{{cs1 config|name-list-style=vanc|display-authors=6}} {{Infobox drug | drug_name = | image = Refisolone.svg | image_class = skin-invert-image | width = 250px | caption =
<!-- Clinical data --> | pronounce = | tradename = | Drugs.com = | MedlinePlus = | licence_CA = | licence_EU = | DailyMedID = | licence_US = | pregnancy_AU = | pregnancy_category = | dependency_liability = | addiction_liability = | routes_of_administration = Intranasal (nasal spray)<ref name="AdisInsight" /><ref name="AdisInsight-2" /><ref name="Ozmosi" /> | class = Vomeropherine | ATC_prefix = | ATC_suffix =
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<!-- Pharmacokinetic data --> | bioavailability = | protein_bound = | metabolism = | metabolites = | onset = | elimination_half-life = | duration_of_action = | excretion =
<!-- Identifiers --> | CAS_number = 202718-04-5 | CAS_supplemental = | PubChem = 21968346 | PubChemSubstance = | IUPHAR_ligand = | DrugBank = | ChemSpiderID = | UNII = 2QA794326X | KEGG = | ChEBI = | ChEMBL = | NIAID_ChemDB = | PDB_ligand = | synonyms = 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
<!-- Chemical data --> | IUPAC_name = (1''S'',2''S'',4''R'',6''S'',7''S'',10''S'',11''S'')-11-hydroxy-7-methyl-5-oxapentacyclo[8.8.0.0<sup>2,7</sup>.0<sup>4,6</sup>.0<sup>11,16</sup>]octadec-15-en-14-one | C=18 | H=24 | O=3 | SMILES = C[C@]12CC[C@H]3[C@H]([C@@H]1C[C@@H]4[C@H]2O4)CCC5=CC(=O)CC[C@]35O | StdInChI = 1S/C18H24O3/c1-17-6-5-13-12(14(17)9-15-16(17)21-15)3-2-10-8-11(19)4-7-18(10,13)20/h8,12-16,20H,2-7,9H2,1H3/t12-,13+,14+,15-,16-,17+,18-/m1/s1 | StdInChIKey = WLYKLZRFENOYIA-QQNKPZKVSA-N }}
'''Refisolone''' ({{Abbrlink|INN|International Nonproprietary Name}}, {{Abbrlink|USAN|United States Adopted Name}}; 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).<ref name="AdisInsight">{{cite web | title = VistaGen Therapeutics | date = 2 December 2025 | work = AdisInsight | publisher = Springer Nature Switzerland AG | url = https://adisinsight.springer.com/drugs/800011065 | access-date = 9 March 2026 }}</ref><ref name="AdisInsight-2">{{cite web | title = Pherin Pharmaceuticals | date = 28 July 2024 | work = AdisInsight | publisher = Springer Nature Switzerland AG | url = https://adisinsight.springer.com/drugs/800043365 | access-date = 9 March 2026 }}</ref><ref name="Synapse">{{cite web | title = Delving into the Latest Updates on Refisolone | date = 28 February 2026 | work = Synapse | publisher = PatSnap | url = https://synapse.patsnap.com/drug/7af4c521c629496ebb00cbf00096bc67 | access-date = 9 March 2026 }}</ref><ref name="Ozmosi">{{cite web | title = PH-80 Drug Profile | website = Ozmosi | url = https://pryzm.ozmosi.com/product/18624 | access-date = 9 March 2026 }}</ref> It is taken intranasally as a nasal spray.<ref name="AdisInsight" /><ref name="AdisInsight-2" /><ref name="Ozmosi" /> The pharmacology of refisolone has been studied and reported.<ref name="Monti_2025">{{cite conference | vauthors = Monti L, Baker RA, Hanover R | title = Refisolone PH80 Nasal Spray Effects on In Vitro Receptor Binding, Reproductive Organs in Mice, and Pharmacokinetic Profile in Humans. | date = 25 November 2025 | conference = The Menopause Society 2025 Annual Meeting. | url = https://www.vistagen.com/static-files/0a5a2149-62d1-42db-89f4-7e9a3dfb812e }}</ref><ref name="Monti_2025a">{{cite conference | vauthors = Monti L, Baker RA, Hanover R | title = Refisolone PH80 Nasal Spray Effects on Brain and Autonomic Activity: A Novel, Investigational, Rapid-Onset Non-Hormonal Treatment for Vasomotor Symptoms Due to Menopause. | date = 25 November 2025 | conference = The Menopause Society 2025 Annual Meeting. | url = https://www.vistagen.com/static-files/2d811630-b66b-45fa-b6da-ba6efacf0619 }}</ref> The drug is under development by Pherin Pharmaceuticals and VistaGen Therapeutics, with the former having been acquired by the latter in 2023.<ref name="AdisInsight" /><ref name="AdisInsight-2" /><ref name="Synapse" /><ref name="Ozmosi" /> As of December 2025, refisolone is in phase 2 clinical trials for all indications.<ref name="AdisInsight" /><ref name="Synapse" /> 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.<ref name="Ozmosi" /><ref name="NCT01217775">{{ClinicalTrialsGov|NCT01217775|Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder (PH80-PMD)}}</ref>
==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== {{Reflist}}
==External links== * [https://www.vistagen.com/ph80-overview Refisolone (PH80) - Vistagen Therapeutics]
{{Pheromones and pherines}}
Category:Alcohols Category:Estranes Category:Experimental drugs Category:Ketones Category:Pherines Category:Epoxides Category:Heterocyclic compounds with 5 rings
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