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Also known as Fasedienol Nasal Spray, Fasedienol Nasal Spray - Fasedienol Nasal Spray, Fasedienol- Fasedienol
Fasedienol · 3 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 | - |
| 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. |
| 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 |
| 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 nasal spray being developed for the acute treatment of anxiety in adults with social anxiety disorder. It is designed to be used as a rapid, as-needed treatment rather than a daily maintenance therapy. It has not been approved by the FDA and remains in clinical development.
Fasedienol is being developed by Vistagen Therapeutics, Inc., which trades on the Nasdaq under the ticker VTGN. The company is running the PALISADE Phase 3 program in adults with social anxiety disorder, along with an additional earlier-stage clinical trial of the nasal spray.
Fasedienol is in Phase 3 clinical development for social anxiety disorder. Two Phase 3 trials, PALISADE-3 and PALISADE-4, are active but no longer recruiting participants, and a separate Phase 2 trial is currently recruiting. Fasedienol is investigational and has not received FDA approval.
Fasedienol is being studied in three registered trials: NCT06358651 (PALISADE-3, Phase 3), NCT06615557 (PALISADE-4, Phase 3), and NCT06809179 (Phase 2). All three enroll adults 18 years and older with social anxiety disorder in the United States, and together they plan to enroll 536 participants.
Yes. Fasedienol Nasal Spray is another name for fasedienol, the same investigational asset developed by Vistagen Therapeutics. The two names refer to the identical product, which is administered intranasally and is being studied for the acute treatment of anxiety in adults with social anxiety disorder.
Fasedienol is given as a nasal spray in its clinical trials. The Phase 3 PALISADE-3 and PALISADE-4 studies and the Phase 2 trial NCT06809179 are randomized, double-blind, controlled trials evaluating the nasal spray for acute treatment of anxiety in adults with social anxiety disorder.