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buspirone

Trade name: buspar

Small moleculeapproved

Approved

Sep 29, 1986

Buspirone is the first of a new class of anxioselective agents, the azaspirodecanediones. Animal studies have suggested antianxiety activity and the absence of abuse potential. Behavioural, electrophysiological and receptor binding experiments gradually led to the idea that buspirone owes much of its anxiolytic activity to its ability to attenuate central 5-hydroxytryptamine neurotransmission. In vitro preclinical studies have shown that buspirone has a high affinity for serotonin (5-HT1A) receptors. Some studies do suggest that buspirone may have indirect effects on other neurotransmitter systems. Buspirone differs from typical benzodiazepine anxiolytics in that it does not exert anticonvulsant or muscle relaxant effects. It also lacks the prominent sedative effect that is associated with more typical anxiolytics. The drug was approved by FDA for the treatment of anxiety. — NCATS

Clinical trial activity

72 trials · 67 clinical orgs · 25 marketing orgs

Phase 1
17
Phase 2
36
Phase 3
9
Phase 4
15

Earliest trial started Jun 1, 1998 (NCT00653419)

Timeline

1980s

  1. Sep 29, 1986

    Bristol-Myers — Earliest FDA Approval

  2. Sep 29, 1986

    Bristol-Myers — NDA Organization

  3. Sep 29, 1986

    Bristol-Myers Squibb — NDA Secondary Org

1990s

  1. Jan 1, 1998

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Mar 28, 2001

    Impax Laboratories — Marketing Organization

  2. Mar 28, 2001

    Mylan — Marketing Organization

  3. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  4. Feb 27, 2002

    Nesher Pharms — Marketing Organization

  5. Mar 1, 2002

    Teva — Marketing Organization

  6. Mar 14, 2002

    Egis — Marketing Organization

  7. Mar 19, 2002

    Fosun — Marketing Organization

  8. Mar 19, 2002

    Graviti Pharmaceuticals — Marketing Organization

  9. Mar 19, 2002

    Rising Pharmaceuticals — Marketing Organization

  10. Apr 5, 2002

    Apotex — Marketing Organization

  11. Apr 5, 2002

    Rubicon Research — Marketing Organization

  12. May 9, 2002

    Oxford Pharmaceuticals — Marketing Organization

  13. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  14. Feb 27, 2009

    Aurobindo Pharma — Marketing Organization

2010s

  1. Feb 7, 2014

    Zydus Discovery DMCC — Marketing Organization

  2. Aug 25, 2014

    Strides Pharma Science — Marketing Organization

  3. Dec 30, 2014

    Accord Research — Marketing Organization

  4. Sep 18, 2015

    Heritage Pharma — Marketing Organization

  5. Sep 18, 2015

    Emcure — Marketing Organization

  6. Dec 16, 2015

    Yiling Pharmaceutical Inc. — Marketing Organization

  7. Dec 16, 2015

    AiPing Pharm Inc — Marketing Organization

  8. May 24, 2017

    Amneal Pharmaceuticals — Marketing Organization

  9. May 3, 2018

    Inventia Hlthcare — Marketing Organization

  10. Apr 16, 2019

    Epic Pharma Llc — Marketing Organization

  11. Nov 14, 2019

    Unichem — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewSep 29, 1986

Chemistry & pharmacology

Loading structure…

SMILES

O=C1CC2(CCCC2)CC(=O)N1CCCCN1CCN(c2ncccn2)CC1
Mol. weight
385.51 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 8-(4-(4-(2-pyrimidinyl)-1-piperizinyl)butyl)-8-azaspiro(4,5)decane-7,9-dione
  • 8-(4-(4-(2-pyrimidinyl)-1-piperizinyl)butyl)-8-azaspiro(4,5)decane-7,9-dione
  • bci-024
  • buspar
  • buspar
  • buspar
  • buspar
  • buspin
  • buspiron
  • buspiron
  • buspirona
  • buspirona
  • buspirone
  • buspirone
  • buspirone
  • buspirone
  • buspirone
  • buspirone
  • buspirone
  • buspirone
  • buspirone
  • buspirone
  • buspirone hcl
  • buspirone hcl
  • buspirone hcl
  • buspirone hydrochloride
  • buspirone hydrochloride
  • buspirone hydrochloride
  • buspirone hydrochloride
  • buspirone hydrochloride
  • buspironum
  • buspironum
  • jm-010
  • mj-9022-1
  • mj-9022-1

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06321341Phase 4Jan 24, 2024Valenta Pharm JSC
NCT06243614Phase 3Jul 24, 2023Government of China, R&G Pharma Studies Co.,Ltd.
NCT06147544Phase 1/Phase 2 (Phase 2)Jul 6, 2023PegBio Co., Ltd., Peking University
NCT05516875Phase 2Jan 31, 2023Contera Pharma
NCT05511909Phase 2Dec 15, 2022Johns Hopkins University
NCT05357547Phase 2May 16, 2022University of Oxford
NCT06906224Early Phase 1 (Phase 1)May 1, 2022Bengbu Medical College
NCT05430217Phase 3Jan 28, 2022Valenta Pharm JSC
NCT05377619Phase 1/Phase 2 (Phase 2)Jan 6, 2022Universidade de Passo Fundo
NCT04807517Phase 4Aug 1, 2021Harvard University
NCT05629325Phase 4Jul 6, 2021Katholieke Universiteit Leuven
NCT05041322Phase 2Nov 29, 2020Harvard University
NCT04458324Phase 2Aug 31, 2020Harvard University
NCT04400266Phase 4Aug 1, 2020Harvard University
NCT05021666Phase 1Jul 29, 2020Covance, Daytona Beach CRU, PegBio Co., Ltd.
NCT04377945Phase 2Jun 1, 2020Bukwang Pharmaceutical
NCT04118387Phase 4Apr 1, 2020Department of Veteran Affairs
NCT04105114Early Phase 1 (Phase 1)Dec 1, 2019University of Louisville
NCT04052776Phase 1Sep 30, 2019Ecole Polytechnique Fédérale de Lausanne, University of Lausanne
NCT03956979Phase 2Jul 31, 2019Bukwang Pharmaceutical, Contera Pharma, University of Rostock
Showing 20 of 72 trials
Page 1 / 4

Organizations

Research & Development (67)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Harvard UniversityAcademic/Hospital101032008
National Institute on Drug Abuse (NIDA)Government7132002
Department of Veteran AffairsGovernment5342002
University of RochesterAcademic/Hospital4442002
Bukwang PharmaceuticalFor profit3212015
Johns Hopkins UniversityAcademic/Hospital3222018
Medical University of South CarolinaAcademic/Hospital3022004
University of South CarolinaAcademic/Hospital3322004
BrainCells Inc.For profit2012008
Contera PharmaFor profit2212019
Emotional Brain NY Inc.Academic/Hospital2212012
Katholieke Universiteit LeuvenAcademic/Hospital2222012
National Institute of Neurological Disorders and Stroke (NINDS)Government2122009
Par PharmaceuticalsFor profit2211998
PegBio Co., Ltd.For profit2222020
Peking UniversityAcademic/Hospital2122014
Phoenix International Life Science Inc.For profit2011998
PRACSFor profit2012001
TevaFor profit2212001
The University of Texas, DallasAcademic/Hospital2112001
67 organizations
Page 1 / 4

Marketing (30)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGDec 30, 2014
AiPing Pharm IncFor profitMKTGDec 16, 2015
Amneal PharmaceuticalsFor profitMKTGMay 24, 2017
ApotexFor profitMKTGApr 5, 2002
Aurobindo PharmaFor profitMKTGFeb 27, 2009
Bristol-MyersFor profitNDASep 29, 1986
Bristol-Myers SquibbFor profitSYNSep 29, 1986
Bristol-Myers SquibbFor profitNDA2Sep 29, 1986
EgisFor profitMKTGMar 14, 2002
EmcureFor profitMKTGSep 18, 2015
Epic Pharma LlcFor profitMKTGApr 16, 2019
FosunFor profitMKTGMar 19, 2002
Graviti PharmaceuticalsFor profitMKTGMar 19, 2002
Heritage PharmaFor profitMKTGSep 18, 2015
Impax LaboratoriesFor profitMKTGMar 28, 2001
Inventia HlthcareFor profitMKTGMay 3, 2018
MylanFor profitMKTGMar 28, 2001
Nesher PharmsFor profitMKTGFeb 27, 2002
Oxford PharmaceuticalsFor profitMKTGMay 9, 2002
Rising PharmaceuticalsFor profitMKTGMar 19, 2002
Rubicon ResearchFor profitMKTGApr 5, 2002
Rubicon ResearchFor profitSYNApr 5, 2002
Strides Pharma ScienceFor profitMKTGAug 25, 2014
TevaFor profitMKTGMar 1, 2002
TevaFor profitSYNFeb 28, 2002
UnichemFor profitSYNNov 14, 2019
UnichemFor profitMKTGNov 14, 2019
Yiling Pharmaceutical Inc.For profitSYNDec 16, 2015
Yiling Pharmaceutical Inc.For profitMKTGDec 16, 2015
Zydus Discovery DMCCFor profitMKTGFeb 7, 2014