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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR RELUGOLIX


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All Clinical Trials for Relugolix

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02083185 ↗ A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer Completed Millennium Pharmaceuticals, Inc. Phase 2 2014-03-26 The purpose of this study is to evaluate the efficacy of TAK 385 for achieving and maintaining testosterone suppression (<50 ng/dL).
NCT02655224 ↗ A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids Completed Takeda Phase 3 2016-03-26 The purpose of this study is to evaluate the efficacy and safety of Relugolix (TAK-385) in patients having pain symptoms associated with uterine fibroids.
NCT02655237 ↗ 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 Completed Takeda Phase 3 2016-03-05 The purpose of this study is to evaluate the efficacy of Relugolix (TAK-385) 40 mg administered orally once daily for 12 weeks, compared with leuprorelin injection (once every 4 weeks, 1.88 mg or 3.75 mg subcutaneously [SC]/time) in patients with uterine fibroids.
NCT03049735 ↗ LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Completed Myovant Sciences GmbH Phase 3 2017-04-26 The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
NCT03085095 ↗ A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer Active, not recruiting Myovant Sciences GmbH Phase 3 2017-04-18 The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer.
NCT03103087 ↗ LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Completed Myovant Sciences GmbH Phase 3 2017-06-14 The purpose of this study is to determine the benefit of relugolix 40 milligrams (mg) once a day co-administered with estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.5 mg compared with placebo for 24 weeks on heavy menstrual bleeding associated with uterine fibroids.
NCT03204318 ↗ SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain Completed Myovant Sciences GmbH Phase 3 2017-12-07 The purpose of this study is to determine the benefit and safety of relugolix 40 milligrams (mg) once daily, co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) compared with placebo for 24 weeks, on dysmenorrhea and on nonmenstrual pelvic pain.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Relugolix

Condition Name

Condition Name for Relugolix
Intervention Trials
Uterine Fibroid 3
Uterine Fibroids 3
Heavy Menstrual Bleeding 3
Prostate Cancer 3
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Condition MeSH

Condition MeSH for Relugolix
Intervention Trials
Myofibroma 7
Leiomyoma 7
Prostatic Neoplasms 7
Endometriosis 5
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Clinical Trial Locations for Relugolix

Trials by Country

Trials by Country for Relugolix
Location Trials
United States 260
Poland 41
Hungary 23
Japan 22
Brazil 18
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Trials by US State

Trials by US State for Relugolix
Location Trials
Florida 13
Ohio 12
Texas 12
South Carolina 11
North Carolina 10
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Clinical Trial Progress for Relugolix

Clinical Trial Phase

Clinical Trial Phase for Relugolix
Clinical Trial Phase Trials
Phase 4 1
Phase 3 13
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Relugolix
Clinical Trial Phase Trials
Completed 11
Recruiting 4
Not yet recruiting 3
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Clinical Trial Sponsors for Relugolix

Sponsor Name

Sponsor Name for Relugolix
Sponsor Trials
Myovant Sciences GmbH 12
National Cancer Institute (NCI) 3
Takeda 2
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Sponsor Type

Sponsor Type for Relugolix
Sponsor Trials
Industry 18
Other 4
NIH 3
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Mallinckrodt
Express Scripts
Dow
AstraZeneca

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