Drug Type Small molecule drug |
Synonyms Enzalutamide (JAN/USAN), 恩杂鲁胺, ASP-9785 + [8] |
Target |
Action antagonists |
Mechanism AR antagonists(Androgen Receptor antagonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (31 Aug 2012), |
RegulationPriority Review (United States), Fast Track (United States), Priority Review (Canada) |
Molecular FormulaC21H16F4N4O2S |
InChIKeyWXCXUHSOUPDCQV-UHFFFAOYSA-N |
CAS Registry915087-33-1 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Prostatic Cancer | South Korea | 03 Dec 2024 | |
Castration-sensitive prostate cancer | United States | 16 Nov 2023 | |
HRR Gene-mutated Castration-Resistant Prostate Cancer | United States | 20 Jun 2023 | |
Metastatic Prostate Carcinoma | Japan | 29 May 2020 | |
Castration-Resistant Prostatic Cancer | European Union | 21 Jun 2013 | |
Castration-Resistant Prostatic Cancer | Iceland | 21 Jun 2013 | |
Castration-Resistant Prostatic Cancer | Liechtenstein | 21 Jun 2013 | |
Castration-Resistant Prostatic Cancer | Norway | 21 Jun 2013 | |
Hormone-dependent prostate cancer | European Union | 21 Jun 2013 | |
Hormone-dependent prostate cancer | Iceland | 21 Jun 2013 | |
Hormone-dependent prostate cancer | Liechtenstein | 21 Jun 2013 | |
Hormone-dependent prostate cancer | Norway | 21 Jun 2013 | |
Metastatic castration-resistant prostate cancer | United States | 31 Aug 2012 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Alzheimer Disease | Phase 3 | China | 02 Sep 2019 | |
Alzheimer Disease | Phase 3 | China | 02 Sep 2019 | |
Advanced Triple-Negative Breast Carcinoma | Phase 3 | United States | 01 Sep 2016 | |
Advanced Triple-Negative Breast Carcinoma | Phase 3 | United States | 01 Sep 2016 | |
Advanced Triple-Negative Breast Carcinoma | Phase 3 | United States | 01 Sep 2016 | |
Adenocarcinoma of prostate | Phase 3 | United States | 22 Jan 2014 | |
Adenocarcinoma of prostate | Phase 3 | United States | 22 Jan 2014 | |
Adenocarcinoma of prostate | Phase 3 | Canada | 22 Jan 2014 | |
Adenocarcinoma of prostate | Phase 3 | Canada | 22 Jan 2014 | |
Adenocarcinoma of prostate | Phase 3 | Puerto Rico | 22 Jan 2014 |
Phase 3 | - | Enzalutamide 160 mg | cwnvcipssm(oghhuvllaa) = mtzsowsrxt wjmrpmmumm (hjddbdrllb ) View more | Positive | 30 May 2025 | ||
Non-steroidal anti-androgen (NSAA) | cwnvcipssm(oghhuvllaa) = ylbwrifyfm wjmrpmmumm (hjddbdrllb ) View more | ||||||
Phase 2 | 36 | Enzalutamide and Docetaxel | hklhckyuwa(ewfikmcpay) = qmmkpgfoti fiyiwaarhd (ycqaomddsg ) View more | Positive | 30 May 2025 | ||
Androgen Deprivation Therapy | qrthiouwnv(fhwckxihfl) = kqjzubrqzb wyypnflwzc (jurpsopzcu ) | ||||||
Not Applicable | 140 | Low-dose Enzalutamide (≤50%) | zjabhzcxym(luuzqaywvr) = eyfshyswze hzktmvclyk (bmhcafdrbf ) View more | Positive | 30 May 2025 | ||
Intermediate-dose Enzalutamide (>50% and ≤80%) | zjabhzcxym(luuzqaywvr) = tivtwdlpfl hzktmvclyk (bmhcafdrbf ) View more | ||||||
Not Applicable | - | - | (AR T878A) | tdyuiquweq(yqsvevslst) = iyqitfwqgq aqaugrpktq (eiavxgzypz ) View more | Positive | 30 May 2025 | |
(AR L702H) | tdyuiquweq(yqsvevslst) = cnizuuczuk aqaugrpktq (eiavxgzypz ) View more | ||||||
Phase 3 | Metastatic castration-resistant prostate cancer prostate-specific antigen | alkaline phosphatase | 446 | Enzalutamide alone (ENZ) | nafffoqffa(ojzemupagk) = djewabyusm vziipzzjps (hyviqvhunv, 2.99 - 14.06) View more | Positive | 30 May 2025 | |
Enzalutamide combined with 6 cycles of Radium 223 (ENZ-RAD) | nafffoqffa(ojzemupagk) = sgawlirysy vziipzzjps (hyviqvhunv, 1.87 - 2.50) View more | ||||||
Phase 3 | 1,150 | Enzalutamide + Androgen-Deprivation Therapy | txhiqpcajr(sjkrqqsepa) = cdgtauanzv wlobialdje (japsivtsie ) | Positive | 30 May 2025 | ||
Placebo + Androgen-Deprivation Therapy | txhiqpcajr(sjkrqqsepa) = hlgablzyxo wlobialdje (japsivtsie ) | ||||||
Phase 2 | Breast Cancer androgen receptor-positive | 201 | cfmksefota(lmoppitxbd) = zruluysxow xjghfibbky (vxnwyvcwel ) | Positive | 30 May 2025 | ||
Treatment of Physician's Choice (TPC) | cfmksefota(lmoppitxbd) = bssxfnajwe xjghfibbky (vxnwyvcwel ) | ||||||
Not Applicable | 160 | (Metastatic castration-sensitive prostate cancer (mCSPC)) | xzcsugppws(bwqpssapmy) = OS from CRPC 2.0 did not differ significantly between mCSPC (13.3 months) and mCRPC (15.3 months) gfwrwddqom (yvkgeamfxy ) | Negative | 30 May 2025 | ||
(Metastatic castration-resistant prostate cancer (mCRPC)) | |||||||
Not Applicable | Metastatic castration-resistant prostate cancer First line chemotherapy-naïve | androgen receptor pathway inhibitor (ARPI)-naïve | 2,733 | epkxflqwqd(ojqfjswmgb) = dhmpawzcci pwlgimijeq (uyulslukoa ) View more | Negative | 30 May 2025 | ||
epkxflqwqd(ojqfjswmgb) = wyxrnfutjr pwlgimijeq (uyulslukoa ) View more | |||||||
Phase 1 | 9 | (Level 1) | jtpqhcccip(mxpdlylequ) = wiytspwuda alpkxjpugf (hjmwsauavk, kppevfgkeu - pwrbwuynsd) View more | - | 13 May 2025 | ||
(Level 2) | cdsyilegwx = wacujovajo yopwobbjsx (mmrhzbvofa, gykmxgsgse - tkfbhvkajw) View more |