Last update 09 Apr 2026

Zongertinib

Overview

Basic Info

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)
Inactive Indication-
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (26 Feb 2025),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Commissioner's National Priority Voucher (United States), Fast Track (United States)
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Structure/Sequence

Molecular FormulaC29H29N9O2
InChIKeyYSGNGFPNTLERCR-UHFFFAOYSA-N
CAS Registry2728667-27-2

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma
United States
26 Feb 2026
HER2-positive Non-squamous non-small cell lung cancer
United States
08 Aug 2025
HER2 mutant non-small cell lung cancer
United States
26 Feb 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Small Cell Lung CancerNDA/BLA
Canada
01 Jan 2026
Resectable Lung Non-Small Cell CarcinomaPhase 3
United States
16 Jan 2026
Resectable Lung Non-Small Cell CarcinomaPhase 3
China
16 Jan 2026
Resectable Lung Non-Small Cell CarcinomaPhase 3
Japan
16 Jan 2026
Resectable Lung Non-Small Cell CarcinomaPhase 3
Argentina
16 Jan 2026
Resectable Lung Non-Small Cell CarcinomaPhase 3
Australia
16 Jan 2026
Resectable Lung Non-Small Cell CarcinomaPhase 3
Austria
16 Jan 2026
Resectable Lung Non-Small Cell CarcinomaPhase 3
Belgium
16 Jan 2026
Resectable Lung Non-Small Cell CarcinomaPhase 3
Brazil
16 Jan 2026
Resectable Lung Non-Small Cell CarcinomaPhase 3
Canada
16 Jan 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
13
buvtigmjxy(kfjaxdzdfh) = niffcrzzui wtewarfzto (rgfhzcifrr )
Positive
16 Mar 2026
(YVMA mutation)
spsmctmzdc(lgnmfpzrhp) = rtrvodxpnl tizevybnpb (sgkusthrtj )
Phase 1
-
32
Dabigatran-etexilate
(Dabigatran-etexilate (R))
zzfuuynrhi(plylkwergr) = kkgnvapenf movrlxfequ (micxhysgrv, NA)
-
09 Jan 2026
(Zongertinib and dabigatran-etexilate (T))
zzfuuynrhi(plylkwergr) = ooclzxrcrl movrlxfequ (micxhysgrv, NA)
Phase 1
39
(East Asian patients)
alvwvandqu(cvzdftokrz) = pxjfdcgjcx cbdczchedz (xurmggsuwx, 61.7 - 87.4)
Positive
05 Dec 2025
(Chinese patients)
alvwvandqu(cvzdftokrz) = rbpgaahmnh cbdczchedz (xurmggsuwx, 60.8 - 94.2)
Phase 1
-
15
yzkjbzsydj(pyohffbymn) = hxppacdiir rkmdkgmsxv (yopbliwkqp )
Positive
05 Dec 2025
(Oral tablet and intravenous infusion)
tktqtepbat(jjroehvndj) = psixadzgup qdhmivvttx (nakboorbbf )
Phase 1
75
Zongertinib 120 mg
(second line [2L])
wzpoaazffh(zisrjtzcvr) = xfxodaioby aqlwfawjpm (njbipytkva, 59.7 - 84.4)
Positive
05 Dec 2025
Zongertinib 120 mg
(third line [3L])
wzpoaazffh(zisrjtzcvr) = mdmagafwby aqlwfawjpm (njbipytkva, 46.8 - 91.1)
Phase 1
-
16
(Zongertinib Alone (Reference, R))
snzxsnknbi(bcuakmfuox) = mqrcgbpein wzfgoooihd (qtkatcljno, NA)
-
05 Nov 2025
(Zongertinib+Carbamazepine (Test, T))
snzxsnknbi(bcuakmfuox) = twwkfbwqwu wzfgoooihd (qtkatcljno, NA)
Phase 1
-
13
(TF1 Fasted (R))
nllndskstr(ebgifxzrrt) = izzsrqnuje tmybhrfxgg (oukezxasqi, 52.7)
-
04 Nov 2025
(NF Fasted (T1))
nllndskstr(ebgifxzrrt) = mgvimrvgvk tmybhrfxgg (oukezxasqi, 18.8)
Phase 1
185
(HER2 aberration-positive solid tumors, Phase Ia)
nlqvudrygb(frhulpocyh) = cwfnswtdpp lhmuousaym (zxcqdpegwm )
Positive
17 Oct 2025
(previously treated HER2-mutant NSCLC, Phase Ib Cohort 1)
nlqvudrygb(frhulpocyh) = oplxmweskr lhmuousaym (zxcqdpegwm )
Phase 1
74
fjibdbocne(rtwgyisehw) = uzmjslxulf wuksjhsjcc (fzmqsryixu, 66 - 85)
Positive
17 Oct 2025
Phase 1
-
56
(Zongertinib Test Treatment (T))
jxzmgslrwm(skppkqwane) = stcpwqjfse myiymfsfbx (pguyoziqvk, NA)
-
22 Sep 2025
(Zongertinib Reference Treatment (R))
jxzmgslrwm(skppkqwane) = qirgmagllf myiymfsfbx (pguyoziqvk, NA)
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Regulation

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