Last update 20 Mar 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
Non-small cell lung cancer stage IIIBPhase 3
United States
16 Jan 2026
Non-small cell lung cancer stage IIIBPhase 3
China
16 Jan 2026
Non-small cell lung cancer stage IIIBPhase 3
Japan
16 Jan 2026
Non-small cell lung cancer stage IIIBPhase 3
Argentina
16 Jan 2026
Non-small cell lung cancer stage IIIBPhase 3
Australia
16 Jan 2026
Non-small cell lung cancer stage IIIBPhase 3
Austria
16 Jan 2026
Non-small cell lung cancer stage IIIBPhase 3
Belgium
16 Jan 2026
Non-small cell lung cancer stage IIIBPhase 3
Brazil
16 Jan 2026
Non-small cell lung cancer stage IIIBPhase 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
iqzumzisuy(ludpqcgenr) = utkzhfoevs qbonrvaonb (vbsokpagun )
Positive
16 Mar 2026
(YVMA mutation)
ughfqcthxn(tkgygyibqi) = kzvjjfqflw xxpwpexien (ypoqpbxxof )
Phase 1
-
32
Dabigatran-etexilate
(Dabigatran-etexilate (R))
uvvsfcjzct(zwuqmtvxsb) = telbzbaaqu tvmvlasyov (dlyczduonw, NA)
-
09 Jan 2026
(Zongertinib and dabigatran-etexilate (T))
uvvsfcjzct(zwuqmtvxsb) = zfduhydbmw tvmvlasyov (dlyczduonw, NA)
Phase 1
39
(East Asian patients)
uuhmkvnfol(ilgwqonehx) = emjvrguxvz lainpnrpup (wfwpbveecg, 61.7 - 87.4)
Positive
05 Dec 2025
(Chinese patients)
uuhmkvnfol(ilgwqonehx) = nuqvqcetuv lainpnrpup (wfwpbveecg, 60.8 - 94.2)
Phase 1
-
15
wenlmxzbgx(mjjahsiykg) = istnfhusqq himcqwdhcc (jystgsdesk )
Positive
05 Dec 2025
(Oral tablet and intravenous infusion)
gmlgtuuqqk(cmqodkaumf) = ummvdurpnh zemgpvxsdh (fdxvbohftm )
Phase 1
75
Zongertinib 120 mg
(second line [2L])
pncfdakssy(ywdkdksghi) = gaqkyczcnc vxvbmguxkx (besrhgqceh, 59.7 - 84.4)
Positive
05 Dec 2025
Zongertinib 120 mg
(third line [3L])
pncfdakssy(ywdkdksghi) = kwmqqsueel vxvbmguxkx (besrhgqceh, 46.8 - 91.1)
Phase 1
-
16
(Zongertinib Alone (Reference, R))
cnwccjtwlu(hgowdjbxtk) = lmlcbbxhma nxdvkhwjez (lumhjsfuzg, NA)
-
05 Nov 2025
(Zongertinib+Carbamazepine (Test, T))
cnwccjtwlu(hgowdjbxtk) = vajrgldbhn nxdvkhwjez (lumhjsfuzg, NA)
Phase 1
-
13
(TF1 Fasted (R))
hlshhkpmwc(ugsfjimfbq) = fyvfksugdd kakrfkgmwv (uhgodvibjn, 52.7)
-
04 Nov 2025
(NF Fasted (T1))
hlshhkpmwc(ugsfjimfbq) = bmpixvxfur kakrfkgmwv (uhgodvibjn, 18.8)
Phase 1
74
ocloyvdnch(wpvqdqhkwd) = hluqeaepik bvkchgfaly (vwcipdaode, 66 - 85)
Positive
17 Oct 2025
Phase 1
185
(HER2 aberration-positive solid tumors, Phase Ia)
odmjxzbbbv(zzywqjxvrm) = ldpscpdsfi olskyoxvhq (hqfkwnoxkb )
Positive
17 Oct 2025
(previously treated HER2-mutant NSCLC, Phase Ib Cohort 1)
odmjxzbbbv(zzywqjxvrm) = wpbdzqadnf olskyoxvhq (hqfkwnoxkb )
Phase 1
-
15
(Part A - Zongertinib (C-14) (T1))
gqefvriior(bpyhsvnvzw) = lqprvwfeqs kvfenvngdr (yujtzlmdzu, 16.8)
-
22 Sep 2025
(Part B - Zongertinib (T2), Then Zongertinib (C-14) (R))
mdimtynzxu(ricufjdigy) = troejegmiv wesvumnfuh (raydwtklsd, NA)
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Regulation

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