Clinical Trials

Numerous clinical trials evaluate the therapeutic profile of darolutamide across various oncological conditions, primarily targeting advanced prostate malignancies—including metastatic castration-resistant and metastatic hormone-sensitive prostate cancer—and androgen receptor-positive triple-negative breast carcinoma. Spanning early safety and pharmacokinetic evaluations to confirmatory Phase 3 and Phase 4 protocols, trial recruitment statuses range from completed and active to currently recruiting. These studies are sponsored by leading pharmaceutical entities such as Bayer and Pfizer alongside academic institutions like the Canadian Cancer Trials Group.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06625970 RECRUITING
High Risk Prostate Carcinoma; Prostate Cancer
UNICANCER
2025-04-10 PHASE3
NCT07190300 RECRUITING
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Novartis Pharmaceuticals
2026-01-13 PHASE1; PHASE2
NCT07730151 NOT_YET_RECRUITING
Prostate Cancer; Prostate; Prostate Cancer Patients
RenJi Hospital
2026-08-01 PHASE2
NCT07649421 NOT_YET_RECRUITING
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
West China Hospital
2026-08-01 PHASE2
NCT07711002 NOT_YET_RECRUITING
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
AstraZeneca
2026-10-01 PHASE3
NCT05367440 ACTIVE_NOT_RECRUITING
Metastatic Prostate Cancer
AstraZeneca
2022-06-02 PHASE1; PHASE2
NCT06592924 RECRUITING
Prostate Cancer (Adenocarcinoma)
Canadian Cancer Trials Group
2025-05-28 PHASE3
NCT06378866 RECRUITING
Recurrent Castration-Sensitive Prostate Carcinoma; Recurrent Prostate Cancer; Castration-resistant Prostate Cancer; Biochemically Recurrent Prostate Carcinoma
Mayo Clinic
2024-06-03 PHASE2
NCT05826509 ACTIVE_NOT_RECRUITING
Prostate Cancer
Institut Claudius Regaud
2023-08-10 PHASE2
NCT04070209 ACTIVE_NOT_RECRUITING
Metastatic Prostate Cancer; Castration-resistant Prostate Cancer
Sir Mortimer B. Davis - Jewish General Hospital
2020-10-19 PHASE2
NCT06282588 RECRUITING
Prostate Cancer
Cancer Research Antwerp
2023-12-13 PHASE2; PHASE3
NCT07142551 RECRUITING
Metastatic Castration-resistant Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2026-03-09 PHASE2
NCT06401980 RECRUITING
Metastatic Castration-resistant Prostate Cancer
Swiss Cancer Institute
2024-10-22 PHASE2
NCT07717099 NOT_YET_RECRUITING
Metastatic Hormone-Sensitive Prostate Cance
Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
2026-09 PHASE2
NCT06660862 NOT_YET_RECRUITING
Prostate Cancer
University of Chicago
2026-11 PHASE4
NCT06276465 RECRUITING
Prostatic Cancer, Castration-Resistant
UNICANCER
2024-10-07 PHASE3
NCT07751133 RECRUITING
Prostate Cancer; mHSPC; mCRPC
University College, London
2026-08-28 PHASE3
NCT07611110 RECRUITING
Metastatic Castration-resistant Prostate Cancer
AstraZeneca
2026-05-04 PHASE3
NCT07282197 NOT_YET_RECRUITING
Prostate Cancer
Peking University First Hospital
2026-01 PHASE2
NCT06844383 RECRUITING
Prostate Cancer (Adenocarcinoma); mCRPC (Metastatic Castration-resistant Prostate Cancer)
Prostate Cancer Clinical Trials Consortium
2026-05-04 PHASE2
NCT05771896 WITHDRAWN
Metastatic Prostate Cancer
GenesisCare USA
2023-09 PHASE3
NCT04176081 NOT_YET_RECRUITING
Prostate Cancer
University Health Network, Toronto
2024-07-02 PHASE2
NCT06463457 ACTIVE_NOT_RECRUITING
Prostate Cancer; Advanced Prostate Cancer; Hormone Sensitive Prostate Cancer
Atish Choudhury, MD
2024-12-13 PHASE2
NCT07450599 RECRUITING
High-risk Localized Prostate Cancer
Bayer
2026-04-27 PHASE2
NCT07016399 RECRUITING
Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma
Vandana Abramson
2025-09-09 PHASE2
NCT06785636 RECRUITING
mCRPC (Metastatic Castration-resistant Prostate Cancer); Prostate Cancer
Pathos AI, Inc.
2025-02-07 PHASE1; PHASE2
NCT04464226 ACTIVE_NOT_RECRUITING
Cancer
Bayer
2020-10-20 PHASE3
NCT07795177 NOT_YET_RECRUITING
Metastatic Hormone-Sensitive Prostate Cancer
Anhui Medical University
2026-10-01 PHASE2
NCT07140900 RECRUITING
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Amgen
2025-10-07 PHASE1
NCT07723248 RECRUITING
Metastatic Castration Resistant Prostate Cancer
ORIC Pharmaceuticals
2026-08-03 PHASE3
NCT04916613 RECRUITING
Prostate Cancer Metastatic
UNICANCER
2022-04-19 PHASE3
NCT07244341 RECRUITING
Metastatic Castration-resistant Prostate Cancer
Daiichi Sankyo
2025-12-03 PHASE1
NCT04136353 ACTIVE_NOT_RECRUITING
Prostate Cancer
University of Sydney
2020-03-31 PHASE3
NCT06190899 RECRUITING
mCRPC (Metastatic Castration-resistant Prostate Cancer); Genital Diseases, Male; Urogenital Diseases, Male; Prostatic Disease; Prostatic Neoplasms, Castration-Resistant; Prostate Cancer
Celcuity Inc
2024-01-01 PHASE1; PHASE2
NCT07476677 NOT_YET_RECRUITING
Prostate Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
2026-04-01 PHASE2
NCT07027124 RECRUITING
Prostate Cancer; High-risk Prostate Cancer
Icahn School of Medicine at Mount Sinai
2026-05-21 PHASE2
NCT07516704 NOT_YET_RECRUITING
Prostate Cancer
Zhongda Hospital
2026-04-01 EARLY_PHASE1
NCT06220864 RECRUITING
Advanced Solid Tumor
Synnovation Therapeutics, Inc.
2024-02-23 PHASE1
NCT07503379 RECRUITING
mHSPC
Yonghong Li
2026-04-16 PHASE2
NCT04025372 ACTIVE_NOT_RECRUITING
Prostate Cancer
Brigham and Women's Hospital
2020-06-01 PHASE2
NCT06120491 ACTIVE_NOT_RECRUITING
Metastatic Castration-Sensitive Prostate Cancer
AstraZeneca
2023-11-21 PHASE3
NCT07103018 RECRUITING
Metastatic Castration-resistant Prostate Cancer; Metastatic Castration-Resistant Prostate Cancer Patients; Metastatic Castration-resistant Prostate Cancer, mCRPC; mCRPC; mCRPC (Metastatic Castration-resistant Prostate Cancer)
K36 Therapeutics, Inc.
2025-11-21 PHASE1
NCT05818683 RECRUITING
Metastatic Castration-resistant Prostate Neoplasms; Metastatic Hormone-sensitive Prostate Cancer
Janssen Research & Development, LLC
2023-04-26 PHASE1
NCT05794906 ACTIVE_NOT_RECRUITING
Biochemically Recurrent Prostate Cancer
Bayer
2023-04-03 PHASE3
NCT07677566 NOT_YET_RECRUITING
Prostate Cancer; Prostate Cancer Patients
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
2026-07-01 PHASE4
NCT05519449 RECRUITING
Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Castration Resistant Prostatic Cancer
Janux Therapeutics
2022-09-15 PHASE1
NCT05413421 RECRUITING
Metastatic Prostate Cancer
ORIC Pharmaceuticals
2022-06-01 PHASE1
NCT07617272 RECRUITING
Prostate Cancer (Adenocarcinoma)
Region Stockholm
2025-11-09 PHASE2
NCT05762536 RECRUITING
Metastatic Castration-resistant Prostate Cancer
Erasmus Medical Center
2023-11-29 PHASE2
NCT05348876 RECRUITING
Non-metastatic Castration-resistant Prostate Cancer
Bayer
2022-08-03 PHASE4
NCT06594926 RECRUITING
Prostate Cancer
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
2024-08-14 PHASE2
NCT07620041 NOT_YET_RECRUITING
Refractory or Relapsed Solid Tumors
Qilu Pharmaceutical Co., Ltd.
2026-06-05 PHASE1
NCT03903835 RECRUITING
Metastatic Castration-resistant Prostate Cancer (mCRPC); Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Karolinska Institutet
2019-02-01 PHASE3
NCT05346848 RECRUITING
Prostate Cancer
Institut Bergonié
2023-02-24 PHASE2
NCT05669664 ACTIVE_NOT_RECRUITING
Locally Advanced Salivary Gland Carcinoma; Metastatic Salivary Gland Carcinoma; Recurrent Salivary Gland Carcinoma; Unresectable Salivary Gland Carcinoma
National Cancer Institute (NCI)
2023-07-20 PHASE2
NCT05050084 ACTIVE_NOT_RECRUITING
Prostate Adenocarcinoma
NRG Oncology
2021-12-06 PHASE3
NCT06173362 RECRUITING
Advanced Prostate Adenocarcinoma; Stage III Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8
University of California, Davis
2023-11-09 PHASE2
NCT07172685 RECRUITING
Prostate Cancer
Qilu Hospital of Shandong University
2025-07-30
NCT05938270 COMPLETED
Prostate Cancer
AstraZeneca
2023-09-21 PHASE1
NCT04484818 ACTIVE_NOT_RECRUITING
Prostate Carcinoma
ECOG-ACRIN Cancer Research Group
2021-03-01 PHASE3
NCT04319783 ACTIVE_NOT_RECRUITING
Advanced Prostate Carcinoma; Cancer of Prostate; PSA; Castrate Resistant Prostate Cancer
Trans Tasman Radiation Oncology Group
2021-06-02 PHASE2
NCT06631521 RECRUITING
Prostate CA; Prostate Cancer (Adenocarcinoma); Prostate Cancer Surgery
AdventHealth
2024-10-22 PHASE1
NCT06568094 RECRUITING
Prostate Cancer
Jiangsu HengRui Medicine Co., Ltd.
2024-09-25 PHASE1; PHASE2
NCT06575257 RECRUITING
Prostate Cancer
Xijing Hospital
2024-05-01 PHASE2
NCT06627530 ACTIVE_NOT_RECRUITING
Prostate Cancer
Brazilian Clinical Research Institute
2025-02-17 PHASE4
NCT04641078 UNKNOWN
Prostate Cancer; Prostate Cancer Recurrent; Prostate Cancer Metastatic; Metastatic Cancer; Oligometastasis
University Hospital, Ghent
2021-02-12 PHASE2
NCT06169124 ACTIVE_NOT_RECRUITING
Adult Ovarian Granulosa Cell Tumor
National Cancer Institute (NCI)
2024-02-08 PHASE2
NCT05116475 RECRUITING
Prostate Cancer
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
2022-08-30 PHASE3
NCT06177015 RECRUITING
Metastatic Prostate Cancer; Intermitent Anti-androgen Therapy
The First Affiliated Hospital with Nanjing Medical University
2023-12-11 PHASE3
NCT05683964 ACTIVE_NOT_RECRUITING
Prostate Adenocarcinoma; Prostate Cancer; Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Beth Israel Deaconess Medical Center
2023-01-19 EARLY_PHASE1
NCT04335682 COMPLETED
Metastatic Prostate Cancer; Prostate Cancer Metastatic; Prostate Cancer; Castrate Resistant Prostate Cancer; Hormone Sensitive Prostate Cancer; Non-metastatic Prostate Cancer
Alliance Foundation Trials, LLC.
2021-08-17 PHASE2
NCT04925648 COMPLETED
Metastatic Prostate Cancer
St Vincent's Hospital, Sydney
2021-10-18 PHASE2
NCT06029036 UNKNOWN
Prostate Cancer
Peking University First Hospital
2023-08-05 PHASE2
NCT05617885 COMPLETED
Metastatic Prostate Cancer; Non-metastatic Prostate Cancer; Prostate Cancer
Praful Ravi, MB BCHir, MRCP
2023-08-09 PHASE1
NCT03568656 COMPLETED
Metastatic Castration-Resistant Prostate Cancer; Metastatic Breast Cancer; Non-small Cell Lung Cancer; Advanced Solid Tumors
CellCentric Ltd.
2018-07-23 PHASE1; PHASE2
NCT05676203 ACTIVE_NOT_RECRUITING
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Jena University Hospital
2023-05-16 PHASE3
NCT05059236 ACTIVE_NOT_RECRUITING
Metastatic Hormone-sensitive Prostate Cancer
Bayer
2021-11-04 PHASE2
NCT05900973 UNKNOWN
Prostate Cancer
D'Or Institute for Research and Education
2023-07-20 PHASE2
NCT05171387 COMPLETED
Prostate Cancer
Bayer
2021-11-30 PHASE2
NCT03385655 ACTIVE_NOT_RECRUITING
Prostate Cancer
Canadian Cancer Trials Group
2018-08-01 PHASE2
NCT05526248 COMPLETED
Biochemically Recurrent Prostate Cancer
Bayer
2022-12-19 PHASE2
NCT05694819 COMPLETED
Salivary Gland Cancer
National Cancer Center Hospital East
2020-04-17 PHASE2
NCT04736199 COMPLETED
Prostatic Neoplasms
Bayer
2021-02-23 PHASE3
NCT05999968 TERMINATED
Prostatic Neoplasms
Eli Lilly and Company
2024-01-12 PHASE1
NCT04558866 COMPLETED
Prostate Cancer
Latin American Cooperative Oncology Group
2021-06-09 PHASE2
NCT02972060 ACTIVE_NOT_RECRUITING
Prostate Cancer
European Organisation for Research and Treatment of Cancer - EORTC
2017-12-01 PHASE2
NCT05249712 UNKNOWN
Prostate Cancer
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
2022-01-01 PHASE2
NCT03724747 COMPLETED
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Bayer
2018-12-18 PHASE1
NCT04737109 TERMINATED
Castrate Resistant Prostate Cancer
David VanderWeele
2021-07-13 PHASE1; PHASE2
NCT04157088 TERMINATED
Prostatic Cancer, Castration-Resistant
Bayer
2019-12-17 PHASE2
NCT04237584 TERMINATED
Metastatic Castration-resistant Prostate Cancer
MANA RBM
2020-06-30 PHASE3
NCT03314324 COMPLETED
Metastatic Castrate-resistant Prostate (CRPC) Cancer
Gustave Roussy, Cancer Campus, Grand Paris
2017-11-29 PHASE2
NCT03383679 COMPLETED
Breast Cancer Female; Triple Negative and Androgen Receptor Positive
UNICANCER
2018-03-14 PHASE2
NCT02799602 COMPLETED
Metastatic Hormone-sensitive Prostate Cancer
Bayer
2016-11-30 PHASE3
NCT02933801 TERMINATED
Prostate Cancer Metastatic; Prostate Cancer
Swiss Cancer Institute
2017-03-31 PHASE2
NCT03878524 TERMINATED
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma
OHSU Knight Cancer Institute
2020-04-01 PHASE1
NCT04070209 Recruiting
Metastatic Prostate Cancer|Castration-resistant Prostate Cancer
Sir Mortimer B. Davis - Jewish General Hospital
2020-10-19 Phase 2
NCT03704519 COMPLETED
Cerebrovascular Circulation
Bayer
2018-10-23 PHASE1
NCT03004534 COMPLETED
Breast Cancer Female
Translational Research in Oncology
2017-09-05 EARLY_PHASE1
NCT02200614 COMPLETED
Prostate Cancer Non-Metastatic; Castration-Resistant
Bayer
2014-09-12 PHASE3
NCT03237416 COMPLETED
Prostatic Neoplasms
Bayer
2017-08-02 PHASE1
NCT03048110 COMPLETED
Biological Availability
Bayer
2017-02-15 PHASE1
NCT02894385 COMPLETED
Pharmacokinetics; Hepatic Insufficiency; Renal Insufficiency
Bayer
2016-09-13 PHASE1
NCT02671097 COMPLETED
Healthy Volunteers; Pharmacokinetics; Drug Interaction
Bayer
2016-02 PHASE1
NCT02363855 COMPLETED
Prostatic Neoplasms
Bayer
2015-02-23 PHASE1
NCT01429064 COMPLETED
Prostate Cancer
Orion Corporation, Orion Pharma
2011-06 PHASE2
NCT02418650 COMPLETED
Healthy
Orion Corporation, Orion Pharma
2015-03 PHASE1
NCT01784757 COMPLETED
Prostate Cancer
Orion Corporation, Orion Pharma
2013-03 PHASE1
NCT01317641 COMPLETED
Prostate Cancer
Orion Corporation, Orion Pharma
2011-03 PHASE1; PHASE2
NCT01317641 Completed
Prostate Cancer
Orion Corporation Orion Pharma|Endo Pharmaceuticals
2011-03 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-07-31)

Check the ODM-201 (Darolutamide) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Darolutamide (ODM-201) functions as a high-affinity androgen receptor antagonist (Ki = 11 nM) that directly blocks ligand binding and prevents receptor nuclear translocation. By disrupting downstream androgen-responsive gene transcription, the agent inhibits tumor cell survival and proliferation, thereby providing therapeutic benefit in clinical indications such as metastatic castration-resistant and hormone-sensitive prostate cancers.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.