VistaGen disclosed on November 26 that it had presented exploratory data on its intranasal pherine candidate PH80 at the Menopause Society Annual Meeting in Orlando, Florida, held from October 21‑25, 2025. The presentation, delivered on October 23, highlighted PH80’s potential as a rapidly‑acting, non‑hormonal treatment for vasomotor symptoms such as hot flashes in menopausal women.
The data showed that PH80 produces effects within seconds, reduces autonomic nervous system activity, and is not absorbed into the bloodstream. In addition, PH80 does not bind to steroid hormone or neurotransmitter receptors and has no observable effects on reproductive organs in pre‑clinical studies. The compound also dose‑dependently depolarizes nasal chemosensory receptors, supporting its mechanism of action through nasal‑to‑brain signaling.
These findings stem from exploratory studies conducted by Pherin Pharmaceuticals between 1995 and 2000. VistaGen acquired Pherin in 2023, gaining access to the historical data. PH80 has also demonstrated positive results in a Phase 2A study for the acute management of premenstrual dysphoric disorder, underscoring its broader therapeutic potential.
PH80 is part of VistaGen’s pherine platform, which targets central nervous system disorders and women’s health conditions. Successful development of PH80 would diversify the company’s revenue base beyond its flagship fasedienol (PH94B) program for social anxiety disorder, reducing concentration risk and expanding VistaGen’s product portfolio.
The competitive landscape for menopausal symptom therapies includes hormone replacement therapy, selective estrogen receptor modulators, and non‑hormonal agents such as gabapentin. PH80’s rapid onset and non‑systemic profile could address an unmet need for patients seeking non‑hormonal options, positioning VistaGen as a potential challenger in this space.
Senior Vice President Louis Monti emphasized that the data reinforce PH80’s unique mechanism and support continued investment in the pherine platform. He noted that the presentation will inform the next steps toward clinical trials and regulatory submissions.
While no financial figures are disclosed, the milestone signals progress toward future revenue streams. VistaGen’s liquidity remains strong, with cash reserves exceeding debt, enabling the company to fund further development of PH80 and other pipeline assets.
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