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  1. pharmadog
  2. ›drugs
  3. ›Orgovyx
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relugolix

Marketedupdated 3mo ago
by Sumitomo Pharma America Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • drugORGOVYX16 co-mentions · 4 sources
  • tagApproval16 co-mentions · 4 sources
  • tagSmall Molecule8 co-mentions · 4 sources

indications

investigational
Prostate Cancer

all catalysts(4)

approval · 4
Dec 18, 2020
approval
6y ago
ORGOVYX (RELUGOLIX) — FDA approval
relugolix
→
Mar 30, 2023
approval
3y ago
ORGOVYX (RELUGOLIX) — FDA approval
relugolix
→
Oct 18, 2024
approval
2y ago
ORGOVYX (RELUGOLIX) — FDA approval
relugolix
→
Oct 8, 2025
approval
11mo ago
ORGOVYX (RELUGOLIX) — FDA approval
relugolix
→

Trials studying relugolix

  • —A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYXcompletedn=999
  • phase3The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trialrecruitingn=110
  • phase2Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CTrecruitingn=50
  • phase2A 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 Metastasescompletedn=108
  • phase2Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancerrecruitingn=70
  • phase2Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)active not recruitingn=33
  • phase1Relugolix + Enzalutamide Study in High-Risk Prostate Cancerrecruitingn=46
  • phase3REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trialrecruitingn=72
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Jan 28, 2029
~2.4 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (11)

  • Sep 29, 2037method-of-use (U-3020)US 10449191
  • Sep 29, 2037method-of-use (U-3020)US 10786501
  • Sep 29, 2037method-of-use (U-3020)US 11583526
  • Sep 29, 2037method-of-use (U-3020)US 12097198
  • Sep 29, 2037method-of-use (U-4035)US 12144809
  • Sep 29, 2037method-of-use (U-3020)US 12336990
  • Feb 25, 2036formulationUS 10350170
  • Sep 27, 2033compositionUS 11795178
  • Sep 27, 2033compositionUS 12325714
  • Jan 28, 2029compositionUS 73009352.4y
  • Jan 28, 2026compositionUS 8058280

News(1)

  • REVELUTION-2 Trial Is Evaluating Cardiovascular Risk With Relugolix Plus Abiraterone Acetate in High-Risk Prostate Cancer
    Sagar A. Patel, MD, discusses the REVELUTION-2 trial evaluating cardiovascular safety with hormone therapy in prostate cancer.
    onclive · 3mo ago
brand
Orgovyx
generic
relugolix
indication
Prostate Cancer
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 7m ago
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