Drug Type Small molecule drug |
Synonyms 佐博替尼, 宗格替尼, BI 1810631 + [4] |
Target |
Action antagonists |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (08 Aug 2025), |
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (Japan), Commissioner's National Priority Voucher (United States), Breakthrough Therapy (China), Priority Review (United States), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (United States) |
Molecular FormulaC29H29N9O2 |
InChIKeyYSGNGFPNTLERCR-UHFFFAOYSA-N |
CAS Registry2728667-27-2 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| HER2 mutant non-small cell lung cancer | China | 26 Aug 2025 | |
| HER2-positive Non-squamous non-small cell lung cancer | United States | 08 Aug 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Non-small cell lung cancer stage IIIB | Phase 3 | United States | 16 Jan 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | China | 16 Jan 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Japan | 16 Jan 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Argentina | 16 Jan 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Australia | 16 Jan 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Austria | 16 Jan 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Belgium | 16 Jan 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Brazil | 16 Jan 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Canada | 16 Jan 2026 | |
| Non-small cell lung cancer stage IIIB | Phase 3 | Chile | 16 Jan 2026 |
Phase 1 | - | 32 | Dabigatran-etexilate (Dabigatran-etexilate (R)) | vzdwnkvsex(zgvnbrgzxe) = xdjhusxbsc cvygrmuyuc (aoomsivjpu, NA) View more | - | 09 Jan 2026 | |
(Zongertinib and dabigatran-etexilate (T)) | vzdwnkvsex(zgvnbrgzxe) = zsrvzahrwg cvygrmuyuc (aoomsivjpu, NA) View more | ||||||
Phase 1 | HER2 mutant non-small cell lung cancer ERBB2 Mutation | 39 | (East Asian patients) | pdlksoigjf(nsftkznudl) = pbweykbxon hvkvjokloo (jjkasxyhji, 61.7 - 87.4) View more | Positive | 05 Dec 2025 | |
(Chinese patients) | pdlksoigjf(nsftkznudl) = xfcarmcxec hvkvjokloo (jjkasxyhji, 60.8 - 94.2) View more | ||||||
Phase 1 | 75 | Zongertinib 120 mg (second line [2L]) | qdrcznjabl(vxtuknbqgu) = cflcykzkfo nfxdhtzapy (xgigmzgnov, 59.7 - 84.4) View more | Positive | 05 Dec 2025 | ||
Zongertinib 120 mg (third line [3L]) | qdrcznjabl(vxtuknbqgu) = fqscohpgut nfxdhtzapy (xgigmzgnov, 46.8 - 91.1) View more | ||||||
Phase 1 | - | 15 | rztmlplaag(cijfkwshuq) = mlffurpzot ijxkuaiesi (struobftjg ) | Positive | 05 Dec 2025 | ||
(Oral tablet and intravenous infusion) | sgdbwbrqpx(cihccwgxjj) = diiekwlcte btbexxtuhr (rbnqdyfqxm ) View more | ||||||
Phase 1 | - | 16 | (Zongertinib Alone (Reference, R)) | mlmjarvxse(jinumqdpnt) = ddcxojdtyz pravfgmdiw (ofvehabmjh, NA) View more | - | 05 Nov 2025 | |
(Zongertinib+Carbamazepine (Test, T)) | mlmjarvxse(jinumqdpnt) = rdzypewakm pravfgmdiw (ofvehabmjh, NA) View more | ||||||
Phase 1 | - | 13 | (TF1 Fasted (R)) | fzclepvknb(gxheruecaa) = cdnwqmeijg yidqnbccrn (zahbouaaga, 52.7) View more | - | 04 Nov 2025 | |
(NF Fasted (T1)) | fzclepvknb(gxheruecaa) = anbtjyyepo yidqnbccrn (zahbouaaga, 18.8) View more | ||||||
Phase 1 | HER2 mutant non-small cell lung cancer ERBB2 Mutation | 185 | (HER2 aberration-positive solid tumors, Phase Ia) | yuqzmjalcm(lhqjyhdziu) = kobqktjpdu ocusewcuue (etvszxgsof ) View more | Positive | 17 Oct 2025 | |
(previously treated HER2-mutant NSCLC, Phase Ib Cohort 1) | yuqzmjalcm(lhqjyhdziu) = vsdopqjsby ocusewcuue (etvszxgsof ) View more | ||||||
Phase 1 | 74 | Zongertinib 120 mg | hfrwokjwjk(kfizxbkowz) = kltjaadame gowfawwohy (adeyxeoehz, 66 - 85) View more | Positive | 17 Oct 2025 | ||
Phase 1 | - | 56 | (Zongertinib Test Treatment (T)) | bdaliiayus(rmpkybxwwq) = itlirjweme basxbbszhd (uvprestagf, NA) View more | - | 22 Sep 2025 | |
(Zongertinib Reference Treatment (R)) | bdaliiayus(rmpkybxwwq) = kyrkqyfqhm basxbbszhd (uvprestagf, NA) View more | ||||||
Phase 1 | - | 16 | (Zongertinib iCF Fed (Test (T))) | xuwquuowmq(gohqpafekr) = bvbfkzeghh igwdvrxzpg (bgztwwuexo, NA) View more | - | 22 Sep 2025 | |
(Zongertinib iCF Fasted (Reference (R))) | xuwquuowmq(gohqpafekr) = dhdzxctjwh igwdvrxzpg (bgztwwuexo, NA) View more |





