ORGOVYX (relugolix)
Orgovyx is a medication used for adult patients who have advanced prostate cancer. It helps manage this condition by lowering the production of hormones that can contribute to cancer growth. This treatment provides a way to suppress testosterone levels in men facing advanced stages of the disease.
How ORGOVYX Works
Relugolix works by binding to specific receptors in the pituitary gland to block the action of the gonadotropin-releasing hormone. This action reduces the release of two other hormones, luteinizing hormone and follicle-stimulating hormone. As a result, the body produces less testosterone, which helps slow the progression of the cancer.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-12-18
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- TABLET
ORGOVYX Approval History
What ORGOVYX Treats
1 indicationsORGOVYX is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prostate Cancer
ORGOVYX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ORGOVYX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ORGOVYX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ORGOVYX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07455903 | 2025-GAR-001 | Ph 2 | recruiting | Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT |
| NCT04423211 | EA8191 NCI-2020-02686, EA8191 | Ph 3 | recruiting | Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging |
| NCT05050084 | NRG-GU010 NCI-2021-08760, NRG-GU010 | Ph 3 | active not recruiting | 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 |
| NCT05053152 | NRG-GU011 NCI-2021-09164, NRG-GU011 | Ph 2 | active not recruiting | Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study |
| NCT04513717 | NRG-GU009 NCI-2020-04705, NRG-GU009 | Ph 3 | active not recruiting | Two Studies for Patients With High 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 High Gene Risk Score, The PREDICT-RT Trial |
| NCT04523207 results posted | CR108875 56021927PCR2041 | Ph 2 | completed | A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases |
| NCT06378866 DIVINE | MC230502 R01CA286127, 23-012176 | Ph 2 | recruiting | 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 |
| NCT07025369 | MC240503 NCI-2025-03965, 25-002008 | Ph 2 | recruiting | 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 |
| NCT06330805 | OSU-23069 NCI-2024-00705 | Ph 2 | recruiting | Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer |
| NCT06463457 | 24-217 | Ph 2 | active not recruiting | Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) |
| NCT06650579 | STUDY00007557 P30CA138292, NCI-2024-07761 | Ph 3 | recruiting | REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial |
| NCT05320406 REVELUTION results posted | STUDY00003654 NCI-2022-00117, STUDY00003654 | Ph 2 | active not recruiting | RElugolix VErsus LeUprolide Cardiac Trial |
| NCT06631521 | IIR-US-00295 2077841 | Ph 1 | recruiting | Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer |
| NCT06671548 | QLG1079-301 | Ph 3 | recruiting | Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT06499870 | NU 24U02 NCI-2024-03934, STU00221219 | Ph 2 | recruiting | Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial |
| NCT05605964 | MVT-601-056 | Ph 3 | completed | Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate |
| NCT04666129 | MVT-601-049 | Ph 1 | completed | Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer |
| NCT05765500 | 22-599 | Ph 2 | recruiting | RecoverPC: Relugolix vs GnRH Agonist in Quality of Life |
| NCT03751124 results posted | MVT-601-035 2018-001368-43 | Ph 3 | completed | Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT03412890 results posted | MVT-601-3003 2017-003310-74 | Ph 3 | completed | LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT06129851 | STUDY00150674 NCI-2023-09079, STUDY00150674 | Ph 2 | not yet recruiting | Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer |
| NCT03654274 results posted | MVT-601-3103 2017-004066-10 | Ph 3 | completed | SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain |
| NCT03103087 results posted | MVT-601-3002 2016-005113-50 | Ph 3 | completed | LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT03049735 results posted | MVT-601-3001 2016-003727-27 | Ph 3 | completed | LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids |
| NCT03085095 HERO results posted | MVT-601-3201 2017-000160-15 | Ph 3 | completed | A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer |
| NCT04714554 | MVT-601-054 | Ph 1 | completed | A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men |
| NCT04978688 | MVT-601-1001 | Ph 1 | completed | Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants |
| NCT03204331 | MVT-601-3102 2017-001632-19 | Ph 3 | completed | SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain |
| NCT03204318 | MVT-601-3101 2017-001588-19 | Ph 3 | completed | SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain |
| NCT02655237 results posted | TAK-385/CCT-002 U1111-1178-0989, JapicCTI-163128 | Ph 3 | completed | A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids |
| NCT02655224 results posted | TAK-385-3008 U1111-1178-1086, JapicCTI-163127 | Ph 3 | completed | A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids |
| NCT02083185 results posted | C27002 U1111-1162-5028, 172837 | Ph 2 | completed | A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ORGOVYX FDA Label Details
Indications & Usage
FDA Label (PDF)ORGOVYX is indicated for the treatment of Prostate Cancer.
ORGOVYX Patents & Exclusivity
Patents (11 active)
Pro Intelligence Preview
Deep insights for ORGOVYX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 11 active patents
Trial Analysis
- • 32 total trials
- • Stage: Expansion
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment