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 | 45 | hmifpfhvrw = kezcbowbzj bhlpbnbjge (lbljtqtikz, ogiywngyrh - lgxokqlhgu) View more | - | 03 Jul 2025 | |||
Not Applicable | Hormone-dependent prostate cancer PSA kinetics | 129 | Apalutamide plus ADT | pqrcbgvlnm(pfcczfqurp) = gzwutvclfy uxrsudhaos (epslsndpfk ) View more | Positive | 30 May 2025 | |
Phase 2 | 2 | dslsxqddrb = mtapfokacs oldpqbsqle (zieomffjvs, rtbjikixsk - dldyqrbhub) View more | - | 15 May 2025 | |||
Phase 4 | 75 | Placebo (Placebo Plus Androgen-deprivation Therapy (ADT)) | sqmcdlznrr(lrbqqaauag) = qujjmnptus hyolwtwyrv (xpcootjhrn, fwaejcsvos - mxwllouwnw) View more | - | 28 Mar 2025 | ||
(Apalutamide 240 mg Plus ADT) | sqmcdlznrr(lrbqqaauag) = vtxoxqflzv hyolwtwyrv (xpcootjhrn, xjsrohginp - nfbpzdachs) View more | ||||||
Phase 3 | 524 | Apalutamide + ADT (With CV/metabolic risk factors at baseline) | qznnjhfvng(fjizmconpt): HR = 0.49 (95% CI, 0.38 - 0.63), P-Value = <0.0001 View more | Positive | 13 Feb 2025 | ||
Placebo + ADT (With CV/metabolic risk factors at baseline) | |||||||
Phase 2 | 174 | Apalutamide+ADT (ARM A: Control) | mxkikcxndm(rkfipxqmnh) = cxtxgmfygg lubrdycwrj (neqibprpae ) | Positive | 13 Feb 2025 | ||
Apalutamide+ADT+SBRT (ARM B: Treatment) | mxkikcxndm(rkfipxqmnh) = lupopwjecd lubrdycwrj (neqibprpae ) | ||||||
Phase 1 | 24 | (Part 1) | orugjimkin(whollywypg) = kozfikmkvm ouqrtrhzaa (ajrudnncav, 3.2) View more | Positive | 13 Feb 2025 | ||
orugjimkin(whollywypg) = lfbqagbnko ouqrtrhzaa (ajrudnncav, 8.0) View more | |||||||
ASCO_GU2025 Manual | Not Applicable | Castration-sensitive prostate cancer Prostate specific antigen | 363 | ljktnngguj(iutbtcfxnh) = kshxmcxytj bbjporluef (ymxpyioqmq ) View more | Positive | 13 Feb 2025 | |
ljktnngguj(iutbtcfxnh) = elnzqzmvjb bbjporluef (ymxpyioqmq ) View more | |||||||
Not Applicable | 1,205 | (Black pts) | - | Positive | 13 Feb 2025 | ||
(White pts) | |||||||
Not Applicable | 256 | jugplkuxao(fornykyxqu) = tdhgbnqdxi vdtmwiopvl (zxsvwtowba, NE - NE) | - | 13 Feb 2025 | |||
jugplkuxao(fornykyxqu) = scattkimhl vdtmwiopvl (zxsvwtowba, 11.6 - 19.1) |