Yselty (linzagolix) demonstrates positive results in two Phase III trials for Uterine Fibroids

Linzagolix, a novel, once-a-day, oral GnRH receptor antagonist was reported to significantly decrease menstrual blood loss vs. placebo at 52 weeks; responder rates for women receiving 200 mg with ‘Add Back Therapy’ (1 mg estradiol and 0.5 mg norethindrone daily) were 91.6 %.

SPS commentary:

The company states it is planning regulatory submissions to the U.S. FDA in the first half of 2021 and to the European medicines Agency in the fourth quarter of 2020.


Biospace Inc.