Yiling Pharmaceutical Secures NMPA Approval for Phase I Study of G201-Na in Premenopausal Women

China-based Yiling Pharmaceutical Co., Ltd (SHE: 002603) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a single-center, randomized, double-blind, placebo-controlled Phase I clinical study. This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of G201-Na in premenopausal healthy adult women.

G201-Na: A Novel GnRH Receptor Antagonist

G201-Na is classified as a Category 1 chemical drug and functions as a small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist. By competitively binding to the pituitary GnRH receptor, it inhibits the pituitary gonadal axis, leading to a reduction in the production and release of endogenous luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This mechanism effectively lowers estrogen levels, positioning G201-Na as a potential treatment for estrogen-dependent diseases, particularly targeting uterine myomas.

Strategic Implications for Yiling Pharmaceutical

The initiation of this Phase I study marks a significant milestone for Yiling Pharmaceutical as it seeks to expand its portfolio in women’s health. With a focus on addressing conditions related to estrogen dependency, the company aims to leverage its innovative therapies to meet the growing demand for effective treatments in this area.-Fineline Info & Tech

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