BUCAPSOL (buspirone hydrochloride)
Bucapsol (buspirone hydrochloride) is an anxiolytic indicated for the management of anxiety disorders or the short-term relief of anxiety symptoms. Its efficacy has been specifically demonstrated in patients with symptoms corresponding to Generalized Anxiety Disorder (GAD), including those with coexisting depressive symptoms. It is intended for the treatment of persistent anxiety (typically lasting at least one month) rather than the routine tension or stress associated with everyday life.
How BUCAPSOL Works
The precise mechanism of action of buspirone is not fully understood. It differs from benzodiazepines in that it does not exert effects on GABA receptors. Buspirone exhibits a high affinity for serotonin 5-HT1A receptors, where it acts as a partial agonist. It also possesses moderate affinity for dopamine D2 receptors. This unique profile results in anxiolytic effects without significant sedation, muscle relaxation, or anticonvulsant activity.
Details
- Status
- Prescription
- First Approved
- 2025-03-13
- Routes
- ORAL
- Dosage Forms
- CAPSULE
BUCAPSOL Approval History
What BUCAPSOL Treats
2 indicationsBUCAPSOL is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety Disorders
- Generalized Anxiety Disorder
BUCAPSOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04458324 | 2020P001363 | Ph 2 | active not recruiting | Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury |
| NCT01743235 | EB90 EB90 | Ph 2 | completed | Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BUCAPSOL FDA Label Details
Indications & Usage
BUCAPSOL is indicated for the treatment of Anxiety Disorders; Generalized Anxiety Disorder.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.