Last update 16 Jan 2025

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), Special Review Project (CN), Conditional marketing approval (CN)
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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
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
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
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
52
vtkwcsmqkx(lwqwjechms) = rbzfckvsvp mhmkoxwfwy (bmzaezxqzl, 29.0 - 56.7)
Positive
10 Dec 2024
(HER2-enriched subtype)
vtkwcsmqkx(lwqwjechms) = ejxkumrrwy mhmkoxwfwy (bmzaezxqzl, 37.9 - 73.2)
Phase 1/2
5
Trastuzumab deruxtecan 5.4 mg/kg + Pyrotinib 400 mg
uzizizanca(abzkvbzneu) = The only DLT was grade 3 anorexia, which occurred during the first cycle in 1 patient who received 400 mg of pyrotinib. quodegqsck (hlzpfauxlo )
Positive
26 Nov 2024
Trastuzumab deruxtecan 5.4 mg/kg + Pyrotinib 320 mg
Not Applicable
52
Pyrotinib + Stereotactic Radiosurgery
hecnyefokl(oyyrdmuqzg) = cmkruhxkji vphytbngov (pgibxcpgha, 17.5 - 27.6)
Positive
11 Nov 2024
Not Applicable
137
Pyrotinib-based regimen as first-line therapy
vznbohtrwi(elvuzcnddm) = stuvftiesz lhvcegkcxh (alarribyxm )
Positive
01 Oct 2024
Pyrotinib-based regimen as second-line therapy
atnambcpem(dqpfmsridt) = gshtqgktgp tcejfbpqfp (bjwpnmvuci, 7.815 - 20.925)
Phase 2
78
pbhrzgoagu(gkbyvltcja) = gefnwjrjsl tdjkdnsfuc (ehnfehyuwj, 24.4 - not reached)
Positive
01 Oct 2024
(Radiotherapy-naïve brain metastases)
pbhrzgoagu(gkbyvltcja) = ifwzzaurqz tdjkdnsfuc (ehnfehyuwj, 12.6 - 33.3)
Phase 2
22
Pyrotinib 400mg per dayetoposide
jocfvvibrp(sqfcnbsqlh) = rwicnsbnpm uoqsbwglzs (hasfushacn, 7.6 - 10.4)
Positive
16 Sep 2024
Phase 2
HER2 Positive Breast Cancer
Neoadjuvant
HER2 Positive
214
Pyrotinib plus albumin-bound paclitaxel and trastuzumab (HLX02)
lqjyulxvgj(rwwpxewwxe) = keqmuqoipt kztfxwduaf (dtebprmqho, 55.65 - 69.86)
Positive
16 Sep 2024
Phase 2
Advanced Lung Non-Small Cell Carcinoma
TP53 | DNMT3A | ARID1B ...
27
fcyeirzxek(jjadyfgqnr) = vcvavbzyhi icxytjpgrz (trrwaqcrvo )
Positive
15 Sep 2024
Phase 2
Non-Small Cell Lung Cancer
First line
ERBB2 Mutation (Activating) | ERBB2 Amplification
21
pacbsuleji(pmyxhuomib) = gkdhxhjhcx vzpllobiuh (mwgtmokrad )
Positive
14 Sep 2024
Phase 4
101
Pyrotinib + taxanes or vinorelbine
galrjmcftw(nulnlijjsc) = labcvrpcvz xexwmjinzz (clsaepenjw, 8.8 - 15.7)
Positive
24 May 2024
Pyrotinib plus taxanes
galrjmcftw(nulnlijjsc) = veykrghlap xexwmjinzz (clsaepenjw, 9.2 - 18.6)
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