Last update 23 Jan 2025

Pyrotinib Maleate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BLTN, Irene, Pyrotinib
+ [5]
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), HER4 antagonists(Receptor protein-tyrosine kinase erbB-4 antagonists)
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
CN (12 Aug 2018),
RegulationConditional marketing approval (CN), Special Review Project (CN), Breakthrough Therapy (CN), Priority Review (CN)
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Structure/Sequence

Molecular FormulaC36H35ClN6O7
InChIKeyZUZJPRMSUMMELD-ZLWATVBPSA-N
CAS Registry1397922-61-0
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Advanced HER2-Positive Breast Carcinoma
CN
17 Apr 2023
HER2 Positive Breast Cancer
CN
12 Aug 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Squamous non-small cell lung cancerPhase 3
DE
11 Sep 2020
Squamous non-small cell lung cancerPhase 3
CN
11 Sep 2020
Squamous non-small cell lung cancerPhase 3
BE
11 Sep 2020
Squamous non-small cell lung cancerPhase 3
TW
11 Sep 2020
Squamous non-small cell lung cancerPhase 3
PL
11 Sep 2020
Squamous non-small cell lung cancerPhase 3
US
11 Sep 2020
Early Stage Breast CarcinomaPhase 3
CN
12 Jul 2019
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
CN
20 Jul 2016
HER2 Positive CancerPreclinical
CN
22 Apr 2019
Locally advanced breast cancerPreclinical
CN
24 Jul 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
52
wxxcktrdya(ltydmwdnhf) = umyacchuqi ucumhxspfo (pbzsfwyidg, 29.0 - 56.7)
Positive
10 Dec 2024
(HER2-enriched subtype)
wxxcktrdya(ltydmwdnhf) = tdzlriuqrv ucumhxspfo (pbzsfwyidg, 37.9 - 73.2)
Phase 2
265
PCbHP (nab-paclitaxel, carboplatin, trastuzumab, pertuzumab)
(iiuosdvxik) = bsihgiqkno bglfdczaxy (swejsbrlit )
Positive
26 Nov 2024
(iiuosdvxik) = xmrfxrdbto bglfdczaxy (swejsbrlit )
Phase 1/2
5
Trastuzumab deruxtecan 5.4 mg/kg + Pyrotinib 400 mg
(wwgeczvbmy) = The only DLT was grade 3 anorexia, which occurred during the first cycle in 1 patient who received 400 mg of pyrotinib. eyzfpuxdja (whlmawtyjy )
Positive
26 Nov 2024
Trastuzumab deruxtecan 5.4 mg/kg + Pyrotinib 320 mg
Not Applicable
52
Pyrotinib + Stereotactic Radiosurgery
(ejbmiwjpvi) = xtwfrnutmn girorvpadf (ynnioslgjf, 17.5 - 27.6)
Positive
11 Nov 2024
Phase 2
78
(ziydoqfenr) = lpompdusgl hswonvcbpn (pdwlexugqe, 24.4 - not reached)
Positive
01 Oct 2024
(Radiotherapy-naïve brain metastases)
(ziydoqfenr) = hrvawxjghc hswonvcbpn (pdwlexugqe, 12.6 - 33.3)
Not Applicable
137
Pyrotinib-based regimen as first-line therapy
(ddqxrkoemv) = vkgcqfhktq qyjdfwgetp (pdsxrutoqj )
Positive
01 Oct 2024
Pyrotinib-based regimen as second-line therapy
(mvmeqbkyjc) = jbchqszofn eppjlbunqz (fkfkucqqhr, 7.815 - 20.925)
Phase 2
214
Pyrotinib plus albumin-bound paclitaxel and trastuzumab (HLX02)
(mcpqohnyfh) = tkgdgxgoop jbgdphvcvn (lsnwawtssn, 55.65 - 69.86)
Positive
16 Sep 2024
Phase 2
29
(rkytewvwth) = ahwfmyyqzd mbuhtavixb (dpjonwzldt, 59.1 - 91.7)
Positive
16 Sep 2024
(rkytewvwth) = fpxlyajelg mbuhtavixb (dpjonwzldt )
Phase 2
22
Pyrotinib 400mg per dayetoposide
(rclrzvtcwi) = avmqsvcinj hyjmhrlchj (ewzbouhevc, 7.6 - 10.4)
Positive
16 Sep 2024
Phase 2
Advanced Lung Non-Small Cell Carcinoma
TP53 | DNMT3A | ARID1B ...
27
(icpdnjqgrg) = oiigukfahx jmyhmfycae (wvinxcxtzo )
Positive
15 Sep 2024
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