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Fasedienol Nasal Spray
Fasedienol is a NMDA receptor antagonist administered as a nasal spray for rapid-onset treatment of depression.
Fasedienol is a NMDA receptor antagonist administered as a nasal spray for rapid-onset treatment of depression. Used for Major depressive disorder (Phase 3), Treatment-resistant depression (exploratory).
At a glance
| Generic name | Fasedienol Nasal Spray |
|---|---|
| Sponsor | VistaGen Therapeutics, Inc. |
| Drug class | NMDA receptor antagonist |
| Target | NMDA receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | Phase 3 |
Mechanism of action
Fasedienol acts as a non-competitive antagonist at the N-methyl-D-aspartate (NMDA) receptor, a glutamate receptor subtype implicated in depression pathophysiology. By blocking NMDA receptor signaling, it is hypothesized to rapidly restore synaptic plasticity and produce fast-acting antidepressant effects. The nasal spray formulation enables direct brain delivery and rapid systemic absorption, potentially providing faster symptom relief compared to oral antidepressants.
Approved indications
- Major depressive disorder (Phase 3)
- Treatment-resistant depression (exploratory)
Common side effects
- Dissociation
- Dizziness
- Nasal irritation
- Headache
Key clinical trials
- A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PHASE2)
- Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4) (PHASE3)
- Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fasedienol Nasal Spray CI brief — competitive landscape report
- Fasedienol Nasal Spray updates RSS · CI watch RSS
- VistaGen Therapeutics, Inc. portfolio CI