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Last Updated: April 2, 2026

CLINICAL TRIALS PROFILE FOR ORGOVYX


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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.
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 NRG Oncology 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.
NCT05053152 ↗ Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer Not yet recruiting National Cancer Institute (NCI) Phase 2 2021-12-10 This phase II trial tests whether relugolix and radiation therapy works to shrink tumors in patients with prostate cancer that has spread in a limited way to 1 to 5 other parts of the body (oligometastatic). Testosterone can cause the growth of prostate cancer cells. Relugolix lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Giving relugolix with radiation therapy may help lower the chance of prostate cancer growing or spreading.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ORGOVYX

Condition Name

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

Condition MeSH for ORGOVYX
Intervention Trials
Prostatic Neoplasms 9
Lung Neoplasms 1
Carcinoma 1
Adenocarcinoma 1
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Clinical Trial Locations for ORGOVYX

Trials by Country

Trials by Country for ORGOVYX
Location Trials
United States 12
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Trials by US State

Trials by US State for ORGOVYX
Location Trials
Maryland 2
Ohio 2
Arizona 1
Kansas 1
Connecticut 1
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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
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Clinical Trial Status

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

Sponsor Name

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

Sponsor Type for ORGOVYX
Sponsor Trials
Industry 10
Other 8
NIH 4
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Clinical Trials Update, Market Analysis, and Projection for ORGOVYX

Last updated: February 19, 2026

What are the recent developments in ORGOVYX clinical trials?

ORGOVYX (relugolix) has completed multiple phases of clinical testing for prostate cancer treatment. As of Q4 2023, the drug is approved by the FDA for advanced prostate cancer. Previous trials confirm its efficacy in reducing testosterone levels and controlling disease progression.

The phase 3 HERO trial (2020) provided primary data: ORGOVYX demonstrated non-inferiority to leuprolide with a safety profile acceptable for long-term use. The trial enrolled 930 patients across North America and Europe. Key outcomes include:

  • Testosterone suppression sustained for 48 weeks in 96% of patients.
  • Similar or fewer adverse events compared to comparator.
  • Lower incidence of cardiovascular events in ORGOVYX group (5%) compared to leuprolide (8%).

Post-approval, ongoing studies assess long-term outcomes and combination therapy efficacy, with preliminary data expected in 2024.

What is the current market landscape for ORGOVYX?

Market entry and regulatory status

  • Approved in the U.S. (April 2022) for advanced prostate cancer.
  • Pending reviews in Europe, with approval anticipated mid-2024.
  • FDA approval granted based on the HERO trial data, positioning ORGOVYX as an alternative to injectable GnRH antagonists.

Competitor landscape

Product Name Class Route of Administration Approval Date Market Share (2023)
ORGOVYX Oral GnRH antagonist Oral (daily) 2022 15%
Lupron Depot GnRH agonist Injection (monthly/quarterly) 1985 50%
Zytiga Androgen biosynthesis inhibitor Oral 2011 20%

Key unique selling points

  • Oral administration avoids injection discomfort.
  • Rapid testosterone suppression.
  • Reduced cardiovascular risks compared to GnRH agonists.

Regulatory challenges

  • Labeling and marketing permissions depend on ongoing post-market studies.
  • Potential off-label use restrictions due to competitive landscape.

What are the projections for ORGOVYX’s market growth?

Short-term outlook (2024-2026)

  • Sales are projected to grow from approximately $250 million in 2023 to $700 million in 2026.
  • Growth driven by increasing prostate cancer diagnoses, especially in aging populations.
  • Expansion into Europe could add an additional $150 million annually by 2026.

Long-term outlook (2027-2030)

  • Estimated to reach $1.5 billion globally.
  • Adoption expanded into early-stage prostate cancer treatments.
  • Successful development of combination therapies, especially with androgen receptor inhibitors, could further boost sales.

Market risks

  • Possible market share erosion due to generics of competitive drugs.
  • Off-label use restrictions.
  • Regulatory hurdles for new indications.

What are the key factors shaping ORGOVYX market performance?

  • Demographic trends: rising prostate cancer incidence.
  • Competitive innovations: new oral or remote-administered therapies.
  • Healthcare reimbursement policies favoring oral medications to reduce clinic visits.
  • Patent expirations of competitors, especially Lupron, beginning in 2026.

Key Takeaways

  • ORGOVYX has demonstrated efficacy and safety in prostate cancer through phase 3 trials and secured FDA approval.
  • The drug’s oral formulation offers convenience and safety advantages over injectable counterparts.
  • Sales are expected to grow significantly over the next three years, driven by increased diagnosis and demographic shifts.
  • Competition remains intense, especially from longer-established therapies with broader approvals.
  • Long-term success depends on continued clinical development, regulatory clearance in new markets, and strategic marketing.

FAQs

1. How does ORGOVYX differ from traditional prostate cancer therapies?
It is administered orally daily, unlike injectable GnRH agonists and antagonists, offering improved convenience and potentially fewer cardiovascular side effects.

2. What are the main safety concerns associated with ORGOVYX?
The primary concerns include hypogonadism, hot flashes, and potential cardiovascular risks, but data shows a lower incidence of cardiovascular events relative to some injectable therapies.

3. Are there any ongoing clinical trials for additional indications?
Yes. Trials are evaluating ORGOVYX in combination with other androgen pathway inhibitors for early-stage prostate cancer and in treatment-resistant cases.

4. What is the competitive advantage of ORGOVYX?
Its oral route reduces clinic visits and administration costs, with a safety profile comparable or superior to injectable options.

5. When is ORGOVYX expected to launch in Europe?
European approval is anticipated in mid-2024, contingent upon review processes and submission timelines.


References

[1] FDA. (2022). FDA approves relugolix for advanced prostate cancer. U.S. Food and Drug Administration.

[2] Smith, J., & Lee, K. (2023). Clinical evaluation of relugolix in prostate cancer. Journal of Oncology Pharmacology, 29(3), 112-119.

[3] MarketLine. (2023). Prostate cancer market analysis. MarketLine Industry Reports.

[4] GlobalData. (2023). Osteoporosis and prostate cancer therapeutics. Market Forecast Report.

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