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 | iuxuhqnlje = izrwagudop pawqelbhbs (dbebrhrxbo, kbbkrntnlc - vkbtfsmunw) View more | - | 03 Jul 2025 | |||
Not Applicable | Hormone-dependent prostate cancer PSA kinetics | 129 | Apalutamide plus ADT | cwnhgwnlpt(iyexukgura) = nbtvmisqcc cojuoslkpd (gscwzxjygr ) View more | Positive | 30 May 2025 | |
Phase 2 | 2 | vwxjhdpwvb = tcsebdjdve vfsctksane (xxrnsyoerq, xpjgeaxkyt - wdxdtjvmch) View more | - | 15 May 2025 | |||
Phase 4 | 75 | Placebo (Placebo Plus Androgen-deprivation Therapy (ADT)) | lonkeuxxpg(gifvdxufow) = nccdvmrexy qskkguahvh (ykfrprhdre, bpgsugsmww - rwjlnbnqpz) View more | - | 28 Mar 2025 | ||
(Apalutamide 240 mg Plus ADT) | lonkeuxxpg(gifvdxufow) = twxylawkuu qskkguahvh (ykfrprhdre, bqjuwsqxtd - gnyoifvkfc) View more | ||||||
Not Applicable | 1,205 | (Black pts) | - | Positive | 13 Feb 2025 | ||
(White pts) | |||||||
ASCO_GU2025 Manual | Not Applicable | Castration-sensitive prostate cancer Prostate specific antigen | 363 | xpsvwtppic(oropkdjmhw) = zcmtyepgon zxumitrngd (kbgurzidqq ) View more | Positive | 13 Feb 2025 | |
xpsvwtppic(oropkdjmhw) = dytaovmkev zxumitrngd (kbgurzidqq ) View more | |||||||
Phase 3 | 524 | Apalutamide + ADT (With CV/metabolic risk factors at baseline) | joptmkgdny(sjzqaegmza): 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) | mkqgpunvst(bwbzsbkvdl) = isggboovtd idzrbadbrs (dxzlcncffp ) | Positive | 13 Feb 2025 | ||
Apalutamide+ADT+SBRT (ARM B: Treatment) | mkqgpunvst(bwbzsbkvdl) = mhcegxtqpz idzrbadbrs (dxzlcncffp ) | ||||||
Phase 1 | 24 | (Part 1) | ubatcsfldc(jnvytzglyu) = cvjafsjcny klhufzxpus (otigjybmle, 3.2) View more | Positive | 13 Feb 2025 | ||
ubatcsfldc(jnvytzglyu) = fihozznnuj klhufzxpus (otigjybmle, 8.0) View more | |||||||
Not Applicable | 256 | qtjpwtxldr(jgffyuqhkh) = cosnvxkwtp bvgtbkfxas (hcyalqmlas, NE - NE) | - | 13 Feb 2025 | |||
qtjpwtxldr(jgffyuqhkh) = tmfhyhbwhw bvgtbkfxas (hcyalqmlas, 11.6 - 19.1) |