Refisolone
| Clinical data | |
|---|---|
| Other names | PH-80; PH80; PH-80-M; PH80-M; PH80M; PH80-PMD NS; PH80-HF; PH80-HF NS; Salubrin; Salubrin HF; ORG-39479; ORG39479; 10-Hydroxy-16α,17α-epoxyestr-4-en-3-one; 16α,17α-Epoxyestr-4-en-10-ol-3-one |
| Routes of administration | Intranasal (nasal spray)[1][2][3] |
| Drug class | Vomeropherine |
| Identifiers | |
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| CAS Number | |
| PubChem CID | |
| UNII | |
| Chemical and physical data | |
| Formula | C18H24O3 |
| Molar mass | 288.387 g·mol−1 |
| 3D model (JSmol) | |
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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][4][3] It is taken intranasally as a nasal spray.[1][2][3] 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][4][3] As of December 2025, refisolone is in phase 2 clinical trials for all indications.[1][4] 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.[3][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
- ^ a b c d e "VistaGen Therapeutics". AdisInsight. Springer Nature Switzerland AG. 2 December 2025. Retrieved 9 March 2026.
- ^ a b c d "Pherin Pharmaceuticals". AdisInsight. Springer Nature Switzerland AG. 28 July 2024. Retrieved 9 March 2026.
- ^ a b c d e "PH-80 Drug Profile". Ozmosi. Retrieved 9 March 2026.
- ^ a b c "Delving into the Latest Updates on Refisolone". Synapse. PatSnap. 28 February 2026. Retrieved 9 March 2026.
- ^ Monti L, Baker RA, Hanover R (25 November 2025). 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.
- ^ Monti L, Baker RA, Hanover R (25 November 2025). 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.
- ^ Clinical trial number NCT01217775 for "Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder (PH80-PMD)" at ClinicalTrials.gov
External links
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