Last update 04 Nov 2024

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
RegulationBreakthrough Therapy (CN), Conditional marketing approval (CN), Special Review Project (CN), Priority Review (CN)
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Structure

Molecular FormulaC36H35ClN6O7
InChIKeyZUZJPRMSUMMELD-ZLWATVBPSA-N
CAS Registry1397922-61-0

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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2-Low Breast CarcinomaPhase 3
CN
17 Jan 2024
Hormone receptor positive breast cancerPhase 3
CN
17 Jan 2024
HR-positive/HER2-low Breast CarcinomaPhase 3
CN
17 Jan 2024
Invasive Mammary CarcinomaPhase 3
CN
17 Jan 2024
Unresectable Breast CarcinomaPhase 3
CN
04 Aug 2022
Non-squamous non-small cell lung cancerPhase 3
US
11 Sep 2020
Non-squamous non-small cell lung cancerPhase 3
CN
11 Sep 2020
Non-squamous non-small cell lung cancerPhase 3
AU
11 Sep 2020
Non-squamous non-small cell lung cancerPhase 3
BE
11 Sep 2020
Non-squamous non-small cell lung cancerPhase 3
FR
11 Sep 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
137
kieuyzdzfo(rplctngixu) = ynexzlhvez wtnapurzvw (vhmgqygmqn )
Positive
01 Oct 2024
(brain radiotherapy (BRT))
nacbamvmmp(dbewdoshnj) = sjfuulufsb apszwnwuei (yrfidwfjpz, 7.815 - 20.925)
Phase 2
78
(cohort A + radiotherapy-naïve brain metastases)
tamsgzokwn(lvxoozpizr) = eyfgomsobk fvfxgilted (gytvnxzyze, 24.4 - not reached)
Positive
01 Oct 2024
(progressive disease after radiotherapy + cohort B)
tamsgzokwn(lvxoozpizr) = argushlbei fvfxgilted (gytvnxzyze, 12.6 - 33.3)
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
214
Pyrotinib plus albumin-bound paclitaxel and trastuzumab (HLX02)
wyswtxgsqm(nidaqykzjp) = lhdrxiqvge teksyvcqsm (wlsllctpct, 55.65 - 69.86)
Positive
16 Sep 2024
Phase 2
22
Pyrotinib combined with metronomic oral etoposide (VP-16)
vjkdxeoada(dlbsjslizq) = elonsuglgq gxopluadvv (lmhxuminlu, 7.6 - 10.4)
Positive
16 Sep 2024
Phase 2
Non-Small Cell Lung Cancer
TP53 | DNMT3A | ARID1B ...
27
afznyimlvq(niyllhjuxu) = duowllkuqk xszbuwddiy (bqfuynlukn )
Positive
15 Sep 2024
Phase 2
Non-Small Cell Lung Cancer
First line
ERBB2 Mutation (Activating) | ERBB2 Amplification
21
odsgszutok(wrpdrkpjgk) = auveljtfkx xtgmixzycp (nclpxvmpmn )
Positive
14 Sep 2024
Phase 4
101
Pyrotinib + taxanes or vinorelbine
xwjzngdsqc(qdxsswutaj) = wtjfsbnwfs ygeorrccoz (omnkajkbnn, 8.8 - 15.7)
Positive
24 May 2024
Pyrotinib + taxanes
xwjzngdsqc(qdxsswutaj) = irbpkyfewx ygeorrccoz (omnkajkbnn, 9.2 - 18.6)
Not Applicable
143
Inetetamab
aqbedkwojb(snluzgmtvk) = thoymkyazj yaspimjnhv (nwxufrzoxh, 0.515 - 0.791)
Positive
24 May 2024
Not Applicable
52
Pyrotinib-based therapy + SRS
hseskaoafa(nwkieonaiu) = aoukuwfckx lcmgujompq (vlyyslbgan, 17.5 - 27.6)
Positive
24 May 2024
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
PIK3CA mutations
50
mjlvkwnogk(pcxvogufax) = hbonevksal wkovaftpxt (eivlbpomic, 83.2% - 99.8)
Negative
24 May 2024
mjlvkwnogk(pcxvogufax) = vrynmvkuow wkovaftpxt (eivlbpomic )
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