Refisolone

Refisolone
Clinical data
Other namesPH-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 classVomeropherine
Identifiers
  • (1S,2S,4R,6S,7S,10S,11S)-11-hydroxy-7-methyl-5-oxapentacyclo[8.8.0.02,7.04,6.011,16]octadec-15-en-14-one
CAS Number
PubChem CID
UNII
Chemical and physical data
FormulaC18H24O3
Molar mass288.387 g·mol−1
3D model (JSmol)
  • C[C@]12CC[C@H]3[C@H]([C@@H]1C[C@@H]4[C@H]2O4)CCC5=CC(=O)CC[C@]35O
  • InChI=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
  • Key:WLYKLZRFENOYIA-QQNKPZKVSA-N

Refisolone (INNTooltip International Nonproprietary Name, USANTooltip 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).[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

References

  1. ^ a b c d e "VistaGen Therapeutics". AdisInsight. Springer Nature Switzerland AG. 2 December 2025. Retrieved 9 March 2026.
  2. ^ a b c d "Pherin Pharmaceuticals". AdisInsight. Springer Nature Switzerland AG. 28 July 2024. Retrieved 9 March 2026.
  3. ^ a b c d e "PH-80 Drug Profile". Ozmosi. Retrieved 9 March 2026.
  4. ^ a b c "Delving into the Latest Updates on Refisolone". Synapse. PatSnap. 28 February 2026. Retrieved 9 March 2026.
  5. ^ 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.
  6. ^ 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.
  7. ^ 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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