Drugs / Apalutamide
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed castration-resistant prostate carcinoma 4 milestones | |||||
| Filed | EU (EMA) | ERLEADA | castration-resistant prostate carcinoma | 2019-09-27 | “Janssen has submitted an application in Europe seeking approval for mCSPC.” jnj.com ↗ |
| Filed | US (FDA) | ERLEADA | castration-resistant prostate carcinoma | 2019-04-29 | “Janssen Submits Application to U.S. FDA Seeking Approval of ERLEADA® (apalutamide) for Patients with Metastatic Castration-Sensitive Prostate Cancer” jnj.com ↗ “Today’s approval follows FDA Priority Review Designation of the supplemental New Drug Application (sNDA) that wassubmittedin April 2019” jnj.com ↗ |
| Filed | EU (EMA) | — | castration-resistant prostate carcinoma | 2018-02-08 | “a marketing authorization application was submitted to the European Medicines Agency for apalutamide, an oral androgen receptor inhibitor for the treatment of patients with...” jnj.com ↗ |
| Filed | US (FDA) | — | castration-resistant prostate carcinoma | 2017-10-11 | “New Drug Applications were submitted to the FDA for apalutamide, an oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer” jnj.com ↗ “Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer” jnj.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 ↗ |
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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 252 trials · 3 missed | ||||||
| Phase 2 | NCT07645326 | Dec 2026 → Aug 2032 expected | metastatic prostate carcinoma | Georgetown University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07795177 | Oct 2026 → Apr 2028 expected | prostate carcinoma | Anhui Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07745361 | Aug 2026 → Oct 2027 expected | castration-resistant prostate carcinoma, prostate adenocarcinoma | Monte Rosa Therapeutics, Inc | 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 2028 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 Stop: Business |
| 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 Stop: Enrollment |
| 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 2028 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 | Mixed |
| 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 Stop: Enrollment |
| 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 | Missed primary |
| 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 | NCT02949284 | Jun 2017 → Jun 2026 overdue | prostate adenocarcinoma | Rutgers, The State University of New Jersey | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03124433 | Jun 2017 → Aug 2019 | prostate cancer | Singapore General Hospital | Completed | Missed primary |
| 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 | Missed primary |
| 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 320 trials · 6 met primary | ||||||
| Phase 3 | NCT07751133 | Aug 2026 → Aug 2029 expected | castration-resistant prostate carcinoma | University College, London | Recruiting | No outcome recorded |
| 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 Stop: Enrollment |
| 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 | Met primary |
| Phase 3 | NCT03903835 | Feb 2019 → Dec 2026 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Karolinska Institutet | Recruiting | Met primary |
| Phase 3 | NCT03009981 | Mar 2017 → Jun 2025 | prostate cancer | Alliance Foundation Trials, LLC. | Completed | Met primary |
| Phase 3 | NCT02489318 | Nov 2015 → Sep 2020 overdue | prostate cancer | Aragon Pharmaceuticals, Inc. | Active not recruiting | Met primary |
| Phase 3 | NCT02531516 | Nov 2015 → Mar 2027 expected | 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 | Met primary |
| Phase 3 | NCT01946204 | Oct 2013 → May 2017 overdue | prostate neoplasm | Aragon Pharmaceuticals, Inc. | Active not recruiting | Met primary |
| Phase 42 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
| Comparator or background therapy31 trials | ||||||
| Phase 0 | NCT07389174 Background | Feb 2026 → Jan 2027 expected | prostate adenocarcinoma | Shanghai Changzheng Hospital | Not yet recruiting | No outcome recorded |
| 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 1/2 | 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 2 | NCT07838753 Comparator | Sep 2026 → Sep 2029 expected | metastatic prostate carcinoma | Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute | Not yet recruiting | No outcome recorded |
| 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 2/3 | NCT04787744 Background | Jul 2021 → Sep 2026 overdue | metastatic prostate carcinoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| 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 |
News releases announcing trial results or a regulatory action · 48
| Date | Issuer | Release |
|---|---|---|
| 2026-05-31 | Janssen Research & Development, LLC | Results Johnson & Johnson’s Phase 3 prostate cancer study shows ERLEADA® (apalutamide) before and after surgery significantly reduces risk of metastasis or death, breaking a decades-long treatment paradigm jnj.com ↗
The combination also reduced the risk of developing metastasis or death by 20 percent and extended the time before patients required subsequent therapy to more than six years. |
| 2026-05-31 | Janssen Research & Development, LLC | Results Johnson & Johnson's Phase 3 prostate cancer study shows ERLEADA® (apalutamide) before and after surgery significantly reduces risk of metastasis or death, breaking a decades-long treatment paradigm jnj.com ↗
Patients treated with apalutamide plus hormone therapy were nine times more likely to have little to no cancer remaining at the time of surgery compared with hormone therapy alone (8.9 percent vs. 1.0 percent; pathologic complete response/minimal residual disease). |
| 2026-02-02 | Janssen Research & Development, LLC | Results Real-world head-to-head analysis shows 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA® (apalutamide) versus darolutamide without docetaxel through 24 months jnj.com ↗
These real-world data show the survival benefit of apalutamide versus darolutamide in patients with mCSPC without the concurrent use of docetaxel. |
| 2026-02-02 | Janssen Research & Development, LLC | Results Real-world head-to-head analysis shows 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA® (apalutamide) versus darolutamide without docetaxel through 24 months jnj.com ↗
Real-world head-to-head analysis shows 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA® (apalutamide) versus darolutamide without docetaxel through 24 months |
| 2025-03-18 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Apalutamide Tablets, 60 mg (Erleada® Tablets, 60 mg). |
| 2024-10-02 | Janssen Research & Development, LLC | Results ERLEADA® (apalutamide) demonstrates statistically significant and clinically meaningful improvement in overall survival compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced the results of a landmark real-world, head-to-head study showing that ERLEADA®(apalutamide) provided a statistically significant overall survival benefit at 24 months compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC). |
| 2024-10-02 | Janssen Research & Development, LLC | Results ERLEADA® (apalutamide) demonstrates statistically significant and clinically meaningful improvement in overall survival compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer jnj.com ↗ |
| 2024-05-03 | Janssen Research & Development, LLC | Results Phase 2 data for ERLEADA® (apalutamide) plus androgen deprivation therapy following radical prostatectomy in patients with high-risk localized prostate cancer show 100% biochemical free recurrence rate more than two years post-surgery jnj.com ↗
Following RP, patients who received the treatment regimen showed a 100% biochemical recurrence (BCR)–free rate at 24 months. |
| 2024-05-03 | Janssen Research & Development, LLC | Results Phase 2 data for ERLEADA® (apalutamide) plus androgen deprivation therapy following radical prostatectomy in patients with high-risk localized prostate cancer show 100% biochemical free recurrence rate more than two years post-surgery jnj.com ↗
Following RP, patients who received the treatment regimen showed a 100% biochemical recurrence (BCR)–free rate at 24 months. |
| 2023-10-13 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Apalutamide Tablets lupin.com ↗
it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Apalutamide Tablets, 60 mg |
| 2022-10-31 | ESSA Pharmaceuticals | Results ESSA Provides an Update on its Clinical Collaboration with Janssen essapharma.com ↗
Initial clinical activity was observed in some patients, with two of the three patients achieving a prostate-specific antigen ("PSA") reduction of 90% ("PSA90") within 12 weeks. |
| 2022-02-14 | Janssen Research & Development, LLC | Results New ERLEADA® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) jnj.com ↗
By six months, 69.3 percent of patients with mCSPC initiated on ERLEADA®attained PSA90 response and 55.6 percent for enzalutamide (HR=1.56; p=0.014). |
| 2022-02-14 | Janssen Research & Development, LLC | Results New ERLEADA® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) jnj.com ↗
Real-world evidence study demonstrates majority of patients with mCSPC achieved over 90 percent decline in PSA by six months after initiation of ERLEADA® |
| 2021-09-11 | Janssen Research & Development, LLC | Results ERLEADA® (apalutamide) Oral Presentations Demonstrate Importance of Prostate Specific Antigen (PSA) as Key Efficacy Indicator and Show Strong Patient Adherence Rates jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new datademonstrating robust prostate-specific antigen (PSA) response and strong adherence rates in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with ERLEADA®(apalutamide) in the real-world clinical setting. |
| 2021-09-11 | Janssen Research & Development, LLC | Results ERLEADA® (apalutamide) Oral Presentations Demonstrate Importance of Prostate Specific Antigen (PSA) as Key Efficacy Indicator and Show Strong Patient Adherence Rates jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data demonstrating robust prostate-specific antigen (PSA) response and strong adherence rates in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with ERLEADA® (apalutamide) in the real-world clinical setting. |
| 2021-05-26 | Janssen Research & Development, LLC | Results Long-Term ERLEADA® (apalutamide) Patient-Reported Outcomes Data in Metastatic Castration-Sensitive Prostate Cancer Demonstrate Maintenance of Health-Related Quality of Life for Patients jnj.com ↗
The new PRO data showed that the addition of ERLEADA®to ADT maintained patients’ health-related quality of life (HRQoL) and did not worsen side effect burden, consistent with ADT alone. |
| 2021-05-26 | Janssen Research & Development, LLC | Results Long-Term ERLEADA® (apalutamide) Patient-Reported Outcomes Data in Metastatic Castration-Sensitive Prostate Cancer Demonstrate Maintenance of Health-Related Quality of Life for Patients jnj.com ↗
The new PRO data showed that the addition of ERLEADA® to ADT maintained patients’ health-related quality of life (HRQoL) and did not worsen side effect burden, consistent with ADT alone. |
| 2021-04-19 | Janssen Research & Development, LLC | Results Janssen Provides Update on Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) Plus Prednisone Combination jnj.com ↗
Safety results from ACIS were consistent with prior studies of ERLEADA and ZYTIGA plus prednisone, with no new safety signals observed. |
| 2021-04-19 | Janssen Research & Development, LLC | Results Janssen Provides Update on Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) Plus Prednisone Combination jnj.com ↗
Safety results from ACIS were consistent with prior studies of ERLEADA and ZYTIGA plus prednisone, with no new safety signals observed. |
| 2021-02-08 | Janssen Research & Development, LLC | Results Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) Combination jnj.com ↗ |
| 2021-02-08 | Janssen Research & Development, LLC | Results Janssen Announces Treatment with ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer jnj.com ↗
The improvement in OS increased to a 48 percent reduction in risk of death after adjusting for patients who crossed over (HR 0.52; p<0.0001). |
| 2021-02-08 | Janssen Research & Development, LLC | Results Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA® (apalutamide) and ZYTIGA® (abiraterone acetate) Combination jnj.com ↗
ACIS study meets primary endpoint of improving time to radiographic progression or death in patients with advanced disease |
| 2021-02-08 | Janssen Research & Development, LLC | Results Janssen Announces Treatment with ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Castration-Sensitive Prostate Cancer jnj.com ↗
Final analysis from Phase 3 TITAN study demonstrated ERLEADA® provided statistically significant overall survival benefit and consistent safety profile in patients with advanced prostate cancer, regardless of extent of disease |
| 2021-02-08 | Bayer | Results New data presented at 2021 ASCO GU Cancers Symposium add to robustness of the overall survival benefit and favorable safety profile for Nubeqa™ bayer.com ↗
A real-world study showed the clinical and resource use burden of AEs among nmCRPC patients treated with enzalutamide or apalutamide and demonstrated safety and tolerability are key considerations in shared clinician-patient decision-making in this area. |
| 2020-05-14 | Janssen Research & Development, LLC | Results ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Non-Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
ERLEADA®in combination with ADT prolonged median overall survival by 14 months and decreased the risk of death by 22 percent. |
| 2020-05-13 | Janssen Research & Development, LLC | Results ERLEADA® (apalutamide) Significantly Improved Overall Survival in Patients with Non-Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA® (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases. |
| 2020-01-30 | Janssen Research & Development, LLC | Regulatory Janssen Announces European Commission Approval for Expanded Use of Erleada®▼ (apalutamide) for Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer jnj.com ↗ |
| 2019-12-13 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for Expanded Use of Erleada® (apalutamide) for Patients with Metastatic Hormone-Sensitive Prostate Cancer jnj.com ↗
Janssen Receives Positive CHMP Opinion for Expanded Use of Erleada® (apalutamide) for Patients with Metastatic Hormone-Sensitive Prostate Cancer |
| 2019-09-27 | Janssen Research & Development, LLC | Results Updated Results of the SPARTAN Study Show 25 Percent Reduction in the Risk of Death in Patients with Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC) Treated with ERLEADA® (apalutamide) jnj.com ↗
Treatment with ERLEADA®(apalutamide) plus androgen deprivation therapy (ADT) resulted in a 25 percent reduction in the risk of death compared with placebo plus ADT in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases. |
| 2019-09-27 | Janssen Research & Development, LLC | Results Updated Results of the SPARTAN Study Show 25 Percent Reduction in the Risk of Death in Patients with Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC) Treated with ERLEADA® (apalutamide) jnj.com ↗
The updated findings showed overall survival (OS) results supported the first interim analysis, despite a crossover of patients receiving placebo to the ERLEADA® treatment group. |
| 2019-09-19 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves Supplemental New Drug Application (sNDA) for ERLEADA® (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved ERLEADA®(apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). |
| 2019-09-17 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves Supplemental New Drug Application (sNDA) for ERLEADA® (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved ERLEADA® (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). |
| 2019-09-17 | Janssen Research & Development, LLC | Results Janssen to Highlight Depth of Prostate Cancer and Solid Tumor Portfolios with Multiple Data Presentations at ESMO 2019 jnj.com ↗
patient-reported outcomes from the ERLEADA® Phase 3 TITAN study in patients with metastatic castration-sensitive prostate cancer (mCSPC), demonstrating preservation of overall health-related quality of life |
| 2019-06-04 | Janssen Research & Development, LLC | Regulatory Janssen Seeks to Expand Use of ERLEADA® (apalutamide) in the Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer jnj.com ↗
Janssen Seeks to Expand Use of ERLEADA® (apalutamide) in the Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer |
| 2019-05-31 | Janssen Research & Development, LLC | Results ERLEADA® (apalutamide) Significantly Improved Overall Survival (OS) and Radiographic Progression-Free Survival (rPFS) in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) jnj.com ↗
ERLEADA plus ADT significantly extended OS compared to placebo plus ADT with a 33 percent reduction in the risk of death (HR=0.67; 95 percent CI, 0.51-0.89; P=0.0053). |
| 2019-05-31 | Janssen Research & Development, LLC | Results ERLEADA® (apalutamide) Significantly Improved Overall Survival (OS) and Radiographic Progression-Free Survival (rPFS) in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) jnj.com ↗ |
| 2019-04-29 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA Seeking Approval of ERLEADA® (apalutamide) for Patients with Metastatic Castration-Sensitive Prostate Cancer jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of a new indication for ERLEADA®(apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). |
| 2019-04-29 | Janssen Research & Development, LLC | Regulatory Janssen Submits Application to U.S. FDA Seeking Approval of ERLEADA® (apalutamide) for Patients with Metastatic Castration-Sensitive Prostate Cance jnj.com ↗
Janssen Submits Application to U.S. FDA Seeking Approval of ERLEADA® (apalutamide) for Patients with Metastatic Castration-Sensitive Prostate Cance |
| 2019-01-30 | Janssen Research & Development, LLC | Results Janssen Announces ERLEADA® (apalutamide) Phase 3 TITAN Study Unblinded as Dual Primary Endpoints Achieved in Clinical Program Evaluating Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer jnj.com ↗
The decision resulted from an Independent Data Monitoring Committee (IDMC) recommendation coinciding with a pre-planned analysis that showed the dual primary endpoints were both achieved, significantly improving radiographic progression-free survival (rPFS) and overall survival (OS). |
| 2019-01-15 | Janssen Research & Development, LLC | Regulatory Janssen announces European Commission approval of ERLEADA® (apalutamide) for non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease jnj.com ↗
Janssen announces European Commission approval of ERLEADA® (apalutamide) for non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease |
| 2018-11-16 | Janssen Research & Development, LLC | Regulatory Janssen receives positive CHMP opinion for ERLEADA™ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease jnj.com ↗
Janssen receives positive CHMP opinion for ERLEADA™ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease |
| 2018-09-11 | Janssen Research & Development, LLC | Results Health-Related Quality of Life Maintained with Addition of ERLEADA® to Androgen Deprivation Therapy for Patients with Non-Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
These data from the pivotal SPARTAN study, in which ERLEADA significantly prolonged median metastasis-free survival (MFS), while preserving HRQoL, and delaying the decrease in HRQoL associated with symptomatic progression, were published today in The Lancet Oncology. |
| 2018-05-18 | Janssen Research & Development, LLC | Results ERLEADA™ Significantly Reduced Risk of Prostate Specific Antigen (PSA) Progression in Patients with Non-Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
ERLEADA™ Significantly Reduced Risk of Prostate Specific Antigen (PSA) Progression in Patients with Non-Metastatic Castration-Resistant Prostate Cancer |
| 2018-02-14 | Janssen Research & Development, LLC | Regulatory ERLEADA™ (apalutamide), a Next-Generation Androgen Receptor Inhibitor, Granted U.S. FDA Approval for the Treatment of Patients with Non-Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved ERLEADA™ ( apalutamide), a next -generation androgen receptor inhibitor,1 for the treatm ent of patients with non-m etastatic castration-resistant prostate cancer ( NM-CRPC). |
| 2018-02-08 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application for Apalutamide to Treat Patients with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
Janssen Submits Marketing Authorisation Application for Apalutamide to Treat Patients with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer |
| 2018-02-08 | Janssen Research & Development, LLC | Results ERLEADA™ (apalutamide), a Next-Generation Androgen Receptor Inhibitor, Lowered Risk of Metastasis or Death in Patients with Non-Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
The results were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco (Abstract #161) and were simultaneously published in The New England Journal of Medicine. |
| 2017-12-21 | Janssen Research & Development, LLC | Regulatory U.S. FDA Grants Priority Review to Janssen for Apalutamide as a Treatment for Non-Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of April 2018 to render a decision on the apalutamide application. |
| 2017-10-11 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
Janssen Biotech, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC). |
All press releases naming this drug 55 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 134 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | apalutamide | “The intervention strictly involves continuing the identical Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) regimen-such as abiraterone,...” NCT07838753 ↗117“This regimen consists of Androgen Deprivation Therapy (ADT) (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix) combined with an oral Androgen Receptor (AR) inhibitor...” NCT07389174 ↗ “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 ↗ “Standard of care Apalutamide 240 mg / Enzalutamide 160mg administered orally and daily on Days 1-28 of every 28 day cycle” NCT05534646 ↗ “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 “Evaluation of Safety and Efficacy of KPG-121 Plus Enzalutamide, Abiraterone or Apalutamide in CRPC Patients” NCT03569280 ↗ “Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)” NCT06350825 ↗ |
| 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 |