How many clinical trials are studying Darolutamide 300 mg?

3 recruiting trials in our tracked data involve Darolutamide 300 mg.

What conditions is Darolutamide 300 mg being studied for?

In our tracked recruiting trials, Darolutamide 300 mg is being studied in trials for Prostate Cancer, Prostate Cancer Metastatic, Prostatic Cancer, Castration-Resistant.

Darolutamide 300 mg: clinical trials recruiting now

Q: Is Darolutamide 300 mg FDA-approved?

Yes. According to the FDA drug label available through openFDA, Darolutamide 300 mg is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Darolutamide 300 mg appears in the FDA drug-label database. Marketed as NUBEQA.

FDA-approved use

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.

FDA label via openFDA

Phase breakdown

Phase 3 3

Conditions being studied

Condition	Trials
Prostate Cancer · Darolutamide 300 mg for Prostate Cancer	3
Prostate Cancer Metastatic	1
Prostatic Cancer, Castration-Resistant	1

Recruiting trials involving Darolutamide 300 mg

ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)
NCT04916613 · Phase: Phase 3 · Ages: 18 Years and older · Sex: Male · 95 locations
Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases
NCT05116475 · Phase: Phase 3 · Ages: 18 Years to 120 Years · Sex: Male · 1 location
Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging
NCT06276465 · Phase: Phase 3 · Ages: 18 Years and older · Sex: Male · 4 locations

Common questions

Is Darolutamide 300 mg FDA-approved?

Yes, marketed as NUBEQA.

How many recruiting trials involve Darolutamide 300 mg?

3 recruiting trials across 3 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.