How many clinical trials are studying Relugolix?

9 recruiting trials in our tracked data involve Relugolix.

What conditions is Relugolix being studied for?

In our tracked recruiting trials, Relugolix is being studied in trials for Prostate Cancer, Prostate Adenocarcinoma, Biochemically Recurrent Prostate Carcinoma.

Relugolix: clinical trials recruiting now

Q: Is Relugolix FDA-approved?

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

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Relugolix appears in the FDA drug-label database. Marketed as Orgovyx.
Drug class: Gonadotropin Releasing Hormone Receptor Antagonist (FDA established pharmacologic class)
Mechanism of action: Gonadotropin Releasing Hormone Receptor Antagonists; Cytochrome P450 3A Inducers; Cytochrome P450 2B6 Inducers; Breast Cancer Resistance Protein Inhibitors; P-Glycoprotein Inhibitors (as stated on the FDA label)

FDA-approved use

ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).

FDA label via openFDA

Phase breakdown

Phase 1 1 Phase 2 6 Phase 3 2

Conditions being studied

Condition	Trials
Prostate Cancer · Relugolix for Prostate Cancer	9
Prostate Adenocarcinoma · Relugolix for Prostate Adenocarcinoma	4
Biochemically Recurrent Prostate Carcinoma	2
Stage IIC Prostate Cancer AJCC v8	2
Stage III Prostate Cancer AJCC v8	2
Castration-resistant Prostate Cancer	1
Localized Prostate Carcinoma	1
Metastatic Prostate Carcinoma	1
Prostate CA	1
Prostate Cancer (Adenocarcinoma)	1
Prostate Cancer Surgery	1
Prostatic Neoplasms	1
Recurrent Castration-Sensitive Prostate Carcinoma	1
Recurrent Prostate Cancer	1
Recurrent Prostate Carcinoma	1

Recruiting trials involving Relugolix

Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial
NCT07025369 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Male · 1 location
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
NCT07455903 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Male · 1 location
Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer
NCT06330805 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Male · 1 location
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
NCT06631521 · Phase: Phase 1 · Ages: 18 Years and older · Sex: Male · 1 location
REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
NCT06650579 · Phase: Phase 3 · Ages: 18 Years and older · Sex: Male · 4 locations
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
NCT05765500 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Male · 3 locations
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
NCT06499870 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Male · 1 location
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
NCT06378866 · Phase: Phase 2 · Ages: 18 Years and older · Sex: Male · 3 locations
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
NCT04423211 · Phase: Phase 3 · Ages: 18 Years and older · Sex: Male · 341 locations

Common questions

Is Relugolix FDA-approved?

Yes, marketed as Orgovyx.

How many recruiting trials involve Relugolix?

9 recruiting trials across 15 conditions.

Is this list of trials complete?

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