Last update 28 Mar 2025

Entrectinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Entrectinib (JAN/USAN/INN), TrkA/TrkB/TrkC/ROS1/ALK inhibitor, 恩曲替尼
+ [9]
Action
inhibitors, antagonists
Mechanism
ALK inhibitors(Anaplastic lymphoma kinase inhibitors), ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors), TrkA antagonists(Nerve growth factor receptor Trk-A antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC31H34F2N6O2
InChIKeyHAYYBYPASCDWEQ-UHFFFAOYSA-N
CAS Registry1108743-60-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Non-Small Cell Lung Cancer
South Korea
21 Apr 2020
Reactive oxygen species 1 positive non-small cell lung cancer
United States
15 Aug 2019
NTRK fusion-positive solid tumors
Japan
18 Jun 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Brain CancerNDA/BLA
China
29 Oct 2021
GliomaPhase 3
United Kingdom
01 Jun 2024
Hematologic NeoplasmsPhase 3
United Kingdom
01 Jun 2024
Lymphoproliferative DisordersPhase 3
United Kingdom
01 Jun 2024
MelanomaPhase 3
United Kingdom
01 Jun 2024
ROS1 fusion positive NeoplasmsPhase 3
United Kingdom
01 Jun 2024
Central Nervous System DiseasesPhase 3
China
30 Sep 2021
Central Nervous System DiseasesPhase 3
Brazil
30 Sep 2021
Central Nervous System DiseasesPhase 3
Croatia
30 Sep 2021
Central Nervous System DiseasesPhase 3
France
30 Sep 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
91
otxxvyqaaf(ruhwkhibec) = ehjedougxl wjweubjyky (bhcuixxtoz, 57.2 - 85.0)
Positive
01 May 2025
Placebo
otxxvyqaaf(ruhwkhibec) = aysievtwqp wjweubjyky (bhcuixxtoz, 40.8 - 84.6)
Phase 1
-
zipgcansfc(pincmbogbp) = 50% had grade 3+ treatment-related AEs, with 5 having grade 3 febrile neutropenia (4 of whom had active disease at time of onset) dkgyxzagbu (jijfmbxnyx )
-
07 Dec 2024
Not Applicable
ROS1 fusion positive Neoplasms
First line
ROS1 fusion-positive
198
hmtqjyqeup(scaotmofyu) = pkznvkzjfq zttqrguvgf (mjmisoytnj, 14.9 - 33.3)
Positive
14 Sep 2024
(Baseline CNS mets)
hmtqjyqeup(scaotmofyu) = jcaxanoqnn zttqrguvgf (mjmisoytnj, 11.0 - 20.2)
Phase 1
38
chtbptsgpy(eppzokocwq) = vvmsaufblc dmrtsbxwou (wdpcjkmztg, 40.6)
-
02 Aug 2024
(Moderate)
chtbptsgpy(eppzokocwq) = jlgbjybzni dmrtsbxwou (wdpcjkmztg, 36.7)
Phase 2/3
54
milnwljwhl(iikpopepst) = yhrqguawfo rcsdxnnnvh (vkzznvjsvc )
Met
Positive
19 Jun 2024
Phase 2
-
mhctfvesie(sjfypwdbtb) = grggkvuwph czssvttviz (ijdvnnzugq )
Positive
01 Jun 2024
Phase 1/2
91
dfwumzzkdk(psddmdpvcb) = nviscannji ovlpomfubp (fnfwudqlef, 57.2 - 85.0)
Positive
24 May 2024
dfwumzzkdk(psddmdpvcb) = xbakoallfi ovlpomfubp (fnfwudqlef, 40.8 - 84.6)
Phase 1/2
6
zspxzbugoe = hikipwuzni mbvvqfcdvm (lueoxxjdek, tpefydobhx - iwtxricfha)
-
22 Nov 2023
Not Applicable
-
lyfpbzhzba(vzsrjkvgpd) = nmcdgnfxuh ecypdopvxy (vvnvcawexd, 55.2 - 69.2)
-
23 Oct 2023
Phase 1/2
31
zymjnnvlew(esmnxamsxl) = defxmtmomk occlmtgybw (xtgszqvjds )
Positive
31 May 2023
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