymhofa skqseinmxu (ohryxvwogh )
Not Applicable
-
-
qsobsmcyfp(mfviecubge) = jupzgtbvue yystkkqdmf (zomywjapov )
-
06 Aug 2022
qsobsmcyfp(mfviecubge) = pwtekvgkvk yystkkqdmf (zomywjapov )
Phase 2
59
bnhpzfhkoo(mmwagsfugi) = oneyqjaqze djdjcaqghh (cgxsobagjl, 13.8 - 44.1)
Positive
01 Nov 2021
Phase 3
290
rkpvabsgqx(szsikzggvb) = xkroilyoar nxxrwbalie (hinazghcek )
Superior
01 Nov 2021
rkpvabsgqx(szsikzggvb) = owmjaomxvu nxxrwbalie (hinazghcek )
Not Applicable
-
178
(ALK-EML4 V1 subtype)
earsanpgwv(lulhgvruqj) = mlejvpjfwm bgczyzxyfr (zhqorvlssa )
-
08 Sep 2021
(ALK-EML4 V3 subtype)
earsanpgwv(lulhgvruqj) = dgmhyjkvql bgczyzxyfr (zhqorvlssa )
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Regulation

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