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Last Updated: May 30, 2023

CLINICAL TRIALS PROFILE FOR DAROLUTAMIDE

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All Clinical Trials for Darolutamide

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02200614 ↗	Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer	Completed	Orion Corporation, Orion Pharma	Phase 3	2014-09-12	The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
NCT02200614 ↗	Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer	Completed	Bayer	Phase 3	2014-09-12	The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.
NCT02799602 ↗	ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer	Active, not recruiting	Orion Corporation, Orion Pharma	Phase 3	2016-11-30	The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
NCT02799602 ↗	ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer	Active, not recruiting	Bayer	Phase 3	2016-11-30	The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Start Date	>Summary

Clinical Trial Conditions for Darolutamide

Condition Name

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Condition Name for Darolutamide
Intervention	Trials
Prostate Cancer	15
Metastatic Prostate Cancer	7
Prostate Adenocarcinoma	5
Prostatic Neoplasms	4
[disabled in preview]	0
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Condition MeSH

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Condition MeSH for Darolutamide
Intervention	Trials
Prostatic Neoplasms	45
Adenocarcinoma	7
Hypersensitivity	5
Carcinoma	4
[disabled in preview]	0
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Clinical Trial Locations for Darolutamide

Trials by Country

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Trials by Country for Darolutamide
Location	Trials
United States	199
Japan	79
Brazil	54
China	45
Canada	44
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Trials by US State

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Trials by US State for Darolutamide
Location	Trials
California	12
Massachusetts	11
New York	10
Florida	9
Pennsylvania	9
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Clinical Trial Progress for Darolutamide

Clinical Trial Phase

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Clinical Trial Phase for Darolutamide
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	14
Phase 2	23
[disabled in preview]	6
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Clinical Trial Status

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Clinical Trial Status for Darolutamide
Clinical Trial Phase	Trials
Recruiting	23
Not yet recruiting	19
Active, not recruiting	5
[disabled in preview]	4
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Clinical Trial Sponsors for Darolutamide

Sponsor Name

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Sponsor Name for Darolutamide
Sponsor	Trials
Bayer	27
National Cancer Institute (NCI)	4
Orion Corporation, Orion Pharma	4
[disabled in preview]	2
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Sponsor Type

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Sponsor Type for Darolutamide
Sponsor	Trials
Other	51
Industry	46
NIH	4
[disabled in preview]	1
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