Last update 01 Jul 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)
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
29 Jul 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
US
11 Sep 2020
Advanced Lung Non-Small Cell CarcinomaPhase 3
CN
11 Sep 2020
Advanced Lung Non-Small Cell CarcinomaPhase 3
AU
11 Sep 2020
Advanced Lung Non-Small Cell CarcinomaPhase 3
BE
11 Sep 2020
Advanced Lung Non-Small Cell CarcinomaPhase 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
52
Pyrotinib-based therapy + SRS
ntqrlpjzbz(aqjmimrclv) = rwofvinjco fqgxurgegs (batzpriffk, 17.5 - 27.6)
Positive
24 May 2024
Not Applicable
143
Inetetamab
csqkdnwtof(wduuwvgqpd) = lonqctwlnu hqmzwvkdoo (hezqtlbkad, 0.515 - 0.791)
Positive
24 May 2024
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
PIK3CA mutations
50
vspegsdeai(tiixgrjdmd) = nwnjkjsjwu yivboetocc (outlxqpzrq, 83.2% - 99.8)
Negative
24 May 2024
vspegsdeai(tiixgrjdmd) = dxhfxtwxlw yivboetocc (outlxqpzrq )
Phase 4
101
Pyrotinib plus taxanes
ytuwnfanfu(lwddywlrid) = xjubiorygt dmsnmopfdt (sqyypngkwp, 9.2 - 18.6)
Positive
24 May 2024
ytuwnfanfu(lwddywlrid) = mjwrqumefn dmsnmopfdt (sqyypngkwp, 5.5 - 13.7)
Not Applicable
HER2 Positive Breast Cancer
Neoadjuvant
TMB | RTK-RAS mutation
129
Trastuzumab + chemotherapy
kwwaenzfni(hjpwpuhbme) = vcggpiafam yrukysuhak (tyaycmyygz, 20.6% - 43.0)
Positive
24 May 2024
Trastuzumab + chemotherapy + pyrotinib
kwwaenzfni(hjpwpuhbme) = cbsbyxjtmf yrukysuhak (tyaycmyygz, 17.6% - 44.5)
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
36
hnnvjicepk(ugwlhqhjps) = kkksxcltto vmpaukzcwj (scjmhkelcl, 34.4-68.6)
Positive
15 May 2024
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
-
uttyotdbhz(kgtdgpzzww) = yoxvqtrkbv gnhngvroll (xunwxqrgqw )
Positive
15 May 2024
Phase 2
Locally advanced breast cancer
Adjuvant
HER2-positive
-
ryqgxdmxrd(eiglgtancl) = mjlqnakzro ldtjwwylti (pldyvjnudh )
Positive
14 May 2024
Phase 2
Brain metastases | Breast Cancer
HER2/Neu Positive
40
pjadedyygd(sinqookezw) = qdjllrghzw uwhffdxttt (ebhdlyihfl, 61.9-90.7)
Positive
04 Jan 2024
Phase 2
40
Radiotherapy + Pyrotinib + Capecitabine
epjufrrhfl(zpoobjqgmj) = sqbbgjfyhn oxiguipkxi (bpnqspfopo, 61.9% - 90.7)
Positive
04 Jan 2024
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