Numerous clinical trials evaluate relugolix across various hormone-dependent conditions, spanning Phase 1 through Phase 4 studies. Covering indications such as advanced prostate cancer, uterine fibroids, endometriosis, and heavy menstrual bleeding, these active, recruiting, and completed protocols assess the drug's therapeutic potential. The investigations are sponsored by academic institutions, including Mayo Clinic and Yale University, as well as pharmaceutical organizations such as Myovant Sciences GmbH and Sumitomo Pharma Switzerland GmbH.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04513717 | ACTIVE_NOT_RECRUITING | Prostate Adenocarcinoma; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8 |
NRG Oncology |
2021-01-21 | PHASE3 |
| NCT04423211 | RECRUITING | Biochemically Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8 |
ECOG-ACRIN Cancer Research Group |
2020-10-08 | PHASE3 |
| NCT06378866 | RECRUITING | Recurrent Castration-Sensitive Prostate Carcinoma; Recurrent Prostate Cancer; Castration-resistant Prostate Cancer; Biochemically Recurrent Prostate Carcinoma |
Mayo Clinic |
2024-06-03 | PHASE2 |
| NCT06499870 | RECRUITING | Prostate Adenocarcinoma |
Sean Sachdev |
2024-09-06 | PHASE2 |
| NCT07216248 | RECRUITING | Metastatic Hormone-sensitive Prostate Cancer (mHSPC) |
University of Utah |
2025-10-27 | PHASE2 |
| NCT06397703 | RECRUITING | Prostate Cancer |
NYU Langone Health |
2024-04-16 | PHASE2 |
| NCT07455903 | RECRUITING | Prostate Cancer; Localized Prostate Carcinoma |
Baptist Health South Florida |
2026-07-29 | PHASE2 |
| NCT06650579 | RECRUITING | Recurrent Prostate Carcinoma; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8 |
Emory University |
2025-01-31 | PHASE3 |
| NCT05862272 | RECRUITING | Uterine Fibroids; Endometriosis |
Sumitomo Pharma Switzerland GmbH |
2023-08-14 | PHASE3 |
| NCT05053152 | ACTIVE_NOT_RECRUITING | Oligometastatic Prostate Carcinoma; Prostate Adenocarcinoma; Prostate Ductal Adenocarcinoma; Prostate Intraductal Carcinoma; Stage IVB Prostate Cancer AJCC v8 |
NRG Oncology |
2022-04-20 | PHASE2 |
| NCT06130995 | RECRUITING | Androgen Deprivation Therapy; Locally Advanced Prostate Cancer |
University of Oklahoma |
2024-12-26 | PHASE1 |
| NCT06463457 | ACTIVE_NOT_RECRUITING | Prostate Cancer; Advanced Prostate Cancer; Hormone Sensitive Prostate Cancer |
Atish Choudhury, MD |
2024-12-13 | PHASE2 |
| NCT06111313 | RECRUITING | Prostate Cancer |
University of Miami |
2024-11-06 | PHASE2 |
| NCT07100782 | RECRUITING | Endometriosis; Pelvic Pain |
University of Michigan |
2025-12-08 | PHASE3 |
| NCT06439524 | RECRUITING | Endometriosis |
Main Line Health |
2024-08-15 | PHASE3 |
| NCT06111781 | RECRUITING | Prostate Cancer |
Yale University |
2024-04-15 | PHASE2 |
| NCT06330805 | RECRUITING | Prostate Adenocarcinoma; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8 |
Ohio State University Comprehensive Cancer Center |
2024-08-12 | PHASE2 |
| NCT07111247 | RECRUITING | Cervical Mucus |
Oregon Health and Science University |
2026-01-02 | PHASE4 |
| NCT05765500 | RECRUITING | Prostate Cancer; Prostatic Neoplasms |
Dana-Farber Cancer Institute |
2024-02-12 | PHASE2 |
| NCT07302451 | RECRUITING | Prostate Cancer (Adenocarcinoma) |
National Cancer Institute, Naples |
2026-02-23 | PHASE2 |
| NCT07025369 | RECRUITING | Prostate Adenocarcinoma; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8 |
Mayo Clinic |
2025-08-25 | PHASE2 |
| NCT06671548 | RECRUITING | Heavy Menstrual Bleeding; Uterine Fibroids |
Qilu Pharmaceutical Co., Ltd. |
2024-01-15 | PHASE3 |
| NCT05050084 | ACTIVE_NOT_RECRUITING | Prostate Adenocarcinoma |
NRG Oncology |
2021-12-06 | PHASE3 |
| NCT04787744 | RECRUITING | Prostate Cancer; Oligometastasis; Oligorecurrence; Recurrent Prostate Cancer; Metastatic Prostate Cancer; De Novo Prostate Cancer |
VA Office of Research and Development |
2021-07-01 | PHASE2; PHASE3 |
| NCT06631521 | RECRUITING | Prostate CA; Prostate Cancer (Adenocarcinoma); Prostate Cancer Surgery |
AdventHealth |
2024-10-22 | PHASE1 |
| NCT06312761 | UNKNOWN | Hypogonadism, Male |
University of Washington |
2024-06-01 | PHASE1; PHASE2 |
| NCT06279195 | WITHDRAWN | Pelvic Pain |
Endeavor Health |
2024-06-01 | PHASE2 |
| NCT06129851 | NOT_YET_RECRUITING | Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8 |
University of Kansas Medical Center |
2023-11-20 | PHASE2 |
| NCT04756037 | COMPLETED | Contraception |
Sumitomo Pharma Switzerland GmbH |
2021-03-18 | PHASE3 |
| NCT05320406 | ACTIVE_NOT_RECRUITING | Biochemically Recurrent Prostate Carcinoma; Localized Prostate Carcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage IIA Prostate Cancer AJCC v8; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8 |
Emory University |
2022-06-06 | PHASE2 |
| NCT05605964 | COMPLETED | Prostate Cancer |
Sumitomo Pharma America, Inc. |
2023-01-28 | PHASE3 |
| NCT07069465 | COMPLETED | Prostate Cancer |
Urology Clinics of North Texas |
2024-06-15 | EARLY_PHASE1 |
| NCT05679388 | TERMINATED | Prostate Cancer; Prostate Cancer Metastatic; Prostate Adenocarcinoma |
University of Chicago |
2023-02-13 | PHASE1 |
| NCT06130995 | Not yet recruiting | Androgen Deprivation Therapy|Locally Advanced Prostate Cancer |
University of Oklahoma |
2024-08 | Phase 1 |
| NCT04666129 | COMPLETED | Metastatic Castration-Resistant Prostate Cancer; Metastatic Castration-Sensitive Prostate Cancer; Non-Metastatic Castration-Resistant Prostate Cancer |
Sumitomo Pharma America, Inc. |
2021-02-18 | PHASE1 |
| NCT04523207 | COMPLETED | Prostatic Neoplasms |
Janssen Research & Development, LLC |
2020-08-19 | PHASE2 |
| NCT05679388 | Recruiting | Prostate Cancer|Prostate Cancer Metastatic|Prostate Adenocarcinoma |
University of Chicago |
2023-02-13 | Phase 1 |
| NCT03654274 | COMPLETED | Endometriosis |
Myovant Sciences GmbH |
2018-05-22 | PHASE3 |
| NCT04714554 | COMPLETED | Healthy |
Myovant Sciences GmbH |
2021-01-06 | PHASE1 |
| NCT04756037 | Active not recruiting | Contraception |
Sumitomo Pharma Switzerland GmbH |
2021-03-18 | Phase 3 |
| NCT03751124 | COMPLETED | Uterine Leiomyoma; Uterine Fibroids |
Myovant Sciences GmbH |
2018-10-16 | PHASE3 |
| NCT03204318 | COMPLETED | Endometriosis Related Pain |
Myovant Sciences GmbH |
2017-12-07 | PHASE3 |
| NCT03204331 | COMPLETED | Endometriosis Related Pain |
Myovant Sciences GmbH |
2017-11-01 | PHASE3 |
| NCT03412890 | COMPLETED | Heavy Menstrual Bleeding; Uterine Fibroid |
Myovant Sciences GmbH |
2017-10-19 | PHASE3 |
| NCT03085095 | COMPLETED | Prostate Cancer |
Myovant Sciences GmbH |
2017-04-18 | PHASE3 |
| NCT03103087 | COMPLETED | Heavy Menstrual Bleeding; Uterine Fibroid |
Myovant Sciences GmbH |
2017-06-14 | PHASE3 |
| NCT03049735 | COMPLETED | Heavy Menstrual Bleeding; Uterine Fibroid |
Myovant Sciences GmbH |
2017-04-26 | PHASE3 |
| NCT02655237 | COMPLETED | Uterine Fibroids |
Takeda |
2016-03-05 | PHASE3 |
| NCT02655224 | COMPLETED | Uterine Fibroids |
Takeda |
2016-03-26 | PHASE3 |
| NCT04978688 | COMPLETED | Healthy |
Myovant Sciences GmbH |
2016-06-16 | PHASE1 |
| NCT02083185 | COMPLETED | Prostate Cancer |
Millennium Pharmaceuticals, Inc. |
2014-03-26 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-17)
Check the
Relugolix (TAK-385, RVT-601)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Relugolix (TAK-385, RVT-601) Solubility in DMSO
- Relugolix (TAK-385, RVT-601) Stock Solution
- Relugolix (TAK-385, RVT-601) Storage
- Relugolix (TAK-385, RVT-601) Stability
- Relugolix (TAK-385, RVT-601) Molecular Weight
- Relugolix (TAK-385, RVT-601) SMILES
- Relugolix (TAK-385, RVT-601) CAS Number
- Relugolix (TAK-385, RVT-601) Chemical Structure (2D and 3D)
- Relugolix (TAK-385, RVT-601) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.