NDAORALTABLETPriority Review
Approved
Dec 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
5/8 — Partial
Priority Review
ORGOVYX (relugolix) by Sumitomo Dainippon Pharma is gonadotropin releasing hormone receptor antagonists [moa]. First approved in 2020.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORGOVYX (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved in December 2020 for advanced prostate cancer. It works by blocking GnRH receptors to suppress testosterone production, a key driver of prostate cancer growth. This oral formulation represents a significant advance over injectable GnRH agonists by offering rapid testosterone suppression without an initial flare.
$0.277BPart D
Peak11.3 years to LOEProduct is in peak commercial phase with $277M in Part D spending (2023), indicating a mature, profitable franchise with established sales infrastructure and stable team requirements.
Mechanism of Action
Gonadotropin Releasing Hormone Receptor Antagonists
Pharmacologic Class:
Gonadotropin Releasing Hormone Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.