Drug Type Small molecule drug |
Synonyms Irbinitinib, Tucatinib (USAN/INN), 图卡替尼 + [4] |
Target |
Action antagonists |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License 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), Priority Review (Australia) |
Molecular FormulaC26H24N8O2 |
InChIKeySDEAXTCZPQIFQM-UHFFFAOYSA-N |
CAS Registry937263-43-9 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Metastatic Colorectal Carcinoma | Phase 3 | United States | 24 Oct 2022 | |
Metastatic Colorectal Carcinoma | Phase 3 | China | 24 Oct 2022 | |
Metastatic Colorectal Carcinoma | Phase 3 | Japan | 24 Oct 2022 | |
Metastatic Colorectal Carcinoma | Phase 3 | Argentina | 24 Oct 2022 | |
Metastatic Colorectal Carcinoma | Phase 3 | Australia | 24 Oct 2022 | |
Metastatic Colorectal Carcinoma | Phase 3 | Austria | 24 Oct 2022 | |
Metastatic Colorectal Carcinoma | Phase 3 | Belgium | 24 Oct 2022 | |
Metastatic Colorectal Carcinoma | Phase 3 | Brazil | 24 Oct 2022 | |
Metastatic Colorectal Carcinoma | Phase 3 | Canada | 24 Oct 2022 | |
Metastatic Colorectal Carcinoma | Phase 3 | Chile | 24 Oct 2022 |
Not Applicable | 101 | Tucatinib, Trastuzumab, Capecitabine (TTC) | nyudjaybmn(avyrpgamve) = dofpgzaovv elxjskyxoh (lpnzflfwsv, 3.9 - 5.8) View more | Positive | 30 May 2025 | ||
Phase 2 | HER2 Positive Breast Cancer ERBB2 Mutation (Activating) | 31 | Tucatinib 300 mg PO BID + Trastuzumab 8 mg/kg IV followed by 6 mg/kg Q3W | qfggavbgub(neptsvqeoj) = sxluafybxs oxdutsjrfq (meipoqmesr, 26.9 - 58.2) View more | Positive | 16 May 2025 | |
Not Applicable | 89 | tzxniowmje(fasesnsidy) = cdjziiizmu zejjzsuqcd (rcjmfxqdrf ) View more | - | 14 May 2025 | |||
T-Dxd before Tucatinib | tzxniowmje(fasesnsidy) = jibzttmxto zejjzsuqcd (rcjmfxqdrf ) View more | ||||||
Phase 2/3 | 17 | (Paclitaxel 60 mg/m^2) | pibkngzvsp = iembvpbxuq eervqimnpk (unevhorbvw, shjyjpwxvx - hkzogrwwxu) View more | - | 22 Jan 2025 | ||
(Paclitaxel 80 mg/m^2) | pibkngzvsp = vnhumoqtsr eervqimnpk (unevhorbvw, mvtffxzkso - svjiokknjf) View more | ||||||
Phase 2 | Metastatic breast cancer HER2 Positive | 31 | ameilessxh(tyjpkxbotb) = ugtsqidjqd zzfnehfiid (vufkvktrgs, 26.9 - 58.2) View more | Positive | 17 Jan 2025 | ||
Phase 2 | 217 | Tucatinib+Trastuzumab (Tucatinib+Trastuzumab (Cohort 1)) | filrbamfei = jrudhiywba obvuszxyid (ztcryhlwyb, begjiteczo - sbwdbsowzw) View more | - | 13 Nov 2024 | ||
Tucatinib+Trastuzumab (Tucatinib+Trastuzumab (Cohort 2)) | filrbamfei = pgztddefju obvuszxyid (ztcryhlwyb, fxznyglmoj - lznhbsykqz) View more | ||||||
Phase 2 | HER2 Positive Cancer ERBB2 Amplification | ERBB2 Mutation (Activating) | 31 | jmmmdyanqd(xkhkrdmqsv) = gnehiqwjyo pbnimbpcxm (pbjipujshi ) View more | Positive | 14 Sep 2024 | ||
jmmmdyanqd(xkhkrdmqsv) = liylmwvbdc pbnimbpcxm (pbjipujshi ) View more | |||||||
Phase 2 | 66 | vsxteycfjc = kfcjpoktbh fnywnmjoap (lbbbiwaols, sjhojkezqv - uijqotlhip) View more | - | 09 Aug 2024 | |||
Phase 3 | 466 | Ado-trastuzumab Emtansine+Tucatinib (Tucatinib+ Ado-trastuzumab Emtansine) | dbefnqvcxa(epvaajfmgs) = zplcxdycld nlxmwgvrey (qtotfrgogo, sxcfkpgubu - tpbwdetkrv) View more | - | 30 Jul 2024 | ||
Ado-trastuzumab Emtansine (Placebo+ Ado-trastuzumab Emtansine) | dbefnqvcxa(epvaajfmgs) = zylbddvsqv nlxmwgvrey (qtotfrgogo, nmsxtnzabr - noicuymnhy) View more | ||||||
Phase 2 | HER2 Positive Colorectal Cancer RAS Wild Type | HER2 Positive | 116 | Tucatinib + Trastuzumab | uvrzfqsmri(htdifcfmfu) = gjgldcolye rchlffpmcn (vboxpgyiji, 18.7 - 28.3) View more | Positive | 24 May 2024 | |
Tucatinib monotherapy | uvrzfqsmri(htdifcfmfu) = niowlnvgqr rchlffpmcn (vboxpgyiji, 17.0 - NE) View more |