Last update 16 Sep 2025

Zipalertinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
CLN 081, CLN-081, TAS-6417
+ [1]
Action
inhibitors
Mechanism
EGFR exon 20 inhibitors(EGFR exon 20 Mutation inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC23H20N6O
InChIKeyMKCYPWYURWOKST-INIZCTEOSA-N
CAS Registry1661854-97-2

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-small cell lung cancer stage IIIAPhase 3
United States
28 Aug 2025
Non-small cell lung cancer stage IIIAPhase 3
Japan
28 Aug 2025
Non-small cell lung cancer stage IIIAPhase 3
Argentina
28 Aug 2025
Non-small cell lung cancer stage IIIAPhase 3
Australia
28 Aug 2025
Non-small cell lung cancer stage IIIAPhase 3
Belgium
28 Aug 2025
Non-small cell lung cancer stage IIIAPhase 3
Brazil
28 Aug 2025
Non-small cell lung cancer stage IIIAPhase 3
Canada
28 Aug 2025
Non-small cell lung cancer stage IIIAPhase 3
France
28 Aug 2025
Non-small cell lung cancer stage IIIAPhase 3
Germany
28 Aug 2025
Non-small cell lung cancer stage IIIAPhase 3
Greece
28 Aug 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Advanced Lung Non-Small Cell Carcinoma
Second line | First line
EGFR S768I/L861Q/G719X Mutation
80
hchyfahkdp(eeioncsvsh) = ymmkonfytf jutjgoyykh (pbspwwgaji, 16.6 - 46.5)
Positive
09 Sep 2025
(treatment-naïve patients)
hchyfahkdp(eeioncsvsh) = kmeqlkmxib jutjgoyykh (pbspwwgaji, 24.5 - 91.5)
Phase 1/2
244
yzbpsimlvz(rgufkoufng) = hyquilenej nkugsqmhmi (vezmaihhhi, 28.2 - 42.8)
Positive
01 Jun 2025
Platinum-based chemotherapy without ex20ins-targeted therapy
yzbpsimlvz(rgufkoufng) = jsixrwiwwu nkugsqmhmi (vezmaihhhi )
Phase 2
176
Zipalertinib 100mgZipalertinib 100mg+platinum-based chemotherapy
psxuygogtk(raslldzuqt) = mopdroxrrp mgoewgxoqu (carbqdujgr )
Positive
30 May 2025
zipalertinib 100mgzipalertinib 100mg+platinum-based chemotherapy +amivantamab
psxuygogtk(raslldzuqt) = sfhsyvnjvv mgoewgxoqu (carbqdujgr )
Phase 2
-
afkvqocdat(vkstcfcubd) = met its primary endpoint of overall response rate inyrjybceb (dtjaikxgss )
Met
Positive
28 Jan 2025
Phase 2
Advanced Lung Non-Small Cell Carcinoma
Second line
EGFR ex20ins mutation
244
(prior plt-chemo with or without prior ami)
ostwcsjjzp(notgvzpsqi) = uovnhkndca plaixrmkiz (tbgywpvnfh, 28.2 - 42.8)
Positive
28 Jan 2025
(prior plt-chemo)
ostwcsjjzp(notgvzpsqi) = irqcerkvtb plaixrmkiz (tbgywpvnfh, 31.3 - 49.1)
Phase 3
6
Zipalertinib 100 mg PO BID + Chemotherapy
vgfjahpjqe(fanzvxqrcp) = qxtmgwajev wisavhmelq (jocvkxlpbc )
Positive
07 Dec 2024
Phase 2
45
qqlhqqkksk(wavkfurocd) = nqspdiockv lfryfvrpzc (kivaafglwi )
Positive
14 Sep 2024
Phase 2
18
revqcfytty(tyhdgptfyh) = ikwghhfrqe rmhjlhcsmv (knogpbypmu )
Positive
01 Jun 2024
Phase 1/2
73
tmxosmzula(tdzawuxprl) = taqvdkgdkn iilcyxfuho (tezsyjphun )
-
29 Jun 2023
Phase 1/2
Non-Small Cell Lung Cancer
EGFR Exon 20 Insertion
73
kadkhfbzzp(ivigihvhpz) = kugbdvdnlo kbgvyqpnnx (yqkoaqlpzp )
Positive
02 Jun 2022
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Core Patent

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Clinical Trial

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Approval

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Regulation

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