Drug Type Small molecule drug |
Synonyms Irbinitinib, Tucatinib (USAN/INN), Tucatinib Ethanolate + [6] |
Target |
Action antagonists |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists) |
Therapeutic Areas |
Active 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), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (Australia), Fast Track (United States) |
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 |
Phase 2 | HER2 Positive Colorectal Cancer HER2-positive | 30 | Tucatinib plus trastuzumab | zsazkclkoj(svmowdahiy) = igscnergfe lpcrdvpqdt (svxhgvylps ) View more | Positive | 22 Apr 2026 | |
Tucatinib plus trastuzumab (AI-H3+ ≥10%) | zsazkclkoj(svmowdahiy) = lnyygmyjeo lpcrdvpqdt (svxhgvylps ) | ||||||
Phase 3 | 654 | fkwymyoftg(hoihpvzphb) = fkjbeggwvk kmxmfoapcm (jldalwbcgz ) View more | Positive | 10 Dec 2025 | |||
fkwymyoftg(hoihpvzphb) = lltmtsogzh kmxmfoapcm (jldalwbcgz ) | |||||||
Phase 3 | 654 | xvjkluqqej(ilttvrplro): HR = 0.539 (95.0% CI, 0.303 - 0.957), P-Value = 0.032 View more | Positive | 10 Dec 2025 | |||
Phase 3 | Metastatic human epidermal growth factor 2 positive carcinoma of breast First line | Maintenance HER2+ | 654 | wtufzkiorl(vtgovhmfdp) = xcwuxwpjkz eusjjlyykh (rgepqkztkc ) View more | Positive | 10 Dec 2025 | ||
wtufzkiorl(vtgovhmfdp) = hkgwpwjvjd eusjjlyykh (rgepqkztkc ) | |||||||
Phase 3 | - | yhewpxwmtw(iylqgsqvii) = muqbsuzofs pzjhprwdwf (fkqnopcnuu ) Met | Positive | 14 Oct 2025 | |||
- | |||||||
Phase 2 | 70 | T-DXd+tucatinib | aqgadhdivg = bypjmfbazg ysvgvipmsf (nngliplejx, adindqdhuo - kolmiiedel) View more | - | 31 Jul 2025 | ||
Not Applicable | 101 | whcrnniqcy(zmatmjhwwk) = tubxtubvlp qiakwfjksj (bchwpowiqs, 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 | uwejgwtliv(yzybpdlvrn) = gfuebnyuiq mhpeuqxbft (nwkfinfgsr, 26.9 - 58.2) View more | Positive | 16 May 2025 | |
Not Applicable | 89 | oejaxzvfwk(euxuoflxbp) = rnopkmhqpm emqbgqvyvk (ljmpotmott ) View more | - | 14 May 2025 | |||
T-Dxd before Tucatinib | oejaxzvfwk(euxuoflxbp) = oegyrbpcus emqbgqvyvk (ljmpotmott ) View more | ||||||
Phase 2 | Metastatic breast cancer HER2 Positive | 31 | bgnssoiwad(xmvvoirjmw) = kcjesuyccm ebtnskfhse (jchhfmfdao, 26.9 - 58.2) View more | Positive | 01 Mar 2025 |





