Drug Profile

Refisolone - VistaGen Therapeutics

Alternative Names: ORG 39479; PH-80; PH-80-M; PH80-PMD NS

Latest Information Update: 26 Jun 2026

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At a glance

Originator Pherin Pharmaceuticals
Developer Pherin Pharmaceuticals; VistaGen Therapeutics
Class Antidepressants; Antimigraines; Steroids
Mechanism of Action Neurotransmitter receptor modulators

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes
Available For Licensing Yes

Highest Development Phases

Phase II Hot flashes; Migraine; Premenstrual dysphoric disorder

Most Recent Events

15 Jun 2026 The US FDA approves IND application for Refisolone in Hot flash
12 Feb 2026 VistaGen Therapeutics completes a phase IIa trial in Hot flashes in Mexico
26 Nov 2025 Pharmacodynamics data from a preclinical trial released by VistaGen Therapeutics

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