MedPath

Buspirone

Generic Name
Buspirone
Brand Names
Buspar
Drug Type
Small Molecule
Chemical Formula
C21H31N5O2
CAS Number
36505-84-7
Unique Ingredient Identifier
TK65WKS8HL

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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