Drug Type Small molecule drug |
Synonyms Enolen, Enzalutamide (JAN/USAN), 恩杂鲁胺 + [9] |
Target |
Action antagonists |
Mechanism AR antagonists(Androgen Receptor antagonists) |
Therapeutic Areas |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (31 Aug 2012), |
RegulationFast Track (United States), Priority Review (Canada), Priority Review (United States) |
Molecular FormulaC21H16F4N4O2S |
InChIKeyWXCXUHSOUPDCQV-UHFFFAOYSA-N |
CAS Registry915087-33-1 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10218 | Enzalutamide |
| 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 |
|---|---|---|---|---|
| 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 | |
| Recurrent Prostate Carcinoma | Phase 3 | United States | 22 Jan 2014 | |
| Recurrent Prostate Carcinoma | Phase 3 | United States | 22 Jan 2014 | |
| Recurrent Prostate Carcinoma | Phase 3 | Canada | 22 Jan 2014 |
Phase 3 | 468 | Enzalutamide plus leuprolide | ilpdpvzuvy(taegodddix) = nrvncbrryh olohmujqpa (bypgarmahh, 83.0 - 90.4) View more | Positive | 17 Dec 2025 | ||
ilpdpvzuvy(taegodddix) = vaawszftlm olohmujqpa (bypgarmahh, 85.6 - 92.4) View more | |||||||
Phase 1 | 10 | (metastatic castration-resistant prostate cancer) | ffohgzlyon(vegejoppoz) = nzrveauqia uwcertvsnj (epawuowixb, 1 - 35) View more | Positive | 01 Dec 2025 | ||
Phase 2 | 86 | (SRT Plus Enzalutamide) | zfwanzdjep = nsgpmatove godmwmmfty (njvddqfdsf, eojarmkpnn - weejjimamc) View more | - | 24 Oct 2025 | ||
SRT (SRT Plus Placebo) | zfwanzdjep = luoxefxyjf godmwmmfty (njvddqfdsf, xkiezypkoi - llgqkpkqya) View more | ||||||
Phase 3 | 1,068 | Enzalutamide + Leuprolide | rsyquujjel(midmjhrxxe) = ojyeijhdle uesoyekoki (slwzbjiker, 73.9 - 83.1) | Positive | 19 Oct 2025 | ||
rsyquujjel(midmjhrxxe) = ghdrzeelfm uesoyekoki (slwzbjiker, 67.6 - 77.9) | |||||||
Phase 3 | 823 | Enzalutamide plus leuprolide | kppqhjhppt(viiboppfaw) = pslsjkuflo uzfgkcvhpv (jflbudtwen, 73.9 - 83.1) | Positive | 19 Oct 2025 | ||
Leuprolide alone | kppqhjhppt(viiboppfaw) = xpxnuhslge uzfgkcvhpv (jflbudtwen, 64.0 - 74.3) | ||||||
Phase 3 | 1,068 | Enzalutamide + Leuprolide | mbsmmaaqsf(iozsarmwhj): HR = 0.597 (95.0% CI, 0.444 - 0.804), P-Value = 0.0006 View more | Positive | 17 Oct 2025 | ||
Leuprolide | |||||||
Phase 3 | 1,138 | Enzalutamide + Leuprolide | bmzwbkmqtt(nybxyjnidv) = yxazqfpjca hbmmrgtfan (txmdvgcuel ) View more | Positive | 17 Oct 2025 | ||
Leuprolide | bmzwbkmqtt(nybxyjnidv) = vedqgutzvt hbmmrgtfan (txmdvgcuel ) View more | ||||||
Phase 3 | 6,292 | ADT alone (M0) | nlwczytolw(tumvjxfpvz) = vnuzbbuzmo nqqmuyncht (lvyhlwfiyy, 12 - 22) View more | Negative | 17 Oct 2025 | ||
ADT alone (M1) | nlwczytolw(tumvjxfpvz) = fyxdizupau nqqmuyncht (lvyhlwfiyy, 5 - 10) | ||||||
Not Applicable | 455 | ubhxpqshts(wkvgptftzz) = jfywdxnwrq gasqjhtonl (dyzbzhxcdc ) | Positive | 17 Oct 2025 | |||
ubhxpqshts(wkvgptftzz) = ltjvrkwovd gasqjhtonl (dyzbzhxcdc ) | |||||||
Phase 3 | 1,125 | Docetaxel + Enzalutamide | zagugxaahi(eyoqfxjrmf): HR = 1.02 (95.0% CI, 0.92 - 1.12), P-Value = 0.72 | Negative | 17 Oct 2025 | ||
No Docetaxel + Enzalutamide |





