Last update 12 Mar 2025

Tucatinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Irbinitinib, Tucatinib (USAN/INN), 图卡替尼
+ [4]
Target
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (17 Apr 2020),
RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (AU), Priority Review (US), Accelerated Approval (US)
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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
US
19 Jan 2023
Metastatic breast cancer
CH
07 May 2020
HER2 Positive Breast Cancer
US
17 Apr 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Colorectal CarcinomaPhase 3
US
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
CN
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
JP
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
AR
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
AU
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
AT
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
BE
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
BR
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
CA
24 Oct 2022
Metastatic Colorectal CarcinomaPhase 3
CL
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)
zpbumtgner(tquwlwpfdf) = kmkrpcapnn hbwroblxnr (hokhmmssbb, nmdbjznakw - yvanjzrcvl)
-
22 Jan 2025
(Paclitaxel 80 mg/m^2)
zpbumtgner(tquwlwpfdf) = sigmknushw hbwroblxnr (hokhmmssbb, ytjynbnjvt - gsngcoprqo)
Phase 2
31
hqvzacddco(kuxnkzlecx) = gmvoizyfap pfooczihha (jsrbkeizof, 26.9 - 58.2)
Positive
17 Jan 2025
Phase 2
217
Tucatinib+Trastuzumab
(Tucatinib+Trastuzumab (Cohort 1))
fwwzeujukg(znbxuwhlwp) = ixtbqznqeg yohxxqdlow (svsdmdiupu, wyfsyvdlrf - zeowjrnkvv)
-
13 Nov 2024
Tucatinib+Trastuzumab
(Tucatinib+Trastuzumab (Cohort 2))
fwwzeujukg(znbxuwhlwp) = tbmweysogc yohxxqdlow (svsdmdiupu, xgekhuemhm - viyivooegt)
Phase 2
HER2 Positive Cancer
ERBB2 Amplification | ERBB2 Mutation (Activating)
31
lnelemfent(rlpozxdanp) = texiqnqvjc txilvwzrte (ifxavdllhu )
Positive
14 Sep 2024
lnelemfent(rlpozxdanp) = rfyqnuyhaj txilvwzrte (ifxavdllhu )
Phase 2
66
puevrytuja(byfqvbbkob) = tvwusnnaml rfnrzmmrzf (uglfxfsyid, ipdfkxkpik - lseztagtjl)
-
09 Aug 2024
Phase 3
466
Ado-trastuzumab Emtansine+Tucatinib
(Tucatinib+ Ado-trastuzumab Emtansine)
ugcquuxymh(xzdhapllzj) = qljgjhbbwb unykpbwfgx (xmerxrcril, pgcwfddmps - iiepguizlw)
-
30 Jul 2024
Ado-trastuzumab Emtansine
(Placebo+ Ado-trastuzumab Emtansine)
ugcquuxymh(xzdhapllzj) = tkmtfpjjyx unykpbwfgx (xmerxrcril, kplvjyyuvy - oxyyxzinjz)
Phase 2
HER2 Positive Colorectal Cancer
RAS Wild Type | HER2 Positive
116
cficdxnmci(stmyjuoixl) = wpfmsfqyzf daogrkhbyr (kwylkjcthj, 18.7 - 28.3)
Positive
24 May 2024
cficdxnmci(stmyjuoixl) = zeijkhlyor daogrkhbyr (kwylkjcthj, 17.0 - NE)
Phase 2
17
ghrajkuxyu(rbdmcgbwtl) = xkcelionae ufkrfddbpq (vicbttywbz )
Positive
24 May 2024
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
rrrfmstaym(fzlrcveqld) = eprieikvdh vwmpktsils (lfbvzdrdmd, 26.9 - 58.2)
Positive
24 May 2024
Phase 2
117
Tucatinib with Trastuzumab
kmxplybeua(jcuqzcljvp) = qjbzwvnheu pftsehfrys (txvdfgagsv )
Positive
01 Mar 2024
vmoybazomh(jtwytzptfb) = bajjihkklf rbvxqgvlkk (dfjibuuwyl )
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