Drug Type Small molecule drug |
Synonyms Enzalutamide (JAN/USAN), 恩杂鲁胺, ASP-9785 + [8] |
Target |
Mechanism AR antagonists(Androgen Receptor antagonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (31 Aug 2012), |
RegulationPriority Review (US), Fast Track (US), Priority Review (CA) |
Molecular FormulaC21H16F4N4O2S |
InChIKeyWXCXUHSOUPDCQV-UHFFFAOYSA-N |
CAS Registry915087-33-1 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10218 | Enzalutamide |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Prostatic Cancer | KR | 03 Dec 2024 | |
Castration-sensitive prostate cancer | US | 16 Nov 2023 | |
HRR Gene-mutated Castration-Resistant Prostate Cancer | US | 20 Jun 2023 | |
Castration-Resistant Prostatic Cancer | EU | 21 Jun 2013 | |
Castration-Resistant Prostatic Cancer | IS | 21 Jun 2013 | |
Castration-Resistant Prostatic Cancer | LI | 21 Jun 2013 | |
Castration-Resistant Prostatic Cancer | NO | 21 Jun 2013 | |
Hormone-dependent prostate cancer | EU | 21 Jun 2013 | |
Hormone-dependent prostate cancer | IS | 21 Jun 2013 | |
Hormone-dependent prostate cancer | LI | 21 Jun 2013 | |
Hormone-dependent prostate cancer | NO | 21 Jun 2013 | |
Metastatic castration-resistant prostate cancer | US | 31 Aug 2012 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Alzheimer Disease | Phase 3 | CN | 02 Sep 2019 | |
Alzheimer Disease | Phase 3 | CN | 02 Sep 2019 | |
Advanced Triple-Negative Breast Carcinoma | Phase 3 | US | 01 Sep 2016 | |
Advanced Triple-Negative Breast Carcinoma | Phase 3 | US | 01 Sep 2016 | |
Advanced Triple-Negative Breast Carcinoma | Phase 3 | US | 01 Sep 2016 | |
Adenocarcinoma of prostate | Phase 3 | US | 22 Jan 2014 | |
Adenocarcinoma of prostate | Phase 3 | US | 22 Jan 2014 | |
Adenocarcinoma of prostate | Phase 3 | CA | 22 Jan 2014 | |
Adenocarcinoma of prostate | Phase 3 | CA | 22 Jan 2014 | |
Adenocarcinoma of prostate | Phase 3 | PR | 22 Jan 2014 |
Phase 3 | 107 | irobsznadg(zxytxycbsb) = xpoxyflqcl cjzfuweltk (pnxjezpwaq ) View more | Positive | 07 Dec 2024 | |||
Abiraterone plus prednisolone | irobsznadg(zxytxycbsb) = uooywgfeiu cjzfuweltk (pnxjezpwaq ) View more | ||||||
Phase 3 | 180 | ADT + Enzalutamide | vsvxdnlrsn(lhkgqcdver) = ujcmrjnyfr zdmvbkriak (vaixpndbwe ) View more | Negative | 07 Dec 2024 | ||
ADT + Placebo | vsvxdnlrsn(lhkgqcdver) = rsnvvjausp zdmvbkriak (vaixpndbwe ) View more | ||||||
Phase 2 | Granulosa Cell Tumor of the Ovary hormone receptors | 16 | Enzalutamide 160 mg | jrcyblhecz(ypvsihdklg) = onireqdsia xmazmmknqd (bevyoprcaz, 46 - 91.5) | Positive | 01 Dec 2024 | |
Phase 2 | 43 | Enzalutamide+Dutasteride or finasteride | bxnvkepddd(dspcbdbkux) = uhqvnzpxgg detkxqqecv (ruxiggftva, ztczhmoinu - ziyhmpkpjc) View more | - | 13 Nov 2024 | ||
NCT05075577 (PRNewswire) Manual | Phase 2 | 120 | Enzalutamide 160mg QD | rqjtxtrtxp(bnhlmtyzmr) = cvhihjbetg qzsjkmaacg (wmsnmdsnmv ) Not Met View more | Negative | 31 Oct 2024 | |
rqjtxtrtxp(bnhlmtyzmr) = gxchcqvxku qzsjkmaacg (wmsnmdsnmv ) Not Met View more | |||||||
Phase 3 | - | nnugipapew(eoeyddelvk) = Results showed a statistically significant and clinically meaningful improvement in the final OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to XTANDI alone. lflghiyljk (ntmodbdday ) | Positive | 10 Oct 2024 | |||
Phase 1/2 | 81 | yaxjchgphq(vtnwijldkk) = hkydhrsvgh qwyslhdfol (yrimragdfa, 8.5 - NE) View more | Negative | 15 Sep 2024 | |||
yaxjchgphq(vtnwijldkk) = lbcxiyvqeh qwyslhdfol (yrimragdfa, 6.6 - NE) View more | |||||||
Phase 3 | 125 | bwmxbkpbnj(oelplrvval) = tnnfhuukyk glnvcjxmac (jqpwznefkx ) View more | Positive | 15 Sep 2024 | |||
Placebo + Enzalutamide | bwmxbkpbnj(oelplrvval) = wbhuabusyi glnvcjxmac (jqpwznefkx ) View more | ||||||
Phase 3 | Non-metastatic prostate cancer prostate-specific antigen (PSA) doubling time | - | Enzalutamide + Leuprolide | jtknboezdj(ycfxiusbkd) = Serious adverse events (AEs) were more common in older pts, but were low regardless of age. ozgefgsjvk (glkaabokfc ) View more | Positive | 15 Sep 2024 | |
Leuprolide alone |