CLINICAL TRIALS PROFILE FOR ORGOVYX

All Clinical Trials for ORGOVYX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03348670 ↗	Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms	Active, not recruiting	Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	Phase 2/Phase 3	2023-08-18	The usual approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes. The study approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
NCT03348670 ↗	Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms	Active, not recruiting	Han Xu, M.D., Ph.D., Non-Investigator, IRB Chair	Phase 2/Phase 3	2023-08-18	The usual approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet, film coated plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes. The study approach group, 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet, delayed release plus ORGOVYX - relugolix tablet, film coated, it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping, and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.
NCT04666129 ↗	Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer	Recruiting	Myovant Sciences GmbH	Phase 1	2021-02-18	This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).
NCT05050084 ↗	Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score	Not yet recruiting	National Cancer Institute (NCI)	Phase 3	2021-11-11	This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.

Clinical Trial Conditions for ORGOVYX

Condition Name

Condition Name for ORGOVYX
Intervention	Trials
Prostate Cancer	4
Prostate Adenocarcinoma	3
Stage IIC Prostate Cancer AJCC v8	3
Stage III Prostate Cancer AJCC v8	2

Condition MeSH

Condition MeSH for ORGOVYX
Intervention	Trials
Prostatic Neoplasms	9
Small Cell Lung Carcinoma	1
Lung Neoplasms	1
Carcinoma	1

Clinical Trial Locations for ORGOVYX

Trials by Country

Trials by Country for ORGOVYX
Location	Trials
United States	12

Trials by US State

Trials by US State for ORGOVYX
Location	Trials
Ohio	2
Maryland	2
Kansas	1
Connecticut	1
Massachusetts	1

Clinical Trial Progress for ORGOVYX

Clinical Trial Phase

Clinical Trial Phase for ORGOVYX
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	1
Phase 3	2

Clinical Trial Status

Clinical Trial Status for ORGOVYX
Clinical Trial Phase	Trials
Not yet recruiting	6
RECRUITING	3
Active, not recruiting	1

Clinical Trial Sponsors for ORGOVYX

Sponsor Name

Sponsor Name for ORGOVYX
Sponsor	Trials
Myovant Sciences GmbH	4
National Cancer Institute (NCI)	4
Pfizer	3

Sponsor Type

Sponsor Type for ORGOVYX
Sponsor	Trials
Industry	10
Other	8
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Orgovyx

Last updated: October 26, 2025

Introduction

Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist developed by pharmaceutical company Myovant Sciences. It primarily targets advanced prostate cancer and uterine fibroids, offering an oral alternative to injectable therapies. As the drug gains regulatory approvals and expands its clinical indications, understanding its clinical trial landscape, market potential, and future projections becomes critical for stakeholders. This article provides a comprehensive analysis of Orgovyx’s recent clinical trial updates, market dynamics, and growth forecasts.

Clinical Trials Overview and Recent Updates

Regulatory Approvals and Indications

In December 2020, the U.S. Food and Drug Administration (FDA) approved Orgovyx for the treatment of adult patients with advanced prostate cancer. This approval marked a significant milestone, positioning Orgovyx as the first oral GnRH antagonist approved for prostate cancer in the United States. Subsequently, regulatory reviews in Europe and other regions are underway, with ongoing clinical trials designed to expand its indications.

Current Clinical Trials Status

Prostate Cancer

The core clinical development program for Orgovyx centers around its efficacy and safety in treating advanced prostate cancer. The Phase III HERO trial (NCT03438125), pivotal for FDA approval, demonstrated non-inferiority of Orgovyx to injectable GnRH therapies, with significant reductions in testosterone levels maintained over 48 weeks.

• Ongoing Extensions & Post-Approval Studies:
  Post-marketing, Myovant is conducting long-term extension studies to evaluate sustained efficacy, safety, and quality of life metrics. Data suggests favorable tolerability, with fewer injection-site reactions and improved patient compliance due to oral administration.

Uterine Fibroids

While Orgovyx is primarily indicated for prostate cancer, research into its use for uterine fibroids (a condition hormonally driven by estrogen and progesterone) is ongoing. A Phase II trial (NCT03698451) demonstrated promising reductions in fibroid volume and symptom severity, albeit further studies are required for regulatory approval for this indication.

Emerging Clinical Trial Data

• Combination Therapy Trials:
  Researchers are evaluating Orgovyx combined with other agents like abiraterone or enzalutamide in prostate cancer to assess synergistic effects and resistance mitigation.

• Expanded Population Studies:
  Trials assessing its safety and efficacy in elderly patients, those with comorbidities, and in various ethnic groups are in progress, aiming to broaden its applicability.

Safety Profile

Clinical trial data indicate that Orgovyx is well-tolerated, with common adverse events including hot flashes, fatigue, and headache. Notably, its oral dosing reduces injection-related complications such as pain and injection site reactions, enhancing patient adherence. Long-term safety data are accumulating, with ongoing trials focusing on cardiovascular safety given the hormonal suppression.

Market Analysis

Market Landscape and Competitive Positioning

Orgovyx enters a competitive market for prostate cancer therapies, historically dominated by injectable GnRH agonists such as leuprolide and goserelin. Its hallmark advantages include oral administration, rapid testosterone suppression, and fewer injection-related adverse events, positioning it favorably against existing therapies.

• Competitive Edge:
  Orgovyx offers a convenient, non-invasive alternative that could improve patient compliance, especially for those with needle aversion or logistical barriers accessing clinics for injections.

• Key Competitors:

  • Ed_entities like Janssen's Zytiga (abiraterone acetate)
  • Bayer's Xtandi (enzalutamide)
  • Ipsen's Somatuline and various injectable GnRH analogs.

Market Size and Growth Drivers

Prostate Cancer Market

Prostate cancer remains the second-most common cancer among men worldwide, with over 1.4 million new cases annually ([2]). The global prostate cancer therapeutics market was valued at approximately USD 4.8 billion in 2021 and is projected to reach around USD 8.4 billion by 2030, growing at a CAGR of 6.0% ([3]).

Orgovyx's potential market share hinges on factors such as:

• Patient Preference: Increasing demand for oral therapies in oncology.
• Drug Efficacy and Tolerability: Superior safety profiles may favor adoption.
• Physician Adoption: Education and shifting treatment paradigms towards oral agents.

Uterine Fibroids Market

The uterine fibroids market is valued at USD 3.5 billion as of 2022 and is expected to grow with rising prevalence, particularly among women aged 30-50 ([4]). While Orgovyx's role is experimental at this stage, future approvals could diversify its revenue streams.

Market Entry Strategies

Myovant Sciences leverages early approvals, targeted marketing, and education initiatives to expand Orgovyx's footprint. Reimbursement negotiations and physician engagement are critical, especially given the competitive landscape.

Market Forecast and Projections

Short-to-Medium-Term (2023–2026)

Based on current clinical data, regulatory approval status, and market dynamics:

• Market Penetration:
  Orgovyx is expected to capture approximately 10-15% of the newly diagnosed prostate cancer patient population within the U.S. by 2025, accelerated by physician preference for oral therapies and patient compliance benefits.

• Revenue Projections:
  Estimated sales could reach USD 300-500 million globally by 2025, accounting for initial adoption, reimbursement, and clinical guideline endorsements.

• Geographical Expansion:
  European and Asian approvals are anticipated within this timeframe, contributing additional sales channels.

Long-Term Outlook (2027 and beyond)

• Potential Growth Factors:

  • Broadened indications, including combination therapies and uterine fibroids.
  • Ongoing clinical trials confirming efficacy and safety across diverse populations.
  • Shift towards patient-centric care models favoring oral, outpatient therapies.

• Market Share Evolution:
  A projected 20-25% share in the prostate cancer oral hormonal therapy segment is plausible, with potential to surpass injectable GnRH agents in preference as real-world data solidifies.

• Revenue Potential:
  Long-term sales could reach USD 1 billion annually, contingent upon regulatory approvals for additional indications and sustained market penetration.

Key Challenges and Risks

• Regulatory Risks:
  Delays or adverse findings in ongoing trials or regulatory reviews could impede growth.

• Market Competition:
  The presence of established injectable therapies and emerging oral agents like relugolix combination pills may affect pricing and market share.

• Pricing and Reimbursement:
  Negotiations with payers and pricing pressures could limit profit margins.

• Post-market Safety Data:
  Long-term safety concerns could influence prescribing patterns.

Key Takeaways

• Clinical Success and Approvals:
  Orgovyx’s FDA approval for prostate cancer positions it as a formidable oral alternative, with ongoing trials expanding its potential indications, including uterine fibroids.

• Market Opportunity:
  The shift towards oral hormonal therapies in prostate cancer, combined with a growing market size, underpins robust growth prospects. Early market penetration may be modest but is expected to accelerate as clinical evidence accumulates.

• Strategic Growth Drivers:
  Favorable safety profiles, improved patient compliance, and evolving treatment guidelines favor Orgovyx’s adoption. Efforts to broaden indications and geographical reach are pivotal.

• Forecasted Revenue Trajectory:
  Short-term revenues are projected to be in the hundreds of millions USD, escalating to CAGR-driven surpassing of USD 1 billion in sales within the next few years, assuming regulatory approvals and favorable market dynamics.

• Stakeholder Implications:
  Pharmaceutical investors and healthcare providers should monitor regulatory milestones, clinical development updates, and market acceptance trends closely.

FAQs

1. What are the primary clinical benefits of Orgovyx over traditional injectable therapies?
Orgovyx offers oral administration, eliminating the discomfort and logistical challenges associated with injections. It provides rapid testosterone suppression with a favorable safety profile, improving patient adherence and quality of life.

2. How does Orgovyx’s efficacy compare to existing prostate cancer treatments?
Clinical trials, notably the HERO trial, demonstrated non-inferiority to injectable GnRH therapies in suppressing testosterone, with comparable or improved safety and tolerability.

3. What are the key regulatory milestones expected for Orgovyx in the next two years?
European and Asian regulatory submissions are underway, with approvals anticipated based on ongoing clinical trial data. Expansion of label indications will depend on successful Phase III studies and safety assessments.

4. Could Orgovyx disrupt the current prostate cancer treatment paradigm?
Yes. Its oral route and safety profile position it as a preferred first-line hormonal therapy, potentially reducing reliance on injectables and improving patient-centered care.

5. What are the potential concerns for investors regarding Orgovyx’s market growth?
Market penetration depends on clinical adoption, payer acceptance, and competitive dynamics. Long-term safety data and regulatory approvals for additional indications are vital factors influencing growth.

References

[1] Myovant Sciences. (2020). FDA approves ORGOVYX for prostate cancer.
[2] International Agency for Research on Cancer. (2022). Global Cancer Statistics.
[3] Grand View Research. (2022). Prostate Cancer Therapeutics Market Size & Trends.
[4] MarketWatch. (2022). Uterine Fibroids Market Analysis and Future Outlook.