Drugs / Apalutamide
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | ERLEADA | — | 2019-09-17 – 2023-12-19 | fda.gov ↗ |
| Approved | EU (EMA) | Erleada | — | 2019-01-14 | europa.eu ↗ |
| Approved | US (FDA) | ERLEADA | — | 2018-02-14 | fda.gov ↗ |
Trials 98 · started per year
today
US approved 2018
EU approved 2019
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05683964 | Jan 2023 → Sep 2025 overdue | prostate adenocarcinoma | Beth Israel Deaconess Medical Center | Active not recruiting | No outcome recorded |
| Phase 120 trials | ||||||
| Phase 1 | NCT06095089 | Nov 2023 → Jun 2027 expected | prostate neoplasm | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT05818683 | Apr 2023 → Aug 2027 expected | prostate carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT05413421 | Jun 2022 → Jun 2027 expected | metastatic prostate carcinoma | ORIC Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT04666129 | Feb 2021 → May 2024 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03569280 | Nov 2019 → Jan 2023 | castration-resistant prostate carcinoma | Kangpu Biopharmaceuticals, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04154774 | Nov 2019 → Feb 2025 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03802682 | Jan → Apr 2019 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03523442 | Aug 2018 → Jul 2019 overdue | prostate neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03551782 | Jun 2018 → Nov 2021 | castration-resistant prostate carcinoma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02913196 | Dec 2016 → Jun 2021 | metastatic prostate carcinoma | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 1 | NCT02924766 | Oct 2016 → Jul 2019 | prostate cancer | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02835508 | Jun → Dec 2016 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT02592317 | Feb → Nov 2016 overdue | castration-resistant prostate carcinoma | Aragon Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02578797 | Dec 2015 → Sep 2016 | castration-resistant prostate carcinoma | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02524717 | Aug 2015 → Feb 2017 | — | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02230033 | Sep → Dec 2014 | — | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02123758 | Jul 2014 → Jun 2016 overdue | castration-resistant prostate carcinoma | Aragon Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02162836 | Jun 2014 → May 2019 | castration-resistant prostate carcinoma | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT02106507 | Apr 2014 → Jun 2021 | prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01792687 | Feb 2013 → May 2014 | prostate cancer | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05367440 | Jun 2022 → Apr 2031 expected | metastatic prostate carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01171898 | Jul 2010 → Aug 2012 | prostate cancer | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 250 trials | ||||||
| Phase 2 | NCT07645326 | Aug 2026 → Aug 2032 expected | metastatic prostate carcinoma | Georgetown University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06758882 | Nov 2024 → Jan 2026 overdue | prostate cancer | Marco Oderda | Recruiting | No outcome recorded |
| Phase 2 | NCT06505278 | Aug 2024 → Mar 2025 overdue | prostate cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05960578 | May 2024 → Jul 2025 overdue | prostate adenocarcinoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06067269 | Mar 2024 → Dec 2026 expected | prostate adenocarcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05849298 | Jan 2024 → Dec 2026 expected | prostate neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05534646 | Dec 2023 → Jan 2027 expected | castration-resistant prostate carcinoma | Edwin Posadas, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05717582 | May 2023 → Dec 2025 overdue | metastatic prostate carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05191680 | Apr 2023 → Oct 2029 expected | prostate cancer | Cambridge University Hospitals NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 2 | NCT05778097 | Apr 2023 → Aug 2026 overdue | prostate cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05751941 | Feb 2023 → Jul 2026 overdue | metastatic prostate carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04926181 | Mar 2022 → Mar 2024 | prostate cancer, small cell carcinoma | Rahul Aggarwal | Terminated | No outcome recorded |
| Phase 2 | NCT05159245 | Dec 2021 → Nov 2026 expected | cancer, hematopoietic and lymphoid cell neoplasm | Helsinki University Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04530552 | Jul 2021 → Nov 2024 | prostate adenocarcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT03902951 | Mar 2021 → Jan 2027 expected | prostate adenocarcinoma, prostate neuroendocrine neoplasm | Jonsson Comprehensive Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04295447 | Dec 2020 → Nov 2028 expected | prostate cancer | University of Münster | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02811809 | Dec 2020 → Dec 2024 | prostate cancer | The University of Texas Health Science Center, Houston | Withdrawn | No outcome recorded |
| Phase 2 | NCT04585932 | Nov 2020 → Jan 2021 | metastatic prostate carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT04523207 | Aug 2020 → Oct 2023 | prostate cancer | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04267887 | May 2020 → Jan 2028 expected | metastatic prostate carcinoma | OHSU Knight Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04325828 | Apr 2020 → Jun 2021 overdue | tumor of salivary gland | Janssen Pharmaceutical K.K. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05406999 | Feb 2020 → Dec 2026 expected | prostate cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | No outcome recorded |
| Phase 2 | NCT03503344 | Dec 2019 → Dec 2024 | castration-resistant prostate carcinoma, post 5-alpha-reductase inhibitors treatment syndrome, prostate adenocarcinoma | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2 | NCT03821792 | Jul 2019 → Oct 2026 expected | metastatic carcinoma in the bone, metastatic prostate carcinoma, prostate adenocarcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03899077 | Apr 2019 → Aug 2025 | prostate cancer | Cancer Research Antwerp | Unknown | No outcome recorded |
| Phase 2 | NCT03080116 | Mar 2019 → Jul 2021 overdue | prostate cancer | Universitaire Ziekenhuizen KU Leuven | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02789878 | Jan 2019 → Apr 2022 | prostate cancer | Cancer Institute of the State of São Paulo | Completed | No outcome recorded |
| Phase 2 | NCT03298087 | Jul 2018 → Mar 2024 | — | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT03436654 | Jun 2018 → Mar 2026 overdue | prostate cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03371719 | Jun 2018 → Mar 2025 overdue | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03365297 | Jun 2018 → Jul 2019 | prostate cancer | CCTU- Cancer Theme | Completed | No outcome recorded |
| Phase 2 | NCT03311555 | Mar 2018 → Dec 2022 | prostate cancer | Andrew J. Armstrong, MD | Completed | No outcome recorded |
| Phase 2 | NCT03412396 | Mar 2018 → Oct 2024 overdue | prostate adenocarcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03360721 | Mar 2018 → Mar 2026 | castration-resistant prostate carcinoma, prostate adenocarcinoma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT03173859 | Jan 2018 → Dec 2020 | castration-resistant prostate carcinoma | University of Athens | Withdrawn | No outcome recorded |
| Phase 2 | NCT03141671 | Nov 2017 → Apr 2025 | prostate cancer | Dana-Farber Cancer Institute | Unknown | No outcome recorded |
| Phase 2 | NCT02721979 | Nov 2017 → Feb 2020 | prostate adenocarcinoma | University of Washington | Terminated | No outcome recorded |
| Phase 2 | NCT03279250 | Oct 2017 → May 2021 | prostate adenocarcinoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02867020 | Oct 2017 → Oct 2019 | prostate cancer | Latin American Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT03098836 | Jul 2017 → Jul 2024 | prostate cancer | Daniel George, MD | Completed | No outcome recorded |
| Phase 2 | NCT03093272 | Jun 2017 → May 2019 | prostate cancer | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT03124433 | Jun 2017 → Aug 2019 | prostate cancer | Singapore General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02949284 | Jun 2017 → Jun 2026 overdue | prostate adenocarcinoma | Rutgers, The State University of New Jersey | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03088124 | Apr 2017 → Oct 2024 | — | Institut Paoli-Calmettes | Completed | No outcome recorded |
| Phase 2 | NCT02849990 | Mar 2017 → Dec 2018 | prostate adenocarcinoma | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT02903368 | Oct 2016 → Apr 2022 | prostate cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02770391 | Oct 2016 → Apr 2020 | prostate cancer | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02703623 | May 2016 → Mar 2028 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma, prostate adenocarcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02772588 | May 2016 → Jan 2026 | prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 319 trials | ||||||
| Phase 3 | NCT05974774 | May 2025 → May 2035 expected | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Recruiting | No outcome recorded |
| Phase 3 | NCT06274047 | Sep 2024 → Jun 2027 expected | prostate cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 3 | NCT07260435 | Feb 2024 → Nov 2027 expected | prostate cancer | Nick Beije | Recruiting | No outcome recorded |
| Phase 3 | NCT05884398 | Aug 2023 → Oct 2026 expected | metastatic prostate carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04513717 | Jan 2021 → Dec 2033 expected | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04557059 | Nov 2020 → Aug 2029 expected | prostate neoplasm | Janssen Pharmaceutica N.V., Belgium | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04423211 | Oct 2020 → Dec 2032 expected | metastatic prostate carcinoma, prostate adenocarcinoma | ECOG-ACRIN Cancer Research Group | Recruiting | No outcome recorded |
| Phase 3 | NCT04409288 | Jul 2020 → Oct 2023 | prostate cancer | Chinese University of Hong Kong | Terminated | No outcome recorded |
| Phase 3 | NCT03777982 | Apr 2020 → Feb 2024 | prostate cancer | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 3 | NCT04134260 | Apr 2020 → Nov 2026 expected | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03488810 | Mar 2020 → Jun 2026 | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 3 | NCT04181203 | Jan 2020 → Sep 2028 expected | prostate cancer | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03767244 | Jun 2019 → Dec 2026 expected | prostate neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03903835 | Feb 2019 → Dec 2026 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Karolinska Institutet | Recruiting | No outcome recorded |
| Phase 3 | NCT03009981 | Mar 2017 → Jun 2025 | prostate cancer | Alliance Foundation Trials, LLC. | Completed | No outcome recorded |
| Phase 3 | NCT02489318 | Nov 2015 → Sep 2020 overdue | prostate cancer | Aragon Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02531516 | Nov 2015 → Jun 2026 overdue | prostate neoplasm | Aragon Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02257736 | Nov 2014 → Mar 2018 overdue | prostate neoplasm | Aragon Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01946204 | Oct 2013 → May 2017 overdue | prostate neoplasm | Aragon Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04601441 | Nov 2020 → Mar 2025 | metastatic prostate carcinoma | Kindai University | Unknown | No outcome recorded |
| Phase 4 | NCT04108208 | Dec 2019 → Jun 2023 overdue | prostate neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT05649943 | Mar 2023 → Jan 2027 expected | metastatic prostate carcinoma | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Recruiting | No outcome recorded |
| — | NCT05740488 | Jan 2022 → Apr 2025 | prostate cancer, hereditary, 10 | Zhujiang Hospital | Unknown | No outcome recorded |
| — | NCT04997252 | Feb 2021 → Aug 2024 | — | Zhujiang Hospital | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03523338 | — | prostate neoplasm | Aragon Pharmaceuticals, Inc. | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 30 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07389174 Background | Feb 2026 → Jan 2027 expected | prostate adenocarcinoma | Shanghai Changzheng Hospital | Not yet recruiting | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT05295927 Background | Mar → Sep 2022 | prostate neoplasm | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT04662580 Background | May 2021 → Dec 2026 expected | metastatic prostate carcinoma | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04421222 Background | Jun 2020 → Oct 2024 | prostate cancer | ESSA Pharmaceuticals | Terminated | No outcome recorded |
| Phase 1 | NCT02160756 Comparator | Jun → Nov 2014 | — | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02031666 Comparator | Dec 2013 → Apr 2014 | — | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01822041 Comparator | Mar → Jun 2013 | — | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07002320 Background | Apr 2025 → Oct 2029 expected | prostate carcinoma | Institute of Cancer Research, United Kingdom | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04946370 Background | Aug 2021 → Oct 2027 expected | prostate cancer | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT07268794 Background | Nov 2025 → Apr 2027 expected | metastatic prostate carcinoma, prostate adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06832774 Background | Aug 2025 → Dec 2027 expected | metastatic prostate carcinoma | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT06734130 Background | Jan 2025 → Jan 2029 expected | metastatic prostate carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06992232 Background | Aug 2024 → Jul 2027 expected | metastatic prostate carcinoma | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | No outcome recorded |
| Phase 2 | NCT06378866 Comparator | Jun 2024 → Feb 2031 expected | castration-resistant prostate carcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT05717660 Background | Mar 2023 → Sep 2024 | prostate carcinoma | Careggi University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05422911 Comparator | Aug 2022 → Dec 2027 expected | metastatic malignant neoplasm, prostate carcinoma | Sun Pharmaceutical Industries, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05212857 Background | Apr 2022 → Feb 2024 | prostate cancer | Fudan University | Unknown | No outcome recorded |
| Phase 2 | NCT04812366 Comparator | Sep 2021 → Apr 2026 overdue | prostate cancer | University of British Columbia | Recruiting | No outcome recorded |
| Phase 2 | NCT04947254 Background | Aug 2021 → Jun 2028 expected | prostate carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT02906605 Background | Oct 2016 → Sep 2018 | castration-resistant prostate carcinoma | Janssen Research & Development, LLC | Withdrawn | No outcome recorded |
| Phase 2 | NCT01790126 Comparator | Mar 2013 → Mar 2019 | prostate cancer | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04787744 Background | Jul 2021 → Sep 2026 expected | metastatic prostate carcinoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT07333066 Background | Jun 2026 → Mar 2030 expected | metastatic prostate carcinoma | Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD | Recruiting | No outcome recorded |
| Phase 3 | NCT07611110 Comparator | May 2026 → Feb 2029 expected | prostate carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06931340 Background | Dec 2025 → Nov 2031 expected | prostate adenocarcinoma | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT06592924 Background | May 2025 → Mar 2031 expected | prostate adenocarcinoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 3 | NCT06496581 Background | Sep 2024 → Feb 2033 expected | metastatic prostate carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT06320067 Background | Jun 2024 → Apr 2031 expected | metastatic prostate carcinoma | University College, London | Recruiting | No outcome recorded |
| Phase 3 | NCT04115007 Comparator | Jun 2020 → Jun 2026 overdue | prostate carcinoma | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06350825 Comparator | Jan 2016 → Dec 2027 expected | metastatic prostate carcinoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 130 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Apalutamide | “This regimen consists of Androgen Deprivation Therapy (ADT) (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix) combined with an oral Androgen Receptor (AR) inhibitor...” NCT07389174 ↗113“Darolutamide is the preferred ARPI for this study; however, patients may receive abiraterone, apalutamide, or enzalutamide at the discretion of their oncologist and based on...” NCT07645326 ↗ “Additional therapy following tumor board meeting : new generation hormonal therapy (abiraterone, enzalutamide, apalutamide or other approved) or chemotherapy (docetaxel).” NCT04115007 ↗ “ADT plus only 12 months of ARPI (apalutamide/enzalutamide) with the possibility to resume treatment with ARSI in case of a confirmed PSA rise.” NCT07260435 ↗ “ADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be administrated according to the standard of care” NCT06496581 ↗ “Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.” NCT06992232 ↗ “Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509), a Potent Androgen Receptor Antagonist” PMID 27160947 ↗ May 2016 “Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)” NCT06350825 ↗ “Evaluation of Safety and Efficacy of KPG-121 Plus Enzalutamide, Abiraterone or Apalutamide in CRPC Patients” NCT03569280 ↗ “Second generation ARPI (Abiraterone Acetate and Prednisolone, Enzalutamide, Apalutamide or Darolutamide).” NCT06320067 ↗ “All participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily.” NCT05649943 ↗ “Enzalutamide, Darolutamide, Apalutamide as prescribed by the local investigator” NCT05849298 ↗ “ARPI (abiraterone or enzalutamide or apalutamide or darolutamide)” NCT05974774 ↗ “Examples include enzalutamide, apalutamide, darolutamide.” NCT04946370 ↗ “androgen receptor antagonist ARN-509 (apalutamide)” NCT02949284 ↗ “Apalutamide 240mg po qd” NCT06145308 ↗ “Apalutamide” NCT06734130 ↗ |
| Known as | Apalutamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL3183409 ↗ |
| Known as | ARN-509 | “A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer” NCT02123758 ↗9“Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509), a Potent Androgen Receptor Antagonist” PMID 27160947 ↗ May 2016 “A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer” NCT01946204 ↗ “neoadjuvant apalutamide (ARN-509) and radical prostatectomy” PMID 36000794 ↗ Aug 2022 |
| Known as | Erleada | “Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]” NCT05683964 ↗2“Apalutamide (Erleada™) 60 mg or 240 mg tablets” NCT05413421 ↗ “Apalutamide (Erleada™) 60 mg or 240 mg tablets” NCT07333066 ↗ |
| Known as | Erleada 60 | “Apalutamide is distributed in Italy under the trade name of Erleada® 60 mg.” NCT05649943 ↗ |
| Known as | JNJ-56021927 | “A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With...” NCT02592317 ↗10“Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone” NCT02257736 ↗ “JNJ-56021927 (Apalutamide)” NCT02531516 ↗ |
| Action | Inhibit | “Apalutamide is a potent androgen receptor (AR) antagonist” PMID 27160947 ↗ May 2016 |
| Modality | Small molecule | “Apalutamide is an investigational antitumor drug, taken by mouth. It is a synthetic compound rationally designed to bind the androgen receptor” NCT02811809 ↗ |
| Route | Oral | “administered orally” NCT01790126 ↗ |
| Target | AR | “targets the AR ligand-binding domain” PMID 27160947 ↗ May 2016 |