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Darolutamide Clinical Trials

25 actively recruiting trials across 14 locations

No change since June 2026

Also known as: Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Darolutamide is also known as Nubeqa +8 more

Pipeline

Phase 1: 6Phase 2: 10Phase 3: 3Phase 1/2: 3Phase 2/3: 1

Top Sponsors

  • Bayer2
  • Xijing Hospital1
  • Vandana Abramson1
  • University of California, Davis1
  • UNICANCER1

Indications

  • Cancer25
  • Metastatic Castration-resistant Prostate Cancer6
  • Prostate Cancer6
  • Metastatic Hormone-sensitive Prostate Cancer (mHSPC)3
  • Metastatic Hormone-sensitive Prostate Cancer2

Other10 trials

A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
Phase 2
Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Phase 2
Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
Phase 2
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
Phase 2
Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
Phase 3
Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScore
Phase 2
Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse
Phase 3
TT-702 in Patients With Advanced Solid Tumours.
Phase 1/2
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers
Phase 2/3

Birmingham, Alabama2 trials

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

University of Alabama at Birmingham Hospital

Phase 1
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Univ of Alabama at Birmingham

Phase 1/2

Dothan, Alabama1 trial

AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

Research Site

Phase 3

Phoenix, Arizona1 trial

Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial

Mayo Clinic in Arizona

Phase 2

La Jolla, California1 trial

A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

University of California San Diego Moores Cancer Center

Phase 1

Sacramento, California1 trial

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

University of California Davis Comprehensive Cancer Center

Phase 2

San Francisco, California1 trial

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

University of California San Francisco

Phase 1

New Haven, Connecticut1 trial

SNV1521 in Participants With Advanced Solid Tumors

Smilow Cancer Hospital at Yale New Haven

Phase 1

Orlando, Florida1 trial

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

AdventHealth Orlando

Phase 1

Sarasota, Florida1 trial

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

Florida Cancer Specialists

Phase 1

Baltimore, Maryland1 trial

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Phase 2

Detroit, Michigan1 trial

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Barbara Ann Karmanos Cancer Institute

Phase 1/2

New York, New York1 trial

Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer

Icahn School of Medicine at Mount Sinai

Phase 2

Cleveland, Ohio1 trial

A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics

Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company

Nashville, Tennessee1 trial

Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC

Vanderbilt University/Ingram Cancer Center

Phase 2

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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