BUSPIRONE HYDROCHLORIDE
Buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of anxiety symptoms. Its efficacy has been specifically demonstrated in Generalized Anxiety Disorder (GAD), characterized by persistent symptoms such as motor tension, autonomic hyperactivity, apprehensive expectation, and vigilance/scanning. Clinical evidence supports its use in patients presenting with anxiety and coexisting depressive symptoms. It is generally not intended for the treatment of anxiety or tension associated with the stress of everyday life.
How BUSPIRONE HYDROCHLORIDE Works
The exact mechanism of action of buspirone is not fully elucidated. Unlike benzodiazepines, buspirone does not interact directly with GABA receptors. It functions primarily as a high-affinity partial agonist at serotonin 5-HT1A receptors. It also exhibits moderate affinity for dopamine D2 receptors, where it acts as an antagonist or partial agonist. It does not possess significant anticonvulsant or muscle relaxant properties and lacks the sedative-hypnotic effects typical of other anxiolytics.
Details
- Status
- Discontinued
- First Approved
- 2001-03-28
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
BUSPIRONE HYDROCHLORIDE Approval History
What BUSPIRONE HYDROCHLORIDE Treats
2 indicationsBUSPIRONE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety Disorders
- Generalized Anxiety Disorder
BUSPIRONE HYDROCHLORIDE 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.
Drugs Similar to BUSPIRONE HYDROCHLORIDE
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
BUSPIRONE HYDROCHLORIDE FDA Label Details
Indications & Usage
BUSPIRONE HYDROCHLORIDE is indicated for the treatment of Anxiety Disorders; Generalized Anxiety Disorder.
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Full clinical data, patents, trials, and competitive landscape for buspirone hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.