Relugolix

(Orgovyx®)

Orgovyx®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 120 mg)
Drug ClassGonadotropin-releasing hormone (GnRH) receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with advanced prostate cancer.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Relugolix demonstrated comparable effectiveness to degarelix in achieving 12-month castration rates (relative risk (RR) 1.09, 95% credible interval (CrI): 0.95-1.23), with subgroup analysis showing that degarelix at 480 mg was associated with a significantly lower castration rate (RR 0.46, 95% Crl: 0.07-0.92).
  • In prostate cancer patients, relugolix ranked as the best treatment option among Catechol-O-Methyltransferase (COMT) inhibitors for increasing total On-State (ON)-time, with a significant reduction in Off-State (OFF)-time (49.91 min, 95% confidence interval (CI): -71.39 to -28.43), and a notable levodopa dose reduction compared to placebo.
  • Relugolix and degarelix were associated with similar rates of all adverse events (AEs) (RR 0.99, 95% CrI: 0.6-1.6 for relugolix; RR 1.1, 95% CrI: 0.75-1.35 for degarelix) and serious adverse events (SAEs) (RR 0.72, 95% CrI: 0.4-1.3 for relugolix; RR 1.05, 95% CrI: 0.42-2.6 for degarelix).
  • Relugolix demonstrated a lower risk of cardiovascular events (RR 0.44, 95% CrI: 0.16-1.2) compared to GnRH agonists, with no injection site reactions due to its oral formulation, a notable difference from degarelix, which can cause injection site reactions.
  • The studies primarily focused on men with advanced prostate cancer. Both relugolix and degarelix demonstrated comparable effectiveness overall, with specific attention to improved cardiovascular safety in these populations when compared to GnRH agonists.

Product Monograph / Prescribing Information

Document TitleYearSource
Orgovyx (relugolix) Prescribing Information.2023Sumitomo Pharma America, Inc., Marlborough, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines