Buspirone
Buspirone (buspirone) is a small molecule pharmaceutical. Buspirone was first approved as Buspar on 1986-09-29. It is used to treat anxiety disorders, depressive disorder, and intellectual disability in the USA. The pharmaceutical is active against 5-hydroxytryptamine receptor 1A. In addition, it is known to target 5-hydroxytryptamine receptor 7.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Bucapsol, Buspirone (discontinued: Buspar, Buspirone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Buspirone hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BUSPAR | Bristol Myers Squibb | N-021190 DISCN | 2000-12-20 | 4 products, RLD |
| BUSPAR | Bristol Myers Squibb | N-018731 DISCN | 1986-09-29 | 4 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bucapsol | ANDA | 2025-06-19 |
| buspar | ANDA | 2016-05-25 |
| buspirone | ANDA | 2010-03-29 |
| buspirone hcl | ANDA | 2025-01-20 |
| buspirone hcl | ANDA | 2025-06-25 |
| buspirone hydrochloride | ANDA | 2025-12-15 |
Indications
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EMA
Agency Specific
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Clinical
Clinical Trials
72 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 2 | 2 | 2 | 4 | 10 |
| Depression | D003863 | — | F33.9 | — | 3 | 1 | 3 | — | 7 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 3 | — | 1 | 2 | 6 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | 1 | 4 | 1 | 1 | 1 | 6 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 2 | — | 2 | 1 | 5 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 2 | — | 2 | 1 | 5 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | 2 | — | 1 | 1 | 4 |
| Pervasive child development disorders | D002659 | EFO_0003756 | F84 | — | 2 | — | 1 | 1 | 4 |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | — | 3 | — | 1 | — | 4 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 1 | — | 1 | — | 3 |
Show 18 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | — | 2 | — | — | 3 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 1 | 1 | — | — | 3 |
| Dyskinesias | D020820 | — | G24 | 1 | — | 1 | — | — | 2 |
| Generalized anxiety disorder | D000098647 | — | — | — | — | 1 | — | 1 | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | 2 | — | — | 2 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | — | 1 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Somatoform disorders | D013001 | — | F45 | — | — | 1 | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | — | — | 1 |
| Ischemic stroke | D000083242 | — | — | — | — | 1 | — | — | 1 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Spinal cord injuries | D013119 | EFO_1001919 | — | 4 | 5 | — | — | — | 7 |
| Cocaine-related disorders | D019970 | — | F14 | — | 2 | — | — | 1 | 3 |
| Quadriplegia | D011782 | — | G82.5 | 2 | 2 | — | — | — | 2 |
| Hypokinesia | D018476 | — | — | — | 2 | — | — | — | 2 |
| Psychological sexual dysfunctions | D020018 | — | F52.0 | — | 2 | — | — | — | 2 |
| Substance withdrawal syndrome | D013375 | EFO_0005800 | — | 1 | 1 | — | — | — | 2 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | 1 | — | — | — | 2 |
| Paraplegia | D010264 | — | G82.2 | 1 | 1 | — | — | — | 1 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | 1 | — | — | — | 1 |
| Hyperkinesis | D006948 | — | — | — | 1 | — | — | — | 1 |
Show 11 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 2 | — | — | — | — | 2 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Disease | D004194 | EFO_0000408 | R69 | 2 | — | — | — | — | 2 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Movement disorders | D009069 | EFO_0004280 | G25 | 1 | — | — | — | — | 1 |
| Traumatic stress disorders | D040921 | — | — | 1 | — | — | — | — | 1 |
| Paralysis | D010243 | — | — | 1 | — | — | — | — | 1 |
| Chronic pain | D059350 | — | — | 1 | — | — | — | — | 1 |
| Psychological dependency | D003858 | — | — | 1 | — | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | — | — | — | — | 1 |
Show 3 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | — | — | — | — | 1 | 1 |
| Leiomyoma | D007889 | — | D25 | — | — | — | — | 1 | 1 |
| Laparoscopy | D010535 | — | — | — | — | — | — | 1 | 1 |
| Ovarian cysts | D010048 | — | N83.1 | — | — | — | — | 1 | 1 |
| Myofibroma | D047708 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Buspirone |
| INN | buspirone |
| Description | Buspirone is an azaspiro compound that is 8-azaspiro[4.5]decane-7,9-dione substituted at the nitrogen atom by a 4-(piperazin-1-yl)butyl group which in turn is substituted by a pyrimidin-2-yl group at the N(4) position. It has a role as an anxiolytic drug, a sedative, a serotonergic agonist and an EC 3.4.21.26 (prolyl oligopeptidase) inhibitor. It is an azaspiro compound, a member of pyrimidines, a N-arylpiperazine, a N-alkylpiperazine, a member of piperidones and an organic heteropolycyclic compound. It is a conjugate base of a buspirone(1+). |
| Classification | Small molecule |
| Drug class | anxiolytics (buspirone type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1CC2(CCCC2)CC(=O)N1CCCCN1CCN(c2ncccn2)CC1 |
Identifiers
| PDB | — |
| CAS-ID | 36505-84-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL49 |
| ChEBI ID | 3223 |
| PubChem CID | 2477 |
| DrugBank | DB00490 |
| UNII ID | TK65WKS8HL (ChemIDplus, GSRS) |
Target
Agency Approved
HTR1A
HTR1A
Organism
Homo sapiens
Gene name
HTR1A
Gene synonyms
ADRB2RL1, ADRBRL1
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 1A
Protein synonyms
5-HT1a receptor, 5-hydroxytryptamine (serotonin) receptor 1A, G protein-coupled, G-21, guanine nucleotide-binding regulatory protein-coupled receptor, Serotonin receptor 1A
Uniprot ID
Mouse ortholog
Htr1a (15550)
5-hydroxytryptamine receptor 1A (Q8BGS4)
Alternate
HTR7
HTR7
Variants
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Financial
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Estimated US medical usage
Buspirone
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,197 adverse events reported
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