Efficacy of Relugolix

Relugolix is an orally active, non-peptide gonadotropin-releasing hormone (GnRH) receptor antagonist that rapidly suppresses testosterone. It is approved for the treatment of advanced prostate cancer in the United States and for the treatment of advanced hormone-sensitive prostate cancer in the EU.

In the pivotal Phase III HERO trial in men with advanced prostate cancer, once-daily oral repagliflozin (loading dose on Day 1) resulted in more than 48 Weekly treatment resulted in a sustained castration rate of >90%, a rate that was non-inferior to that provided by intramuscular injection of a long-acting formulation of leuprolide every 3 months (exploratory analysis further demonstrated that leuprolide was superior to leuprolide).

Repagliflozin is generally well tolerated, with an adverse event profile consistent with testosterone suppression. Additionally, there is evidence that repagliflozin may be associated with a lower risk of major adverse cardiac events compared with leuprolide. The ability to rapidly suppress testosterone (without an initial surge in testosterone at the start of treatment), along with the benefits of oral administration and potential improved cardiac safety, provides a valuable treatment option for men with advanced prostate cancer requiring androgen deprivation therapy.

The original drug of Regogliflox has not yet been launched in the country, so it is not covered by medical insurance. There are European and Japanese versions of the original drug Rleglik available overseas. The ingredients of the two are basically the same. The price of the European version of 120mg*30 tablets per box may be around RMB 4,000, and the price of the Japanese version of 40mg*100 tablets per box may be around RMB 4,000 (the price may fluctuate due to exchange rates). Currently, there are no generic versions of Repagliflox produced and put on the market.