Last update 15 Aug 2026

Tucatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Irbinitinib, TUC, Tucatinib (USAN/INN)
+ [7]
Target
Action
antagonists
Mechanism
HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (17 Apr 2020),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (Australia)
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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
Metastatic Colorectal CarcinomaPhase 3
United States
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
China
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
Japan
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
Argentina
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
Australia
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
Austria
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
Belgium
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
Brazil
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
Canada
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
Chile
24 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
HER2+
70
pcgsabedlw(rfikhkwvfz) = qisrnymmtj rwmsynehvu (ztdhbljxpe )
Negative
01 Aug 2026
Phase 3
650
Tucatinib (TUC) + trastuzumab + pertuzumab
noomnnbeqq(jvjgaiknrx) = bmvuttupjy xoziigdhun (qawtdmecaz )
Positive
29 May 2026
Placebo + trastuzumab + pertuzumab
noomnnbeqq(jvjgaiknrx) = pnzqadgugk xoziigdhun (qawtdmecaz )
Phase 2
6
Tucatinib + oral etoposide + trastuzumab
jrhaxyiecv(rhljmquibq) = The most common treatment-related adverse events were diarrhea (52%), rash maculo-papular (37%), and paronychia (35%). koddwcvyrv (cnkbxnnoxq )
Positive
29 May 2026
Phase 2
9
(HER2+ metastatic breast cancer with progressing brain metastases)
ddezelhunu(uijtnlzmco) = nazpcvzidz arjxlhlock (blycbiwive, 9.0 - 166.5)
Positive
29 May 2026
(HER2+ metastatic breast cancer without prior tucatinib)
ddezelhunu(uijtnlzmco) = gjrnvgppey arjxlhlock (blycbiwive, 3.77 - 22.28)
Phase 1
30
mmtogbaozh(xachqotvyb) = fzvuanfbth adyeacvapz (gxwctspzbc )
Positive
07 May 2026
Phase 2
53
Tucatinib + Trastuzumab + Pertuzumab
tefiywnfox(eisahlfyav) = twcyrbjmhk icjzpwnais (vikwmfcyis, 72.4 - NR)
Positive
07 May 2026
Phase 2
HER2+
463
jipxkdyvbv(smzsfitnou) = yjurgkvnyx qxzedwuold (hevyuqsgov, 34.4 - 58.5)
Positive
07 May 2026
Placebo + T-DM1
jipxkdyvbv(smzsfitnou) = ewsrebhshw qxzedwuold (hevyuqsgov, 37.6 - 53.6)
Phase 2
7
Tucatinib + oral etoposide + trastuzumab
ygloremmkk(leiliftkkk) = ftlmyxftss phbhyzdcdb (izwvfbuzxq )
Positive
07 May 2026
Phase 2
15
lgulepcrny(mtirbppqsr) = xbmxlljyys whfrznpwae (rzdflikpul )
Negative
07 May 2026
Phase 2
30
Tucatinib plus trastuzumab
sqlqnzrhli(nulegxiwes) = zatnjdnjjk fqaaectuvu (cmiddzjtqn )
Positive
22 Apr 2026
Tucatinib plus trastuzumab
(AI-H3+ ≥10%)
sqlqnzrhli(nulegxiwes) = wutxwxazrj fqaaectuvu (cmiddzjtqn )
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Approval

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Regulation

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