Drugs / PH80
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01217775 | Mar 2016 → Mar 2017 | premenstrual dysphoric disorder | Pherin Pharmaceuticals, Inc. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-04-22 | VistaGen Therapeutics, Inc. | Regulatory Vistagen Receives FDA “Study May Proceed” Letter Under its Refisolone IND Application, Enabling Further Phase 2 Clinical Development for the Treatment of Vasomotor Symptoms (Hot Flashes) due to Menopause vistagen.com ↗ |
| 2025-11-26 | VistaGen Therapeutics, Inc. | Results Vistagen Reports Findings on PH80’s Brain and Autonomic Effects in Women with Menopausal Hot Flashes at The Menopause Society 2025 Annual Meeting vistagen.com ↗
These findings demonstrate PH80’s potential as a rapidly-acting pherine product candidate for treating vasomotor symptoms (hot flashes) due to menopause. |
| 2024-07-09 | VistaGen Therapeutics, Inc. | Regulatory Vistagen Broadens PH80 Global Intellectual Property Portfolio with New Patents for the Treatment of Migraine vistagen.com ↗
today announced the broadening of its global intellectual property portfolio after receiving multiple new patents related to the use of PH80 for the treatment of migraine. |
| 2023-11-07 | VistaGen Therapeutics, Inc. | Results Vistagen to Present Positive Fasedienol Phase 3 Data and Positive PH80 Phase 2A Data at Upcoming Scientific Conferences vistagen.com ↗
PH80 data demonstrating statistically significant reduction in the number of hot flashes compared to placebo (p<.001) after four weeks of treatment in women diagnosed with vasomotor symptoms (hot flashes) due to menopause. |
| 2023-09-12 | VistaGen Therapeutics, Inc. | Results Vistagen Announces Positive Results from Exploratory Phase 2A Study of PH80 for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder vistagen.com ↗
PH80 nasal spray demonstrated statistically and clinically significant improvement versus placebo in an exploratory double-blind, placebo-controlled Phase 2A study (n=52) in subjects with a history of premenstrual dysphoric disorder (PMDD) |
| 2023-06-07 | VistaGen Therapeutics, Inc. | Results Vistagen Announces Positive Results from Exploratory Phase 2A Study of PH80 in Women Diagnosed with Menopausal Hot Flashes vistagen.com ↗
PH80 was well-tolerated with no serious adverse events, and the adverse event profiles were comparable between PH80 and placebo. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PH80 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01217775 ↗ |
| Action | Activate | “Pherines such as PH80 are thought to exert their activity by rapid stimulation of the hypothalamus” NCT01217775 ↗ |
| Modality | Other / unclassified | “PH80 is a pherine shown to bind to a subset of peripheral receptors in nasal chemosensory neurons.” NCT01217775 ↗ |