refisolone

Refisolone (formerly PH80) is a non-hormonal, non-systemic pherine drug candidate being developed by VistaGen Therapeutics for the treatment of women's health disorders, specifically moderate to severe vasomotor symptoms (hot flashes) associated with menopause and premenstrual dysphoric disorder (PMDD). As a pherine, refisolone is designed for intranasal administration, where it binds to peripheral receptors in the nasal chemosensory system. This binding modulates the hypothalamic-pituitary-gonadal axis and the autonomic nervous system without requiring systemic absorption or direct binding to neuronal receptors in the brain. The drug has completed positive Phase 2A clinical trials in Mexico, which demonstrated statistically significant reductions in the frequency and severity of hot flashes compared to placebo. VistaGen plans to advance the candidate into further Phase 2 clinical development in the United States following an IND submission planned for the first half of 2026.

Other names

ph80ph-80ph 80