Drugs / Abiraterone acetate
Abiraterone acetate
English name Abiraterone
also known as
abiraterone · Zytiga · CB7630 · JNJ-212082 · JNJ-589485 · ATRS-2002 · BR9004 · BR9004-1 · +3 more
Small molecule targets AR, CYP17A1, CYP2D6 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed castration-resistant prostate carcinoma 2 milestones | |||||
| Filed | China (NMPA) | — | castration-resistant prostate carcinoma | — | “此外，2025年10月，氟唑帕利联合阿比特龙和泼尼松或泼尼松龙用于DNA修复基因缺陷阳性的转移性去势抵抗性前列腺癌的一线治疗上市申请已获国家药监局受理。” hengrui.com ↗ |
| Filed | EU (EMA) | — | castration-resistant prostate carcinoma | — | “In April 2022, Janssen submitted a marketing authorisation application to the European Medicines Agency seeking approval for niraparib in combination with abiraterone acetate” jnj.com ↗ |
| Filed progesterone-receptor positive breast cancer 3 milestones | |||||
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2023-02-28 | “submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate” jnj.com ↗ |
| Filed | US (FDA) | ZYTIGA | progesterone-receptor positive breast cancer | 2017-09-14 | “a supplemental New Drug Application (sNDA) was submitted to the FDA to expand the indication for ZYTIGA® (abiraterone acetate)” jnj.com ↗ “Janssen Submits Supplemental New Drug Application to U.S. FDA for ZYTIGA® (abiraterone acetate)” jnj.com ↗ |
| Filed | EU (EMA) | ZYTIGA | progesterone-receptor positive breast cancer | 2017-04 | “a marketing authorization application was submitted to the European Medicines Agency for ZYTIGA (abiraterone acetate)” jnj.com ↗ |
| Filed prostate cancer, hereditary, X-linked 3 1 milestone | |||||
| Filed | Japan (PMDA) | — | prostate cancer, hereditary, X-linked 3 | — | “Janssen Pharmaceuticals K.K. submitted a marketing approval application for abiraterone acetate to the Japanese Ministry of Health, Labour and Welfare in July 2013” astrazeneca.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | ZYTIGA | — | 2012-12-10 – 2019-06-03 | fda.gov ↗ |
| Approved | EU (EMA) | Zytiga | — | 2011-09-05 | europa.eu ↗ |
| Approved | US (FDA) | ZYTIGA | — | 2011-04-28 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials · 1 met primary | ||||||
| Phase 0 | NCT04735913 | May → Aug 2020 | — | Zhongnan Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT03511196 | Sep 2018 → Jun 2022 overdue | prostate adenocarcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | Met primary |
| Phase 0 | NCT02415621 | Apr 2015 → Aug 2019 | prostate cancer | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 149 trials · 1 met primary | ||||||
| Phase 1 | NCT07570979 | May 2026 → Jun 2030 expected | castration-resistant prostate carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT07140900 | Oct 2025 → Mar 2028 expected | metastatic prostate carcinoma | Amgen | Recruiting | No outcome recorded |
| Phase 1 | NCT06421935 | Aug 2024 → Feb 2027 expected | neoplasm | EMD Serono Research & Development Institute, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06014853 | Aug → Oct 2023 | prostate cancer | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT05733351 | Aug 2023 → Jun 2025 | prostate adenocarcinoma | Emory University | Terminated | No outcome recorded |
| Phase 1 | NCT05818683 | Apr 2023 → Aug 2027 expected | prostate carcinoma | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT05276492 | Jan 2023 → Nov 2024 | metastatic prostate carcinoma, prostate adenocarcinoma | University of Chicago | Terminated | No outcome recorded |
| Phase 1 | NCT04879589 | Sep 2022 → Apr 2023 | prostate carcinoma | Syneos Health | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05413421 | Jun 2022 → Jun 2027 expected | metastatic prostate carcinoma | ORIC Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT06193993 | Nov 2021 → Sep 2023 overdue | castration-resistant prostate carcinoma, metastatic malignant neoplasm | National University Hospital, Singapore | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04889651 | Apr → Jun 2021 | prostate cancer | Boryung Pharmaceutical Co., Ltd | Completed | 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 | NCT04577833 | Nov 2020 → Oct 2021 overdue | prostate neoplasm | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 1 | NCT04296578 | Oct 2020 → Oct 2022 | castration-resistant prostate carcinoma | Stanford University | Withdrawn | No outcome recorded |
| Phase 1 | NCT04399876 | Jun 2020 → Aug 2027 expected | prostate cancer | Brigham and Women's Hospital | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04221542 | Mar 2020 → Mar 2030 expected | prostate cancer | Amgen | Recruiting | No outcome recorded |
| Phase 1 | NCT04291664 | Jan 2020 → Jan 2023 | prostate cancer | DisperSol Technologies, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04179396 | Dec 2019 → Nov 2021 | castration-resistant prostate carcinoma | pharmaand GmbH | Completed | No outcome recorded |
| Phase 1 | NCT03569280 | Nov 2019 → Jan 2023 | castration-resistant prostate carcinoma | Kangpu Biopharmaceuticals, Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04108247 | Sep 2019 → Jun 2023 | castration-resistant prostate carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04087174 | Aug 2019 → Jun 2021 | prostate cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04295161 | Jun → Nov 2019 | — | Zentiva, k.s. | Completed | No outcome recorded |
| Phase 1 | NCT02574910 | Aug 2017 → Jun 2023 | classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency | University of Texas Southwestern Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT03150056 | Jul 2017 → Jul 2020 | cancer | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 1 | NCT02924766 | Oct 2016 → Jul 2019 | prostate cancer | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02883166 | Aug 2016 → Mar 2019 | prostate cancer | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02740985 | Jun 2016 → Dec 2020 | castration-resistant prostate carcinoma, colorectal carcinoma, high grade malignant neoplasm, non-small cell lung carcinoma | AstraZeneca | 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 | NCT02730975 | May 2014 → Oct 2020 | prostate cancer | Andalusian Public Foundation for Health Research in Seville | Completed | No outcome recorded |
| Phase 1 | NCT01913015 | Jul 2013 → Jun 2014 | hormone-resistant prostate carcinoma, prostate adenocarcinoma | OHSU Knight Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01897389 | Jul → Sep 2013 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01873001 | May → Jul 2013 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01678573 | Jul → Sep 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01588782 | Jan → Feb 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01655147 | Jan → Mar 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01516047 | Jan → Sep 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01575587 | Jan → May 2012 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01495910 | Dec 2011 → Feb 2013 | classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT01400555 | Sep 2011 → May 2014 | prostate cancer | Cougar Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01362764 | May → Jun 2011 | — | Cougar Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01186484 | Jun 2010 → Oct 2014 | prostate cancer | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT01017939 | Jan → Jun 2010 | prostate cancer | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01798628 | Sep → Oct 2009 | — | Cougar Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01715259 | Aug 2009 → Jan 2010 | impaired renal function disease | Cougar Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02001571 | Aug 2009 → Apr 2010 | prostate cancer | Cougar Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00910754 | May → Nov 2009 | prostate neoplasm | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00600535 | Jul 2007 → Mar 2012 | prostate neoplasm | Cougar Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01664728 | Apr 2007 → Feb 2009 | prostate neoplasm | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1/222 trials | ||||||
| Phase 1/2 | NCT07190300 | Jan 2026 → Aug 2032 expected | metastatic prostate carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07198633 | Nov 2025 → Dec 2026 expected | prostate cancer | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06863272 | Jul 2025 → Oct 2031 expected | castration-resistant prostate carcinoma, metastatic neoplasm | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06329830 | Oct 2024 → Oct 2026 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Baptist Health South Florida | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT06568094 | Sep 2024 → Dec 2026 expected | prostate cancer | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06457919 | Jun 2024 → Jun 2027 expected | prostate cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05914116 | Aug 2023 → Dec 2027 expected | cancer | DualityBio Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05367440 | Jun 2022 → Apr 2031 expected | metastatic prostate carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05067140 | Sep 2021 → May 2027 expected | metastatic prostate carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04631601 | Jan 2021 → Oct 2023 | prostate carcinoma | Amgen | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT03587285 | Sep 2018 → Jul 2021 | prostate neoplasm | Guangzhou University of Traditional Chinese Medicine | Unknown | No outcome recorded |
| Phase 1/2 | NCT03568656 | Jul 2018 → Jul 2025 | breast cancer, castration-resistant prostate carcinoma, non-small cell lung carcinoma | CellCentric Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT03480646 | Nov 2017 → Feb 2021 | castration-resistant prostate carcinoma | Constellation Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02861573 | Nov 2016 → Oct 2027 expected | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02049190 | Feb 2014 → Jul 2017 | prostate carcinoma | Arno Therapeutics | Unknown | No outcome recorded |
| Phase 1/2 | NCT01780220 | Dec 2012 → Jan 2022 | prostate adenocarcinoma | UNICANCER | Completed | No outcome recorded |
| Phase 1/2 | NCT01688492 | Sep 2012 → Sep 2027 expected | prostate cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01685268 | Sep 2012 → Jul 2014 | prostate cancer | Astex Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT01511536 | Mar 2012 → Jul 2014 | prostate cancer | Sanofi | Completed | No outcome recorded |
| Phase 1/2 | NCT00755885 | Oct 2008 → Jun 2016 | breast cancer | Cancer Research UK | Completed | No outcome recorded |
| Phase 1/2 | NCT00473746 | Jun 2006 → Dec 2012 | prostate neoplasm | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1/2 | NCT00473512 | Nov 2005 → Nov 2008 | prostate neoplasm | Cougar Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 2118 trials · 8 met primary · 10 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 | NCT07815522 | Oct 2026 → Oct 2028 expected | salivary gland carcinoma | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Recruiting | No outcome recorded |
| Phase 2 | NCT07650240 | Aug 2026 → Dec 2030 expected | metastatic prostate carcinoma, prostate adenocarcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT07237269 | Apr 2026 → Apr 2033 expected | prostate cancer | University of Nebraska | Recruiting | No outcome recorded |
| Phase 2 | NCT07299292 | Dec 2025 → Dec 2026 expected | — | SMED Clinical Research | Recruiting | No outcome recorded |
| Phase 2 | NCT06392841 | Oct 2025 → Jan 2028 | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, CHEK2-related cancer predisposition, Fanconi anemia complementation group A +2 | Qian Qin | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT06894511 | Sep 2025 → Oct 2026 expected | prostate carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05361915 | Sep 2025 → Jan 2028 | metastatic prostate carcinoma | Sorrento Therapeutics, Inc. | Suspended | No outcome recorded |
| Phase 2 | NCT07093866 | Jul 2025 → Dec 2026 expected | castration-resistant prostate carcinoma | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | No outcome recorded |
| Show all 118 trials opens the full record — a long page | ||||||
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT07641855 | Jun 2026 → Dec 2028 expected | castration-resistant prostate carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT03348670 | Aug 2023 → Nov 2026 expected | prostate cancer | Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT00268476 | Jul 2005 → Mar 2026 overdue | prostate cancer | Medical Research Council | Active not recruiting | Mixed |
| Phase 320 trials · 7 met primary · 1 missed | ||||||
| Phase 3 | NCT07751133 | Aug 2026 → Aug 2029 expected | castration-resistant prostate carcinoma | University College, London | Recruiting | No outcome recorded |
| Phase 3 | NCT07213674 | Nov 2025 → Jan 2030 expected | prostate carcinoma | Amgen | Recruiting | No outcome recorded |
| Phase 3 | NCT06855277 | Jul 2025 → Sep 2028 expected | prostate cancer | Novartis Pharmaceuticals | 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 | NCT06650579 | Jan 2025 → Jul 2029 expected | prostate carcinoma | Emory University | Recruiting | No outcome recorded |
| Phase 3 | NCT06768255 | Jan 2025 → Dec 2028 expected | castration-resistant prostate carcinoma | Ding-Wei Ye | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03777982 | Apr 2020 → Feb 2024 | prostate cancer | Dana-Farber Cancer Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04139772 | Sep 2019 → Dec 2023 | castration-resistant prostate carcinoma | National Cancer Institute, Naples | Unknown | No outcome recorded |
| 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 | NCT02887976 | Sep 2016 → Oct 2017 | prostate cancer | GU Research Network, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04056754 | Jul 2014 → Mar 2018 | castration-resistant prostate carcinoma | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01949337 | Jan 2014 → Nov 2018 | hormone-resistant prostate carcinoma, prostate adenocarcinoma | Alliance for Clinical Trials in Oncology | Unknown | Missed primary |
| Phase 3 | NCT01957436 | Nov 2013 → Aug 2021 overdue | metastatic prostate carcinoma | UNICANCER | Active not recruiting | Met primary |
| Phase 3 | NCT01715285 | Feb 2013 → Oct 2016 | prostate neoplasm | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01695135 | Aug 2012 → Jun 2014 | prostate neoplasm | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01517802 | Mar 2012 → Apr 2021 | breast cancer, prostate carcinoma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01591122 | Mar 2012 → Dec 2016 | prostate cancer | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00887198 | Apr 2009 → Mar 2014 | prostate cancer | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT00638690 | May 2008 → Aug 2010 | prostate neoplasm | Cougar Biotechnology, Inc. | Completed | Met primary |
| Phase 44 trials · 1 met primary | ||||||
| Phase 4 | NCT07001709 | Apr 2024 → Dec 2025 overdue | prostate cancer | Deventer Ziekenhuis | Recruiting | No outcome recorded |
| Phase 4 | NCT03016741 | Mar 2017 → Jan 2023 overdue | castration-resistant prostate carcinoma, hormone-resistant prostate carcinoma, metastatic prostate carcinoma | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02485691 | Nov 2015 → Mar 2019 | metastatic prostate carcinoma | Sanofi | Completed | Met primary |
| Phase 4 | NCT02405858 | Apr 2015 → Dec 2017 | castration-resistant prostate carcinoma | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase not applicable4 trials · 1 met primary | ||||||
| — | NCT06198387 | Jan 2024 → Sep 2025 overdue | metastatic prostate carcinoma | Changhai Hospital | Not yet recruiting | No outcome recorded |
| — | NCT03449719 | May 2018 → Sep 2021 | — | Lorenzo Livi | Unknown | Met primary |
| — | NCT01961843 | Jan 2014 → Apr 2023 | prostate cancer | Massachusetts General Hospital | Completed | No outcome recorded |
| — | NCT01858441 | Apr 2013 → Sep 2020 | — | Centre Antoine Lacassagne | Completed | No outcome recorded |
| Phase not stated3 trials | ||||||
| — | NCT05401214 | — | prostate carcinoma | Janssen Research & Development, LLC | Approved for marketing | No outcome recorded |
| — | NCT01217697 | — | prostate cancer, urinary system neoplasm | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Approved for marketing | No outcome recorded |
| — | NCT01834209 | — | prostate neoplasm | Janssen Research & Development, LLC | No longer available | No outcome recorded |
| Comparator or background therapy129 trials | ||||||
| Phase 0 | NCT07389174 Background | Feb 2026 → Jan 2027 expected | prostate adenocarcinoma | Shanghai Changzheng Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06220864 Background | Feb 2024 → Dec 2027 expected | neoplasm | Synnovation Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06099990 Background | Oct 2023 → Dec 2028 expected | prostate carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05942001 Comparator | Aug 2023 → Sep 2026 overdue | castration-resistant prostate carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT05177042 Background | May 2022 → Jul 2024 | metastatic prostate carcinoma | Arvinas Inc. | Completed | No outcome recorded |
| Show all 129 trials opens the full record — a long page | ||||||
News releases announcing trial results or a regulatory action · 92
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | AstraZeneca | Regulatory Truqap combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer astrazeneca.com ↗ |
| 2026-06-02 | Jiangsu HengRui Medicine Co., Ltd. | Results 2026 ASCO口头报告｜恒瑞创新药氟唑帕利联合AA-P一线治疗转移性去势抵抗性前列腺癌期中分析结果重磅发布 hengrui.com ↗
研究结果显示，氟唑帕利联合AA-P组较安慰剂联合AA-P组显著延长rPFS（中位rPFS 24.8个月 [95% CI：20.4-30.4] vs. 19.9个月 [95% CI：15.2-22.2]；HR 0.71 [95% CI：0.55-0.91]；单侧p=0.0034），达到了主要研究终点。 |
| 2026-04-30 | AstraZeneca | Regulatory Truqap recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer astrazeneca.com ↗
The Committee voted 7 to 1, with 1 abstaining. |
| 2026-03-09 | Janssen Research & Development, LLC | Regulatory European Commission approves AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with BRCA1/2-mutated metastatic hormone-sensitive prostate cancer (mHSPC) jnj.com ↗
Today’s approval of niraparib in combination with abiraterone acetate introduces a new precision-based treatment option for these patients, with the potential to delay progression. |
| 2026-01-30 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives CHMP positive opinion for AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with BRCA1/2 mutations jnj.com ↗
Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an indication extension for AKEEGA®(niraparib and abiraterone acetate dual action tablet). |
| 2025-12-12 | Janssen Research & Development, LLC | Regulatory U.S. FDA approves AKEEGA® as the first precision therapy for BRCA2-mutated metastatic castration-sensitive prostate cancer with 54% reduction in disease progression vs standard of care* jnj.com ↗ |
| 2025-12-12 | Janssen Research & Development, LLC | Regulatory U.S. FDA approves AKEEGA® as the first precision therapy for BRCA2-mutated metastatic castration-sensitive prostate cancer with 54% reduction in disease progression vs standard of care* jnj.com ↗ |
| 2025-10-16 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives U.S. FDA Priority Review for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) in BRCA-mutated metastatic castration-sensitive prostate cancer jnj.com ↗ |
| 2025-07-03 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application to the European Medicines Agency seeking indication extension of AKEEGA® (niraparib and abiraterone acetate dual action tablet) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer and HRR gene alterations jnj.com ↗ |
| 2025-06-03 | Janssen Research & Development, LLC | Results Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC jnj.com ↗
Johnson & Johnson announced today first results from the Phase 3, randomized, double-blind, placebo-controlled AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations including BRCA. |
| 2025-06-03 | Janssen Research & Development, LLC | Results Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC jnj.com ↗ |
| 2025-05-20 | Astellas Pharma Inc | Results Astellas Presents New Data that Explores Potential of its Cancer Therapies at 2025 ASCO Annual Meeting astellas.com ↗
Abiraterone acetate is associated with shorter overall survival than enzalutamide in patients with chemotherapy naïve metastatic castration-resistant prostate cancer: Real world data from the Flatiron electronic health records database |
| 2024-11-25 | AstraZeneca | Results Truqap combination in PTEN-deficient metastatic hormone-sensitive prostate cancer demonstrated statistically significant and clinically meaningful improvement in radiographic progression-free survival in CAPItello-281 Phase III trial astrazeneca.com ↗
Overall survival (OS) data were immature at the time of this analysis; however, the Truqap combination showed an early trend towards an OS improvement versus abiraterone and ADT with placebo. |
| 2024-06-05 | Kangpu Biopharmaceuticals, Ltd. | Regulatory FDA Approved Phase II/III Clinical Study of KPG-121 in Combination with Abiraterone as a First Line Treatment for mCRPC kangpugroup.com ↗
Hefei, China, June 5, 2024 -- Kangpu Biopharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has recently approved a Phase II/III clinical trial of KPG-121 in combination with Abiraterone for a first-line treatment of metastatic castration resistant prostate cancer (mCRPC). |
| 2023-10-22 | Janssen Research & Development, LLC | Results Final Multivariate Analysis from the Phase 3 MAGNITUDE Study Shows Trend Toward Improvement in Overall Survival in Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone jnj.com ↗ |
| 2023-10-22 | Janssen Research & Development, LLC | Results Final Multivariate Analysis from the Phase 3 MAGNITUDE Study Shows Trend Toward Improvement in OS in Patients with mCRPC with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone jnj.com ↗
Niraparib and abiraterone acetate plus prednisone combination therapy also showed clinically relevant improvement versus standard of care in time to symptomatic progression and time to cytotoxic chemotherapy |
| 2023-08-24 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib)Plus Abiraterone and Prednisolone Approved in Japan for the Treatment of BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisolone (abi/pred) has been approved in Japan for the treatment of adult patients with BRCA -mutated ( BRCA m) castration-resistant prostate cancer with distant metastasis (mCRPC). |
| 2023-08-24 | AstraZeneca | Regulatory Lynparza plus abiraterone approved in Japan for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisolone has been approved in Japan for the treatment of adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC). |
| 2023-08-11 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer jnj.com ↗ |
| 2023-08-11 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves AKEEGA™ (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer jnj.com ↗ |
| 2023-06-01 | Merck Sharp & Dohme LLC | Regulatory FDA Approves LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) merck.com ↗
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that LYNPARZA in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). |
| 2023-06-01 | AstraZeneca | Regulatory Lynparza plus abiraterone approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). |
| 2023-05-31 | Tavanta Therapeutics | Results Tavanta Therapeutics to Showcase Specialty Pipeline During the 2023 American Society of Clinical Oncology (ASCO) and American Society of Colon and Rectal Surgeons (ASCRS) Annual Congresses tavanta.com ↗
TAVT-45 (abiraterone acetate) Oral Suspension: Phase 3 Trial Demonstrates Therapeutic Equivalence Between TAVT-45 and Zytiga® with a Comparable Safety Profile, Suggesting the Potential of TAVT-45 as an Alternative to Zytiga® for Metastatic Prostate Cancer Patients Who Have Difficulty Swallowing (Dysphagia) |
| 2023-04-28 | Merck Sharp & Dohme LLC | Regulatory Update on FDA Advisory Committee Vote on LYNPARZA® (olaparib) Plus Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer merck.com ↗
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCA m mCRPC patients, recommending against approval beyond this patient population. |
| 2023-04-28 | AstraZeneca | Regulatory Update on FDA Advisory Committee vote on Lynparza plus abiraterone for metastatic castration-resistant prostate cancer astrazeneca.com ↗
The Committee voted 11 to 1, with 1 abstaining, that the indication should be limited to patients whose tumours have a BRCA mutation. |
| 2023-04-21 | Janssen Research & Development, LLC | Regulatory Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations jnj.com ↗
The EC authorisation, which also marks the first worldwide approval for AKEEGA®, is based on results of the randomised, double-blind, placebo controlled, Phase 3 MAGNITUDE study (NCT03748641). |
| 2023-04-21 | Janssen Research & Development, LLC | Regulatory Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorisation for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations jnj.com ↗ |
| 2023-03-02 | Merck Sharp & Dohme LLC | Regulatory Merck and AstraZeneca Provide Update on US Regulatory Review of LYNPARZA® (olaparib) for Use in Combination With Abiraterone and Prednisone or Prednisolone for the Treatment of Metastatic Castration-Resistant Prostate Cancer merck.com ↗
The ODAC Meeting is scheduled for April 28, 2023. |
| 2023-03-02 | AstraZeneca | Regulatory Update on US regulatory review of Lynparza in combination with abiraterone for metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD today announced that the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). |
| 2023-03-01 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations jnj.com ↗
today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate |
| 2023-02-28 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate Dual-Action Tablet, Plus Prednisone, as a First-Line Targeted Treatment for Patients with Metastatic Castration-Resistant Prostate Cancer with BRCA Gene Mutations jnj.com ↗
Janssen Submits New Drug Application to the U.S. Food and Drug Administration Seeking Approval of Niraparib and Abiraterone Acetate |
| 2023-02-27 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer jnj.com ↗ |
| 2023-02-24 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) Plus Prednisone or Prednisolone for the Treatment of Adult Patients with BRCA1/2 Gene-Mutated Metastatic Castration Resistant Prostate Cancer jnj.com ↗ |
| 2023-02-16 | Merck Sharp & Dohme LLC | Results Merck and AstraZeneca Present Final Results of Key Secondary Overall Survival Endpoint From Phase 3 PROpel Trial at 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium merck.com ↗
This OS trend did not reach statistical significance. |
| 2023-02-16 | Janssen Research & Development, LLC | Results Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
Updated review of the primary endpoints in radiographic progression free survival (rPFS) were consistent with the initial results, which showed a statistically significant benefit in both the HRR-positive population and BRCA subgroup. |
| 2023-02-16 | Janssen Research & Development, LLC | Results Janssen Presents Updated Data Demonstrating Improved Outcomes from the Use of Niraparib in Combination with Abiraterone Acetate Plus Prednisone as a First-Line Therapy in Patients with BRCA-Positive Metastatic Castration - Resistant Prostate Cancer jnj.com ↗ |
| 2023-02-16 | AstraZeneca | Results AstraZeneca and MSD present final results of key secondary overall survival endpoint from Phase III PROpel trial at ASCO GU Cancers Symposium astrazeneca.com ↗
Results showed an absolute difference of an additional 7.4 months in median overall survival for Lynparza plus abiraterone in this setting vs. abiraterone alone |
| 2023-01-05 | Tavanta Therapeutics | Results Tavanta Therapeutics Announces Positive Top-line Results from Pivotal Phase 3 Trial of TAVT-45 for the Treatment of Metastatic Prostate Cancer tavanta.com ↗
The trial met its primary objective of establishing therapeutic equivalence of TAVT-45 to Zytiga ® in patients with metastatic castrate-resistant prostate cancer (mCRPC) and metastatic high-risk castrate-sensitive prostate cancer (mCSPC), in addition to demonstrating a comparable safety profile. |
| 2022-12-21 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone Approved in the EU as Treatment for Certain Patients With Metastatic Castration-Resistant Prostate Cancer merck.com ↗ |
| 2022-12-21 | AstraZeneca | Regulatory Lynparza in combination with abiraterone approved in the EU as 1st-line treatment for patients with metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the European Union for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men for whom chemotherapy is not clinically indicated. |
| 2022-12-15 | Merck Sharp & Dohme LLC | Regulatory AstraZeneca and Merck Provide Update on US Regulatory Review of LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone as Treatment of Metastatic Castration-Resistant Prostate Cancer merck.com ↗
The purpose of the extension is to provide further time for the full review of the submission. |
| 2022-12-15 | AstraZeneca | Regulatory Update on US regulatory priority review of Lynparza in combination with abiraterone in metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca and MSD today announced that the US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date by three months to provide further time for a full review of the supplementary new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC). |
| 2022-11-14 | Merck Sharp & Dohme LLC | Regulatory LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone Receives Positive Opinion From EU CHMP as Treatment for Certain Patients With Metastatic Castration-Resistant Prostate Cancer merck.com ↗ |
| 2022-11-14 | AstraZeneca | Regulatory Lynparza in combination with abiraterone recommended for approval in the EU by CHMP as 1st-line treatment for patients with metastatic castration-resistant prostate cancer astrazeneca.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the PROpel Phase III trial which were published in NEJM Evidence in June 2022. |
| 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. |
| 2022-08-16 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) in Combination With Abiraterone and Prednisone or Prednisolone for Patients With Metastatic Castration-Resistant Prostate Cancer and Grants Priority Review merck.com ↗ |
| 2022-08-16 | AstraZeneca | Regulatory Lynparza in combination with abiraterone granted Priority Review in the US for patients with metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the US for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). |
| 2022-06-21 | Merck Sharp & Dohme LLC | Results Results From Phase 3 PROpel Trial of LYNPARZA® (olaparib) Plus Abiraterone in First-Line Metastatic Castration-Resistant Prostate Cancer Published in NEJM Evidence merck.com ↗
The data published in NEJM Evidence emphasize the therapeutic potential of combining olaparib with abiraterone and prednisone and demonstrate efficacy in a wider group of patients beyond those with documented DNA repair deficiency. |
| 2022-05-20 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives sANDA approval for Abiraterone Acetate Tablets USP, 500 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 500 mg, the generic version of Zytiga®1 Tablets, 500 mg, of Janssen Biotech Inc. |
| 2022-05-05 | Cardiff Oncology | Results Cardiff Oncology Reports First Quarter 2022 Results and Provides Business Updates cardiffoncology.com ↗
Results from the trial, which were presented in a poster at the American Association for Cancer Research (AACR) Annual Meeting, showed clinically meaningful disease control rates that rose with increasing onvansertib dose density. |
| 2022-04-08 | Cardiff Oncology | Results Cardiff Oncology Announces Updated Clinical and New Biomarker Data from Phase 2 Metastatic Castration-Resistant Prostate Cancer Trial at the AACR Annual Meeting cardiffoncology.com ↗
Median progression-free survival (mPFS) has increased with increasing onvansertib dose density from 4.1 months in Arm A to 13.2 months to-date in Arm C patients |
| 2022-03-08 | Cardiff Oncology | Results Cardiff Oncology Announces Upcoming Poster Presentations at the AACR Annual Meeting cardiffoncology.com ↗
Collectively, these analyses suggest that alterations in PTEN and MTOR, two key genes of the PI3K signaling pathway, are potential biomarkers for sensitivity to onvansertib-abiraterone combination therapy in mCRPC patients with early abiraterone-resistance. |
| 2022-02-22 | MSD R&D (China) Co., Ltd. | Results LYNPARZA®（オラパリブ）、アビラテロンとの併用療法が、 転移性去勢抵抗性前立腺がん（mCRPC）の一次治療において、バイオマーカーのステータスに かかわらず疾患進行または死亡のリスクをアビラテロンと比較して34%減少 PROpel試験は第3相試験として初めて、mCRPCの一次治療において PARP阻害剤との併用で画像診断に基づく無増悪生存期間の臨床的有用性を示す msd.co.jp ↗
LYNPARZA ® とアビラテロン＋プレドニゾロンの併用療法（399例）では、mCRPC患者において、HRR関連遺伝子変異の有無にかかわらず、アビラテロン＋プレドニゾロンおよびプラセボ（397例）と比較して、疾患進行または死亡のリスクが34%低下しました（HR=0.66 [95% CI, 0.54-0.81]; p<0.0001）。 |
| 2022-02-14 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) Plus Abiraterone Reduced Risk of Disease Progression or Death by 34% Versus Abiraterone in First-Line Metastatic Castration-Resistant Prostate Cancer, Regardless of Biomarker Status merck.com ↗ |
| 2022-02-14 | Janssen Research & Development, LLC | Results Janssen Presents New Data Demonstrating the Combination of Niraparib and Abiraterone Acetate Plus Prednisone Significantly Improved Radiographic Progression-Free Survival as a First-Line Therapy in Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
At the final analysis for radiographic progression-free survival (rPFS), the treatment combination of niraparib and abiraterone acetate plus prednisone demonstrated a statistically significant improvement in patients with HRR gene alterations. |
| 2022-02-14 | Janssen Research & Development, LLC | Results Janssen Presents New Data Demonstrating the Combination of Niraparib and Abiraterone Acetate Plus Prednisone Significantly Improved Radiographic Progression-Free Survival as a First-Line Therapy in Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
At the final analysis for radiographic progression-free survival (rPFS), the treatment combination of niraparib and abiraterone acetate plus prednisone demonstrated a statistically significant improvement in patients with HRR gene alterations. |
| 2022-02-14 | AstraZeneca | Results Lynparza plus abiraterone reduced risk of disease progression by 34% vs. standard-of-care in 1st-line metastatic castration-resistant prostate cancer astrazeneca.com ↗ |
| 2021-09-24 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) in Combination With Abiraterone Significantly Delayed Disease Progression in Patients Regardless of Biomarker Status in PROpel Phase 3 Trial in First-Line Metastatic Castration-Resistant Prostate Cancer (mCRPC) merck.com ↗
At a planned interim analysis, the Independent Data Monitoring Committee concluded that the trial met the primary endpoint of rPFS in men with mCRPC who had not received treatment in the first-line setting, including new hormonal agents (NHAs) or chemotherapy. |
| 2021-09-24 | AstraZeneca | Results Lynparza in combination with abiraterone significantly delayed disease progression in all-comers in PROpel Phase III trial in 1st-line metastatic castration-resistant prostate cancer astrazeneca.com ↗
The trial also showed a trend at this interim analysis towards improved overall survival (OS). |
| 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. |
| 2021-04-10 | Cardiff Oncology | Results Cardiff Oncology in Collaboration with MIT Presents Gene Signature Analyses Data Identifying Androgen-Independent Mechanism for Onvansertib-Abiraterone Synergy in mCRPC cardiffoncology.com ↗
Onvansertib and the androgen receptor (AR) signaling inhibitor abiraterone synergize in an AR-independent manner in in-vitro and in-vivo metastatic castrate-resistant prostate cancer (mCRPC) models |
| 2021-03-10 | Cardiff Oncology | Results Cardiff Oncology Announces Upcoming Presentations at the AACR Annual Meeting 2021 cardiffoncology.com ↗
The selective polo-like kinase (Plk1) inhibitor onvansertib and the antiandrogen abiraterone synergistically kill cancer cells through disruption of mitosis |
| 2021-02-11 | Cardiff Oncology | Results Cardiff Oncology Presents Phase 2 mCRPC Trial Data Showing a Two-Fold Increase in Efficacy with an Optimized Onvansertib Dosing Schedule cardiffoncology.com ↗
75% (6/8) of evaluable patients in the optimized dosing cohort had stable disease upon radiographic scan at 12 weeks |
| 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 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 |
| 2021-01-08 | Impax Laboratories, LLC | Regulatory Amneal Launches Generic Abiraterone Acetate Tablets, USP, 500 mg, Following ANDA Approval by FDA amneal.com ↗
This ANDA is approved for its use in combination with Prednisone. |
| 2020-09-20 | Merck Sharp & Dohme LLC | Results LYNPARZA Reduced Risk of Death by 31% vs. Enzalutamide or Abiraterone for Men with BRCA1/2 or ATM-Mutated Metastatic Castration Resistant Prostate Cancer Who Progressed Following Enzalutamide or Abiraterone in Phase 3 PROfound Trial merck.com ↗
Median OS was 19.1 months for LYNPARZA vs. 14.7 months for enzalutamide or abiraterone, despite 66% of men on these treatments having crossed over to receive treatment with LYNPARZA following disease progression. |
| 2020-06-19 | Hoffmann-La Roche | Results Roche’s IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints roche.com ↗
In this patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. |
| 2020-06-19 | Chugai Pharmaceutical | Results Phase III IPATential150 Study Evaluating Ipatasertib in Combination with Abiraterone and Prednisone/Prednisolone in Patients with Metastatic Castration-Resistant Prostate Cancer Meets One of Its Co-Primary Endpoint chugai-pharm.co.jp ↗ |
| 2020-06-18 | Genentech, Inc. | Results Genentech’s IPATential150 Study Evaluating Ipatasertib in Combination With Abiraterone and Prednisone/Prednisolone Met One of Its Co-Primary Endpoints gene.com ↗
In this patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. |
| 2020-02-13 | Cardiff Oncology | Results Trovagene Presents Phase 2 Data Demonstrating the Ability of Onvansertib to Overcome Zytiga®-Resistance and Provide Clinical Benefit for mCRPC Patients cardiffoncology.com ↗
In patients with AR alterations, 86% had decreases in PSA levels with the addition of onvansertib to daily Zytiga®. |
| 2019-10-17 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Abiraterone Acetate Tablets USP, 250 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 250 mg, a generic version of Zytiga®1 Tablets, 250 mg, of Janssen Biotech, Inc. |
| 2019-03-01 | Wockhardt | Regulatory WOCKHARDT RECEIVES US FDA APPROVAL FOR PROSTATE CANCER DRUG wockhardt.com ↗
Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 250mg tablet of Abiraterone acetate, which is used to treat Prostate Cancer. |
| 2018-06-04 | Merck Sharp & Dohme LLC | Results LYNPARZA® (olaparib) in Combination with Abiraterone Delayed Disease Progression in Metastatic Castration-Resistant Prostate Cancer merck.com ↗ |
| 2018-06-04 | AstraZeneca | Results Lynparza in combination with abiraterone delayed disease progression in metastatic castration-resistant prostate cancer astrazeneca.com ↗
today presented data, which showed clinical improvement in median radiologic progression-free survival (rPFS) with Lynparza (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a standard of care, in metastatic castration-resistant prostate cancer (mCRPC). |
| 2018-05-23 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Announces USFDA Approval of YONSA sunpharma.com ↗
Sun Pharma Announces USFDA Approval of YONSA® |
| 2018-02-15 | Janssen Research & Development, LLC | Regulatory Health Canada Approves New Indication for ZYTIGA®* (abiraterone acetate), Broadening its Use for Treatment of Newly Diagnosed Metastatic Prostate Cancer jnj.com ↗
Health Canada Approves New Indication for ZYTIGA®* (abiraterone acetate), Broadening its Use for Treatment of Newly Diagnosed Metastatic Prostate Cancer |
| 2018-02-08 | Janssen Research & Development, LLC | Regulatory ZYTIGA® (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for ZYTIGA® (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). |
| 2017-11-30 | Bayer | Results Phase III trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone for patients with metastatic castration-resistant prostate cancer unblinded early bayer.com ↗
Bayer today announced that an Independent Data Monitoring Committee (IDMC) has recommended to unblind a Phase III trial of radium-223 dichloride (radium-223) in combination with abiraterone acetate and prednisone/prednisolone in prostate cancer. |
| 2017-10-13 | Janssen Research & Development, LLC | Regulatory CHMP Issues a Positive Opinion on Janssen's ZYTIGA® to Include Earlier Stage Prostate Cancer Patients jnj.com ↗
CHMP Issues a Positive Opinion on Janssen’s ZYTIGA® to Include Earlier Stage Prostate Cancer Patients |
| 2017-09-14 | Janssen Research & Development, LLC | Regulatory Janssen Submits Supplemental New Drug Application to U.S. FDA for ZYTIGA® (abiraterone acetate) to Treat Men with Earlier Stages of Metastatic Prostate Cancer jnj.com ↗
Janssen Submits Supplemental New Drug Application to U.S. FDA for ZYTIGA® (abiraterone acetate) to Treat Men with Earlier Stages of Metastatic Prostate Cancer |
| 2017-09-08 | Janssen Research & Development, LLC | Results New Data Presented at ESMO 2017 Shows That Abiraterone Acetate Plus Prednisone Provides Benefits in Patient Reported Outcomes in Both Metastatic Hormone-Sensitive and Castration-Resistant Prostate Cancer jnj.com ↗ |
| 2016-12-14 | Pfizer | Results Pfizer and Astellas Announce Top-Line Results from Phase 4 PLATO Trial of XTANDI® (enzalutamide) Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503) today announced the Phase 4 PLATO study, evaluating the efficacy and safety of continued treatment with XTANDI ® (enzalutamide), plus abiraterone acetate and prednisone as compared to treatment with abiraterone acetate and prednisone alone, did not meet its primary endpoint of improvement in progression-free survival (PFS) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (CRPC) whose prostate-specific antigen (PSA) has previously progressed on XTANDI. |
| 2016-12-09 | Tavanta Therapeutics | Results DRGT’s novel Abiraterone Acetate composition provides opportunity for dose reduction and increased efficacy in prostate cancer tavanta.com ↗
In a Phase I clinical study DRGT-45 improved exposure four-fold, eliminated the food effect and significantly reduced patient variability. |
| 2016-03-14 | Janssen Research & Development, LLC | Results Greater Survival Benefit Shown in Men with Early and Less Aggressive Metastatic Castration-Resistant Prostate Cancer Treated with ZYTIGA® Plus Prednisone jnj.com ↗ |
| 2015-03-30 | Janssen Research & Development, LLC | Regulatory FDA Approves Label Update for ZYTIGA® to Include Statistically Significant Overall Survival Results in Chemotherapy-Naïve Men with Metastatic Castration-Resistant Prostate Cancer jnj.com ↗ |
| 2014-09-28 | Janssen Research & Development, LLC | Results ZYTIGA® Plus Prednisone Demonstrates Statistically Significant Overall Survival After 49-Month Follow-Up Analysis in Chemotherapy-Naïve Men with Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
The Janssen Research & Development, LLC ("Janssen")-sponsored registration study demonstrated a 19 percent reduction in risk of death in this study population (median OS, 34.7 vs 30.3 months, respectively; HR= 0.81 [95% CI, 0.70-0.93]; p = 0.0033), after a median follow-up of more than four years (49.2 months). |
| 2014-06-02 | Janssen Research & Development, LLC | Results IMAAGEN Data Demonstrate that Abiraterone Acetate Plus Prednisone (5mg once daily) Lowers PSA Levels in Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer (M0-CRPC) jnj.com ↗
Abiraterone acetate (ZYTIGA®) plus prednisone demonstrated statistically significant reductions in PSA levels at six months, the primary endpoint of the IMAAGEN trial, which evaluates the investigational use of abiraterone acetate plus prednisone (5 mg once daily) in patients with non-metastatic castration-resistant prostate cancer (M0-CRPC) at high risk of developing metastatic disease. |
| 2013-09-30 | Janssen Research & Development, LLC | Results New Study Shows Circulating Tumor Cell Enumeration - as Part of Composite Biomarker Panel -May Serve as a Surrogate for Efficacy Response in Metastatic Castration-Resistant Prostate Cancer jnj.com ↗
Findings suggest therapeutic alternatives should be considered for patients in the high -risk category at 12 weeks. |
| 2013-02-12 | Janssen Research & Development, LLC | Results Follow-up Data Show ZYTIGA® Plus Prednisone Continues to Delay Progression of Metastatic Castration-Resistant Prostate Cancer in Patients without Prior Chemotherapy jnj.com ↗ |
| 2013-01-11 | Janssen Research & Development, LLC | Regulatory Zytiga® Approved In the EU For Use In The Treatment Of Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy jnj.com ↗ |
All press releases naming this drug 103 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 103 releases opens the full record — a long page | ||
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 358 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | abiraterone acetate | “This is a randomized (study drug is assigned by chance), open-label (all people know the identity of the intervention), parallel-arm, multicenter, phase 2 study of treatment...” NCT01867710 ↗194“This regimen consists of Androgen Deprivation Therapy (ADT) (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix) combined with an oral Androgen Receptor (AR) inhibitor...” NCT07389174 ↗ “Abiraterone acetate (JanssenBiotech, Inc/Johnson \& Johnson) 1000 mg orally daily plus prednisone 5 mg orally twice daily will be administered continuously during the duration...” NCT01688492 ↗ “These dosages are as follows: leuprolide acetate 22.5 mg depot injection x one dose, abiraterone acetate 1000 mg by mouth daily, and belzutifan120 mg administered by mouth once daily.” NCT05574712 ↗ “A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration-Resistant Prostate Cancer Patients Who Have Received Docetaxel-based Chemotherapy” NCT01795703 ↗ “Abiraterone acetate (AA) has been approved for the treatment of mCRPC after docetaxel progression at doses of 1.000 mg per day taken in fasting conditions.” NCT02730975 ↗ “1000 mg abiraterone acetate (4 250-mg tablets - current commercial formulation, reference drug) administered as a single oral dose under fasted conditions” NCT01897389 ↗ “Participants will receive niraparib/abiraterone acetate fixed-dose combination 100/500 mg 2 tablets once daily on days 1-28 of each 28-day cycle.” NCT06527690 ↗ “The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment” NCT01516047 ↗ “The ARPI drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi).” NCT04597125 ↗ “ZYTIGA - abiraterone acetate tablet, film coated plus prednisone tablet plus BICALUTAMIDE tablet for Oral” NCT03348670 ↗ |
| Known as | abiraterone | “The intervention strictly involves continuing the identical Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) regimen-such as abiraterone,...” NCT07838753 ↗162“The drugs to be administered are: prednisone 5 mg orally twice daily, abiraterone 1000 mg orally once daily, enzalutamide 160 mg orally once daily, and cabazitaxel intravenous...” NCT03110588 ↗ “Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel,...” NCT03556904 ↗ “Bridging therapy including Anti-AR agents (example, abiraterone, enzalutamide) will be administered orally and radiotherapy, or chemotherapy (example, docetaxel) will be...” NCT05022849 ↗ “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 ↗ “Androgen deprivation with or without docetaxel chemotherapy, Abiraterone, Enzalutamide or any other proven agent) treatment as determined by treating physician (positive control).” NCT03763253 ↗ “Additional therapy following tumor board meeting : new generation hormonal therapy (abiraterone, enzalutamide, apalutamide or other approved) or chemotherapy (docetaxel).” NCT04115007 ↗ “Agents of interest included Abiraterone, Enzalutamide, Pembrolizumab, Ipilimumab, Carboplatin, Docetaxel, and Olaparib as well as combinations” NCT04399876 ↗ “Abiraterone acetate (abiraterone) plus prednisone is approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC).” PMID 38926066 ↗ Jun 2024 “ADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be administrated according to the standard of care” NCT06496581 ↗ “In addition to ADT, participants may be treated with second-generation anti-androgen drugs such as Abiraterone or Enzalutamide.” NCT06655259 ↗ |
| Known as | ATRS-2002 | “single Subcutaneous (SC) dose of ATRS-2002 (abiraterone acetate), or a single oral dose of the commercially available formulation of abiraterone acetate (Zytiga®).” NCT04879589 ↗ |
| Known as | BR9004 | “BR9004: Abiraterone acetate 200mg, Boryung Pharmaceutical Co., Ltd.” NCT04889651 ↗ |
| Known as | BR9004-1 | “BR9004-1: Zytiga Tab. 500mg (Abiraterone acetate 500mg), Janssen Korea” NCT04889651 ↗ |
| Known as | CB7630 | “The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of capsule and tablet formulations of CB7630 (abiraterone acetate)...” NCT00600535 ↗6“The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activities of abiraterone acetate (also referred to as CB7630) in...” NCT00473746 ↗ “A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic...” NCT00887198 ↗ “A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy” NCT00474383 ↗ “An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001” NCT01664728 ↗ “A QT/QTc and Multi-dose PK Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration- Resistant Prostate Cancer” NCT00910754 ↗ “Abiraterone Acetate (CB7630)” NCT00638690 ↗ |
| Known as | JNJ-212082 | “A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate...” NCT01695135 ↗3“Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer...” NCT01381874 ↗ “Abiraterone Acetate (JNJ-212082) Plus Prednisone” NCT01591122 ↗ |
| Known as | JNJ-589485 | “An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone (JNJ-589485) Following Administration of Abiraterone...” NCT01588782 ↗1“A Study to Assess the Effect of Abiraterone (JNJ-589485) on the Pharmacokinetics of Pioglitazone Following Administration of Abiraterone Acetate (JNJ-212082) and Pioglitazone...” NCT01873001 ↗ |
| Known as | OAA | “ZYTIGA®, the originator abiraterone acetate (OAA), in patients with metastatic CRPC.” PMID 40346626 ↗ May 2025 |
| Known as | SoluMatrix | “SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) is an androgen synthesis inhibitor” NCT02887976 ↗ |
| Known as | Zygita | “abiraterone (Zygita®, "Zytiga is a trademark of Janssen Biotech, Inc.")” NCT02380313 ↗ |
| Known as | Zytiga | “In April 2011, the United States Food and Drug Administration (FDA) approved the oral drug abiraterone acetate (Zytiga ®) in combination with prednisone (a steroid) to treat...” NCT01751451 ↗7“The ARPI drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi).” NCT04597125 ↗ “For novel hormone therapy, there are also 3 options available. 1. "Abiraterone"/ "ZYTIGA®".” NCT06832774 ↗ “Abiraterone acetate tablets (250 mg, produced by Patheon Ich, trade name: Zytiga®)” NCT04735913 ↗ “abiraterone (Zygita®, "Zytiga is a trademark of Janssen Biotech, Inc.")” NCT02380313 ↗ “Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets” NCT05413421 ↗ |
| Action | Inhibit | “abiraterone, a steroid synthesis inhibitor” NCT00268476 ↗ |
| Modality | Small molecule | “Abiraterone acetate is a steroidal irreversible inhibitor” NCT00638690 ↗ |
| Route | Oral | “oral abiraterone acetate (1000 mg daily)” PMID 34953525 ↗ Dec 2021 |
| Target | CYP17 | “inhibitor of CYP17” NCT00638690 ↗ |