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BuSpar

(Buspirone)

ApprovedSmall molecule

Bristol-Myers Squibb

Buspirone is used to treat anxiety disorders and help reduce feelings of worry and nervousness. It works by affecting certain chemicals in the brain that control mood and anxiety.[2] BuSpar is currently approved and in use across 21 indications[4].[1]

BuSpar is one of 409 small molecule programs targeting Dyspepsia. It is currently in Approved.

21

Indications

48

Total Trials

6

Active Trials

408

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

DyspepsiaCompleted

DysphagiaActive, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Williams SyndromeCompleted

Parkinson DiseaseApproved

Brain InjuryCompleted

ParalysisActive, not recruiting

Sexual DysfunctionApproved

Gastroesophageal Reflux DiseaseActive, not recruiting

Cocaine Use DisorderActive, not recruiting

DyspepsiaApproved

Completed

DysphagiaPreclinical

Active, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Approved

Williams SyndromeApproved

Completed

Parkinson DiseaseApproved

Approved

Brain InjuryApproved

Completed

ParalysisPhase 1

Active, not recruiting

Sexual DysfunctionApproved

Approved

Gastroesophageal Reflux DiseasePreclinical

Active, not recruiting

Cocaine Use DisorderPreclinical

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

116 competitors in Ischemic Stroke

#DrugCompanyPhaseTrials

BuSpar

Bristol-Myers Squibb

Ozempic

Atorvastatin Calcium

Butylphthalide

PPeking Union Medical College Hospital

PCSK9 Inhibitor

Tegoprazan

SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Aggrastat

Edaravone Dexborneol

SSimcere Pharmaceutical Co., Ltd

Proamatine

Levaquin

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Spinal Cord Injury

NCT02313194

Q1 2027

Phase 2Recruiting

Opioid Use Disorder

NCT05511909

Q4 2027

MPA

NCT03954483

Phase 1Active, not recruiting

Paralysis

NCT04105114

Q2 2029

ApprovedRecruiting

Anxiety

NCT07439042

Clinical

Trials by Indication[1]

Treatment5 trials

Buspirone as a Potential Treatment for Recurrent Central Apnea

Terminated·VVA Office of Research and Development·Phase 3·NCT00746954·8 enrolled

Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar

Completed· Pfizer logo

Pfizer·Phase 2·NCT00174226·241 enrolled

A Placebo-Controlled Trial of Buspirone for Treatment of Marijuana Dependence

Completed·MMedical University of South Carolina·Phase 2·NCT00360191·81 enrolled

Show 2 more trials

Buspirone Treatment of Iatrogenic Dyskinesias in Advanced Parkinson' Disease

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02617017·99 enrolled

Buspirone Treatment for Marijuana Dependence

Completed·MMedical University of South Carolina·Phase 4·NCT00875836·175 enrolled

Autism Spectrum Disorder4 trials

Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT01395953

A Pilot Study of Buspirone for the Treatment of Anxiety in Youth with Autism Spectrum Disorders

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT03432065

An Open-Label Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders

Completed·MMassachusetts General Hospital·N/A·NCT01850355·9 enrolled

Show 1 more trial

Improving Driving in Young People With Autism Spectrum Disorders

Completed·MMassachusetts General Hospital·Phase 4·NCT03538431·26 enrolled

Brain Injury2 trials

Buspirone and Melatonin for Depression Following Traumatic Brain Injury

Recruiting·MMassachusetts General Hospital·Phase 4·NCT04400266·10 enrolled

Buspirone for the Treatment of Traumatic Brain Injury (TBI) Irritability and Aggression

Completed·IIndiana University·Phase 4·NCT01821690·81 enrolled

Cocaine Dependence2 trials

Study of Buspirone for Relapse-Prevention in Adults With Cocaine Dependence

Completed·UUniversity of Cincinnati·Phase 2·NCT01641159·62 enrolled

Psychopharmacology for Cocaine Dependence - Buspirone

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT01267292·50 enrolled

Generalized Anxiety Disorder1 trial

Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type

Unknown status·SSun Qing·N/A·NCT02186366·140 enrolled

34 more indications

Gastroparesis1 trial

Buspirone for Early Satiety and Symptoms of Gastroparesis

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 2·NCT03587142·96 enrolled

Chronic1 trial

Improving Ventilatory Capacity in Those With Chronic High Level SCI

Completed·SSpaulding Rehabilitation Hospital·Phase 2·NCT05041322·13 enrolled

Sleep Apnea1 trial

Role of Enhancing Serotonin Receptors Activity for Sleep Apnea Treatment in Patients With SCI

Completed·VVA Office of Research and Development·Phase 2·NCT02458469·15 enrolled

Spinal Cord Injury1 trial

Spinal Cord Neuromodulation for Spinal Cord Injury

Active, not recruiting·UUniversity of California, Los Angeles·Phase 1/2·NCT02313194·12 enrolled

Dysphagia1 trial

Buspirone for Functional Dysphagia

Completed·TThe Cleveland Clinic·N/A·NCT02674412·10 enrolled

Age1 trial

Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT04352686·10 enrolled

Autism1 trial

Early Pharmacotherapy Aimed at Neuroplasticity in Autism : Safety and Efficacy

Completed·CChugani, Diane C.·Phase 1/2·NCT00166621·20 enrolled

Amantadine1 trial

Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia

Terminated·OOregon Health and Science University·Phase 1·NCT02589340·6 enrolled

Neuromodulation1 trial

Acute Effects of Pharmacological Neuromodulation on Leg Motor Activity in Patients With SCI Treated With EES

Completed·—·Phase 1·NCT04052776·3 enrolled

Marijuana1 trial

Buspirone, Stress, and Attentional Bias to Marijuana Cues

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02132832·45 enrolled

Concentration1 trial

Mechanistic Investigation Of Intestinal Cytochrome p450 3A4 Following Roux-en-Y Surgery And Its Effect on Plasma Concentrations of Buspirone

Terminated·NNorth Dakota State University·Phase 4·NCT02483598·12 enrolled

AIN1 trial

Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine

Completed·WWilliam Stoops·N/A·NCT01639157·9 enrolled

Clinical Trial1 trial

Preventing Gastric Glitch With Prucalopride and Buspirone: N-of-1 Clinical Trial

Completed·UUniversidade de Passo Fundo·Phase 1/2·NCT05377619·1 enrolled

Vertigo1 trial

Efficacy and Safety of Buspirone, Sustained-release Tablets, 15 mg in Patients With Autonomic Dysfunction Syndrome Accompanied by Vertigo

Completed·VValenta Pharm JSC·Phase 3·NCT05430217·268 enrolled

Humans1 trial

Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET

Completed·CCentre for Addiction and Mental Health·Phase 1/2·NCT01699828·6 enrolled

Depression1 trial

Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00021528·4,000 enrolled

Opioid1 trial

Buspirone for Opioid Tapering

Completed·JJohns Hopkins University·Phase 1·NCT03521960·18 enrolled

ESS1 trial

Serotonin-receptor Agonism in Reward Processing

Completed·UUniversity of Oxford·Phase 2·NCT05357547·63 enrolled

MPA1 trial

Measurement of the Hippocampal Theta Rhythm From the Outer Ear Canal

Recruiting·UUniversity of Manitoba·N/A·NCT03954483·42 enrolled

Effectiveness1 trial

Effectiveness of Buspirone and Motivational Enhancement Therapy for the Treatment of Marijuana Dependence - 1

Completed·MMedical University of South Carolina·Phase 2·NCT00149617·81 enrolled

Withdrawal1 trial

Effects of Buspirone in Opiate Withdrawal

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 4·NCT00326235

Paralysis1 trial

Transformation of Paralysis to Stepping

Active, not recruiting·UUniversity of Louisville·Phase 1·NCT04105114·15 enrolled

Dyspepsia1 trial

Buspirone Plus Omeprazole for Functional Dyspepsia

Completed·IIsfahan University of Medical Sciences·Phase 4·NCT03444831·70 enrolled

Tic Disorder1 trial

Buspirone in the Treatment of 2-6 Year Old Children With Autistic Disorder

Completed·CChugani, Diane C.·Phase 2/3·NCT00873509·166 enrolled

Function1 trial

Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)

Completed·LLaikο General Hospital, Athens·Phase 1·NCT02363478·22 enrolled

Shivering1 trial

Dexmed/Buspirone Synergism on Shivering

Completed·TThe Cleveland Clinic·Phase 4·NCT00334360·8 enrolled

Williams syndrome1 trial

Buspirone Treatment of Anxiety in Williams Syndrome

Completed·MMassachusetts General Hospital·Phase 4·NCT04807517·20 enrolled

Parkinson's Disease1 trial

Buspirone in Parkinson's Disease

Completed·UUniversity of Rochester·Phase 2·NCT02803749·21 enrolled

Epilepsy1 trial

Buspirone Therapy for Localized Epilepsy

Terminated·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT01496612·9 enrolled

Stroke1 trial

Cooling Plus Best Medical Treatment Versus Best Medical Treatment Alone for Acute Ischaemic Stroke

Terminated·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT01833312·98 enrolled

Major Depression1 trial

Randomized，Controlled and Open-label Study of Buspirone add-on Treatment in Patients With Major Depression Disorder

Unknown status·SSi Tianmei·Phase 4·NCT02273154·240 enrolled

Anxiety1 trial

A Randomized Controlled Trial of Buspirone for Anxiety in Autistic Youth

Recruiting·MMassachusetts General Hospital·Approved·NCT07439042·20 enrolled

Opioid Use Disorder1 trial

Evaluating a Mechanistically-Supported Pharmacotherapy to Treat Opioid Withdrawal

Recruiting·JJohns Hopkins University·Phase 2·NCT05511909·100 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 29, 1986

BUSPAR

NDA NDA018731

Dec 20, 2000

BUSPAR

NDA NDA021190

Sources

References

[1]
ClinicalTrials.gov — 48 trial records for Buspirone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — BuSpar drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Buspirone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Buspirone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021190). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 1a (5-Ht1a) Receptor Partial Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bristol-Myers Squibb

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