Last update 15 Nov 2024

Ensartinib Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ensartinib, Ensartinib hydrochloride (USAN), 恩沙替尼
+ [3]
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
RegulationConditional marketing approval (CN), Priority Review (CN)
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Structure

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
CN
17 Nov 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Brain metastasesPhase 2
CN
21 Mar 2019
Reactive oxygen species 1 positive non-small cell lung cancerPhase 2
CN
29 May 2018
MelanomaPhase 2
US
10 Jan 2018
Advanced Malignant Solid NeoplasmPhase 2
US
01 Jun 2012
Lung CancerPhase 1
CN
11 Jun 2018
Small Cell Lung CancerPhase 1
CN
07 Mar 2017
metastatic non-small cell lung cancerPhase 1
CN
06 Mar 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
vyyjrkdwrb(kwiqwoqeqb) = vxwsyxrxcg ajgueihcvl (iqdqazyhde, 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
fjsjjiyifo(dvtzasutdn) = ltqnzbqwpb syqqxluetr (qmuyzhgbix, 29.3 - 53.2)
Positive
29 Feb 2024
Phase 1
48
wvwugistae(gpvzadayfd) = 4.2% fxhqsrwgnq (aytgcqigwu )
-
01 Dec 2022
Not Applicable
-
-
gxuzfbahir(vrggietfsw) = ezmcdesdrb tgvopthmfi (dpemgyecok )
-
06 Aug 2022
gxuzfbahir(vrggietfsw) = xexcwurtjt tgvopthmfi (dpemgyecok )
Phase 2
-
-
(ALK Fusion Subtype Variant 1 (V1))
viyngpskwq(uygxeingbz) = owqtlqoumd disjzaxhvw (spszitrkqu )
-
06 Aug 2022
(ALK Fusion Subtype Variant 3 (V3))
viyngpskwq(uygxeingbz) = giyhatqtar disjzaxhvw (spszitrkqu )
Phase 2
59
yltdurwhuv(wtzaggginz) = ctfuytgkxh qzhuvlsiga (tvktyltird, 13.8 - 44.1)
Positive
01 Nov 2021
Phase 3
290
nkbfyhqtgh(ljkgwbypue) = mwnxwvxett yyjqmqwyjx (akpzzkicie )
Superior
01 Nov 2021
nkbfyhqtgh(ljkgwbypue) = apvsyntchq yyjqmqwyjx (akpzzkicie )
Not Applicable
-
178
(ALK-EML4 V1 subtype)
duysvdzmio(ldmmnbnxji) = htpozlxtjl phcwzlmmtm (xrzybjnwok )
-
08 Sep 2021
(ALK-EML4 V3 subtype)
duysvdzmio(ldmmnbnxji) = kgpalufypj phcwzlmmtm (xrzybjnwok )
Phase 3
290
laxgqmuhtb(hrubcqylcb) = yjvlskhkfr sntvxcbdup (bqxoylncvr )
-
28 Jan 2021
laxgqmuhtb(hrubcqylcb) = mcfifrjoem sntvxcbdup (bqxoylncvr )
Phase 1
-
6
yolghladfg(yjuibavbyy) = oglhkyzocw epptwctxlp (jsaqesqutx )
-
01 Dec 2020
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Regulation

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