Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate buspirone across diverse therapeutic indications and pharmacokinetic assessments. Sponsored by academic institutions, hospital networks, and pharmaceutical manufacturers, these studies encompass recruitment statuses including recruiting, completed, active not recruiting, and terminated. Key evaluations focus on generalized anxiety disorder, major depressive disorder, Parkinson's disease, forelimb function following cervical spinal cord injury, and bioequivalence under fed and fasting conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07439042 NOT_YET_RECRUITING
Anxiety; Autism Spectrum Disorder
Massachusetts General Hospital
 2026-09 PHASE4
NCT04400266 RECRUITING
Depression; Brain Injuries, Traumatic
Massachusetts General Hospital
 2020-08-01 PHASE4
NCT05511909 RECRUITING
Opioid Use Disorder; Opioid Withdrawal; Opioid Craving; Anxiety
University of Maryland, Baltimore
 2022-12-15 PHASE2
NCT04118387 RECRUITING
Sleep Disordered Breathing; Able Bodied
VA Office of Research and Development
 2021-01-07 PHASE4
NCT03954483 RECRUITING
Anxiety
University of Manitoba
 2023-10-16
NCT04458324 ACTIVE_NOT_RECRUITING
Spinal Cord Injuries
Spaulding Rehabilitation Hospital
 2020-12-22 PHASE2
NCT06243614 RECRUITING
Generalized Anxiety Disorder
Beijing Union Pharmaceutical Factory Ltd
 2023-07-24 PHASE3
NCT02313194 ACTIVE_NOT_RECRUITING
Cervical Spinal Cord Injury; Tetraparesis; Tetraplegia
University of California, Los Angeles
 2013-07 PHASE1; PHASE2
NCT01821690 COMPLETED
Traumatic Brain Injury
Indiana University
 2013-05-15 PHASE4
NCT04105114 ACTIVE_NOT_RECRUITING
Spinal Cord Injuries
University of Louisville
 2019-09-30 EARLY_PHASE1
NCT03432065 WITHDRAWN
Autism Spectrum Disorder; Anxiety
Massachusetts General Hospital
 2024-12 PHASE2
NCT01850355 COMPLETED
Autism Spectrum Disorders; Anxiety
Massachusetts General Hospital
 2013-07
NCT05041322 COMPLETED
Spinal Cord Injuries
Spaulding Rehabilitation Hospital
 2020-11-29 PHASE2
NCT05629325 UNKNOWN
Dysphagia, Esophageal
Universitaire Ziekenhuizen KU Leuven
 2021-07-06 PHASE4
NCT06906224 COMPLETED
Schizophrenia
Chuanfu Song
 2022-05-01 EARLY_PHASE1
NCT04052776 COMPLETED
Spinal Cord Injuries; Drug Effect
Centre Hospitalier Universitaire Vaudois
 2020-09-11 PHASE1
NCT04807517 COMPLETED
Williams Syndrome; Anxiety
Massachusetts General Hospital
 2021-08-01 PHASE4
NCT05357547 COMPLETED
Anhedonia
University of Oxford
 2022-05-13 PHASE2
NCT02617017 COMPLETED
Parkinson
Assistance Publique - Hôpitaux de Paris
 2016-06-17 PHASE3
NCT05430217 COMPLETED
Vertigo; Autonomic Dysfunction
Valenta Pharm JSC
 2022-01-28 PHASE3
NCT03587142 COMPLETED
Gastroparesis
Johns Hopkins Bloomberg School of Public Health
 2019-08-27 PHASE2
NCT05377619 COMPLETED
Dyspepsia
Universidade de Passo Fundo
 2022-01-06 PHASE1; PHASE2
NCT02589340 TERMINATED
Parkinson's Disease; Dyskinesias; Movement Disorders
Oregon Health and Science University
 2016-01 PHASE1
NCT03521960 COMPLETED
Opioid-Related Disorders; Dependency (Psychology); Pain, Chronic; Opiate Withdrawal Syndrome
Johns Hopkins University
 2018-05-30 PHASE1
NCT03538431 COMPLETED
Autism Spectrum Disorder
Massachusetts General Hospital
 2018-10-31 PHASE4
NCT02458469 COMPLETED
Spinal Cord Injury; Sleep Disordered Breathing
VA Office of Research and Development
 2015-05-14 PHASE2
NCT02803749 COMPLETED
Parkinson Disease; Anxiety
University of Rochester
 2016-10 PHASE2
NCT01833312 TERMINATED
Acute Ischemic Stroke
University of Erlangen-Nürnberg Medical School
 2013-07 PHASE3
NCT02483598 TERMINATED
Gastric Bypass
North Dakota State University
 2015-06 PHASE4
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02674412 COMPLETED
Functional Dysphagia; Ineffective Esophageal Motility
The Cleveland Clinic
 2016-02
NCT03444831 COMPLETED
Dyspepsia
Isfahan University of Medical Sciences
 2016-03-01 PHASE4
NCT01843205 COMPLETED
Methamphetamine Dependence; Methamphetamine Abuse
University of Kentucky
 2013-04 PHASE1
NCT01496612 TERMINATED
Anxiety Disorder; Seizures; Epilepsy; Partial Epilepsy; Depression
National Institute of Neurological Disorders and Stroke (NINDS)
 2011-11-22 PHASE2
NCT02132832 COMPLETED
Cannabis Use Disorder
The University of Texas Health Science Center, Houston
 2013-06 PHASE2
NCT02273154 UNKNOWN
Major Depression Disorder
Si Tianmei
 2014-08 PHASE4
NCT01267292 COMPLETED
Cocaine Dependence
The University of Texas Health Science Center, Houston
 2011-03 PHASE2
NCT02186366 UNKNOWN
Anxiety Disorders
Sun Qing
 2014-09
NCT02363478 COMPLETED
Systemic Sclerosis
Laikο General Hospital, Athens
 2014-12 EARLY_PHASE1
NCT01484184 COMPLETED
Spinal Cord Injury
Nordic Life Science Pipeline Inc.
 2013-07 PHASE1; PHASE2
NCT00873509 COMPLETED
Autistic Disorder
Chugani, Diane C.
 2009-05 PHASE2; PHASE3
NCT01639157 COMPLETED
Cocaine Use Disorders
William Stoops
 2012-09
NCT02101203 COMPLETED
Hypoactive Sexual Desire Disorder
Emotional Brain NY Inc.
 2013-07 PHASE2
NCT00875836 COMPLETED
Marijuana Dependence
Medical University of South Carolina
 2009-09 PHASE4
NCT01699828 COMPLETED
Smoking Cessation; Tobacco Use Cessation
Centre for Addiction and Mental Health
 2012-10 PHASE1; PHASE2
NCT01546896 WITHDRAWN
Anxiety Disorder
Seoul National University Hospital
 2012-03 PHASE4
NCT01395953 WITHDRAWN
Autism Spectrum Disorder (ASD)
Massachusetts General Hospital
 2011-11 PHASE2
NCT01743235 COMPLETED
Hypoactive Sexual Desire Disorder
Emotional Brain NY Inc.
 2012-07 PHASE2
NCT01641159 COMPLETED
Cocaine Dependence
University of Cincinnati
 2012-08 PHASE2
NCT04352686 COMPLETED
Gastroesophageal Reflux
Universitaire Ziekenhuizen KU Leuven
 2012-02
NCT00746954 TERMINATED
Central Apnea; Heart Failure
VA Office of Research and Development
 2008-09 PHASE3
NCT00053846 COMPLETED
Dyspnea; Pulmonary Complications; Unspecified Adult Solid Tumor, Protocol Specific
University of Rochester
 2002-11 PHASE2; PHASE3
NCT00705003 COMPLETED
Major Depressive Disorder
Massachusetts General Hospital
 2008-05 PHASE2
NCT00334360 COMPLETED
Hypothermia
The Cleveland Clinic
 2004-09 PHASE4
NCT00178971 COMPLETED
Schizophrenia; Schizoaffective Disorder
Northwestern University
 2003-01 PHASE3
NCT00840398 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2001-12 PHASE1
NCT00840606 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2001-12 PHASE1
NCT00652730 COMPLETED
To Determine Bioequivalence Under Fed Conditions
Par Pharmaceutical, Inc.
 1998-07 PHASE1
NCT00653419 COMPLETED
To Determine Bioequivalence Under Fasting Conditions
Par Pharmaceutical, Inc.
 1998-06 PHASE1
NCT00149617 COMPLETED
Marijuana Abuse; Mood Disorders
Medical University of South Carolina
 2004-04 PHASE2
NCT00166621 COMPLETED
Autism
Chugani, Diane C.
 2004-03 PHASE1; PHASE2
NCT00021528 COMPLETED
Depression
National Institute of Mental Health (NIMH)
 2001-07 PHASE4
NCT00360191 COMPLETED
Marijuana Abuse
Medical University of South Carolina
 2004-04 PHASE2
NCT00326235 COMPLETED
Heroin Dependence
National Institute on Drug Abuse (NIDA)
 2002-01 PHASE4
NCT00174226 COMPLETED
Attention Deficit Disorder With Hyperactivity
Pfizer
 2004-11 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the BUSPIRONE product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Buspirone acts as a potent agonist at serotonin 5-HT1A receptors while simultaneously functioning as an antagonist at dopamine D2 autoreceptors, thereby modulating central monoaminergic transmission and downstream adenylate cyclase activity. This receptor-mediated signaling shift reduces neuronal hyperexcitability and suppresses neuroinflammation, mediating its therapeutic clinical relevance in the management of generalized anxiety disorder and major depressive disorder.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.