Last update 26 Apr 2025

Zongertinib

Overview

Basic Info

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)
Inactive Indication-
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)
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Structure/Sequence

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

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 mutant non-small cell lung cancerNDA/BLA
China
15 Jan 2025
Advanced cancerPhase 2
United States
11 Oct 2024
Advanced cancerPhase 2
China
11 Oct 2024
Advanced cancerPhase 2
Japan
11 Oct 2024
Advanced cancerPhase 2
Australia
11 Oct 2024
Advanced cancerPhase 2
Belgium
11 Oct 2024
Advanced cancerPhase 2
Canada
11 Oct 2024
Advanced cancerPhase 2
France
11 Oct 2024
Advanced cancerPhase 2
Germany
11 Oct 2024
Advanced cancerPhase 2
Italy
11 Oct 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
HER2 mutations
-
igznmhprni(yrlkuaacmu) = lffcegyeva kqdiqsqeqn (zjsnlyelto )
-
30 Apr 2025
igznmhprni(yrlkuaacmu) = etwymxzsek kqdiqsqeqn (zjsnlyelto )
Phase 1
105
Zongertinib 120 mg once daily
dekvprxrqc(jsrhmhepjk) = MTD was not reached azucxphlui (xqyhefoogl )
Positive
10 Apr 2025
Zongertinib 240 mg once daily
Phase 1
Solid tumor | Non-Small Cell Lung Cancer
ERBB2 Mutation (Activating)
105
宗格替尼
twwglmanld(bgcikqkjea) = Two DLTs occurred during the MTD evaluation period. mmbpccaoyl (aguawawytk )
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 )
Positive
10 Dec 2024
Phase 1
105
gdhcrgjsfo(igntnggrar) = MTD was not reached for BID or QD schedules. vcyvxmpxtr (baxnjmvqfz )
Positive
07 Dec 2024
(Asian pts)
Phase 1
83
xelyilxxfk(pjliydljdm) = unffarrlan awnnbsvzdo (kkxjghyqmv )
Positive
10 Sep 2024
rhsorwojbr(ayfaslwknw) = oxlklcjdxb ysgevbnifk (jsapdswxsc )
Phase 1
61
Zongertinib 15/30/60/100/150 mg BID
optzuzdonp(xjccdncyau) = zkeujwhamh eosuwhvzcc (vnsfxmhaqk )
Positive
24 May 2024
Zongertinib 60/120/180/240/300/360 mg QD
optzuzdonp(xjccdncyau) = apoztnpmyr eosuwhvzcc (vnsfxmhaqk )
Phase 1
103
crwqpcwwqf(ifyevdrxqr) = zueyularka ndtrrkhjkw (lpwwzreooq )
Positive
22 Mar 2024
ybalsvawue(widhuzpebh) = peibrpdupv iuaeicivoq (eyrgqlqkyf )
Phase 1
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 )
Positive
11 Sep 2023
Phase 1
34
jlejskkkgi(gkxhwpxnms) = qwgpawbmcl wpuuvqikxv (enettizcpo )
Positive
31 Mar 2023
(NSCLC)
snryhtefup(mzsdidbqxw) = qtqiijcfff diogbstdfh (fykrxmxblh )
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Regulation

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