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Also known as Fasedienol Nasal Spray
Fasedienol · 2 trials · 2 indications
The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt).
| Arm | Type | Description |
|---|---|---|
| Fasedienol Nasal Spray | EXPERIMENTAL | - |
| Placebo Nasal Spray | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Fasedienol Nasal Spray | DRUG | Nasal spray delivered 20 minutes before the PSC |
| Placebo Nasal Spray | DRUG | Nasal spray delivered 20 minutes before the PSC |
Inclusion Criteria: * Written informed consent provided prior to conducting any study-specific assessment. * Male and female adults, 18 through 65 years of age, inclusive. * Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, and confirmed ...
Fasedienol is an investigational small molecule nasal spray being developed for the acute treatment of anxiety in adults with Social Anxiety Disorder (SAD). It is currently in Phase 3 clinical development and has not been approved by the FDA.
Fasedienol is being developed by Vistagen Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol VTGN. The company is conducting Phase 3 clinical trials for this investigational nasal spray.
Fasedienol is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 3 trials, PALISADE-3 and PALISADE-4, are currently active but not recruiting participants.
Fasedienol is being studied in two Phase 3 clinical trials: PALISADE-3 (NCT06358651) and PALISADE-4 (NCT06615557). Both are randomized, double-blind, placebo-controlled studies enrolling 238 adults aged 18 years and older with Social Anxiety Disorder in the United States.
Yes, Fasedienol is also known as Fasedienol Nasal Spray. The drug is administered as a nasal spray and is being investigated for the acute treatment of anxiety in adults with Social Anxiety Disorder.