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Also known as Fasedienol Nasal Spray - Fasedienol Nasal Spray
Fasedienol- Fasedienol · 1 trial · 1 indication
The SUDS is a patient self-rated acute measurement scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety at all and 100=highest distress or anxiety ever felt.
| Arm | Type | Description |
|---|---|---|
| Fasedienol Nasal Spray (single dose) | EXPERIMENTAL | Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by one dose of Placebo Nasal Spray, separated by 10-minutes in between the two doses. |
| Fasedienol Nasal Spray (repeat dose) | EXPERIMENTAL | Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by a second dose of Fasedienol Nasal Spray, separated by 10-minutes in between the two doses. |
| Placebo Nasal Spray | EXPERIMENTAL | Twenty minutes prior to the PSC, subjects will receive one dose of Placebo Nasal Spray followed by a second dose of Placebo Nasal Spray, separated by 10-minutes between the two doses. |
| Name | Type | Description |
|---|---|---|
| Fasedienol Nasal Spray - Placebo Nasal Spray | DRUG | Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by one dose of Placebo Nasal Spray, separated by 10-minutes in between the two doses. |
| Fasedienol Nasal Spray - Fasedienol Nasal Spray | DRUG | Twenty minutes prior to the PSC, subjects will receive one dose of Fasedienol Nasal Spray followed by a second dose of Fasedienol Nasal Spray, separated by 10-minutes in between the two doses. |
| Placebo Nasal Spray - Placebo Nasal Spray | DRUG | Twenty minutes prior to the PSC, subjects will receive one dose of Placebo Nasal Spray followed by a second dose of Placebo Nasal Spray, separated by 10-minutes between the two doses. |
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 studied for the acute treatment of anxiety in adults with Social Anxiety Disorder. It is currently in Phase 2 clinical development and is not yet approved by the FDA.
Fasedienol is a small molecule administered as a nasal spray. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its efficacy, safety, and tolerability in reducing anxiety symptoms in patients with Social Anxiety Disorder.
Fasedienol is being developed by Vistagen Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VTGN. The company is conducting clinical trials to assess the drug's potential as a treatment for Social Anxiety Disorder.
Fasedienol is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not received regulatory approval and is still being studied in clinical trials to evaluate its safety and efficacy for the treatment of Social Anxiety Disorder.
Fasedienol is being studied in a Phase 2 clinical trial with the identifier NCT06809179. This randomized, double-blind, controlled trial is recruiting 60 adult participants in the United States to assess the efficacy, safety, and tolerability of a repeat dose of Fasedienol Nasal Spray for the acute treatment of anxiety in Social Anxiety Disorder.
Yes, Fasedienol is also known as Fasedienol Nasal Spray. The drug is administered as a nasal spray formulation and is being investigated for the acute treatment of anxiety in adults with Social Anxiety Disorder.