Success Metrics

Clinical Success Rate
77.8%

Based on 7 completed trials

Completion Rate
78%(7/9)
Active Trials
39(71%)
Results Posted
29%(2 trials)
Terminated
2(4%)

Phase Distribution

Ph early_phase_1
1
2%
Ph phase_3
7
13%
Ph phase_4
1
2%
Ph phase_2
24
44%
Ph phase_1
17
31%

Phase Distribution

18

Early Stage

24

Mid Stage

8

Late Stage

Phase Distribution50 total trials
Early Phase 1First-in-human
1(2.0%)
Phase 1Safety & dosage
17(34.0%)
Phase 2Efficacy & side effects
24(48.0%)
Phase 3Large-scale testing
7(14.0%)
Phase 4Post-market surveillance
1(2.0%)

Highest Phase Reached

Phase 4

Trial Status & Enrollment

Completion Rate

70.0%

7 of 10 finished

Non-Completion Rate

30.0%

3 ended early

Currently Active

39

trials recruiting

Total Trials

55

all time

Status Distribution
Active(45)
Completed(7)
Terminated(3)

Detailed Status

Recruiting26
Active, not recruiting13
Completed7
Not yet recruiting6
Terminated2
Withdrawn1

Development Timeline

Analytics

Development Status

Total Trials
55
Active
39
Success Rate
77.8%
Most Advanced
Phase 4

Trials by Phase

Early Phase 11 (2.0%)
Phase 117 (34.0%)
Phase 224 (48.0%)
Phase 37 (14.0%)
Phase 41 (2.0%)

Trials by Status

recruiting2647%
completed713%
active_not_recruiting1324%
not_yet_recruiting611%
terminated24%
withdrawn12%

Recent Activity

Clinical Trials (55)

Showing 20 of 55 trialsScroll for more
NCT04136353Phase 3

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

Active Not Recruiting
NCT04484818Phase 3

Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study

Active Not Recruiting
NCT07140900Phase 1

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

Recruiting
NCT05050084Phase 3

Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

Active Not Recruiting
NCT06169124Phase 2

Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

Active Not Recruiting
NCT04925648Phase 2

Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction

Completed
NCT06378866Phase 2

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

Recruiting
NCT05997615Phase 1

Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

Recruiting
NCT07538843

An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment

Not Yet Recruiting
NCT07450599Phase 2

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.

Not Yet Recruiting
NCT06220864Phase 1

SNV1521 in Participants With Advanced Solid Tumors

Recruiting
NCT05818683Phase 1

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

Recruiting
NCT06190899Phase 1

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

Recruiting
NCT07406282

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

Recruiting
NCT05694819Phase 2

Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)

Completed
NCT07190300Phase 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)

Recruiting
NCT06401980Phase 2

Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Recruiting
NCT07027124Phase 2

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

Recruiting
NCT06282588Phase 2

Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

Recruiting
NCT07428642

PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.

Completed

Drug Details

Intervention Type
DRUG
Total Trials
55