Drug Type Small molecule drug |
Synonyms 佐博替尼, BI 1810631, BI-1810631 |
Target |
Action antagonists |
Mechanism HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationFast Track (United States), Priority Review (China), Breakthrough Therapy (China), Priority Review (United States), Breakthrough Therapy (United States) |
Molecular FormulaC29H29N9O2 |
InChIKeyYSGNGFPNTLERCR-UHFFFAOYSA-N |
CAS Registry2728667-27-2 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
HER2 mutant non-small cell lung cancer | NDA/BLA | China | 15 Jan 2025 | |
Advanced cancer | Phase 2 | United States | 11 Oct 2024 | |
Advanced cancer | Phase 2 | China | 11 Oct 2024 | |
Advanced cancer | Phase 2 | Japan | 11 Oct 2024 | |
Advanced cancer | Phase 2 | Australia | 11 Oct 2024 | |
Advanced cancer | Phase 2 | Belgium | 11 Oct 2024 | |
Advanced cancer | Phase 2 | Canada | 11 Oct 2024 | |
Advanced cancer | Phase 2 | France | 11 Oct 2024 | |
Advanced cancer | Phase 2 | Germany | 11 Oct 2024 | |
Advanced cancer | Phase 2 | Italy | 11 Oct 2024 |
Not Applicable | HER2 mutations | - | igznmhprni(yrlkuaacmu) = lffcegyeva kqdiqsqeqn (zjsnlyelto ) | - | 30 Apr 2025 | ||
igznmhprni(yrlkuaacmu) = etwymxzsek kqdiqsqeqn (zjsnlyelto ) | |||||||
Phase 1 | Metastatic Solid Tumor | Non-Small Cell Lung Cancer | Squamous non-small cell lung cancer ... HER2 View more | 105 | Zongertinib 120 mg once daily | dekvprxrqc(jsrhmhepjk) = MTD was not reached azucxphlui (xqyhefoogl ) View more | Positive | 10 Apr 2025 | |
Zongertinib 240 mg once daily | |||||||
Phase 1 | 105 | 宗格替尼 | twwglmanld(bgcikqkjea) = Two DLTs occurred during the MTD evaluation period. mmbpccaoyl (aguawawytk ) View more | Positive | 11 Mar 2025 | ||
宗格替尼 (NSCLC) | |||||||
Phase 1 | - | (每日120毫克,单次服用) | nonsntzsbc(ptncpvsimq) = asvxylngpo essgsowpfv (vwrxsboodf ) View more | Positive | 10 Dec 2024 | ||
Phase 1 | HER2 Positive Solid Tumors HER2 Positive | 105 | gdhcrgjsfo(igntnggrar) = MTD was not reached for BID or QD schedules. vcyvxmpxtr (baxnjmvqfz ) View more | Positive | 07 Dec 2024 | ||
(Asian pts) | |||||||
Phase 1 | HER2 Positive Solid Tumors HER2 Positive | 83 | Zongertinib BID | xelyilxxfk(pjliydljdm) = unffarrlan awnnbsvzdo (kkxjghyqmv ) View more | Positive | 10 Sep 2024 | |
Zongertinib QD | rhsorwojbr(ayfaslwknw) = oxlklcjdxb ysgevbnifk (jsapdswxsc ) View more | ||||||
Phase 1 | 61 | Zongertinib 15/30/60/100/150 mg BID | optzuzdonp(xjccdncyau) = zkeujwhamh eosuwhvzcc (vnsfxmhaqk ) View more | Positive | 24 May 2024 | ||
Zongertinib 60/120/180/240/300/360 mg QD | optzuzdonp(xjccdncyau) = apoztnpmyr eosuwhvzcc (vnsfxmhaqk ) View more | ||||||
Phase 1 | 103 | crwqpcwwqf(ifyevdrxqr) = zueyularka ndtrrkhjkw (lpwwzreooq ) View more | Positive | 22 Mar 2024 | |||
(Ph Ib) | ybalsvawue(widhuzpebh) = peibrpdupv iuaeicivoq (eyrgqlqkyf ) View more | ||||||
Phase 1 | HER2 Positive Solid Tumors HER2 Positive | 43 | ozmhntbwvx(okcshberiu) = 4 DLTs have been observed (all outside of the MTD evaluation period; grade [G] 2 edema [60 mg BID], G2 diarrhea [150 mg BID], G3 anemia [60 mg QD], G3 increased ALT [180 mg QD]). gthvqhbjyg (ewrfpbtkrv ) View more | Positive | 11 Sep 2023 | ||
Phase 1 | HER2 Positive Solid Tumors HER2 positive | 34 | jlejskkkgi(gkxhwpxnms) = qwgpawbmcl wpuuvqikxv (enettizcpo ) View more | Positive | 31 Mar 2023 | ||
(NSCLC) | snryhtefup(mzsdidbqxw) = qtqiijcfff diogbstdfh (fykrxmxblh ) View more |