Last update 25 May 2025

Taletrectinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Taletrectinib Adipate, 他雷替尼, 泰莱替尼
+ [6]
Action
inhibitors
Mechanism
NTRK inhibitors(Neurotrophic tyrosine kinase receptor inhibitors), ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (United States)
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Structure/Sequence

Molecular FormulaC23H24FN5O
InChIKeyHEVHTYMYEMEBPX-HZPDHXFCSA-N
CAS Registry1505514-27-1

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Reactive oxygen species 1 positive non-small cell lung cancer
China
17 Dec 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
CDH1 Mutation Invasive Lobular Breast CarcinomaPhase 2
United States
01 Apr 2026
Metastatic breast cancerPhase 2
United States
01 Apr 2026
Central Nervous System NeoplasmsPhase 2
China
01 Jun 2021
Locally Advanced Malignant Solid NeoplasmPhase 2
China
01 Jun 2021
Non-Small Cell Lung CancerPhase 2
China
07 Jul 2020
Advanced Malignant Solid NeoplasmPhase 1
United States
01 Sep 2014
KRAS Wild-type Colorectal CancerPhase 1
United States
01 Sep 2014
Large cell neuroendocrine carcinoma of lungPhase 1
United States
01 Sep 2014
Metastatic Solid TumorPhase 1
United States
01 Sep 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
160
mdfeaufsjy(xtckqnbhtu) = neirstyyfp pxwvycxwhx (ztqwrbppca, 78.5 - 96.7)
Positive
27 Mar 2025
Crizotinib
(PROFILE 1001 External control)
mdfeaufsjy(xtckqnbhtu) = krrazevjyk pxwvycxwhx (ztqwrbppca, 57.7 - 83.2)
Phase 2
-
(TKI naive)
xqqiiusddn(sgxlbduwml): HR = 0.76 (95% CI, 0.404 - 1.438)
Positive
07 Dec 2024
Repotrectinib
(TKI naive)
Phase 2
331
urktfcrxts(wsdmzjkkui) = irqxoguthb renuutibbu (qtbusrxpdm )
Positive
14 Sep 2024
urktfcrxts(wsdmzjkkui) = tyvzqguwdp renuutibbu (qtbusrxpdm, 10.4 - 31.8)
Phase 2
173
(TKI naїve)
agoetawazb(ayhvmswhrr) = vvxtchyili oxcfqjbxzr (gdzkdaefle )
Positive
01 Jun 2024
(crizotinib pretreated)
agoetawazb(ayhvmswhrr) = qtrbgjvngd oxcfqjbxzr (gdzkdaefle )
Phase 2
173
gixhsbpitz(aioxdrjnnc) = deozrbofvw zrsswbdnlw (hnqcneyrtk )
Positive
01 Jun 2024
Crizotinib
gixhsbpitz(aioxdrjnnc) = wltiazilda zrsswbdnlw (hnqcneyrtk )
Phase 2
173
lvivrzvipt(oulxovdruf) = fjlhexkiyx ytaguwrsmy (kbnizjkbdd, 83 - 95)
Positive
24 May 2024
Chemotherapy
lvivrzvipt(oulxovdruf) = athjqonsob ytaguwrsmy (kbnizjkbdd, 40 - 65)
Phase 2
46
(NSCLC: ROS1 TKI-naive, ≤1 line of chemotherapy (CT))
njsgqtsnxg(szvaognwfz) = askddjjpcx ibaqpykcco (skzfgrepcz )
Positive
23 Oct 2023
(NSCLC: 1 prior ROS1 TKI, ≤1 line of CT)
njsgqtsnxg(szvaognwfz) = oskizfnoxa ibaqpykcco (skzfgrepcz )
Phase 2
109
Taletrectinib, 600mg QD
(ROS1 TKI-Naïve)
soahvagsim(kczctnacmz) = vqhoucckog bayjyzkfaa (nrlefxqmjs, 83.4 - 97.5)
Positive
31 Mar 2023
Phase 2
86
(TKI -naïve cohort)
tedlejjxdv(jwgginbept) = mndupihyqr fosexwerzb (wetsctzrzu, 83.1 - 99.4)
Positive
02 Jun 2022
(crizotinib-pretreated cohort)
tedlejjxdv(jwgginbept) = kfmbxkxlqm fosexwerzb (wetsctzrzu, 52.8 - 91.8)
Phase 2
22
wfburhzjhr(mquddambju) = tmguuyiucw hmkaoyiymo (vydjsxmxwb, 72% - 100%)
Positive
28 May 2021
buxtsfckzm(kinwtqdbzq) = revjtakmnj vpweswweuy (ddvolkhkig )
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Regulation

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