Orgovyx

(Relugolix)

ApprovedSmall molecule

Orgovyx is a small molecule that works as a Gonadotropin-Releasing Hormone Receptor Antagonist.[2] It is being used across 16 indications, with its most advanced program in Approved.[1]

Orgovyx is one of 204 small molecule programs targeting Hypogonadism. It is currently in Approved.

Indications

Total Trials

Active Trials

203

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

HypogonadismApproved

ContraceptionApproved

MenorrhagiaActive, not recruiting

Abdominal PainActive, not recruiting

LeiomyomaActive, not recruiting

AnemiaActive, not recruiting

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)Recruiting

Oligometastatic Prostate CarcinomaActive, not recruiting

Biochemically Recurrent Prostate CarcinomaRecruiting

CardiacActive, not recruiting

HypogonadismApproved

Approved

ContraceptionApproved

Approved

MenorrhagiaApproved

Active, not recruiting

Abdominal PainApproved

Active, not recruiting

LeiomyomaApproved

Active, not recruiting

AnemiaApproved

Active, not recruiting

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)Phase 2

Recruiting

Oligometastatic Prostate CarcinomaPhase 2

Active, not recruiting

Biochemically Recurrent Prostate CarcinomaPhase 3

Recruiting

CardiacPhase 2

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Orgovyx

Sumitomo Pharma America, Inc.

Approved

14 2

Paraplatin

AAvyxa

Phase 3

25 3

Antibiotic

Pfizer

Phase 3

1 4

Docetaxel /m²

AstraZeneca

Phase 3

2 5

Piflufolastat

Novartis

Phase 3

2 6

Luteinizing Hormone Releasing Hormone

UUS Department of Veterans Affairs

Phase 3

2 7

Fuzuloparib

JJiangsu HengRui Medicine Co., Ltd.

Phase 3

1 8

Trexall

Duragesic

1 10

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Not yet recruiting

Prostate Cancer

NCT06129851

Phase 2Active, not recruiting

Cardiac

NCT05320406

Phase 2Recruiting

Prostate Cancer

NCT07025369

Q1 2027

Phase 3Recruiting

Uterine Fibroid

NCT06671548

Q4 2027

Phase 2Recruiting

Prostate Cancer

NCT06330805

Q1 2028

Phase 2Recruiting

Prostate Cancer

NCT05765500

Clinical

Trials by Indication[1]

Prostate Cancer14 trials

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

Recruiting·OOhio State University Comprehensive Cancer Center·Phase 2·NCT06330805·70 enrolled

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

Not yet recruiting·UUniversity of Kansas Medical Center·Phase 2·NCT06129851·90 enrolled

A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

Completed·MMyovant Sciences GmbH·Phase 3·NCT03085095·1,134 enrolled

Show 11 more trials

Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 3·NCT05605964·387 enrolled

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Recruiting·AAdventHealth·Phase 1·NCT06631521·30 enrolled

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

Recruiting·MMayo Clinic·Phase 2·NCT07025369·30 enrolled

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· Takeda logo

Takeda·Phase 2·NCT02083185·136 enrolled

Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1·NCT04666129·48 enrolled

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

Completed· Pfizer logo

Pfizer··NCT06462014·507 enrolled

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

Recruiting·NNorthwestern University·Phase 2·NCT06499870·50 enrolled

The SUGAR Study: (SBRT and Ultrashort GnRH Antagonist-Relugolix) for Clinicogenomic Unfavorable Intermediate Risk Prostate Cancer

Recruiting·YYale University·Phase 2·NCT06111781·60 enrolled

Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET/CT in Patients With High-Risk Localized Prostate Cancer (LHRPC)

Recruiting·BBaptist Health South Florida·Phase 2·NCT07455903·50 enrolled

RecoverPC: A Phase 2 Study of RElugolix Versus GnRH Agonist Quality of Life (QOL) and Testosterone reCOVERy in Men With Prostate Cancer

Recruiting·DDana-Farber Cancer Institute·Phase 2·NCT05765500·110 enrolled

A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.··NCT05467176·999 enrolled

Uterine Fibroid7 trials

LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Completed·MMyovant Sciences GmbH·Phase 3·NCT03049735·388 enrolled

A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids

Completed· Takeda logo

Takeda·Phase 3·NCT02655224·65 enrolled

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

Recruiting· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT06671548·120 enrolled

Show 4 more trials

Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Completed·MMyovant Sciences GmbH·Phase 3·NCT03751124·229 enrolled

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 logo

Takeda·Phase 3·NCT02655237·281 enrolled

LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Completed·MMyovant Sciences GmbH·Phase 3·NCT03103087·382 enrolled

LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Completed·MMyovant Sciences GmbH·Phase 3·NCT03412890·477 enrolled

Endometriosis3 trials

SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

Completed·MMyovant Sciences GmbH·Phase 3·NCT03204318·638 enrolled

SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

Completed·MMyovant Sciences GmbH·Phase 3·NCT03654274·802 enrolled

SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

Completed·MMyovant Sciences GmbH·Phase 3·NCT03204331·623 enrolled

Androgen Deprivation Therapy2 trials

Pilot Study: Androgen Deprivation Therapy Impact on PSMA-PET Sensitivity in Prostatectomy Staging

Completed·UUrology Clinics of North Texas·Phase 1·NCT07069465·10 enrolled

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

Active, not recruiting·—·Phase 2·NCT06463457·33 enrolled

Prostate Adenocarcinoma2 trials

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)

Active, not recruiting·NNRG Oncology·Phase 3·NCT04513717·2,753 enrolled

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Active, not recruiting·NNRG Oncology·Phase 3·NCT05050084·2,050 enrolled

9 more indications

Premenopausal1 trial

Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants

Completed·MMyovant Sciences GmbH·Phase 1·NCT04978688·48 enrolled

Postmenopausal Women1 trial

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

Completed·MMyovant Sciences GmbH·Phase 1·NCT04714554·43 enrolled

Cardiac1 trial

RElugolix VErsus LeUprolide Cardiac Trial

Active, not recruiting·EEmory University·Phase 2·NCT05320406·94 enrolled

Abiraterone Acetate1 trial

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

Recruiting·EEmory University·Phase 3·NCT06650579·72 enrolled

Metastatic Prostate Cancer1 trial

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04523207·108 enrolled

Biochemically Recurrent Prostate Carcinoma1 trial

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT04423211·804 enrolled

Oligometastatic Prostate Carcinoma1 trial

A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

Active, not recruiting·NNRG Oncology·Phase 2·NCT05053152·194 enrolled

Recurrent Castration-Sensitive Prostate Carcinoma1 trial

MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer

Recruiting·MMayo Clinic·Phase 2·NCT06378866·532 enrolled

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)1 trial

A Phase II Randomized, Decentralized, De-escalation Study in Patients With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Response (OPTIMAS)

Recruiting·UUniversity of Utah·Phase 2·NCT07216248·160 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 18, 2020

ORGOVYX

NDA NDA214621

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for Relugolix. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Relugolix compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Relugolix. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214621). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Orgovyx. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sumitomo Pharma America, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Gonadotropin-Releasing Hormone Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Sumitomo Pharma America, Inc.

Patent Landscape[5]

Patent Cliff

Jan 28, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7300935Jan 28, 2029

11795178Sep 27, 2033

10350170Feb 25, 2036

12097198Sep 29, 2037

10449191Sep 29, 2037

5 more patents

10786501Sep 29, 2037

12144809Sep 29, 2037

12629370Sep 29, 2037

11583526Sep 29, 2037

12336990Sep 29, 2037

Orgovyx

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Prostate Cancer14 trials

Uterine Fibroid7 trials

Endometriosis3 trials

Androgen Deprivation Therapy2 trials

Prostate Adenocarcinoma2 trials

Premenopausal1 trial

Postmenopausal Women1 trial

Cardiac1 trial

Abiraterone Acetate1 trial

Metastatic Prostate Cancer1 trial

Biochemically Recurrent Prostate Carcinoma1 trial

Oligometastatic Prostate Carcinoma1 trial

Recurrent Castration-Sensitive Prostate Carcinoma1 trial

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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