EX404

**EX404** is a proprietary effervescent oral solution formulation of **metformin** developed by EffRx Pharmaceuticals for the treatment of **pediatric polycystic ovary syndrome (PCOS)**, also known as Stein-Leventhal syndrome, a disorder characterized by chronic anovulation, hyperandrogenism, and hormonal imbalance involving elevated androgens and insulin. The formulation is designed to be age-appropriate for children and adolescents, addressing unmet needs in this population where early intervention can mitigate symptoms like menstrual dysfunction, acne, hirsutism, obesity, infertility, and risks for type 2 diabetes and metabolic syndrome. It received **FDA orphan drug designation** and was part of the EU FP7 METFIZZ project, which demonstrated stability up to 24 months but was ultimately discontinued due to commercial viability challenges in Europe and regulatory hurdles for US approval.[1][3][5][11]

Other names

EX 404EX404EX-404