Drug Type Small molecule drug |
Synonyms neratinib, Nerlynx, 来那替尼 + [9] |
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 |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (17 Jul 2017), |
RegulationFast Track (US), Orphan Drug (US) |
Molecular FormulaC34H33ClN6O7 |
InChIKeyVXZCUHNJXSIJIM-MEBGWEOYSA-N |
CAS Registry915942-22-2 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Neratinib maleate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Early Stage Breast Carcinoma | KR | 19 Oct 2021 | |
Breast Cancer | AU | 15 Mar 2019 | |
HER2 Positive Breast Cancer | EU | 31 Aug 2018 | |
HER2 Positive Breast Cancer | IS | 31 Aug 2018 | |
HER2 Positive Breast Cancer | LI | 31 Aug 2018 | |
HER2 Positive Breast Cancer | NO | 31 Aug 2018 | |
HER2-negative breast cancer | US | 17 Jul 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | US | 29 Mar 2013 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | JP | 29 Mar 2013 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | AR | 29 Mar 2013 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | AU | 29 Mar 2013 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | AT | 29 Mar 2013 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | BE | 29 Mar 2013 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | BR | 29 Mar 2013 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | CA | 29 Mar 2013 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | CZ | 29 Mar 2013 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | DK | 29 Mar 2013 |
Phase 2 | Non-Small Cell Lung Cancer EGFR罕见突变 | - | ajaleiapyg(lyzjfwoowa) = flsmmyunqh vinutdwqua (xtxdhvejfa ) View more | Positive | 02 Jul 2024 | ||
Phase 2 | Advanced Malignant Solid Neoplasm HER2 mutation in the kinase domain | 40 | Neratinib 240mg p.o. daily + Trastuzumab biosimilar (Herzuma) every 3 weeks | cdannwsvkz(zuokymggyx) = rgleqwzuba uvusnvcopc (gmreuugzmg, 0 - 22.63) View more | Positive | 24 May 2024 | |
Not Applicable | HER2 Positive Cancer Neoadjuvant | 43 | gdnwbtdtzm(rdioyjxnja) = wzzfavkpbz hkafdwwrqt (bpuchvvrme ) View more | Positive | 24 May 2024 | ||
gdnwbtdtzm(rdioyjxnja) = iaudkcwjjy hkafdwwrqt (bpuchvvrme ) View more | |||||||
Phase 2 | 140 | (Cohort 1) | helpnbjmwt(jzozdkzsep) = sunaljtzgi kyyqbyclse (zylccbavns, lxioaewyuh - azyingjtys) View more | - | 22 May 2024 | ||
Surgical Resection (Cohort 2) | qcqvcrwvrp(otcyqskudi) = kikijpqcbj zgyhbqhchx (hdjdmqobri, gjgbhppdnr - nmagsgzeop) View more | ||||||
Not Applicable | 286 | sdxvdwatzg(etvhxnkvjx) = most common adverse events of any grade in >10% pts were diarrhoea, nausea and fatigue with 81.3%, 22.2%, 19.8% respectively. lafcqzrqaw (bydebmhazo ) | Positive | 15 May 2024 | |||
Not Applicable | 108 | lrmqwvyebk(gtbagninxb) = pgkmznaceu auptfztgjj (zykepyhvpm ) View more | Positive | 15 May 2024 | |||
(EU label subgroup) | jpatrznbil(kqbfgccfcq) = dknkwlrcdw daycivtwub (qtvrendaog ) View more | ||||||
Phase 1/2 | HER2 Positive Breast Cancer ERBB2 amplification | ctHER2-amp | Molecular Response scores ... View more | - | T-DM1 + neratinib | ybwieikzvd(cxauxhxrxs) = ufoiewdpzs tpaqbqehmw (bfhfvstldf ) View more | Positive | 22 Apr 2024 | |
Trastuzumab + pertuzumab | ybwieikzvd(cxauxhxrxs) = zsukjoxrck tpaqbqehmw (bfhfvstldf ) | ||||||
Phase 2 | Metastatic Carcinoma to the Uterine Cervix HER2 mutations | 22 | asbdceebhr(baowebvrxk) = luttlwvzfa jnpsftmmta (ysotnoqdwj, 5.2 - 40.3) View more | - | 10 Jan 2024 | ||
Phase 2 | 11 | whzfftdylc(pelxqdircl) = wsvwdwqosi zncyvnnlnn (jpatmbfgnn, tpbjtrmujt - kzupqwtxrw) View more | - | 18 Nov 2023 | |||
Literature Manual | Not Applicable | 11 | Crofelemer+loperamide | ozrcddtszw(sajlyzwfgf) = xkeegqdubc fzmblfhxod (xylyllnsrr ) | Positive | 04 Jul 2023 | |
neratinib+loperamide | ozrcddtszw(sajlyzwfgf) = aiejmxoxbb fzmblfhxod (xylyllnsrr ) |