Chemistry:Refisolone
Refisolone (INN, USAN; developmental code names PH-80, Salubrin, and ORG-39479), also known as 10-hydroxy-16α,17α-epoxyestr-4-en-3-one, is a vomeropherine (pherine) which is under development for the treatment of hot flashes, migraine, and premenstrual dysphoric disorder (PMDD).[1][2][3][4] It is taken intranasally as a nasal spray.[1][2][4] The pharmacology of refisolone has been studied and reported.[5][6] The drug is under development by Pherin Pharmaceuticals and VistaGen Therapeutics, with the former having been acquired by the latter in 2023.[1][2][3][4] As of December 2025, refisolone is in phase 2 clinical trials for all indications.[1][3] However, a phase 3 trial of refisolone for PMDD is also reported to have been registered in 2015, though its status is listed as unknown.[4][7]
See also
- List of neurosteroids § Pheromones and pherines
- List of investigational sex-hormonal agents
- List of investigational PMS/PMDD drugs
- List of investigational headache and migraine drugs
- Fasedienol (PH94B; Aloradine)
- Itruvone (PH10)
References
- ↑ 1.0 1.1 1.2 1.3 "VistaGen Therapeutics". AdisInsight. Springer Nature Switzerland AG. 2 December 2025. https://adisinsight.springer.com/drugs/800011065.
- ↑ 2.0 2.1 2.2 "Pherin Pharmaceuticals". AdisInsight. Springer Nature Switzerland AG. 28 July 2024. https://adisinsight.springer.com/drugs/800043365.
- ↑ 3.0 3.1 3.2 "Delving into the Latest Updates on Refisolone". Synapse. PatSnap. 28 February 2026. https://synapse.patsnap.com/drug/7af4c521c629496ebb00cbf00096bc67.
- ↑ 4.0 4.1 4.2 4.3 "PH-80 Drug Profile". https://pryzm.ozmosi.com/product/18624.
- ↑ "Refisolone PH80 Nasal Spray Effects on In Vitro Receptor Binding, Reproductive Organs in Mice, and Pharmacokinetic Profile in Humans.". The Menopause Society 2025 Annual Meeting.. 25 November 2025. https://www.vistagen.com/static-files/0a5a2149-62d1-42db-89f4-7e9a3dfb812e.
- ↑ "Refisolone PH80 Nasal Spray Effects on Brain and Autonomic Activity: A Novel, Investigational, Rapid-Onset Non-Hormonal Treatment for Vasomotor Symptoms Due to Menopause.". The Menopause Society 2025 Annual Meeting.. 25 November 2025. https://www.vistagen.com/static-files/2d811630-b66b-45fa-b6da-ba6efacf0619.
- ↑ Clinical trial number NCT01217775 for "Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder (PH80-PMD)" at ClinicalTrials.gov
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