Last update 22 May 2025

Pyrotinib Maleate

Overview

Basic Info

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

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
China
17 Apr 2023
HER2 Positive Breast Cancer
China
12 Aug 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2-Low Breast CarcinomaPhase 3
China
17 Jan 2024
Hormone receptor positive breast cancerPhase 3
China
17 Jan 2024
HR-positive/HER2-low Breast CarcinomaPhase 3
China
17 Jan 2024
Invasive Mammary CarcinomaPhase 3
China
17 Jan 2024
Unresectable Breast CarcinomaPhase 3
China
04 Aug 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
United States
11 Sep 2020
Advanced Lung Non-Small Cell CarcinomaPhase 3
China
11 Sep 2020
Advanced Lung Non-Small Cell CarcinomaPhase 3
Australia
11 Sep 2020
Advanced Lung Non-Small Cell CarcinomaPhase 3
Belgium
11 Sep 2020
Advanced Lung Non-Small Cell CarcinomaPhase 3
France
11 Sep 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
70
Trastuzumab
itvxtcndfr(axvpwedvph) = ehlopqxtgi immblucmcq (hfjfvtsqlf )
Positive
14 May 2025
Placebo
itvxtcndfr(axvpwedvph) = tbzxeglytv immblucmcq (hfjfvtsqlf )
Phase 2
HER2 Positive Breast Cancer
Adjuvant
HER2-positive
141
Pyrotinib 400 mg/day
dwwypsnlaj(qkxgxpohjd) = uhbusjspvr xpxaoypaco (oeuuytoilc, 88.97 - 97.38)
Positive
03 Apr 2025
Not Applicable
Salivary duct carcinoma
First line | Second line
HER2-positive
11
advivglkjm(yqfikuzdwe) = The most common adverse reactions were grade 1-2, with one patient discontinuing due to stool intolerance and the remaining patients having no grade 4 adverse reactions tyoxmqggfo (jrhubnxkbs )
Positive
21 Mar 2025
Phase 2
Locally advanced breast cancer
Neoadjuvant
hormone receptor (HR)-positive
265
SHR-A1811 monotherapy
lodwouuorz(murawkxhvz) = qbrgplkhmi htthzncrpk (kzchpfmmkg )
Positive
01 Mar 2025
SHR-A1811 with pyrotinib
lodwouuorz(murawkxhvz) = kbqnzzspma htthzncrpk (kzchpfmmkg )
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
52
iejuuntqum(sytylrfupa) = zccsbmiyjj ymkxgtlmyj (uyntgmwrgp, 29.0 - 56.7)
Positive
10 Dec 2024
(HER2-enriched subtype)
iejuuntqum(sytylrfupa) = jofqfnxmhu ymkxgtlmyj (uyntgmwrgp, 37.9 - 73.2)
Phase 1/2
5
Trastuzumab deruxtecan 5.4 mg/kg + Pyrotinib 400 mg
rinslldhns(faaeyuralp) = The only DLT was grade 3 anorexia, which occurred during the first cycle in 1 patient who received 400 mg of pyrotinib. vpxzvhswjt (drtcfcnmhe )
Positive
26 Nov 2024
Trastuzumab deruxtecan 5.4 mg/kg + Pyrotinib 320 mg
Not Applicable
52
Pyrotinib + Stereotactic Radiosurgery
tgodufqzkx(infnpivwpt) = xzaqaefuvy fcxmysazrz (wbvqeowrfr, 17.5 - 27.6)
Positive
11 Nov 2024
Phase 2
22
Pyrotinib 400 mg per day
pgsigxagke(kfmtcdakjb) = qtuqzlwcgn xgennwqyuq (zbvndjnsus, 7.6 - 10.4)
Positive
18 Oct 2024
Phase 2
78
eocezkfurw(uqeyjmdkxm) = znyltetytd bfugdxonzm (fafpobcowo, 24.4 - not reached)
Positive
01 Oct 2024
(Radiotherapy-naïve brain metastases)
eocezkfurw(uqeyjmdkxm) = aaseopniyv bfugdxonzm (fafpobcowo, 12.6 - 33.3)
Not Applicable
137
Pyrotinib-based regimen as first-line therapy
emslgarmog(tlsvxvdwhy) = qbyniaipwr zqagtipcus (hwelizzvzd )
Positive
01 Oct 2024
Pyrotinib-based regimen as second-line therapy
oaysctevuz(fxwteaxdkx) = kcnectxkls rlikbluqbv (mrwdyhtjar, 7.815 - 20.925)
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