NDAORALTABLETPriority Review
Approved
Dec 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
6/8 — Strong
Priority Review
ORGOVYX (relugolix) by Sumitomo Dainippon Pharma is gonadotropin releasing hormone receptor antagonists [moa]. Approved for prostate cancer. First approved in 2020.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORGOVYX (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA on December 18, 2020. It represents a novel mechanism of action in the GnRH antagonist class, offering an oral alternative to injectable therapies. The product is indicated for conditions requiring testosterone suppression, providing rapid onset of action without the initial testosterone surge associated with GnRH agonists. ORGOVYX addresses an unmet need in patient convenience and treatment adherence through its oral tablet formulation.
$0.3BPart D
11.4 years to LOEMechanism of Action
Gonadotropin Releasing Hormone Receptor Antagonists
Pharmacologic Class:
Gonadotropin Releasing Hormone Receptor Antagonist
Indications (1)
Clinical Trials (12)
REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial
Started Jan 2025
72 enrolled
Recurrent Prostate CarcinomaStage III Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8
Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
Started Dec 2024
46 enrolled
Androgen Deprivation TherapyLocally Advanced Prostate Cancer
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
Started Dec 2024
33 enrolled
Prostate CancerAdvanced Prostate CancerHormone Sensitive Prostate Cancer
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
Started Oct 2024
30 enrolled
Prostate CAProstate Cancer (Adenocarcinoma)Prostate Cancer Surgery
Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer
Started Aug 2024
70 enrolled
Prostate AdenocarcinomaStage IIB Prostate Cancer AJCC v8Stage IIC Prostate Cancer AJCC v8
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.