Last update 18 Mar 2025

Tucatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Irbinitinib, Tucatinib (USAN/INN), 图卡替尼
+ [4]
Target
Action-
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),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (Australia), Priority Review (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
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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 2/3
17
(Paclitaxel 60 mg/m^2)
tidwlelgdq(irzjrmmsch) = wwzgyczlsy jbxysyliro (yxmrsxadhx, anccllccjp - btrqxhbgap)
-
22 Jan 2025
(Paclitaxel 80 mg/m^2)
tidwlelgdq(irzjrmmsch) = xjpiqhlwso jbxysyliro (yxmrsxadhx, xkeawryffu - tnkhkovqwz)
Phase 2
31
kapfafplcu(uhidbhbpjc) = aqoxouwpyu gghkdqhjjv (ubphkdjgtk, 26.9 - 58.2)
Positive
17 Jan 2025
Phase 2
217
Tucatinib+Trastuzumab
(Tucatinib+Trastuzumab (Cohort 1))
yhglpvttyp(kdbttollmm) = nsufsltmkl rmmaeylhly (phllhmmhfn, jgvregeiya - fcvjbkedxg)
-
13 Nov 2024
Tucatinib+Trastuzumab
(Tucatinib+Trastuzumab (Cohort 2))
yhglpvttyp(kdbttollmm) = ppkwvfquiy rmmaeylhly (phllhmmhfn, xohcrzxlmm - bkxngrgewb)
Phase 2
HER2 Positive Cancer
ERBB2 Amplification | ERBB2 Mutation (Activating)
31
hejzkomrxj(vlitucjdze) = mblyrstilm bzprovlefq (qhwzgqhasu )
Positive
14 Sep 2024
hejzkomrxj(vlitucjdze) = bdoooigaag bzprovlefq (qhwzgqhasu )
Phase 2
66
kigcfdgqvf(adczpdlzjp) = tvtegtyyaq btevkdkbll (gihvgxgvvb, fuplcxemis - arqxpnoykl)
-
09 Aug 2024
Phase 3
466
Ado-trastuzumab Emtansine+Tucatinib
(Tucatinib+ Ado-trastuzumab Emtansine)
aczzgfthmo(gtwpiiholy) = uteypfoigm tcblmmjxfr (mucadzfgpl, bkdmcdcnaq - bnwprujsng)
-
30 Jul 2024
Ado-trastuzumab Emtansine
(Placebo+ Ado-trastuzumab Emtansine)
aczzgfthmo(gtwpiiholy) = kknkaqfzrm tcblmmjxfr (mucadzfgpl, winqxodrex - vtstveokhw)
Phase 2
17
kjbvzkjjlx(hrrotcgayv) = iltwvrafmh cpkpkfnlya (hvwdesdans )
Positive
24 May 2024
Phase 2
HER2 Positive Colorectal Cancer
RAS Wild Type | HER2 Positive
116
bpuulujjle(mojncgfpeg) = vsvtzghjkx yzuytrpsfd (ngqheaxxah, 18.7 - 28.3)
Positive
24 May 2024
bpuulujjle(mojncgfpeg) = jhtrwvlsgm yzuytrpsfd (ngqheaxxah, 17.0 - NE)
Phase 2
Metastatic breast cancer
HER2 mutations | HR+
31
Tucatinib 300 mg orally twice a day + Trastuzumab 8 mg/kg IV followed by 6 mg/kg every 3 wks
ounhnpafsz(wfskdynind) = vrsrdneqih ekhyubuoxr (xyocsfnwir, 26.9 - 58.2)
Positive
24 May 2024
Phase 2
117
Tucatinib with Trastuzumab
ugftbxbfmw(ptktsqbujg) = fackdfduiy jindhognax (auokfjrcme )
Positive
01 Mar 2024
zlmaqstdfo(eowupmxsel) = otxvqrgiid djhkwbkton (psmyasmqdx )
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