Primary completion· ClinicalTrials.gov
A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
Relugolix History and Updates
232 events · 1998 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
132
FDA Approvals
5
Label Revisions
300
Trial Milestones
2
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-08Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Relugolix since 1998, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (14)
2026
- Label revisionEstradiol and Norethindrone Acetate Label Adds Boxed Warning for Major Risks· May 29, 2026
- Results postedRelugolix Combination Therapy Shows Contraceptive Efficacy in Phase 3 Trial· May 13, 2026
- Primary completionRelugolix Phase 3 Endometriosis Trial Completes Primary Data Collection· Feb 15, 2026
- Label revisionRelugolix Label Updated with Boxed Warning on Cardiovascular Risk· Jan 29, 2026
2025
- Results postedRelugolix Real-World Study Describes Prostate Cancer Patient Characteristics· Dec 11, 2025
- Label revisionEstradiol Label Receives New Boxed Warning for Serious Risks· Nov 25, 2025
- Label revisionMicrogestin 1/20 Label Adds Boxed Warning on Cardiovascular Risks· Nov 12, 2025
- Label revisionOrgovyx Label Updated for Advanced Prostate Cancer Indication· Oct 10, 2025
- Results postedRelugolix, Leuprolide Show Increased Coronary Plaque in Prostate Cancer· Sep 22, 2025
- Results postedCannabidiol (CBD) for Endometriosis Pain: High Dose Shows Lower Pain AUC· Apr 4, 2025
- Primary completionRelugolix Combination Therapy Phase 3 Trial Reports 1.2% 1-Year Pregnancy Rate· Feb 25, 2025
- Primary completionRelugolix Contraception Trial Completes Primary Phase on 2025-02-18· Feb 18, 2025
2022
- Pivotal publicationRelugolix Combination Therapy Efficacy for Endometriosis Pain Published· Jan 1, 2022
2020
- Pivotal publicationRelugolix Publication Details Oral ADT for Advanced Prostate Cancer· Jan 1, 2020
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Identifying Oxytocin Deficiency in Adults With Pituitary Disease
Primary completion· ClinicalTrials.gov
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
Primary completion· ClinicalTrials.gov
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligomet
Primary completion· ClinicalTrials.gov
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk
Primary completion· ClinicalTrials.gov
Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Primary completion· ClinicalTrials.gov
Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very Hig
Primary completion· ClinicalTrials.gov
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Primary completion· ClinicalTrials.gov
MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relu
Primary completion· ClinicalTrials.gov
REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
Primary completion· ClinicalTrials.gov
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
Primary completion· ClinicalTrials.gov
Insights in Endocervical Mucus Secretion
Primary completion· ClinicalTrials.gov
Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer
Primary completion· ClinicalTrials.gov
The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
Primary completion· ClinicalTrials.gov
Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
Primary completion· ClinicalTrials.gov
IUD and Norethindrone Acetate for Treatment of Endometriosis
Primary completion· ClinicalTrials.gov
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Primary completion· ClinicalTrials.gov
The University of Miami Adapt (UAdapt) Trial
Primary completion· ClinicalTrials.gov
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
Primary completion· ClinicalTrials.gov
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Primary completion· ClinicalTrials.gov
Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
Primary completion· ClinicalTrials.gov
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
Primary completion· ClinicalTrials.gov
REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
Primary completion· ClinicalTrials.gov
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endom
Primary completion· ClinicalTrials.gov
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
Primary completion· ClinicalTrials.gov
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
Primary completion· ClinicalTrials.gov
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
Primary completion· ClinicalTrials.gov
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Primary completion· ClinicalTrials.gov
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvag
Primary completion· ClinicalTrials.gov
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
Primary completion· ClinicalTrials.gov
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offs
Primary completion· ClinicalTrials.gov
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a
Past events
2026
Trial started· ClinicalTrials.gov
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Label revision· FDA
WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER S ee full prescribing information for complete boxed war
Results posted· ClinicalTrials.gov
Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at R
Trial registered· ClinicalTrials.gov
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Primary completion· ClinicalTrials.gov
Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study
Trial started· ClinicalTrials.gov
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
FDA approval (supplemental)· FDA
Sponsor: BRECKENRIDGE PHARM. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BRECKENRIDGE PHARM. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BRECKENRIDGE PHARM. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BRECKENRIDGE PHARM. Class: Labeling.
Primary completion· ClinicalTrials.gov
Identifying Oxytocin Deficiency in Adults With Pituitary Disease
Trial registered· ClinicalTrials.gov
Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT
Primary completion· ClinicalTrials.gov
The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
Label revision· FDA
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 ye
Trial started· ClinicalTrials.gov
Insights in Endocervical Mucus Secretion
Trial started· ClinicalTrials.gov
IUD and Norethindrone Acetate for Treatment of Endometriosis
2025
Primary completion· ClinicalTrials.gov
Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17
Trial registered· ClinicalTrials.gov
REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
Results posted· ClinicalTrials.gov
Description of Relugolix Use in Patients With Prostate Cancer Within the VHA
Trial started· ClinicalTrials.gov
Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
Trial started· ClinicalTrials.gov
REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)
Label revision· FDA
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Add
Label revision· FDA
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age.
Primary completion· ClinicalTrials.gov
Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment
Trial started· ClinicalTrials.gov
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
Primary completion· ClinicalTrials.gov
Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer
Trial registered· ClinicalTrials.gov
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
Label revision· FDA
1 INDICATIONS AND USAGE ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanc
FDA approval (supplemental)· FDA
Sponsor: SUMITOMO PHARMA AM. Class: Labeling.
Trial started· ClinicalTrials.gov
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Results posted· ClinicalTrials.gov
RElugolix VErsus LeUprolide Cardiac Trial
FDA approval (supplemental)· FDA
Sponsor: SUMITOMO PHARMA AM. Class: Labeling.
Trial started· ClinicalTrials.gov
Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very Hig
Trial registered· ClinicalTrials.gov
Insights in Endocervical Mucus Secretion
Trial registered· ClinicalTrials.gov
Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
FDA approval (supplemental)· FDA
Sponsor: MILLICENT PR. Class: Labeling.
Results posted· ClinicalTrials.gov
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associ
Trial registered· ClinicalTrials.gov
Pilot Study: Androgen Deprivation Therapy Impact on PSMA-PET Sensitivity in Prostatectomy Staging
FDA approval (supplemental)· FDA
Sponsor: XIROMED. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: AUROBINDO PHARMA LTD. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: XIROMED. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: XIROMED. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: XIROMED. Class: Labeling.
Trial registered· ClinicalTrials.gov
Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very Hig
Trial started· ClinicalTrials.gov
Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study
Trial registered· ClinicalTrials.gov
Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study
Trial started· ClinicalTrials.gov
MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relu
Results posted· ClinicalTrials.gov
Cannabidiol and Management of Endometriosis Pain
Primary completion· ClinicalTrials.gov
Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at R
Primary completion· ClinicalTrials.gov
Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at R
Trial started· ClinicalTrials.gov
REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
Primary completion· ClinicalTrials.gov
RElugolix VErsus LeUprolide Cardiac Trial
Primary completion· ClinicalTrials.gov
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
2024
Primary completion· ClinicalTrials.gov
Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen
Trial started· ClinicalTrials.gov
Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
Trial started· ClinicalTrials.gov
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
Primary completion· ClinicalTrials.gov
Description of Relugolix Use in Patients With Prostate Cancer Within the VHA
Results posted· ClinicalTrials.gov
A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy
Trial started· ClinicalTrials.gov
Identifying Oxytocin Deficiency in Adults With Pituitary Disease
Primary completion· ClinicalTrials.gov
Pilot Study: Androgen Deprivation Therapy Impact on PSMA-PET Sensitivity in Prostatectomy Staging
Trial started· ClinicalTrials.gov
The University of Miami Adapt (UAdapt) Trial
Trial registered· ClinicalTrials.gov
Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Primary completion· ClinicalTrials.gov
Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)
Trial started· ClinicalTrials.gov
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
Trial registered· ClinicalTrials.gov
REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
FDA approval (supplemental)· FDA
Sponsor: SUMITOMO PHARMA AM. Class: Efficacy.
Trial registered· ClinicalTrials.gov
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
Trial started· ClinicalTrials.gov
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Trial started· ClinicalTrials.gov
The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
Trial started· ClinicalTrials.gov
Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer
Primary completion· ClinicalTrials.gov
A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients
FDA approval· FDA
Sponsor: AUROBINDO PHARMA.
FDA approval· FDA
Sponsor: MILLICENT PR. Class: Type 3 - New Dosage Form.
FDA approval (supplemental)· FDA
Sponsor: SUMITOMO PHARMA AM. Class: Labeling.
Results posted· ClinicalTrials.gov
Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate
Trial registered· ClinicalTrials.gov
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Primary completion· ClinicalTrials.gov
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associ
Results posted· ClinicalTrials.gov
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Trial started· ClinicalTrials.gov
Description of Relugolix Use in Patients With Prostate Cancer Within the VHA
Trial registered· ClinicalTrials.gov
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
Trial registered· ClinicalTrials.gov
Description of Relugolix Use in Patients With Prostate Cancer Within the VHA
Trial started· ClinicalTrials.gov
Pilot Study: Androgen Deprivation Therapy Impact on PSMA-PET Sensitivity in Prostatectomy Staging
Trial registered· ClinicalTrials.gov
Identifying Oxytocin Deficiency in Adults With Pituitary Disease
Trial registered· ClinicalTrials.gov
The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
Trial started· ClinicalTrials.gov
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvag
Trial started· ClinicalTrials.gov
Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17
Trial started· ClinicalTrials.gov
Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment
FDA approval (supplemental)· FDA
Sponsor: GLENMARK PHARMS LTD. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: GLENMARK PHARMS LTD. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: NOVAST LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: GLENMARK PHARMS LTD. Class: Labeling.
Primary completion· ClinicalTrials.gov
Cannabidiol and Management of Endometriosis Pain
Primary completion· ClinicalTrials.gov
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate
Results posted· ClinicalTrials.gov
LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Trial registered· ClinicalTrials.gov
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
FDA approval (supplemental)· FDA
Sponsor: SUMITOMO PHARMA AM. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: XIROMED. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: XIROMED. Class: Labeling.
Trial registered· ClinicalTrials.gov
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvag
Trial started· ClinicalTrials.gov
ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer
Trial started· ClinicalTrials.gov
The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
Trial registered· ClinicalTrials.gov
Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen
FDA approval (supplemental)· FDA
Sponsor: NOVAST LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: NOVAST LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: NOVAST LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: XIROMED. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: XIROMED. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: AUROBINDO PHARMA. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: AUROBINDO PHARMA. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: AUROBINDO PHARMA. Class: Labeling.
Trial registered· ClinicalTrials.gov
Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer
Primary completion· ClinicalTrials.gov
Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation
Trial registered· ClinicalTrials.gov
Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17
Trial registered· ClinicalTrials.gov
Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment
FDA approval (supplemental)· FDA
Sponsor: GLENMARK PHARMS LTD. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: LUPIN. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: ENCUBE. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: NOVAST LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: NOVEN PHARMS INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BARR LABS INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: AMNEAL. Class: Labeling.
Trial started· ClinicalTrials.gov
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
FDA approval (supplemental)· FDA
Sponsor: AUROBINDO PHARMA. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: AUROBINDO PHARMA. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: AUROBINDO PHARMA. Class: Labeling.
Primary completion· ClinicalTrials.gov
Ovulation Incidence in Oral Contraceptive Users
FDA approval (supplemental)· FDA
Sponsor: BARR LABS INC. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: ENCUBE. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: GLENMARK PHARMS LTD. Class: Labeling.
Trial started· ClinicalTrials.gov
Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
2023
Trial started· ClinicalTrials.gov
Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer
Trial registered· ClinicalTrials.gov
Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
Trial registered· ClinicalTrials.gov
Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer
Trial registered· ClinicalTrials.gov
The SUGAR Study; SBRT and Relugolix) for Prostate Cancer
Trial registered· ClinicalTrials.gov
The University of Miami Adapt (UAdapt) Trial
Primary completion· ClinicalTrials.gov
A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy
FDA approval (supplemental)· FDA
Sponsor: NOVAST LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BARR LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BARR. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BARR LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BARR. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: GLENMARK SPECLT. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: GLENMARK SPECLT. Class: Labeling.
Trial started· ClinicalTrials.gov
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endom
Trial started· ClinicalTrials.gov
Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation
Results posted· ClinicalTrials.gov
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
FDA approval· FDA
Sponsor: AUROBINDO PHARMA LTD.
Trial registered· ClinicalTrials.gov
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
FDA approval (supplemental)· FDA
Sponsor: NOVAST LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: NOVAST LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: NOVAST LABS. Class: Labeling.
Primary completion· ClinicalTrials.gov
The Effect of Dienogest vs. Norethindrone Acetate Treatment in Endometriosis
Trial registered· ClinicalTrials.gov
A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endom
Trial started· ClinicalTrials.gov
Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen
Trial started· ClinicalTrials.gov
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offs
Primary completion· ClinicalTrials.gov
Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate
Trial registered· ClinicalTrials.gov
Estrogen (Gel)Transdermal vs Oral Estrogen for Endometrial Preparation
FDA approval (supplemental)· FDA
Sponsor: SUMITOMO PHARMA AM. Class: Labeling.
Trial registered· ClinicalTrials.gov
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
Trial registered· ClinicalTrials.gov
MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relu
Trial registered· ClinicalTrials.gov
Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offs
Trial started· ClinicalTrials.gov
A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients
FDA approval (supplemental)· FDA
Sponsor: SUMITOMO PHARMA AM. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: SUMITOMO PHARMA AM. Class: Efficacy.
Trial started· ClinicalTrials.gov
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
Trial registered· ClinicalTrials.gov
A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients
2022
Primary completion· ClinicalTrials.gov
PRE-GAiN Bone Health Pilot Study
Trial started· ClinicalTrials.gov
Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)
Trial registered· ClinicalTrials.gov
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
Results posted· ClinicalTrials.gov
Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis
Trial started· ClinicalTrials.gov
A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
Trial registered· ClinicalTrials.gov
Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)
FDA approval (supplemental)· FDA
Sponsor: SUMITOMO PHARMA AM. Class: Efficacy.
Trial registered· ClinicalTrials.gov
The Effect of Dienogest vs. Norethindrone Acetate Treatment in Endometriosis
Trial started· ClinicalTrials.gov
Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate
Trial registered· ClinicalTrials.gov
A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
Primary completion· ClinicalTrials.gov
Effects of a Progestin on Frequent and/or Prolonged Bleeding With Nexplanon™
Trial started· ClinicalTrials.gov
RElugolix VErsus LeUprolide Cardiac Trial
Trial started· ClinicalTrials.gov
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
Results posted· ClinicalTrials.gov
LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Results posted· ClinicalTrials.gov
LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Trial registered· ClinicalTrials.gov
RElugolix VErsus LeUprolide Cardiac Trial
Trial registered· ClinicalTrials.gov
Metabolism of 0.35mg Norethindrone vs 5mg Norethindrone Acetate
Results posted· ClinicalTrials.gov
Use of Norethindrone Acetate for Management of Bleeding Associated With the Etonogestrel Contraceptive Implant
FDA approval (supplemental)· FDA
Sponsor: NOVAST LABS. Class: Labeling.
Recall· FDA
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19
Recall· FDA
Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 1
Pivotal publication· PubMed
SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain
2021
Primary completion· ClinicalTrials.gov
SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain
Trial started· ClinicalTrials.gov
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk
Trial registered· ClinicalTrials.gov
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
Trial registered· ClinicalTrials.gov
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk
FDA approval (supplemental)· FDA
Sponsor: BARR LABS. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: BARR. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: AMNEAL. Class: Labeling.
FDA approval (supplemental)· FDA
Sponsor: AMNEAL. Class: Labeling.
Recall· FDA
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist
Recall· FDA
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist.
Trial registered· ClinicalTrials.gov
Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants
Trial registered· ClinicalTrials.gov
IUD and Norethindrone Acetate for Treatment of Endometriosis
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.