EST-001

EST-001 is a clinical-stage topical formulation of estradiol developed by Estrenue for the treatment of facial skin aging. It utilizes Estrenue's proprietary Foroderm platform, which consists of elongated silicon-based microparticles applied via a microtextured applicator to deliver the active hormone directly into the viable epidermis. This localized delivery system is designed to produce targeted hormonal effects in facial skin while minimizing systemic exposure, maintaining serum estradiol levels within the post-menopausal range. EST-001 is being developed under the FDA's 505(b)(2) regulatory pathway, bridging to the established safety and pharmacokinetic profiles of approved topical estradiol products.