Daewon Pharmaceutical's Merigolix Proven Effective for Treating Uterine Fibroids and Endometriosis

Improvement in Excessive Menstrual Bleeding Demonstrated in Domestic Phase 2 Trial

Daewon Pharmaceutical announced on May 7 that "Merigolix (DW-4902)," for which it acquired domestic development rights from TiumBio, achieved its primary endpoint of "reduction in excessive menstrual bleeding" in a domestic Phase 2 clinical trial for uterine fibroids.

Merigolix is an oral gonadotropin-releasing hormone (GnRH) antagonist. Unlike existing GnRH agonists, it does not cause a rapid surge in hormone levels at the start of administration, while still delivering rapid effects in a short period. Additionally, whereas GnRH agonists are mainly administered via injection, which poses challenges for patient convenience and treatment adherence, Merigolix is administered orally, improving patient convenience.

It also has a mechanism of action that allows it to be used in various conditions related to female hormones, such as endometriosis, uterine fibroids, assisted reproductive technology (ART), and precocious puberty. Previously, in a Phase 2 clinical trial for endometriosis conducted in Europe, Merigolix demonstrated significant therapeutic efficacy and safety, confirming its potential as a new drug candidate.

In this domestic Phase 2 trial involving 71 patients with uterine fibroids, patients were randomly assigned to four groups: high dose, medium dose, low dose, and placebo. They took the medication orally once daily for 12 weeks, followed by a 12-week observation period. The results showed that all dosage groups experienced a statistically significant improvement in menorrhagia compared to the placebo group. Secondary endpoints, such as reduction in fibroid size, increase in hemoglobin levels (improvement in anemia), and reduction in pain, also showed clear improvement.

Baek Inhwan, CEO of Daewon Pharmaceutical, stated, "Uterine fibroids are a disease that causes significant suffering for many women. We expect Merigolix, as an oral therapy, to become an important new drug for this condition." Kim Huntaek, CEO of TiumBio, said, "Merigolix has demonstrated excellent therapeutic effects not only in endometriosis but also in uterine fibroids. Having secured efficacy and safety in Phase 2, which is considered the most challenging clinical trial phase, we plan to expand development into the global uterine fibroid treatment market."

Uterine fibroids are benign tumors that develop in the uterus, primarily affecting women in their 30s and older, with a high incidence rate of about 20% among women over the age of 35. The most common symptom is excessive menstrual bleeding, but abnormal uterine bleeding, pelvic pain, and anemia may also occur. According to market research firm Global Market Insights, the global uterine fibroid treatment market is projected to grow from 2.5 trillion KRW in 2022 to 6.6 trillion KRW by 2032.