Drug Pipeline

Darolutamide Clinical Trials

Data updated daily from ClinicalTrials.gov — last refresh 2026-06-12
122
Active Studies
63
Recruiting
32
Phase 3
10
Top Sponsors
22
Changes, 30 Days
What Changed in the Last 30 Days
DetectedTrialChange
2026-06-12 NCT05669664
Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary…
date change Primary completion moved earlier: 2027-04-11 -> 2026-11-30
2026-06-12 NCT05669664
Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary…
date change Completion moved earlier: 2027-04-11 -> 2026-11-30
2026-06-10 NCT06592924
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration…
Trial sites expanded: 340 -> 368 locations
2026-06-09 NCT06855277
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With…
Trial sites expanded: 55 -> 69 locations
2026-06-05 NCT07287150
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant…
Trial sites expanded: 20 -> 32 locations
2026-06-05 NCT07213674
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With…
Trial sites expanded: 129 -> 133 locations
2026-06-04 NCT03419234
Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone…
date change Completion pushed: 2026-04-01 -> 2028-04-01
2026-06-04 NCT05797168
Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With…
Trial arms changed: 5 -> 6
2026-06-04 NCT06136650
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA)…
Trial sites expanded: 324 -> 327 locations
2026-06-03 NCT07226986
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan…
Trial sites expanded: 12 -> 17 locations
2026-06-03 NCT07190300
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With…
Trial sites expanded: 25 -> 29 locations
2026-06-03 NCT03732820
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic…
date change Completion pushed: 2026-04-27 -> 2027-02-05
2026-05-28 NCT06120491
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate…
overall status: "Recruiting" → "Active Not Recruiting"
2026-05-28 NCT06120491
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate…
Trial sites reduced: 410 -> 322 locations
2026-05-28 NCT06120491
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate…
date change Primary completion moved earlier: 2028-01-11 -> 2027-09-30
2026-05-28 NCT05849298
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With…
Trial sites reduced: 41 -> 37 locations
2026-05-23 NCT03860987
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using…
Trial completed
2026-05-23 NCT03860987
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using…
date change Primary completion moved earlier: 2026-07-31 -> 2026-05-11
2026-05-23 NCT03860987
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using…
date change Completion moved earlier: 2028-08-01 -> 2026-05-18
2026-05-16 NCT06691984
Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy…
overall status: "Recruiting" → "Active Not Recruiting"
Showing 20 of 22 changes detected in the last 30 days.
New Trial Filings, Last 30 Days
First PostedTrialPhaseStatus
2026-06-11 NCT07641855 A Study of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant… Phase 2/3 Not Yet Recruiting
2026-06-02 NCT07620041 QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug… Phase 1 Not Yet Recruiting
2026-06-02 NCT07620574 Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored… Phase 3 Not Yet Recruiting
2026-06-01 NCT07617272 Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting… Phase 2 Recruiting
2026-05-28 NCT07611110 AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant… Phase 3 Recruiting
Active Studies by Phase
Phase 4
4
Phase 3
28
Phase 2/3
4
Phase 2
46
Phase 1/2
15
Phase 1
17
Early Phase 1
1
Not specified
7
Active Trials — top 25 of 122
NCT IDTitleConditionStatus
Phase 4
NCT05348876 A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real… Non-metastatic Castration-resistant Prostate Cancer Recruiting
NCT06660862 Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in… Prostate Cancer Not Yet Recruiting
NCT03016741 Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer Castration-Resistant Prostatic Cancer Active, Not Recruiting
NCT05457257 Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With… Metastatic Castration-resistant Prostate Cancer Active, Not Recruiting
Phase 3
NCT06470243 Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will… Castration-Resistant Prostate Carcinoma Recruiting
NCT06650579 REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial Recurrent Prostate Carcinoma Recruiting
NCT04916613 ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable… Prostate Cancer Metastatic Recruiting
NCT06136624 Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) Prostate Cancer Metastatic Recruiting
NCT06764485 A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice… Metastatic Castration-resistant Prostate Cancer Recruiting
NCT06380751 Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine… Advanced Breast Cancer Recruiting
NCT06952803 A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT… Prostate Cancer Recruiting
NCT06520345 The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT… Metastatic Castration-resistant Prostate Cancer Recruiting
NCT07611110 AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant… Metastatic Castration-resistant Prostate Cancer Recruiting
NCT07213674 A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With… Metastatic Castration-resistant Prostate Cancer Recruiting
NCT06136650 A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA)… Metastatic Castration-resistant Prostate Cancer (mCRPC) Recruiting
NCT06592924 Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration… Prostate Cancer (Adenocarcinoma) Recruiting
NCT06855277 Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With… Prostate Cancer Recruiting
NCT04647526 Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line… Metastatic Castration-Resistant Prostate Cancer Active, Not Recruiting
NCT05171816 Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic… Metastatic Castration-resistant Prostate Cancer Active, Not Recruiting
NCT04464226 Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in… Cancer Active, Not Recruiting
NCT05050084 Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less… Prostate Adenocarcinoma Active, Not Recruiting
NCT04484818 Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy… Prostate Carcinoma Active, Not Recruiting
NCT04493853 Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive… Hormone-Sensitive Prostate Cancer Active, Not Recruiting
NCT04136353 Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate Prostate Cancer Active, Not Recruiting
NCT06691984 Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy… Metastatic Castration-resistant Prostate Cancer Active, Not Recruiting
Sponsors Running Darolutamide Trials
Disease Areas
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