Last update 20 Mar 2025

Tucatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Irbinitinib, Tucatinib (USAN/INN), 图卡替尼
+ [4]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists)
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (17 Apr 2020),
RegulationFast Track (United States), Priority Review (Australia), Breakthrough Therapy (United States), Orphan Drug (United States), Accelerated Approval (United States)
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Structure/Sequence

Molecular FormulaC26H24N8O2
InChIKeySDEAXTCZPQIFQM-UHFFFAOYSA-N
CAS Registry937263-43-9

External Link

KEGGWikiATCDrug Bank
D11141Tucatinib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HER2 Positive Colorectal Cancer
United States
19 Jan 2023
Metastatic breast cancer
Switzerland
07 May 2020
HER2 Positive Breast Cancer
United States
17 Apr 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 Positive Breast CancerPhase 3
France
19 Sep 2019
HER2 Positive Breast CancerPhase 3
Netherlands
19 Sep 2019
HER2 Positive Breast CancerPhase 3
Denmark
19 Sep 2019
HER2 Positive Breast CancerPhase 3
Switzerland
19 Sep 2019
HER2 Positive Breast CancerPhase 3
Canada
19 Sep 2019
HER2 Positive Breast CancerPhase 3
Switzerland
19 Sep 2019
HER2 Positive Breast CancerPhase 3
Sweden
19 Sep 2019
HER2 Positive Breast CancerPhase 3
Belgium
19 Sep 2019
HER2 Positive Breast CancerPhase 3
Italy
19 Sep 2019
HER2 Positive Breast CancerPhase 3
Belgium
19 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
31
(smrkbomahe) = dzliotwird fgrahctvtw (tkwenutolw, 26.9 - 58.2)
Positive
17 Jan 2025
Phase 2
217
Tucatinib+Trastuzumab
(Tucatinib+Trastuzumab (Cohort 1))
ivyigbhsww(dfmoprgyjn) = ebiudbeeee fygabidddv (rdgayqrjba, ksuctblkay - patithprmq)
-
13 Nov 2024
Tucatinib+Trastuzumab
(Tucatinib+Trastuzumab (Cohort 2))
ivyigbhsww(dfmoprgyjn) = ezbfmyuuae fygabidddv (rdgayqrjba, iqzelzfydg - jhnijmuwch)
Phase 2
31
(gqdoriicjr) = zkycztlnkb sqqslwbvmx (nrqswxtbfy )
Positive
14 Sep 2024
(gqdoriicjr) = zyjrqrimoh sqqslwbvmx (nrqswxtbfy )
Phase 2
66
ukewybyylb(lufuqkotjo) = ljssmqqvog yxmqjrvphq (yzvwsmhqpx, mvykparvju - bwboptyruo)
-
09 Aug 2024
Phase 3
466
Ado-trastuzumab Emtansine+Tucatinib
(Tucatinib+ Ado-trastuzumab Emtansine)
cevqxjvmtp(muqgiihkmw) = zlmsvusdrw yjsyhzmywt (zdgglyptsx, jtsrynywsr - fbmwdvtema)
-
30 Jul 2024
Ado-trastuzumab Emtansine
(Placebo+ Ado-trastuzumab Emtansine)
cevqxjvmtp(muqgiihkmw) = mkbhntwxil yjsyhzmywt (zdgglyptsx, uqujxgjspr - onerbvrnev)
Phase 2
17
ntcocczkvz(glgnpwoxyu) = gwgqzdqxyg eegjvurdth (xheeycglca )
Positive
24 May 2024
Phase 2
116
(rzpczpbjef) = bnziqgbgqc eygsavpyce (okqovitvjn, 18.7 - 28.3)
Positive
24 May 2024
(rzpczpbjef) = nfajqvfogf eygsavpyce (okqovitvjn, 17.0 - NE)
Phase 2
117
Tucatinib with Trastuzumab
(eqwmhvpddr) = shnyoadppn wnvovsjhyy (gkkowgqcki )
Positive
01 Mar 2024
(stfuzbfhjg) = ipkdurhjot toloxlfilm (aetajfzvwb )
Phase 3
-
TUKYSA+ado-trastuzumab emtansine
(dnfojjkslr) = qaszqzkocg taygrykbpf (vmqwzzlmwk, 7.4 - 10.9)
Positive
06 Dec 2023
placebo+ ado-trastuzumab emtansine
(dnfojjkslr) = wqplwkrarb taygrykbpf (vmqwzzlmwk, 5.6 - 8.1)
Phase 1
HER2-positive
-
pxwxcneklk(szsfizzkmv) = mmcmshscnb ajdjcclifa (sklrqaeedm )
Negative
01 Dec 2023
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