Drugs / Fasedienol
Fasedienol
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06809179 | Jan 2025 → Apr 2026 overdue | social phobia | VistaGen Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04404192 | Oct 2021 → Dec 2022 | adjustment disorder | VistaGen Therapeutics, Inc. | Completed | Missed primary |
| Phase 2 | NCT01217788 | Feb 2008 → Feb 2011 | social phobia | Pherin Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 36 trials · 2 met primary · 3 missed | ||||||
| Phase 3 | NCT06615557 | Sep 2024 → Apr 2026 overdue | social phobia | VistaGen Therapeutics, Inc. | Active not recruiting | Missed primary |
| Phase 3 | NCT06358651 | Mar 2024 → Oct 2025 overdue | social phobia | VistaGen Therapeutics, Inc. | Active not recruiting | Missed primary |
| Phase 3 | NCT05030350 | Oct 2021 → Sep 2022 | social phobia | VistaGen Therapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05011396 | Aug 2021 → Aug 2022 | social phobia | VistaGen Therapeutics, Inc. | Terminated | Met primary Stop: Business |
| Phase 3 | NCT04754802 | May 2021 → Jun 2022 | social phobia | VistaGen Therapeutics, Inc. | Completed | Missed primary |
| Phase 3 | NCT02622958 | Mar → Oct 2014 | social phobia | Pherin Pharmaceuticals, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2026-09-10 | VistaGen Therapeutics, Inc. | Results Vistagen to Present at Psych Congress 2026 vistagen.com ↗
Poster presentation highlights positive efficacy signal for fasedienol nasal spray in study participants with very severe social anxiety disorder |
| 2026-08-14 | VistaGen Therapeutics, Inc. | Results Vistagen Reports Fiscal Year 2027 First Quarter Financial Results and Corporate Update vistagen.com ↗
Announced preliminary data from the open label extension (OLE) portion of PALISADE-3. |
| 2026-08-06 | VistaGen Therapeutics, Inc. | Results Vistagen Announces Topline Results for Repeat Dose Study of Fasedienol for Acute Treatment of Social Anxiety Disorder vistagen.com ↗
today announced the topline results of its exploratory Phase 2 repeat dose study evaluating fasedienol nasal spray in adult subjects with social anxiety disorder. |
| 2026-06-30 | VistaGen Therapeutics, Inc. | Results Vistagen Announces Topline and Post-Hoc Data from PALISADE-4 Phase 3 Public Speaking Challenge Trial of Fasedienol for the Acute Treatment of Social Anxiety Disorder vistagen.com ↗
Fasedienol did not achieve statistically significant improvement on primary and secondary endpoints |
| 2026-05-12 | VistaGen Therapeutics, Inc. | Results Vistagen Announces Preliminary Positive Data in Ongoing Open-Label Extension Portion of PALISADE-3 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder vistagen.com ↗ |
| 2025-12-17 | VistaGen Therapeutics, Inc. | Results Vistagen Announces Topline Results from PALISADE-3 Phase 3 Public Speaking Challenge Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder vistagen.com ↗ |
| 2025-04-17 | VistaGen Therapeutics, Inc. | Results Vistagen Presents New Research on the Impact of Social Anxiety Disorder at The Anxiety and Depression Association 2025 Conference vistagen.com ↗
Vistagen (Nasdaq: VTGN), a clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, presented new data on social anxiety disorder (SAD) at the 2025 Anxiety and Depression Association of America (ADAA) Conference in Las Vegas, Nevada . |
| 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 ↗
Fasedienol data demonstrating statistically significant rapid-onset reduction in patient-reported Subjective Units of Distress Scale (SUDS) score compared to placebo in a public speaking challenge (primary endpoint, p=0.015) in adults diagnosed with social anxiety disorder (SAD). |
| 2023-08-07 | VistaGen Therapeutics, Inc. | Results Vistagen Announces Positive Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder vistagen.com ↗
The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015). |
| 2023-06-01 | VistaGen Therapeutics, Inc. | Results Vistagen Presents Fasedienol (PH94B) Safety and Exploratory Efficacy Data from Phase 3 Open-Label Social Anxiety Disorder Study at American Society for Clinical Psychopharmacology Annual Meeting vistagen.com ↗
Favorable long-term, open-label treatment data from nearly 500 patients in real-world setting suggest that patient-tailored, as-needed administrations of fasedienol over time were safe and well-tolerated |
| 2023-04-19 | VistaGen Therapeutics, Inc. | Results Vistagen Presents New Fasedienol (PH94B) Research at 2023 Anxiety and Depression Association of America Conference vistagen.com ↗
Findings from the study demonstrate local metabolism and clearance of fasedienol from the nasal passages. |
| 2023-03-22 | VistaGen Therapeutics, Inc. | Results Vistagen Announces Positive Data in Fasedienol (PH94B) Phase 3 Open-Label Study in Adults with Social Anxiety Disorder vistagen.com ↗
Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today announced positive data from its Phase 3 open-label study designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of fasedienol (PH94B) over time in adults with social anxiety disorder (SAD). |
| 2022-09-19 | VistaGen Therapeutics, Inc. | Results Vistagen Presents Poster at Psych Congress 2022 Highlighting Effect of PH94B on Nasal Electrogram Responses and Biomarkers of Autonomic Nervous System Activity in Healthy Human Subjects vistagen.com ↗
After receiving intranasal PH94B, subjects felt calmer and less tense per self-report, suggesting an anxiolytic effect, while steroid hormones or placebo had no such effect on the measured biological or behavioral parameters. |
| 2022-09-08 | VistaGen Therapeutics, Inc. | Results Vistagen to Proceed with PALISADE-2 Phase 3 Clinical Trial of PH94B in Social Anxiety Disorder following Interim Analysis vistagen.com ↗ |
| 2022-08-11 | VistaGen Therapeutics, Inc. | Results VistaGen Therapeutics Reports First Quarter Financial Results and Provides Corporate Update vistagen.com ↗
Preliminary data from nearly 200 subjects in the PALISADE open label safety study suggest that continued as-needed use of PH94B has potential to achieve cumulative functional improvement in the severity of social anxiety disorder (SAD) |
| 2022-07-22 | VistaGen Therapeutics, Inc. | Results VistaGen Announces Topline Results from PALISADE-1 Phase 3 Clinical Trial for Investigational Drug PH94B vistagen.com ↗
PH94B did not achieve its primary endpoint, as measured by change from baseline using the Subjective Units of Distress Scale (SUDS) compared to placebo. |
| 2022-05-05 | VistaGen Therapeutics, Inc. | Regulatory VistaGen Announces Key Regulatory Update on PH94B for the Acute Treatment of Social Anxiety Disorder vistagen.com ↗
The FDA agreed that data from nonclinical and clinical studies of PH94B completed to date provide no signal of abuse potential |
| 2022-04-21 | VistaGen Therapeutics, Inc. | Results VistaGen to Present Preclinical Data on Lead Candidate PH94B at Upcoming Scientific Congresses vistagen.com ↗
These preclinical data demonstrate that intranasal radiolabelled-PH94B is largely confined to the nasal passages where it stimulates chemosensory neurons located in the nasal epithelium. |
| 2022-04-13 | AffaMed Therapeutics Limited | Regulatory VistaGen and AffaMed Complete Key Regulatory Submissions for PALISADE Global Phase 3 Clinical Trial for PH94B affamed.com ↗
AffaMed’s recent receipt of regulatory clearance of its Clinical Trial Application (CTA) from the National Medical Products Administration (NMPA) in China |
| 2022-04-12 | VistaGen Therapeutics, Inc. | Regulatory VistaGen and AffaMed Complete Key Regulatory Submissions for PALISADE Global Phase 3 Clinical Trial for PH94B vistagen.com ↗
VistaGen Therapeutics, Inc. (Nasdaq: VTGN) (VistaGen) and AffaMed Therapeutics (AffaMed) today announced they have completed regulatory preparations to initiate PALISADE Global, a Phase 3 clinical trial to evaluate the efficacy, safety, and tolerability of VistaGen’s PH94B |
| 2021-10-05 | VistaGen Therapeutics, Inc. | Results VistaGen Therapeutics Reports New Preclinical Mechanism of Action Data Supporting PH94B’s Potential Anti-Anxiety Activity via Peripheral Nasal Neurons without Entry into the Brain vistagen.com ↗
No appreciable activity was observed in the brain. |
| 2021-03-22 | VistaGen Therapeutics, Inc. | Results VistaGen’s Poster Presentation at the Anxiety and Depression Association of America’s 2021 Annual Conference Differentiates PH94B’s Mechanism of Action from Highly-Addictive Benzodiazepines vistagen.com ↗ |
| 2020-11-12 | VistaGen Therapeutics, Inc. | Results VistaGen Reports Positive Preclinical Data Differentiating Mechanism of Action of PH94B from Risk-Ridden Benzodiazepines vistagen.com ↗
New electrophysiological data demonstrate that PH94B does not directly modulate GABA (gamma aminobutyric acid) receptors |
| 2019-12-10 | VistaGen Therapeutics, Inc. | Regulatory U.S. FDA Grants VistaGen Therapeutics Fast Track Designation for PH94B for Treatment of Social Anxiety Disorder vistagen.com ↗
VistaGen's PH94B is the first drug candidate to be granted U.S. FDA Fast Track designation for treatment of social anxiety disorder |
| 2019-04-01 | VistaGen Therapeutics, Inc. | Results Positive Pilot Phase 3 Data Position VistaGen's PH94B Neuroactive Nasal Spray for Pivotal Phase 3 Development as a Novel, As-Needed Treatment for Social Anxiety Disorder vistagen.com ↗
In the 22-patient, four-week, randomized, double blind, placebo-controlled pilot Phase 3 crossover study, subjects receiving PH94B had a significantly greater decrease in average peak Subjective Units of Distress scores compared to placebo within one week of treatment. |
All press releases naming this drug 46 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fasedienol | “acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social...” NCT06358651 ↗ |
| Known as | 4-androstadienol | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095042 ↗ |
| Known as | Aloradine | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095042 ↗ |
| Known as | Androsta-4,16-dien-3-ol, (3.beta.)- | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095042 ↗ |
| Known as | PH94B | “Fasedienol (PH94B) Nasal Spray” NCT06809179 ↗ |
| Modality | Small molecule | — CHEMBL5095042 ↗ |
| Route | Intranasal | “administered intranasally” NCT01217788 ↗ |