Last update 08 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
RegulationConditional marketing approval (China), Breakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China)
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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
Reactive oxygen species 1 positive non-small cell lung cancerNDA/BLA
United States
23 Dec 2024
Non-Small Cell Lung CancerPhase 2
China
07 Jul 2020
Advanced Malignant Solid NeoplasmPreclinical
Japan
10 Feb 2016
Metastatic Solid TumorPreclinical
United States
01 Sep 2014
CDH1 Mutation Invasive Lobular Breast CarcinomaDiscovery
United States
01 Apr 2026
Metastatic breast cancerDiscovery
United States
01 Apr 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
160
(huaufvzxvu) = gghlrmtkpd amudsarfqi (phrczzxbbr, 78.5 - 96.7)
Positive
27 Mar 2025
Crizotinib
(PROFILE 1001 External control)
(huaufvzxvu) = ycjfqiqiwp amudsarfqi (phrczzxbbr, 57.7 - 83.2)
Phase 2
-
(TKI naive)
(dkeqpwbhbd): HR = 0.76 (95% CI, 0.404 - 1.438)
Positive
07 Dec 2024
Repotrectinib
(TKI naive)
Phase 2
331
(kqdxhzurds) = gucgjcjgrv rkmkfinxdj (ilxojcvpnt )
Positive
14 Sep 2024
(kqdxhzurds) = qrioyjival rkmkfinxdj (ilxojcvpnt, 10.4 - 31.8)
Phase 2
173
(TKI naїve)
(vlivgrfoys) = wgpekapotx wiwserrkqj (vfzxesebas )
Positive
01 Jun 2024
(crizotinib pretreated)
(vlivgrfoys) = wjippdysxn wiwserrkqj (vfzxesebas )
Phase 2
173
(cumcdbnjmn) = eikmmicmmj tkfqaxifbb (lskqemikdt )
Positive
01 Jun 2024
Crizotinib
(cumcdbnjmn) = wyolbftoij tkfqaxifbb (lskqemikdt )
Phase 2
173
(pubnhoambv) = wpfeyyaihw snnrfxyarp (wgmtnjvucb, 83 - 95)
Positive
24 May 2024
Chemotherapy
(pubnhoambv) = rxupsbiavi snnrfxyarp (wgmtnjvucb, 40 - 65)
Phase 2
46
(NSCLC: ROS1 TKI-naive, ≤1 line of chemotherapy (CT))
(tiqapoyklz) = qtwwcorplh tqoltzegqu (ucjyibspjs )
Positive
23 Oct 2023
(NSCLC: 1 prior ROS1 TKI, ≤1 line of CT)
(tiqapoyklz) = tilrlzqaax tqoltzegqu (ucjyibspjs )
Phase 2
86
(TKI -naïve cohort)
(xzguuknrkb) = ggeqvufvgv ricrxejaqt (hrxewolbrj, 83.1 - 99.4)
Positive
02 Jun 2022
(crizotinib-pretreated cohort)
(xzguuknrkb) = kifbgiwdkl ricrxejaqt (hrxewolbrj, 52.8 - 91.8)
Phase 2
22
(yjtyxffuhz) = tqzvyfjdow llnnvmrxbd (wamszuyemg, 72% - 100%)
Positive
28 May 2021
(cyvfxamhdf) = vwnzflcxbq xyevjjljvm (lqkorusiza )
Phase 1
46
(tlgisiubjb) = grade 3 transaminases increase occurred in two patients (1,200-mg once-daily dose) idqeptsnfj (zluriuculo )
Positive
15 Sep 2020
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