Relugolix

Generic Name: Relugolix

Brand Names: Myfembree, Orgovyx

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₂₇F_₂N_₇O_₅S

CAS Number: 737789-87-6

Unique Ingredient Identifier: P76B05O5V6

Background: Relugolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist used in the treatment of several hormone-responsive conditions. It was first approved in Japan in 2019, under the brand name Relumina, for the symptomatic treatment of uterine fibroids, and more recently by the United States' FDA in 2020, under the brand name Orgovyx, for the treatment ...

Indication: 适用于治疗成年晚期前列腺癌症患者。

Associated Conditions: Advanced Hormone Sensitive Prostate Cancer, Advanced Prostate Cancer, Heavy Menstrual Bleeding, Severe Pain

Associated Therapies: -

Clinical Trials

Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Phase 3

Not yet recruiting

Conditions: Heavy Menstrual Bleeding
Uterine Fibroids

Interventions: Drug: Relugolix
Drug: Relugolix placebo

First Posted Date: 2024-11-04

Last Posted Date: 2024-11-05

Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Target Recruit Count: 120

Registration Number: NCT06671548

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, China

REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial

Phase 3

Not yet recruiting

Conditions: Recurrent Prostate Carcinoma
Stage III Prostate Cancer AJCC V8
Stage IVA Prostate Cancer AJCC V8

Interventions: Drug: Abiraterone Acetate
Drug: Bicalutamide
Procedure: Biospecimen Collection
Procedure: Computed Tomography Angiography
Drug: Leuprolide
Drug: Prednisone
Drug: Relugolix
Radiation: Radiation Therapy

First Posted Date: 2024-10-21

Last Posted Date: 2024-10-23

Lead Sponsor: Emory University

Target Recruit Count: 72

Registration Number: NCT06650579

Locations: 🇺🇸
Emory Proton Therapy Center, Atlanta, Georgia, United States
🇺🇸
Winship at Emory Midtown, Atlanta, Georgia, United States
🇺🇸
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

and more 1 locations

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Phase 1

Recruiting

Conditions: Prostate CA
Prostate Cancer (Adenocarcinoma)
Prostate Cancer Surgery

Interventions: Drug: Darolutamide
Drug: Relugolix
Procedure: Radical Prostatectomy

First Posted Date: 2024-10-08

Last Posted Date: 2024-10-30

Lead Sponsor: AdventHealth

Target Recruit Count: 30

Registration Number: NCT06631521

Locations: 🇺🇸
AdventHealth Orlando, Orlando, Florida, United States

Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial

Phase 2

Recruiting

Conditions: Prostate Adenocarcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Enzalutamide
Other: Fluorine F 18 Piflufolastat
Radiation: Image Guided Radiation Therapy
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Other: Questionnaire Administration
Drug: Relugolix

First Posted Date: 2024-07-15

Last Posted Date: 2024-10-09

Lead Sponsor: Northwestern University

Target Recruit Count: 50

Registration Number: NCT06499870

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States

Description of Relugolix Use in Patients With Prostate Cancer Within the VHA

Active, not recruiting

Conditions: Prostate Cancer

Interventions: Drug: Relugolix

First Posted Date: 2024-06-17

Last Posted Date: 2024-08-09

Lead Sponsor: Pfizer

Target Recruit Count: 500

Registration Number: NCT06462014

Locations: 🇺🇸
Pfizer, New York, New York, United States

Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

Phase 2

Recruiting

Conditions: Hormone Sensitive Prostate Cancer
Prostate Cancer
Advanced Prostate Cancer

Interventions: Drug: Darolutamide
Drug: Relugolix

First Posted Date: 2024-06-17

Last Posted Date: 2024-12-18

Lead Sponsor: Atish Choudhury, MD

Target Recruit Count: 33

Registration Number: NCT06463457

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial

First Posted Date: 2024-04-23

Last Posted Date: 2024-11-26

Lead Sponsor: Mayo Clinic

Target Recruit Count: 120

Registration Number: NCT06378866

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

Phase 2

Not yet recruiting

Conditions: Prostate Adenocarcinoma
Stage IIB Prostate Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Other: Contrast Agent
Drug: Leuprolide
Procedure: Magnetic Resonance Imaging
Other: Physical Performance Testing
Drug: Relugolix

First Posted Date: 2024-03-26

Last Posted Date: 2024-03-26

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Target Recruit Count: 70

Registration Number: NCT06330805

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer

Phase 2

Not yet recruiting

Conditions: Stage IV Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Scan
Radiation: Brachytherapy
Procedure: Computed Tomography
Procedure: Dual X-ray Absorptiometry
Radiation: External Beam Radiation Therapy
Procedure: Magnetic Resonance Imaging
Procedure: PSMA PET Scan
Other: Questionnaire Administration
Drug: Relugolix

First Posted Date: 2023-11-13

Last Posted Date: 2023-11-13

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 90

Registration Number: NCT06129851

Locations: 🇺🇸
University of Kansas Cancer Center, Kansas City, Kansas, United States

RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

Phase 2

Recruiting

Conditions: Prostate Cancer
Prostatic Neoplasms

Interventions: Drug: Leuprolide
Drug: Relugolix

First Posted Date: 2023-03-13

Last Posted Date: 2024-02-14

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 110

Registration Number: NCT05765500

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute at Foxborough, Foxboro, Massachusetts, United States

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