Overview
Buspirone is a novel anxiolytic agent with a unique structure and a pharmacological profile. Belonging to the azaspirodecanedione drug class, buspirone is a serotonin 5-HT receptor agonist that is not chemically or pharmacologically related to benzodiazepines, barbiturates, and other sedative/anxiolytic drugs. Unlike many drugs used to treat anxiety, buspirone does not exhibit anticonvulsant, sedative, hypnotic, and muscle-relaxant properties. Due to these characteristics, buspirone been termed 'anxioselective'. First synthesized in 1968 then patented in 1975, it is commonly marketed under the brand name Buspar®. Buspirone was first approved in 1986 by the FDA and has been used to treat anxiety disorders, such as generalized anxiety disorder (GAD), and relieve symptoms of anxiety. It has also been used as a second-line therapy for unipolar depression when the use of selective serotonin reuptake inhibitors (SSRIs) is deemed clinically inadequate or inappropriate. The potential use of buspirone in combination with melatonin in depression and cognitive impairment via promoting neurogenesis has also been investigated.
Indication
Indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety.
Associated Conditions
- Anxiety Disorders
- Depression
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/03/20 | Phase 4 | Recruiting | |||
2024/02/06 | Phase 3 | Recruiting | Beijing Union Pharmaceutical Factory Ltd | ||
2022/11/29 | Phase 4 | Recruiting | |||
2022/08/23 | Phase 2 | Recruiting | |||
2022/06/24 | Phase 3 | Completed | |||
2022/05/17 | Phase 1 | Completed | Universidade de Passo Fundo | ||
2022/05/03 | Phase 2 | Completed | |||
2021/09/13 | Phase 2 | Recruiting | Spaulding Rehabilitation Hospital | ||
2021/03/19 | Phase 4 | Completed | |||
2020/07/07 | Phase 2 | Recruiting | Spaulding Rehabilitation Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Quality Care Products, LLC | 55700-937 | ORAL | 5 mg in 1 1 | 2/24/2022 | |
Direct_Rx | 72189-458 | ORAL | 7.5 mg in 1 1 | 3/31/2023 | |
Zydus Pharmaceuticals USA Inc. | 68382-181 | ORAL | 10 mg in 1 1 | 9/14/2023 | |
Yiling Pharmaceutical, Inc. | 69117-0043 | ORAL | 30 mg in 1 1 | 1/3/2023 | |
REMEDYREPACK INC. | 70518-4052 | ORAL | 15 mg in 1 1 | 6/19/2025 | |
Zydus Pharmaceuticals USA Inc. | 68382-180 | ORAL | 5 mg in 1 1 | 9/14/2023 | |
Cardinal Health 107, LLC | 55154-4305 | ORAL | 10 mg in 1 1 | 4/4/2023 | |
NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7714 | ORAL | 5 mg in 1 1 | 12/5/2022 | |
A-S Medication Solutions | 50090-4862 | ORAL | 30 mg in 1 1 | 12/31/2016 | |
Bryant Ranch Prepack | 72162-1927 | ORAL | 30 mg in 1 1 | 8/29/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Buspirone Hydrochloride Tablets | 国药准字HJ20240078 | 化学药品 | 片剂 | 7/30/2024 | |
Buspirone Hydrochloride Tablets | 国药准字H20000199 | 化学药品 | 片剂 | 8/27/2020 | |
Buspirone Hydrochloride Tablets | 国药准字HJ20240077 | 化学药品 | 片剂 | 7/30/2024 | |
Buspirone Hydrochloride Tablets | 国药准字H20247318 | 化学药品 | 片剂 | 12/16/2024 | |
Buspirone Hydrochloride Tablets | 国药准字H20247244 | 化学药品 | 片剂 | 10/17/2024 | |
Buspirone Hydrochloride Tablets | 国药准字H19991024 | 化学药品 | 片剂 | 7/14/2020 | |
Buspirone Hydrochloride Tablets | 国药准字H20247245 | 化学药品 | 片剂 | 10/17/2024 | |
Buspirone Hydrochloride Tablets | 国药准字H19990302 | 化学药品 | 片剂 | 4/20/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ANKSILON buspirone hydrochloride 5 mg tablet blister pack | 422891 | Medicine | A | 1/16/2025 | |
ANKSILON buspirone hydrochloride 10 mg tablet blister pack | 422890 | Medicine | A | 1/16/2025 |
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