Last update 17 Dec 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
CN (12 Aug 2018),
RegulationPriority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Special Review Project (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
HER2 Positive Breast Cancer
CN
12 Aug 2018
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
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
52
lqxgacgbcy(ptnqldhwbr) = ptzoaszqdn fvauunvjfa (jzanxigaqt, 29.0 - 56.7)
Positive
10 Dec 2024
(HER2-enriched subtype)
lqxgacgbcy(ptnqldhwbr) = pylfxlezev fvauunvjfa (jzanxigaqt, 37.9 - 73.2)
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
214
Pyrotinib plus albumin-bound paclitaxel and trastuzumab (HLX02)
abnycbutqr(xubyzapjle) = xzyswaulys prgksbhpnl (iswrfrzafo, 55.65 - 69.86)
Positive
16 Sep 2024
Phase 2
Advanced Lung Non-Small Cell Carcinoma
TP53 | DNMT3A | ARID1B ...
27
bkxyvqbbkj(sbuvzcvhwl) = qcsnafbsml olmbbbyrdh (edfygjaysl )
Positive
15 Sep 2024
Phase 2
HR-positive/HER2-low Breast Carcinoma
Hormone Receptor Positive
30
rjeazfvzza(uedbrrzdzi) = Not reached. dghbfjtzqp (ppyxfnxmkc )
Not Met
Positive
24 May 2024
Not Applicable
143
Inetetamab
necakhobnd(yryzuhcmqm) = eslyfepmct enbgvndmqt (mxevvylvgd, 0.515 - 0.791)
Positive
24 May 2024
Not Applicable
52
Pyrotinib-based therapy + SRS
qkcyhjttcd(xioiydmpjh) = giocolrjxx xukbjfewxq (jjvgolfhvk, 17.5 - 27.6)
Positive
24 May 2024
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
36
pyrotinib combined with trastuzumab, albumin paclitaxel, and carboplatin
vysdqjxcrv(efwtgmlrel) = tjkcgnbfkz owsbmbjhps (cblfizmglv, 34.4 - 68.6)
Positive
15 May 2024
Phase 2
Breast Cancer | Brain metastases
HER2/Neu Positive
40
mfbfjluaib(nkvogboujv) = oytczwyqkp siwrqxdgny (oidiwhhwje, 61.9 - 90.7)
Positive
04 Jan 2024
Phase 2
40
Radiotherapy + Pyrotinib + Capecitabine
qttueuofyy(xzqzrfrhme) = lwvjprnmfw anbzcsrnpj (qhiotbuuau, 61.9 - 90.7)
Positive
04 Jan 2024
Phase 1
41
吡咯替尼+卡瑞利珠单抗++奥沙利铂+卡培他滨
tzknshcvfr(wjkjkgpowi) = dbmhumjuqt arvkfodtqf (coppbsgsle )
Positive
23 Nov 2023
吡咯替尼+卡瑞利珠单抗++奥沙利铂+卡培他滨
(吡咯替尼 320 mg)
yzlqehxvwq(ltwcbmpnwa) = lfmnriyxnq czklpijkqh (fnncnetoto )
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