Drugs / Darolutamide
Darolutamide
also known as
BAY1841788 · Nubeqa · ODM-201 · Darolutamida · Darolutamide is also known as Nubeqa · Darolutamide: ODM-201
Other / unclassified targets AR via inhibition
Regulatory milestones approvals, filings & regulatory actions · 18 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed castration-resistant prostate carcinoma 4 milestones | |||||
| Filed | US (FDA) | — | castration-resistant prostate carcinoma | 2019-04-29 | “29 Apr 2019 The United States Food and Drug Administration (FDA) accepted the marketing authorisation application for darolutamide for review” orionpharma.com ↗ |
| Filed | EU (EMA) | — | castration-resistant prostate carcinoma | 2019-03-08 | “Orion Corporation and Bayer today announced that a marketing authorization application (MAA) has been submitted to the European Medicines Agency (EMA) for darolutamide” orionpharma.com ↗ “Bayer has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for darolutamide” bayer.com ↗ |
| Filed | Japan (PMDA) | — | castration-resistant prostate carcinoma | 2019-03-05 | “Bayer has submitted an application for marketing authorization to the Ministry of Health, Labor and Welfare (MHLW) in Japan for darolutamide” bayer.com ↗ “an application for marketing authorization has been submitted to the Ministry of Health, Labor and Welfare (MHLW) in Japan for darolutamide” orionpharma.com ↗ |
| Filed | US (FDA) | — | castration-resistant prostate carcinoma | 2019-02-27 | “Bayer today announced the completion of the rolling submission of a New Drug Application (NDA) for darolutamide to the U.S. Food and Drug Administration (FDA).” bayer.com ↗ “today announced the completion of the rolling submission of a New Drug Application (NDA) for darolutamide to the U.S. Food and Drug Administration (FDA).” bayer.com ↗ |
| Filed metastatic prostate carcinoma 1 milestone | |||||
| Filed | Japan (PMDA) | — | metastatic prostate carcinoma | 2022-03-11 | “Submission to the Ministry of Health, Labor and Welfare (MHLW) in Japan for an additional indication of darolutamide in prostate cancer with distant metastases” orionpharma.com ↗ |
| Filed progesterone-receptor positive breast cancer 8 milestones | |||||
| Filed | EU (EMA) | Nubeqa | progesterone-receptor positive breast cancer | 2024-10-14 | “Bayer today announced the submission of an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide.” bayer.com ↗ “submission of an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide.” bayer.com ↗ |
| Filed | US (FDA) | Nubeqa | progesterone-receptor positive breast cancer | 2024-09-26 | “Bayer today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the oral androgen receptor inhibitor (ARi)...” bayer.com ↗ “submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the oral androgen receptor inhibitor (ARi) darolutamide.” bayer.com ↗ |
| Filed | Japan (PMDA) | — | progesterone-receptor positive breast cancer | 2022-08-30 | “submitted applications for darolutamide in combination with docetaxel in mHSPC to the European Medicine Agency (EMA), the Ministry of Health, Labor, and Welfare (MHLW)” bayer.com ↗ |
| Filed | EU (EMA) | — | progesterone-receptor positive breast cancer | 2022-08-30 | “submitted applications for darolutamide in combination with docetaxel in mHSPC to the European Medicine Agency (EMA)” bayer.com ↗ |
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2022-05-03 | “Orion’s collaboration partner Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority...” orionpharma.com ↗ |
| Filed | Japan (PMDA) | Nubeqa | progesterone-receptor positive breast cancer | 2022-03-11 | “Submission to the Ministry of Health, Labor and Welfare (MHLW) in Japan for an additional indication of darolutamide in prostate cancer with distant metastases” bayer.com ↗ |
| Filed | US (FDA) | Nubeqa | progesterone-receptor positive breast cancer | 2022-03-09 | “for this third indication for darolutamide, in addition to filings in the EU and the U.S. earlier in 2024.” bayer.com ↗ “submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA)” bayer.com ↗ |
| Filed | EU (EMA) | Nubeqa | progesterone-receptor positive breast cancer | 2022-03-09 | “for this third indication for darolutamide, in addition to filings in the EU and the U.S. earlier in 2024.” bayer.com ↗ “as well as the submission of a Variation Type II to the European Medicines Agency (EMA)” orionpharma.com ↗ “submission of a Variation Type II application to the European Medicines Agency (EMA)” bayer.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | NUBEQA | — | 2021-01-07 – 2025-06-03 | fda.gov ↗ |
| Approved | EU (EMA) | Nubeqa | — | 2020-03-27 | europa.eu ↗ |
| Approved | US (FDA) | NUBEQA | — | 2019-07-30 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT07516704 | Apr 2026 → Dec 2027 expected | prostate cancer | Zhongda Hospital | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT05683964 | Jan 2023 → Sep 2025 overdue | prostate adenocarcinoma | Beth Israel Deaconess Medical Center | Active not recruiting | No outcome recorded |
| Phase 0 | NCT03004534 | Sep 2017 → Feb 2019 | female breast carcinoma | Translational Research in Oncology | Completed | No outcome recorded |
| Phase 117 trials | ||||||
| Phase 1 | NCT07620041 | Jun → Dec 2026 expected | neoplasm | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT07140900 | Oct 2025 → Mar 2028 expected | metastatic prostate carcinoma | Amgen | Recruiting | No outcome recorded |
| Phase 1 | NCT06631521 | Oct 2024 → Jun 2026 overdue | prostate adenocarcinoma | AdventHealth | Recruiting | No outcome recorded |
| Phase 1 | NCT05938270 | Sep 2023 → Jun 2026 | prostate cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05617885 | Aug 2023 → Jul 2025 | metastatic prostate carcinoma | Praful Ravi, MB BCHir, MRCP | Completed | 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 | 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 | NCT03724747 | Dec 2018 → Aug 2022 | prostate carcinoma | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03704519 | Oct 2018 → Oct 2019 | cerebrovascular disorder | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03237416 | Aug → Oct 2017 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT03048110 | Feb → May 2017 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02894385 | Sep 2016 → Apr 2017 | impaired renal function disease, liver disorder | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02671097 | Feb → May 2016 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02418650 | Mar → May 2015 | — | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02363855 | Feb → Nov 2015 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01784757 | Mar → Aug 2013 | prostate cancer | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT07190300 | Jan 2026 → Aug 2032 expected | metastatic prostate carcinoma | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06785636 | Feb 2025 → Jun 2028 expected | prostate carcinoma | Pathos AI, 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 | NCT05272709 | Jan 2022 → Jun 2027 expected | cancer | Cancer Research UK | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04737109 | Jul 2021 → Aug 2022 | castration-resistant prostate carcinoma | David VanderWeele | Terminated | No outcome recorded Stop: Business |
| 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 | NCT01317641 | Mar 2011 → Jul 2013 | prostate cancer | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 242 trials · 1 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 | NCT07649421 | Sep 2026 → Aug 2031 expected | metastatic prostate carcinoma | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07027124 | May 2026 → Dec 2027 expected | prostate cancer | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 2 | NCT07450599 | Apr 2026 → Jun 2028 expected | — | Bayer | Recruiting | No outcome recorded |
| Phase 2 | NCT07503379 | Apr 2026 → Dec 2027 expected | — | Yonghong Li | Recruiting | No outcome recorded |
| Phase 2 | NCT07476677 | Apr 2026 → Dec 2027 expected | prostate cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07142551 | Mar 2026 → Jun 2030 expected | castration-resistant prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT07282197 | Jan 2026 → Mar 2029 expected | prostate cancer | Peking University First Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07617272 | Nov 2025 → Jun 2027 expected | prostate adenocarcinoma | Region Stockholm | Recruiting | No outcome recorded |
| Phase 2 | NCT07016399 | Sep 2025 → Sep 2028 expected | triple-negative breast carcinoma | Vandana Abramson | Recruiting | No outcome recorded |
| Phase 2 | NCT06463457 | Dec 2024 → Nov 2028 expected | prostate cancer | Atish Choudhury, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06401980 | Oct 2024 → Jun 2030 expected | prostate carcinoma | Swiss Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04176081 | Jul 2024 → Dec 2028 expected | prostate cancer | University Health Network, Toronto | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06575257 | May 2024 → May 2026 overdue | prostate cancer | Xijing Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06169124 | Feb 2024 → May 2027 expected | ovarian granulosa cell tumor | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05849298 | Jan 2024 → Dec 2026 expected | prostate neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05762536 | Nov 2023 → May 2027 expected | prostate carcinoma | Erasmus Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06173362 | Nov 2023 → Nov 2026 expected | prostate adenocarcinoma | University of California, Davis | 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 | NCT05826509 | Aug 2023 → Feb 2031 expected | prostate cancer | Institut Claudius Regaud | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06029036 | Aug 2023 → Jul 2025 overdue | prostate cancer | Peking University First Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05900973 | Jul 2023 → May 2025 | prostate cancer | D'Or Institute for Research and Education | Unknown | No outcome recorded |
| Phase 2 | NCT05669664 | Jul 2023 → Nov 2026 expected | salivary gland carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05346848 | Feb 2023 → Dec 2026 expected | prostate cancer | Institut Bergonié | Recruiting | No outcome recorded |
| Phase 2 | NCT05526248 | Dec 2022 → Aug 2024 | prostate carcinoma | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT05249712 | Jan 2022 → Jan 2023 | prostate cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Unknown | No outcome recorded |
| Phase 2 | NCT05171387 | Nov 2021 → Dec 2024 | prostate cancer | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT05059236 | Nov 2021 → May 2025 | prostate carcinoma | Bayer | Completed | No outcome recorded |
| Phase 2 | NCT04558866 | Jun 2021 → Mar 2024 overdue | prostate cancer | Latin American Cooperative Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04319783 | Jun 2021 → Jun 2026 overdue | prostate carcinoma | Trans Tasman Radiation Oncology Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04641078 | Feb 2021 → Feb 2026 | metastatic malignant neoplasm, metastatic prostate carcinoma | University Hospital, Ghent | Unknown | No outcome recorded |
| Phase 2 | NCT04070209 | Oct 2020 → Nov 2030 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Sir Mortimer B. Davis - Jewish General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04025372 | Jun 2020 → Oct 2027 expected | prostate cancer | Brigham and Women's Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05694819 | Apr 2020 → Aug 2024 | salivary gland cancer | National Cancer Center Hospital East | Completed | No outcome recorded |
| Phase 2 | NCT04157088 | Dec 2019 → Jul 2022 | castration-resistant prostate carcinoma | Bayer | Terminated | No outcome recorded |
| Phase 2 | NCT03385655 | Aug 2018 → Oct 2024 overdue | prostate cancer | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03383679 | Mar 2018 → Nov 2021 | female breast carcinoma, triple-negative breast carcinoma | UNICANCER | Completed | No outcome recorded |
| Phase 2 | NCT02972060 | Dec 2017 → Jan 2023 overdue | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03314324 | Nov 2017 → Jan 2022 | castration-resistant prostate carcinoma | Gustave Roussy, Cancer Campus, Grand Paris | Completed | Missed primary |
| Phase 2 | NCT02933801 | Mar 2017 → Jun 2021 | metastatic prostate carcinoma | Swiss Cancer Institute | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01429064 | Jun 2011 → Nov 2015 | prostate cancer | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07852195 | Jan 2027 → Mar 2029 expected | prostate adenocarcinoma | ECOG-ACRIN Cancer Research Group | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT06282588 | Dec 2023 → Jul 2030 expected | prostate cancer | Cancer Research Antwerp | Recruiting | No outcome recorded |
| Phase 315 trials · 5 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 | NCT06625970 | Apr 2025 → Oct 2033 expected | prostate cancer | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT06276465 | Oct 2024 → Oct 2029 expected | castration-resistant prostate carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT05794906 | Apr 2023 → Jul 2027 expected | prostate carcinoma | Bayer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05116475 | Aug 2022 → Feb 2026 overdue | prostate cancer | Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie | Recruiting | No outcome recorded |
| Phase 3 | NCT04916613 | Apr 2022 → Mar 2028 expected | metastatic prostate carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 3 | NCT05050084 | Dec 2021 → Nov 2026 expected | prostate adenocarcinoma | NRG Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04484818 | Mar 2021 → Sep 2026 overdue | prostate carcinoma | ECOG-ACRIN Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04736199 | Feb 2021 → Jun 2024 | prostate neoplasm | Bayer | Completed | Met primary |
| Phase 3 | NCT04237584 | Jun 2020 → Mar 2022 | castration-resistant prostate carcinoma | MANA RBM | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT04136353 | Mar 2020 → Jan 2028 expected | prostate cancer | University of Sydney | Active not recruiting | 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 | NCT02799602 | Nov 2016 → Oct 2021 | prostate carcinoma | Bayer | Completed | Met primary |
| Phase 3 | NCT02200614 | Sep 2014 → Sep 2018 | castration-resistant prostate carcinoma | Bayer | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT06660862 | Nov 2026 → Nov 2029 expected | prostate cancer | University of Chicago | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07677566 | Jul 2026 → Jul 2027 expected | prostate cancer | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06627530 | Feb 2025 → Mar 2026 overdue | prostate cancer | Brazilian Clinical Research Institute | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05348876 | Aug 2022 → Apr 2027 expected | castration-resistant prostate carcinoma | Bayer | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07172685 | Jul 2025 → Jun 2026 overdue | prostate cancer | Qilu Hospital of Shandong University | Recruiting | No outcome recorded |
| Comparator or background therapy29 trials | ||||||
| Phase 0 | NCT07389174 Background | Feb 2026 → Jan 2027 expected | prostate adenocarcinoma | Shanghai Changzheng Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07244341 Background | Dec 2025 → Jan 2028 expected | castration-resistant prostate carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 1 | NCT07103018 Background | Nov 2025 → Sep 2027 expected | prostate carcinoma | K36 Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06220864 Background | Feb 2024 → Dec 2027 expected | neoplasm | Synnovation Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05999968 Background | Jan → Feb 2024 | prostate neoplasm | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 1 | NCT05519449 Background | Sep 2022 → Jul 2027 expected | castration-resistant prostate carcinoma | Janux Therapeutics | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06190899 Background | Jan 2024 → Jan 2028 expected | castration-resistant prostate carcinoma | Celcuity Inc | 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 | 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 | NCT04925648 Comparator | Oct 2021 → Sep 2025 | metastatic prostate carcinoma | St Vincent's Hospital, Sydney | Completed | No outcome recorded |
| Phase 2 | NCT04335682 Comparator | Aug 2021 → Sep 2025 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Alliance Foundation Trials, LLC. | Completed | No outcome recorded |
| Phase 3 | NCT07711002 Background | Oct 2026 → Jun 2031 expected | metastatic prostate carcinoma | AstraZeneca | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07591467 Background | Sep 2026 → Sep 2036 expected | hereditary neoplastic syndrome, prostate cancer, prostate neuroendocrine neoplasm | Gustave Roussy, Cancer Campus, Grand Paris | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07723248 Comparator | Aug 2026 → Mar 2028 expected | castration-resistant prostate carcinoma | ORIC Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT07611110 Comparator | May 2026 → Feb 2029 expected | prostate carcinoma | AstraZeneca | 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 | NCT06177015 Comparator | Dec 2023 → Dec 2025 overdue | metastatic prostate carcinoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 3 | NCT06120491 Background | Nov 2023 → Sep 2027 expected | metastatic prostate carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05771896 Background | Sep 2023 → Dec 2028 | metastatic prostate carcinoma | GenesisCare USA | Withdrawn | No outcome recorded |
| Phase 3 | NCT05676203 Background | May 2023 → Jul 2025 overdue | metastatic prostate carcinoma | Jena University Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04464226 Background | Oct 2020 → Jun 2028 expected | cancer | Bayer | 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 |
| — | NCT06306612 Background | Mar 2024 → Dec 2028 expected | prostate cancer | RenJi Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 85
| Date | Issuer | Release |
|---|---|---|
| 2026-05-01 | Alembic Pharmaceuticals Ltd. | Regulatory 14th May, 2026 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Darolutamide Tablets, 300 mg. |
| 2026-04-17 | ORIC Pharmaceuticals | Results ORIC® Pharmaceuticals Presents Preclinical Data to Support the Potential of Rinzimetostat Across Prostate Cancer and in Emerging Resistance Settings at the 2026 American Association for Cancer Research (AACR) Annual Meeting oricpharma.com ↗
Rinzimetostat in combination with darolutamide demonstrated antitumor activity across a breadth of in vivo models representing the prostate cancer continuum, including CSPC and CRPC. |
| 2026-03-31 | ORIC Pharmaceuticals | Results ORIC® Pharmaceuticals Reports Selection of Rinzimetostat RP3D in Combination with Darolutamide for Himalayas-1 Phase 3 Global Study with Dose Optimization Data Supporting Its Potential Best-in-Disease Profile oricpharma.com ↗
47% of patients (7/15) achieved a PSA50 response, with 33% (5/15) confirmed. |
| 2026-03-17 | ORIC Pharmaceuticals | Results ORIC® Pharmaceuticals Announces Preclinical Rinzimetostat (ORIC-944) Presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting oricpharma.com ↗
Together, these findings suggest that targeting PRC2 with rinzimetostat re-sensitizes ARPI-resistant tumors to AR pathway inhibition and blocks prostate tumor adaptation. |
| 2026-02-03 | Bayer | Regulatory Nubeqa™ (darolutamide) receives third approval in China for men with advanced prostate cancer bayer.com ↗
The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in combination with androgen deprivation therapy (ADT) for use in patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 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 |
| 2025-07-21 | Orion Corporation, Orion Pharma | Regulatory Darolutamide receives EU approval in third indication for patients with advanced prostate cancer orionpharma.com ↗
European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2025-07-21 | Bayer | Regulatory Bayer’s Nubeqa™ (darolutamide) receives EU approval in third indication for patients with advanced prostate cancer bayer.com ↗
The European Commission has granted marketing authorization in the European Union (EU) for Nubeqa™ (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2025-06-20 | Orion Corporation, Orion Pharma | Regulatory CHMP recommends third indication for darolutamide for patients with advanced prostate cancer orionpharma.com ↗
CHMP adopts positive opinion for the marketing authorisation of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the European Union. |
| 2025-06-20 | Bayer | Regulatory CHMP recommends third indication for Bayer’s Nubeqa™ (darolutamide) for patients with advanced prostate cancer bayer.com ↗ |
| 2025-06-03 | Orion Corporation, Orion Pharma | Regulatory U.S. FDA approves third indication of darolutamide for patients with advanced prostate cancer orionpharma.com ↗ |
| 2025-06-03 | Bayer | Regulatory U.S. FDA approves third indication of Bayer blockbuster Nubeqa™ (darolutamide) for patients with advanced prostate cancer bayer.com ↗
With this approval, Nubeqa plus ADT is indicated in the U.S. for the treatment of adult patients with mHSPC, either with or without docetaxel. |
| 2025-01-07 | Orion Corporation, Orion Pharma | Regulatory Orion’s collaboration partner Bayer submits application in China for third indication of darolutamide orionpharma.com ↗
Orion’s collaboration partner Bayer has submitted an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the oral androgen receptor inhibitor (ARi) darolutamide. |
| 2025-01-07 | Bayer | Regulatory Bayer submits application in China for third indication of darolutamide bayer.com ↗ |
| 2024-10-14 | Orion Corporation, Orion Pharma | Regulatory Orion’s collaboration partner Bayer submits application for third indication of darolutamide in the EU orionpharma.com ↗
Orion’s collaboration partner Bayer today announced the submission of an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide. |
| 2024-10-14 | Bayer | Regulatory Bayer submits application for third indication of darolutamide in the EU bayer.com ↗
Bayer today announced the submission of an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide. |
| 2024-09-26 | Orion Corporation, Orion Pharma | Regulatory Orion’s collaboration partner Bayer submits application to U.S. FDA for third indication of darolutamide which has become the first ever Orion-originated blockbuster orionpharma.com ↗ |
| 2024-09-26 | Bayer | Regulatory Bayer submits application to U.S. FDA for third indication of darolutamide bayer.com ↗
Bayer today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the oral androgen receptor inhibitor (ARi) darolutamide. |
| 2024-09-16 | Orion Corporation, Orion Pharma | Results Darolutamide plus androgen deprivation therapy significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer orionpharma.com ↗
Results from the pivotal Phase III ARANOTE trial evaluating darolutamide plus androgen deprivation therapy (ADT) showed a statistically significant increase in radiological progression-free survival (rPFS) compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer |
| 2024-09-16 | Bayer | Results Darolutamide plus ADT significantly reduced the risk of radiological progression or death compared to placebo plus ADT in patients with mHSPC bayer.com ↗
Consistent benefits in rPFS were observed across pre-specified subgroups, including patients with high- and low-volume mHSPC. |
| 2024-07-17 | Orion Corporation, Orion Pharma | Results Inside information: Phase III ARANOTE trial of darolutamide in combination with androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer meets primary endpoint orionpharma.com ↗
The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS. |
| 2024-07-17 | Bayer | Results Darolutamide meets primary endpoint in Phase III ARANOTE trial in men with metastatic hormone-sensitive prostate cancer bayer.com ↗
The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC), has met its primary endpoint of rPFS. |
| 2024-04-03 | Bayer | Results Bayer and Vividion Therapeutics to highlight advancing oncology portfolio at AACR 2024 Annual Meeting bayer.com ↗
Another abstract will highlight the synergistic anti-cancer effects of targeted alpha therapy radium-223 dichloride (Xofigo™) in combination with darolutamide in preclinical prostate cancer models. |
| 2024-04-03 | Vividion Therapeutics, Inc. | Results Bayer and Vividion Therapeutics to highlight advancing oncology portfolio at AACR 2024 Annual Meeting vividion.com ↗
Another abstract will highlight the synergistic anti-cancer effects of targeted alpha therapy radium-223 dichloride (Xofigo™) in combination with darolutamide in preclinical prostate cancer models. |
| 2023-03-20 | Orion Corporation, Orion Pharma | Regulatory Darolutamide approved for additional prostate cancer indication in China orionpharma.com ↗
The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2023-03-20 | Bayer | Regulatory Nubeqa™ (darolutamide) approved for additional prostate cancer indication in China bayer.com ↗
The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2023-03-01 | Orion Corporation, Orion Pharma | Regulatory Darolutamide receives EU approval for additional indication in prostate cancer orionpharma.com ↗
The European Commission has granted marketing authorisation in the European Union (EU) for darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2023-03-01 | Bayer | Regulatory Nubeqa™ (darolutamide) receives EU approval for additional indication in prostate cancer bayer.com ↗ |
| 2023-02-27 | Orion Corporation, Orion Pharma | Regulatory Darolutamide receives approval for additional prostate cancer indication in Japan orionpharma.com ↗
The MHLW approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2023-02-27 | Bayer | Regulatory Nubeqa™ approved for additional indication in Japan bayer.com ↗
The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer. |
| 2023-01-27 | Orion Corporation, Orion Pharma | Regulatory Positive CHMP opinion for darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer orionpharma.com ↗
Positive CHMP opinion for darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer |
| 2023-01-27 | Bayer | Regulatory CHMP recommends Bayer’s darolutamide for the treatment of metastatic hormone-sensitive prostate cancer bayer.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus ADT in combination with docetaxel for marketing authorization in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2022-09-11 | Bayer | Results New ARASENS data reinforce strong tolerability profile of darolutamide plus ADT and docetaxel without compromising quality of life for patients with mHSPC bayer.com ↗
The full results were presented during the ESMO Congress 2022. |
| 2022-08-08 | Orion Corporation, Orion Pharma | Regulatory U.S. FDA approves additional indication of darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) orionpharma.com ↗
Orion’s collaboration partner Bayer today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2022-08-08 | Bayer | Regulatory U.S. FDA approves additional indication of darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) bayer.com ↗
Bayer announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2022-07-04 | Bayer | Results Darolutamide plus androgen deprivation therapy and docetaxel demonstrates consistent overall survival benefits across various patient segments in metastatic hormone-sensitive prostate cancer bayer.com ↗
New subgroup analysis from Phase III ARASENS trial in patients with metastatic hormone-sensitive prostate cancer (mHSPC), shows that darolutamide plus androgen deprivation therapy (ADT) and docetaxel provides consistently favorable overall survival (OS) benefits across patient subgroups with various types of metastatic disease, compared to placebo plus ADT and docetaxel(1) |
| 2022-05-03 | Orion Corporation, Orion Pharma | Regulatory U.S. FDA accepts supplemental new drug application (sNDA) and grants priority review for additional indication of darolutamide orionpharma.com ↗
U.S. FDA accepts supplemental new drug application (sNDA) and grants priority review for additional indication of darolutamide |
| 2022-05-03 | Bayer | Regulatory U.S. FDA accepts supplemental new drug application (sNDA) and grants priority review for darolutamide in combination with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) bayer.com ↗
Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2022-04-22 | Orion Corporation, Orion Pharma | Regulatory Orion’s collaboration partner Bayer submits application for additional indication of darolutamide in China orionpharma.com ↗
Orion’s collaboration partner Bayer today announced the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), for the oral androgen receptor inhibitor (ARi) darolutamide. |
| 2022-04-22 | Bayer | Regulatory Bayer submits application in China for additional indication of darolutamide bayer.com ↗
Bayer today announced the submission of a regulatory application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), for the oral androgen receptor inhibitor (ARi) darolutamide. |
| 2022-03-11 | Orion Corporation, Orion Pharma | Regulatory Orion’s collaboration partner Bayer submits application for additional indication of darolutamide in Japan orionpharma.com ↗ |
| 2022-03-11 | Bayer | Regulatory Bayer submits application for additional indication of Nubeqa™ (darolutamide) in Japan bayer.com ↗
Bayer today announced the submission to the Ministry of Health, Labor and Welfare (MHLW) in Japan for an additional indication for the oral androgen receptor inhibitor (ARi) darolutamide. |
| 2022-03-09 | Orion Corporation, Orion Pharma | Regulatory Orion’s collaboration partner Bayer submits applications in the U.S. and EU for additional indication of darolutamide orionpharma.com ↗
Orion’s collaboration partner Bayer submits applications in the U.S. and EU for additional indication of darolutamide |
| 2022-03-09 | Bayer | Regulatory Bayer submits applications in the U.S. and EU for additional indication of Nubeqa™ (darolutamide) bayer.com ↗
Bayer today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) as well as the submission of a Variation Type II application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide. |
| 2022-02-17 | Orion Corporation, Orion Pharma | Results Darolutamide plus androgen deprivation therapy and docetaxel significantly increases overall survival in patients with metastatic hormone-sensitive prostate cancer orionpharma.com ↗
Results from the Phase III ARASENS trial have shown that the use of the oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel. |
| 2022-02-17 | Bayer | Results Darolutamide plus androgen deprivation therapy and docetaxel significantly increases overall survival in patients with metastatic hormone-sensitive prostate cancer bayer.com ↗
Darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P<0.001). |
| 2022-02-17 | Bayer | Results Bayer raises peak sales for Nubeqa to exceed three billion euro amid positive Phase III ARASENS trial data bayer.com ↗
Darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P<0.001). |
| 2021-12-03 | Orion Corporation, Orion Pharma | Results ARASENS trial with darolutamide in combination with docetaxel and androgen deprivation therapy meets primary endpoint of significantly increasing overall survival in patients with metastatic hormone-sensitive prostate cancer orionpharma.com ↗
In the ARASENS trial, darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to placebo, docetaxel and ADT. |
| 2021-12-03 | Bayer | Results Darolutamide in combination with docetaxel and ADT meets primary endpoint of significantly increasing overall survival in patients with metastatic hormone-sensitive prostate cancer bayer.com ↗
In the ARASENS trial, darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to docetaxel and ADT. |
| 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 ↗
The safety profile of darolutamide continued to be favorable at the final analysis. |
| 2021-02-03 | Bayer | Regulatory Bayer receives approval for Nubeqa™ in China for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC) bayer.com ↗
The Chinese National Medical Products Administration (NMPA) has approved Nubeqa™ (darolutamide) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. |
| 2020-09-10 | Orion Corporation, Orion Pharma | Results New England Journal of Medicine publishes final overall survival data for darolutamide showing treatment significantly extends life in men with non-metastatic prostate cancer orionpharma.com ↗
Men with non-metastatic castration-resistant prostate cancer (nmCRPC) receiving darolutamide plus androgen deprivation therapy (ADT) had a significant improvement in overall survival (OS) compared to placebo plus ADT (HR=0.69, 95% CI 0.53-0.88; p=0.003) |
| 2020-09-09 | Bayer | Results New England Journal of Medicine publishes final overall survival data for Nubeqa™ (darolutamide) showing treatment significantly extends life in men with non-metastatic prostate cancer bayer.com ↗
Men receiving darolutamide plus androgen deprivation therapy (ADT) demonstrated a significant improvement in OS compared to placebo plus ADT, with a 31 percent reduction in risk of death (HR=0.69, 95% CI 0.53-0.88; p=0.003). |
| 2020-05-14 | Orion Corporation, Orion Pharma | Results New ARAMIS Phase III data to be presented at ASCO 2020: Nubeqa® (darolutamide) significantly improved overall survival with a favorable safety profile in men with non-metastatic prostate cancer orionpharma.com ↗
Darolutamide significantly reduced risk of death by 31 percent (HR=0.69, 95% CI 0.53-0.88; p=0.003) in men with non-metastatic castration-resistant prostate cancer (nmCRPC) |
| 2020-03-30 | Orion Corporation, Orion Pharma | Regulatory Nubeqa® (darolutamide) receives EU approval as a new treatment for men with non-metastatic castration-resistant prostate cancer orionpharma.com ↗
The European Commission has granted marketing authorisation in the European Union (EU) for Nubeqa® (darolutamide), an oral androgen receptor inhibitor (ARi). |
| 2020-03-30 | Bayer | Regulatory Nubeqa™ (darolutamide) receives EU approval as a new treatment for men with non-metastatic castration-resistant prostate cancer bayer.com ↗
Bayer today announced that the European Commission has granted marketing authorization in the European Union (EU) for Nubeqa™ (darolutamide), an oral androgen receptor inhibitor (ARi). |
| 2020-01-31 | Orion Corporation, Orion Pharma | Regulatory Positive CHMP opinion for darolutamide as a new treatment for men with non-metastatic castration-resistant prostate cancer orionpharma.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended darolutamide, an androgen receptor inhibitor (ARi), for marketing authorization in the European Union (EU). |
| 2020-01-31 | Bayer | Regulatory Bayer receives positive CHMP opinion for darolutamide as a new treatment for men with non-metastatic castration-resistant prostate cancer bayer.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, a non-steroidal androgen receptor inhibitor (ARi), for marketing authorization in the European Union (EU). |
| 2020-01-30 | Orion Corporation, Orion Pharma | Results Darolutamide plus androgen deprivation therapy significantly increased overall survival in men with non-metastatic castration-resistant prostate cancer orionpharma.com ↗
Results from the preplanned final overall survival analysis of the Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC) show a statistically significant improvement in overall survival (OS) in patients receiving darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT. |
| 2020-01-30 | Bayer | Results Darolutamide plus androgen deprivation therapy significantly increased overall survival in men with non-metastatic castration-resistant prostate cancer bayer.com ↗ |
| 2020-01-23 | Orion Corporation, Orion Pharma | Regulatory Marketing authorization granted for darolutamide in Japan orionpharma.com ↗
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for darolutamide, under the brand name Nubeqa®, for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC). |
| 2020-01-23 | Bayer | Regulatory Bayer receives approval for darolutamide in Japan bayer.com ↗
Bayer announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for darolutamide, under the brand name Nubeqa®, for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC). |
| 2019-07-31 | Orion Corporation, Orion Pharma | Regulatory U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer (nmCRPC) orionpharma.com ↗
The U.S. Food and Drug Administration (FDA) has granted approval to darolutamide, a non-steroidal androgen receptor inhibitor (ARi), under the brand name Nubeqa®. |
| 2019-07-31 | Bayer | Regulatory U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer bayer.com ↗
The U.S. Food and Drug Administration (FDA) has approved darolutamide, a non-steroidal androgen receptor inhibitor (ARi), under the brand name Nubeqa®. |
| 2019-05-31 | Orion Corporation, Orion Pharma | Results 2019 American Society of Clinical Oncology (ASCO) Annual Meeting - Darolutamide data presented orionpharma.com ↗
Results of a new post-hoc analysis showed that treatment with darolutamide plus androgen deprivation therapy (ADT) delayed worsening of urinary and bowel symptoms versus placebo plus ADT1 |
| 2019-05-31 | Bayer | Results Bayer’s darolutamide plus ADT delays worsening of disease-related symptoms and maintains quality of life beyond end of study treatment compared to placebo plus ADT in men with nmCRPC bayer.com ↗
Data also indicate that darolutamide plus ADT maintained quality of life, compared to placebo plus ADT even beyond the end of study treatment. |
| 2019-04-29 | Orion Corporation, Orion Pharma | Regulatory U.S. FDA accepts New Drug Application for review and grants Priority Review for darolutamide orionpharma.com ↗ |
| 2019-04-29 | Bayer | Regulatory U.S. FDA accepts new drug application and grants priority review for darolutamide bayer.com ↗
Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review to darolutamide for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). |
| 2019-03-08 | Orion Corporation, Orion Pharma | Regulatory Darolutamide submitted for European marketing authorization orionpharma.com ↗
Orion Corporation and Bayer today announced that a marketing authorization application (MAA) has been submitted to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). |
| 2019-03-08 | Bayer | Regulatory Bayer submits European marketing authorization application for darolutamide bayer.com ↗
Bayer has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). |
| 2019-03-05 | Orion Corporation, Orion Pharma | Regulatory Darolutamide submitted for marketing authorization in Japan orionpharma.com ↗
Orion Corporation and Bayer today announced that an application for marketing authorization has been submitted to the Ministry of Health, Labor and Welfare (MHLW) in Japan for darolutamide for the treatment of patients with castration-resistant prostate cancer (CRPC). |
| 2019-03-05 | Bayer | Regulatory Bayer submits darolutamide for marketing authorization in Japan bayer.com ↗
Bayer has submitted an application for marketing authorization to the Ministry of Health, Labor and Welfare (MHLW) in Japan for darolutamide for the treatment of patients with castration-resistant prostate cancer (CRPC). |
| 2019-02-27 | Orion Corporation, Orion Pharma | Regulatory The rolling submission to FDA for darolutamide in the U.S. completed orionpharma.com ↗
Orion Corporation and Bayer today announced the completion of the rolling submission of a New Drug Application (NDA) for darolutamide to the U.S. Food and Drug Administration (FDA). |
| 2019-02-27 | Bayer | Regulatory Bayer completes rolling submission for darolutamide in U.S. bayer.com ↗
Bayer today announced the completion of the rolling submission of a New Drug Application (NDA) for darolutamide to the U.S. Food and Drug Administration (FDA). |
| 2019-02-14 | Orion Corporation, Orion Pharma | Results Orion's and Bayer's darolutamide shows substantial efficacy and a favourable safety profile in the treatment of prostate cancer in the ARAMIS trial orionpharma.com ↗
Statistically significant improvement in metastasis-free survival (MFS), with a median MFS of 40.4 months with darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT (18.4 months). |
| 2019-02-14 | Bayer | Results Bayer’s darolutamide plus ADT significantly extends metastasis-free survival with a favorable safety profile compared to placebo plus ADT in non-metastatic castration-resistant prostate cancer bayer.com ↗ |
| 2018-10-24 | Orion Corporation, Orion Pharma | Results Orion Group Interim Report January-September 2018 orionpharma.com ↗
On 24 October 2018, Orion and Bayer announced that Phase III trial of prostate cancer drug darolutamide met primary endpoint. |
| 2018-10-24 | Orion Corporation, Orion Pharma | Results Orion and Bayer have completed the phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer - The primary endpoint was met orionpharma.com ↗
The primary endpoint of the trial was met: Darolutamide significantly extended metastasis-free survival compared to placebo. |
| 2018-10-24 | Bayer | Results Phase III trial of darolutamide in patients with non-metastatic castration-resistant prostate cancer meets primary endpoint bayer.com ↗
The Phase III ARAMIS (Androgen Receptor inhibiting Agent for MetastatIc-free Survival) trial that investigated darolutamide in men with non-metastatic castration-resistant prostate cancer (nmCRPC) met its primary endpoint. |
| 2014-04-14 | Orion Corporation, Orion Pharma | Results ODM-201 offers a new therapeutic option for the treatment of prostate cancer orionpharma.com ↗
It was shown that ODM-201 daily doses between 1200-1800 mg was well tolerated, and produce marked, long-lasting declines in PSA in majority of these patients. |
| 2014-02-03 | Orion Corporation, Orion Pharma | Results The androgen receptor inhibitor ODM-201 - New insights in the treatment of prostate cancer orionpharma.com ↗
The majority of ODM-201 treated patients had stabilization of disease in soft tissue or avoidance of progression in bone metastases up to 12 weeks. |
| 2013-09-28 | Orion Corporation, Orion Pharma | Results Encouraging results from a clinical Phase II trial of ODM-201 for advanced prostate cancer (ARADES Trial) orionpharma.com ↗
Eighty-six percent of patients who had not received earlier chemotherapy or abiraterone experienced a >50% PSA decrease at week 12 on dose level 700 mg twice a day. |
| 2013-02-15 | Orion Corporation, Orion Pharma | Results Promising preclinical and Phase I data of a new generation androgen receptor (AR) inhibitor, ODM- 201, presented at ASCO GU 2013 symposium orionpharma.com ↗
Prof Karim Fizazi, M.D., principal investigator in ODM-201 ARADES trial presented results from preclinical experiments and the Phase I component of the Arades trial at the 2013 Genitourinary Cancers Symposium of the American Society of Clinical Oncology (ASCO) in Orlando, FL on Thursday 14 February 2013. |
| 2012-09-30 | Orion Corporation, Orion Pharma | Results Phase I/II ARADES trial of a new generation anti-androgen, ODM- 201, presented at ESMO 2012 congress orionpharma.com ↗
Prostate specific antigen (PSA) response (defined as >= 50 percent PSA decrease) was obtained in 13 (87 percent) of 15 patients currently evaluable at 12-weeks. |
All press releases naming this drug 101 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 101 releases opens the full record — a long page | ||
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 126 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | darolutamide | “The intervention strictly involves continuing the identical Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) regimen-such as abiraterone,...” NCT07838753 ↗110“This regimen consists of Androgen Deprivation Therapy (ADT) (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix) combined with an oral Androgen Receptor (AR) inhibitor...” NCT07389174 ↗ “A Randomized, Open-label, Cross-over Phase 2 Trial of Darolutamide and Enzalutamide in Men with Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate...” PMID 37271630 ↗ Jun 2023 “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 ↗ “Darolutamide is a second-generation androgen receptor inhibitor approved for the treatment of nonmetastatic castration-resistant prostate cancer at a dosage of 600 mg orally...” PMID 34866168 ↗ Dec 2021 “ADT, abiraterone and each ARSI (Apalutamide, Darolutamide, Enzalutamide) will be administrated according to the standard of care” NCT06496581 ↗ “Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.” NCT06992232 ↗ “Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)” NCT06350825 ↗ “Second generation ARPI (Abiraterone Acetate and Prednisolone, Enzalutamide, Apalutamide or Darolutamide).” NCT06320067 ↗ “Enzalutamide, Darolutamide, Apalutamide as prescribed by the local investigator” NCT05849298 ↗ “Lifelong continuous ADT and darolutamide, similarly to standard of care” NCT07591467 ↗ |
| Known as | BAY1841788 | “Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients” PMID 28753851 ↗ Feb 201719“Drug: Darolutamide (Nubeqa, BAY1841788)” NCT04157088 ↗ “BAY1841788 / darolutamide (ODM-201)” NCT02799602 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT05348876 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT04736199 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT04464226 ↗ “Darolutamide (BAY1841788, Nubeqa)” NCT05794906 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT02200614 ↗ “Darolutamide (BAY1841788, Nubeqa)” NCT05059236 ↗ “Darolutamide(BAY1841788, Nubeqa)” NCT05526248 ↗ “Drug: Darolutamide (BAY 1841788)” NCT06592924 ↗ |
| Known as | Darolutamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297185 ↗ |
| Known as | Darolutamide is also known as Nubeqa | “Darolutamide is also known as Nubeqa” NCT05938270 ↗ |
| Known as | Darolutamide: ODM-201 | “Darolutamide: ODM-201” NCT03704519 ↗ |
| Known as | Nubeqa | “KTX-2001 in combination with darolutamide (NUBEQA®), and to establish a recommended Phase 2 dose(s) of KTX-2001 for future study.” NCT07103018 ↗12“Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.” NCT04157088 ↗ “Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]” NCT05683964 ↗ “darolutamide (also known by the brand name Nubeqa®)” PMID 35656777 ↗ Jun 2022 “Darolutamide (Nubeqa®) 300 mg tablets” NCT05413421 ↗ “Darolutamide Oral Tablet [Nubeqa]” NCT05900973 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT04464226 ↗ “Darolutamide (BAY1841788, Nubeqa)” NCT05794906 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT04736199 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT02200614 ↗ “Darolutamide (BAY1841788, Nubeqa)” NCT05059236 ↗ |
| Known as | ODM-201 | “All subjects will receive a single dose BAY1841788 (ODM-201) (600 mg) followed by multiple doses BAY1841788 (ODM-201) (600 mg BID) as well as 2 times a single dose rosuvastatin...” NCT02671097 ↗11“A Randomized Non-comparative Phase II Multicentric Trial on Short Term Darolutamide (ODM-201) Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk...” NCT05346848 ↗ “ODM 201 will be administered as oral 300-mg tablets.” NCT02972060 ↗ “BAY1841788 / darolutamide (ODM-201)” NCT02799602 ↗ “BAY1841788 (ODM-201)” NCT03048110 ↗ “BAY 1841788(ODM-201)” NCT02363855 ↗ |
| Action | Inhibit | “ODM-201 is a novel androgen receptor (AR) inhibitor designed to block the growth of prostate cancer cells” PMID 24974051 ↗ Jun 2014 |
| Modality | Other / unclassified | “Darolutamide is an androgen receptor inhibitor (ARI)” PMID 41760423 ↗ Feb 2026 |
| Route | Oral | “ODM-201 administered orally daily” NCT01317641 ↗ |
| Target | AR | “high-affinity binding to the AR and inhibition of AR nuclear translocation” PMID 24974051 ↗ Jun 2014 |