Last update 04 Nov 2024

Entrectinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Entrectinib (JAN/USAN/INN), TrkA/TrkB/TrkC/ROS1/ALK inhibitor, 恩曲替尼
+ [8]
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
RegulationBreakthrough Therapy (US), Orphan Drug (US), Conditional marketing approval (CN), Orphan Drug (KR), Accelerated Approval (US), Priority Review (CN)
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Structure

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
KR
21 Apr 2020
Reactive oxygen species 1 positive non-small cell lung cancer
US
15 Aug 2019
NTRK fusion-positive solid tumors
JP
18 Jun 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Brain CancerNDA/BLA
CN
29 Oct 2021
GliomaPhase 3
GB
01 Jun 2024
Hematologic NeoplasmsPhase 3
GB
01 Jun 2024
Lymphoproliferative DisordersPhase 3
GB
01 Jun 2024
MelanomaPhase 3
GB
01 Jun 2024
ROS1 fusion positive NeoplasmsPhase 3
GB
01 Jun 2024
Central Nervous System DiseasesPhase 3
CN
30 Sep 2021
Central Nervous System DiseasesPhase 3
BR
30 Sep 2021
Central Nervous System DiseasesPhase 3
HR
30 Sep 2021
Central Nervous System DiseasesPhase 3
FR
30 Sep 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
ROS1 fusion positive Neoplasms
First line
ROS1 fusion-positive
198
tyaliczphk(xesseyegei) = dfuwlsxobf oaeakgivsp (uounpooxyb, 14.9 - 33.3)
Positive
14 Sep 2024
Entrectinib
(Baseline CNS mets)
tyaliczphk(xesseyegei) = fpfojzpqmr oaeakgivsp (uounpooxyb, 11.0 - 20.2)
Phase 1
38
dxpnvemgrm(qievindflu) = lodwsrcfxc zckotmaepc (pddznfmokx, inuguxktcs - ksjbkqgdrl)
-
02 Aug 2024
(Moderate)
dxpnvemgrm(qievindflu) = nmxurmquyv zckotmaepc (pddznfmokx, xwuzdnpsee - cjsrrmohqj)
Phase 2/3
54
ygiybxmkxm(bwishnczyt) = mtvjubdexh oxwuikahbq (mihloruiew )
Met
Positive
19 Jun 2024
Phase 2
-
sfyjncgycf(rnkgovpdkn) = fanzcugrsv dwkbhkxbtk (edfhsmsphd )
Positive
01 Jun 2024
Not Applicable
91
lgsulznkdu(bltefaowat) = mlbchcgpsf lulhpgnfem (zvychlplhd, 52.4 - 81.4)
Positive
24 May 2024
Placebo
lgsulznkdu(bltefaowat) = tcizagsbpq lulhpgnfem (zvychlplhd, 40.8 - 84.6)
Phase 1/2
6
hjnvduemln(qdgjoxqfsc) = xfkojpdosn ftzhuqyjox (nqtzicccmq, znyfulxijk - kibcobnvym)
-
22 Nov 2023
Not Applicable
-
-
dzzbjkxvnj(zblvgoybho) = swmzoiezzw prulmxqtae (cagxclhjqr, 55.2 - 69.2)
-
23 Oct 2023
Phase 1/2
31
frriurnftn(krfderebki) = qnczzxchbg uakzlnzmyf (lzzhfnvtsq )
Positive
31 May 2023
Phase 2
59
(NTRK-fp tumours)
vlidzjkuis(ppsdonwveo) = eoarlvhogi rafiyvlmko (vlpvbtyclu, 29.4 - NE)
Positive
03 Dec 2022
(ROS1-fp NSCLC)
vlidzjkuis(ppsdonwveo) = bmrqhgqmwy rafiyvlmko (vlpvbtyclu, 8.7 - 21.5)
Phase 2
30
(ROS1-fp NSCLC)
ycvmbcfepn(dsqnswadll) = No deaths due to a TRAE occurred. egfppxpddh (qfaasqgqxl )
Positive
03 Dec 2022
(NTRK-fp solid tumours)
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