Kissei Pharmaceutical’s Linzagolix approved in Taiwan for uterine fibroids

Kissei Pharmaceutical announced its GnRH antagonist, Linzagolix, has received marketing approval from the Taiwan Food and Drug Administration (TFDA) under the brand name "Yselty" for uterine fibroids. This approval follows a November 2022 licensing agreement with Synmosa Biopharma Corporation, granting them development and marketing rights for Linzagolix in Taiwan. Linzagolix, an orally administered GnRH antagonist, is designed to reduce estrogen production, thereby improving symptoms of uterine fibroids and endometriosis.

In Japan, Kissei Pharmaceutical has a new drug application for Linzagolix for uterine fibroids under regulatory review, and a Phase III clinical trial for endometriosis is ongoing. Overseas, Theramex (UK) launched Yselty for uterine fibroids in Europe in September 2024 and received approval for an additional endometriosis indication from the European Medicines Agency (EMA) in November of the same year.

Development efforts are also underway in South Korea and Canada through other partners. This latest approval in Taiwan is expected to provide a new treatment option for patients with uterine fibroids. Its financial impact has already been incorporated into Kissei Pharmaceutical’s consolidated earnings forecast for the fiscal year ending March 31, 2026.