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 · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 ↗ |
Trials 88 · started per year
today
US approved 2019
EU approved 2020
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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 | refractory malignant neoplasm | Qilu Pharmaceutical Co., Ltd. | Not yet 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 |
| 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 | 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 | NCT06568094 | Sep 2024 → Jun 2026 overdue | prostate cancer | Jiangsu HengRui Medicine Co., Ltd. | 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 |
| Phase 1/2 | NCT01317641 | Mar 2011 → Jul 2013 | prostate cancer | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 241 trials | ||||||
| Phase 2 | NCT07649421 | Aug 2026 → Aug 2031 expected | metastatic prostate carcinoma | West China Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07645326 | Aug 2026 → Aug 2032 expected | metastatic prostate carcinoma | Georgetown University | 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 | 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 | NCT07503379 | Apr 2026 → Dec 2027 expected | — | Yonghong Li | 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 overdue | metastatic prostate carcinoma | Bayer | Active not recruiting | 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 | No outcome recorded |
| Phase 2 | NCT02933801 | Mar 2017 → Jun 2021 | metastatic prostate carcinoma | Swiss Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT01429064 | Jun 2011 → Nov 2015 | prostate cancer | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06282588 | Dec 2023 → Jul 2030 expected | prostate cancer | Cancer Research Antwerp | Recruiting | No outcome recorded |
| Phase 314 trials | ||||||
| Phase 3 | NCT05974774 | May 2025 → May 2035 expected | prostate cancer | European Organisation for Research and Treatment of Cancer - EORTC | Recruiting | No outcome recorded |
| Phase 3 | 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 expected | prostate carcinoma | ECOG-ACRIN Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04736199 | Feb 2021 → Jun 2024 | prostate neoplasm | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT04237584 | Jun 2020 → Mar 2022 | castration-resistant prostate carcinoma | MANA RBM | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02799602 | Nov 2016 → Oct 2021 | prostate carcinoma | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT02200614 | Sep 2014 → Sep 2018 | castration-resistant prostate carcinoma | Bayer | Completed | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 28 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07389174 Background | Feb 2026 → Jan 2027 expected | prostate adenocarcinoma | Shanghai Changzheng Hospital | Not yet recruiting | No outcome recorded |
| Phase 15 trials | ||||||
| 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 1/23 trials | ||||||
| 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 1/2 | NCT03568656 Background | Jul 2018 → Jul 2025 | breast cancer, castration-resistant prostate carcinoma, non-small cell lung carcinoma | CellCentric Ltd. | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07268794 Background | Nov 2025 → Apr 2027 expected | metastatic prostate carcinoma, prostate adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | 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 312 trials | ||||||
| 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 | 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 |
| Phase not applicable1 trial | ||||||
| — | NCT06306612 Background | Mar 2024 → Dec 2028 expected | prostate cancer | RenJi Hospital | Recruiting | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 122 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | darolutamide | “This regimen consists of Androgen Deprivation Therapy (ADT) (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix) combined with an oral Androgen Receptor (AR) inhibitor...” NCT07389174 ↗106“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 ↗ “ARPI (abiraterone or enzalutamide or apalutamide or darolutamide)” NCT05974774 ↗ “Examples include enzalutamide, apalutamide, darolutamide.” NCT04946370 ↗ “oral darolutamide 600mg twice per day” NCT06306612 ↗ “Darolutamide 600mg po bid” NCT06145308 ↗ “Darolutamide” NCT06734130 ↗ |
| 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 (BAY1841788, Nubeqa)” NCT05059236 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT04464226 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT05348876 ↗ “Darolutamide (BAY1841788, Nubeqa)” NCT05794906 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT04736199 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT02200614 ↗ “Darolutamide(BAY1841788, Nubeqa)” NCT05526248 ↗ “Drug: Darolutamide (BAY 1841788)” NCT06592924 ↗ “Darolutamide (BAY 1841788)” NCT07282197 ↗ “Darolutamide (BAY1841788)” NCT04070209 ↗ “Darolutamide (BAY1841788)” NCT03704519 ↗ “BAY1841788 (darolutamide)” NCT03237416 ↗ “Darolutamide(BAY1841788)” NCT03724747 ↗ |
| 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 (BAY1841788, Nubeqa)” NCT05059236 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT02200614 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT05348876 ↗ “Darolutamide Oral Tablet [Nubeqa]” NCT05900973 ↗ “Darolutamide (BAY1841788, Nubeqa)” NCT05794906 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT04464226 ↗ “Darolutamide (Nubeqa, BAY1841788)” NCT04736199 ↗ “Darolutamide(BAY1841788, Nubeqa)” NCT05526248 ↗ |
| 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 |