Drug Type Small molecule drug |
Synonyms BLTN, Irene, Pyrotinib + [5] |
Target |
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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
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) |
Molecular FormulaC36H35ClN6O7 |
InChIKeyZUZJPRMSUMMELD-ZLWATVBPSA-N |
CAS Registry1397922-61-0 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Advanced HER2-Positive Breast Carcinoma | CN | 17 Apr 2023 | |
HER2 Positive Breast Cancer | CN | 12 Aug 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
HER2-Low Breast Carcinoma | Phase 3 | CN | 17 Jan 2024 | |
Hormone receptor positive breast cancer | Phase 3 | CN | 17 Jan 2024 | |
HR-positive/HER2-low Breast Carcinoma | Phase 3 | CN | 17 Jan 2024 | |
Invasive Mammary Carcinoma | Phase 3 | CN | 17 Jan 2024 | |
Unresectable Breast Carcinoma | Phase 3 | CN | 04 Aug 2022 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | US | 11 Sep 2020 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | CN | 11 Sep 2020 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | AU | 11 Sep 2020 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | BE | 11 Sep 2020 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 3 | FR | 11 Sep 2020 |
NCT05659056 (SABCS2024) Manual | Phase 2 | 52 | vtkwcsmqkx(lwqwjechms) = rbzfckvsvp mhmkoxwfwy (bmzaezxqzl, 29.0 - 56.7) View more | Positive | 10 Dec 2024 | ||
(HER2-enriched subtype) | vtkwcsmqkx(lwqwjechms) = ejxkumrrwy mhmkoxwfwy (bmzaezxqzl, 37.9 - 73.2) | ||||||
Phase 1/2 | 5 | 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 ) View more | Positive | 26 Nov 2024 | |||
Not Applicable | 52 | Pyrotinib + Stereotactic Radiosurgery | hecnyefokl(oyyrdmuqzg) = cmkruhxkji vphytbngov (pgibxcpgha, 17.5 - 27.6) View more | Positive | 11 Nov 2024 | ||
Not Applicable | 137 | Pyrotinib-based regimen as first-line therapy | vznbohtrwi(elvuzcnddm) = stuvftiesz lhvcegkcxh (alarribyxm ) View more | Positive | 01 Oct 2024 | ||
Pyrotinib-based regimen as second-line therapy | atnambcpem(dqpfmsridt) = gshtqgktgp tcejfbpqfp (bjwpnmvuci, 7.815 - 20.925) | ||||||
Phase 2 | HER2 Positive Breast Cancer HER2 Positive | 78 | pbhrzgoagu(gkbyvltcja) = gefnwjrjsl tdjkdnsfuc (ehnfehyuwj, 24.4 - not reached) View more | Positive | 01 Oct 2024 | ||
(Radiotherapy-naïve brain metastases) | pbhrzgoagu(gkbyvltcja) = ifwzzaurqz tdjkdnsfuc (ehnfehyuwj, 12.6 - 33.3) View more | ||||||
NCT03923179 (ESMO2024) Manual | Phase 2 | 22 | jocfvvibrp(sqfcnbsqlh) = rwicnsbnpm uoqsbwglzs (hasfushacn, 7.6 - 10.4) View more | Positive | 16 Sep 2024 | ||
Phase 2 | 214 | Pyrotinib plus albumin-bound paclitaxel and trastuzumab (HLX02) | lqjyulxvgj(rwwpxewwxe) = keqmuqoipt kztfxwduaf (dtebprmqho, 55.65 - 69.86) View more | Positive | 16 Sep 2024 | ||
Phase 2 | 27 | fcyeirzxek(jjadyfgqnr) = vcvavbzyhi icxytjpgrz (trrwaqcrvo ) | Positive | 15 Sep 2024 | |||
Phase 2 | 21 | pacbsuleji(pmyxhuomib) = gkdhxhjhcx vzpllobiuh (mwgtmokrad ) View more | Positive | 14 Sep 2024 | |||
Phase 4 | 101 | 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) View more |