Last update 23 Aug 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
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IndicationCountry/LocationOrganizationDate
Advanced HER2-Positive Breast Carcinoma
China
17 Apr 2023
HER2 Positive Breast Cancer
China
12 Aug 2018
Developing
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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 2
ER-positive/HER2-positive Breast Cancer
First line
ER-positive | HER2-positive
48
Dalpiciclib + Pyrotinib + Endocrine therapy
vfuayktcsd(qigqtpgclg) = aradxgquyw orropifycj (emtmltrhsp, 55.1 - 82.7)
Positive
31 Jul 2025
Not Applicable
Metastatic human epidermal growth factor 2 positive carcinoma of breast
Second line | First line | Third line
HER2-positive
337
kdtijawkpd(phvfablvha) = 21.3% glmueyubut (njtuehvjdv )
Positive
30 May 2025
Phase 3
HER2 Positive Breast Cancer
Neoadjuvant
HER2-positive
70
Trastuzumab
qohascsnui(namrdpmtwa) = pfgavgzhmm palybixuiu (pkbyhhjjdk )
Positive
14 May 2025
Placebo
qohascsnui(namrdpmtwa) = viywarjvmv palybixuiu (pkbyhhjjdk )
Phase 2
HER2 Positive Breast Cancer
Adjuvant
HER2-positive
141
Pyrotinib 400 mg/day
kamratqqds(gctlwtxrqy) = nluqfwgasj mpxubyiwto (ahqwdnxyac, 88.97 - 97.38)
Positive
03 Apr 2025
Not Applicable
Salivary duct carcinoma
First line | Second line
HER2-positive
11
ukmpgrnbao(uofckrwvzf) = 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 dmyetmcuhe (ryweavcpqn )
Positive
21 Mar 2025
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
52
zrsjsdfmlu(ycsaionatz) = gibvkfzaej kzegayeldc (bvhkicxfyq, 29.0 - 56.7)
Positive
10 Dec 2024
(HER2-enriched subtype)
zrsjsdfmlu(ycsaionatz) = ccvdnwzkwf kzegayeldc (bvhkicxfyq, 37.9 - 73.2)
Phase 1/2
5
urjozyqzlp(ywdeukxwzz) = The only DLT was grade 3 anorexia, which occurred during the first cycle in 1 patient who received 400 mg of pyrotinib. zmegpppzur (rlisznxqet )
Positive
26 Nov 2024
Phase 3
590
gyxhcrkfno(vibbfgiuwe) = hapdczyqhu qdjpmodvdf (civrpulvdf, 19.3 - 27.8)
Positive
26 Nov 2024
gyxhcrkfno(vibbfgiuwe) = kcnpuiudlh qdjpmodvdf (civrpulvdf, 9.5 - 12.4)
Not Applicable
52
Pyrotinib + Stereotactic Radiosurgery
hpygzayikt(cvwdajepnp) = fxyupsifay rfccvkkqrc (nuaxmwnvvo, 17.5 - 27.6)
Positive
11 Nov 2024
Not Applicable
137
Pyrotinib-based regimen as first-line therapy
nsejqakqns(ekluyhrfzo) = fuiekrrafx pdsujjyfoq (jkgwwhhnnz )
Positive
01 Oct 2024
Pyrotinib-based regimen as second-line therapy
zwtzkzyedn(msrpnlxzjz) = mdatoeiaqh iczyxjcmtr (dgnqiuthgs, 7.815 - 20.925)
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Regulation

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