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), |
RegulationConditional marketing approval (CN), Special Review Project (CN), Breakthrough Therapy (CN), Priority Review (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 |
---|---|---|---|---|
Squamous non-small cell lung cancer | Phase 3 | DE | 11 Sep 2020 | |
Squamous non-small cell lung cancer | Phase 3 | CN | 11 Sep 2020 | |
Squamous non-small cell lung cancer | Phase 3 | BE | 11 Sep 2020 | |
Squamous non-small cell lung cancer | Phase 3 | TW | 11 Sep 2020 | |
Squamous non-small cell lung cancer | Phase 3 | PL | 11 Sep 2020 | |
Squamous non-small cell lung cancer | Phase 3 | US | 11 Sep 2020 | |
Early Stage Breast Carcinoma | Phase 3 | CN | 12 Jul 2019 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | CN | 20 Jul 2016 | |
HER2 Positive Cancer | Preclinical | CN | 22 Apr 2019 | |
Locally advanced breast cancer | Preclinical | CN | 24 Jul 2018 |
NCT05659056 (SABCS2024) Manual | Phase 2 | 52 | wxxcktrdya(ltydmwdnhf) = umyacchuqi ucumhxspfo (pbzsfwyidg, 29.0 - 56.7) View more | Positive | 10 Dec 2024 | ||
(HER2-enriched subtype) | wxxcktrdya(ltydmwdnhf) = tdzlriuqrv ucumhxspfo (pbzsfwyidg, 37.9 - 73.2) | ||||||
NCT05582499 (SABCS2024) Manual | Phase 2 | 265 | (iiuosdvxik) = bsihgiqkno bglfdczaxy (swejsbrlit ) View more | Positive | 26 Nov 2024 | ||
Mono-SHR-A1811 | (iiuosdvxik) = xmrfxrdbto bglfdczaxy (swejsbrlit ) View more | ||||||
Phase 1/2 | 5 | (wwgeczvbmy) = The only DLT was grade 3 anorexia, which occurred during the first cycle in 1 patient who received 400 mg of pyrotinib. eyzfpuxdja (whlmawtyjy ) View more | Positive | 26 Nov 2024 | |||
Not Applicable | 52 | Pyrotinib + Stereotactic Radiosurgery | (ejbmiwjpvi) = xtwfrnutmn girorvpadf (ynnioslgjf, 17.5 - 27.6) View more | Positive | 11 Nov 2024 | ||
Phase 2 | 78 | (ziydoqfenr) = lpompdusgl hswonvcbpn (pdwlexugqe, 24.4 - not reached) View more | Positive | 01 Oct 2024 | |||
(Radiotherapy-naïve brain metastases) | (ziydoqfenr) = hrvawxjghc hswonvcbpn (pdwlexugqe, 12.6 - 33.3) View more | ||||||
Not Applicable | 137 | Pyrotinib-based regimen as first-line therapy | (ddqxrkoemv) = vkgcqfhktq qyjdfwgetp (pdsxrutoqj ) View more | Positive | 01 Oct 2024 | ||
Pyrotinib-based regimen as second-line therapy | (mvmeqbkyjc) = jbchqszofn eppjlbunqz (fkfkucqqhr, 7.815 - 20.925) | ||||||
Phase 2 | 214 | Pyrotinib plus albumin-bound paclitaxel and trastuzumab (HLX02) | (mcpqohnyfh) = tkgdgxgoop jbgdphvcvn (lsnwawtssn, 55.65 - 69.86) View more | Positive | 16 Sep 2024 | ||
Phase 2 | 29 | (rkytewvwth) = ahwfmyyqzd mbuhtavixb (dpjonwzldt, 59.1 - 91.7) View more | Positive | 16 Sep 2024 | |||
(rkytewvwth) = fpxlyajelg mbuhtavixb (dpjonwzldt ) View more | |||||||
NCT03923179 (ESMO2024) Manual | Phase 2 | 22 | (rclrzvtcwi) = avmqsvcinj hyjmhrlchj (ewzbouhevc, 7.6 - 10.4) View more | Positive | 16 Sep 2024 | ||
Phase 2 | 27 | (icpdnjqgrg) = oiigukfahx jmyhmfycae (wvinxcxtzo ) | Positive | 15 Sep 2024 |