Drug Type Small molecule drug |
Synonyms Apalutamide (JAN/INN), 阿帕鲁胺, ARN-509 + [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 (14 Feb 2018), |
RegulationFast Track (United States), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia) |
Molecular FormulaC21H15F4N5O2S |
InChIKeyHJBWBFZLDZWPHF-UHFFFAOYSA-N |
CAS Registry956104-40-8 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D11040 | Apalutamide |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Metastatic Prostate Carcinoma | Japan | 29 May 2020 | |
Metastatic castration-resistant prostate cancer | United States | 17 Sep 2019 | |
Hormone-dependent prostate cancer | European Union | 14 Jan 2019 | |
Hormone-dependent prostate cancer | Iceland | 14 Jan 2019 | |
Hormone-dependent prostate cancer | Liechtenstein | 14 Jan 2019 | |
Hormone-dependent prostate cancer | Norway | 14 Jan 2019 | |
Prostatic Cancer | Canada | 27 Jul 2018 | |
Castration-sensitive prostate cancer | Australia | 05 Jul 2018 | |
Castration-Resistant Prostatic Cancer | United States | 14 Feb 2018 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Adenocarcinoma of prostate | Phase 3 | Hong Kong | 20 Jul 2020 | |
Recurrent Prostate Carcinoma | Phase 3 | Hong Kong | 20 Jul 2020 | |
Non-metastatic prostate cancer | Phase 3 | France | 09 Jan 2020 | |
Alzheimer Disease | Phase 3 | United States | 07 Dec 2015 | |
Alzheimer Disease | Phase 3 | United States | 07 Dec 2015 | |
Alzheimer Disease | Phase 3 | United States | 07 Dec 2015 | |
Alzheimer Disease | Phase 3 | Japan | 07 Dec 2015 | |
Alzheimer Disease | Phase 3 | Japan | 07 Dec 2015 | |
Alzheimer Disease | Phase 3 | Japan | 07 Dec 2015 | |
Alzheimer Disease | Phase 3 | Argentina | 07 Dec 2015 |
Phase 2 | 93 | (Caucasian) | gfmieoxppm = veekctmqxe ytjrfplxfm (mzznwnfjtf, qiloaacqfj - zcfegagmyq) View more | - | 12 Sep 2025 | ||
(African American) | gfmieoxppm = sogbcxhcmu ytjrfplxfm (mzznwnfjtf, dnezmwwqbe - qspxljkgan) View more | ||||||
Phase 2 | 34 | (Cohort 1) | blvjdkhasd = wwnlbkqepb lahkfgityw (vgfgxquhnl, fxfjkvjwye - rgyxknudgc) View more | - | 29 Aug 2025 | ||
(Cohort 2) | blvjdkhasd = eczckbsucy lahkfgityw (vgfgxquhnl, apvuxpeuhw - nlxfzufcli) View more | ||||||
Phase 2 | 28 | tsiaruxhve = fmnwcqqhfe mbgirufqmi (jziarvydot, sbmrnrjurd - fmvilkyoal) View more | - | 01 Aug 2025 | |||
Phase 2 | 45 | phztsogjab = dwenlygypf kgjhkafzfy (ujnruibpan, rnpjcqnvuv - uwolxnitjt) View more | - | 03 Jul 2025 | |||
Not Applicable | Hormone-dependent prostate cancer PSA kinetics | 129 | Apalutamide plus ADT | sxvmqcjovn(kypacdjfug) = tdlhriuggd wihrzmpivp (ljtzcgibry ) View more | Positive | 30 May 2025 | |
Phase 2 | 2 | vpotzhyehe = pbuzctrcfd kemynpkhxn (bavcdmruah, zsbmnoiujz - hycwrpxfla) View more | - | 15 May 2025 | |||
Phase 4 | 75 | Placebo (Placebo Plus Androgen-deprivation Therapy (ADT)) | jepxheoiyx(xjvsfourfv) = dluajqhwrq cqvpnzxiud (oclwgximxh, fadbgnelyh - qkvwczbngg) View more | - | 28 Mar 2025 | ||
(Apalutamide 240 mg Plus ADT) | jepxheoiyx(xjvsfourfv) = rzvonqyskl cqvpnzxiud (oclwgximxh, aetsoyrcxt - vikdlehyvg) View more | ||||||
ASCO_GU2025 Manual | Not Applicable | Castration-sensitive prostate cancer Prostate specific antigen | 363 | ifuopqivot(iycjtlewaj) = fsozyauzye xonqdzglrd (ygnvjrnuom ) View more | Positive | 13 Feb 2025 | |
ifuopqivot(iycjtlewaj) = zvkwiugrzv xonqdzglrd (ygnvjrnuom ) View more | |||||||
Not Applicable | 1,205 | (Black pts) | - | Positive | 13 Feb 2025 | ||
(White pts) | |||||||
Phase 1 | 24 | (Part 1) | vseihfcwac(bymityitux) = ajixwvzyml mvjezrnbvw (rkjrxlzpxu, 3.2) View more | Positive | 13 Feb 2025 | ||
vseihfcwac(bymityitux) = xrcrofwnks mvjezrnbvw (rkjrxlzpxu, 8.0) View more |