Data updated: Sep 20, 2026
RELUGOLIX · Novartis
Approved 2020-12-18
RELUGOLIX is FDA-approved to treat 1 condition (same as ORGOVYX).
Source: FDA Label
Details
- Status
- Prescription
- First Approved
- 2020-12-18
- Routes
- ORAL
- Dosage Forms
- TABLET
RELUGOLIX Approval History
No approval records found
What RELUGOLIX Treats
1 indicationsRELUGOLIX is approved for 1 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as ORGOVYX (same active ingredient).
Source: FDA Label
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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 results posted | 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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
RELUGOLIX FDA Label Details
Indications & Usage
RELUGOLIX is FDA-approved to treat 1 condition — same approved indications as ORGOVYX.
Looking for the branded version?
ORGOVYX
Full clinical data, patents, trials, and competitive landscape for relugolix.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.