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Last Updated: April 30, 2025

CLINICAL TRIALS PROFILE FOR BUSPIRONE HYDROCHLORIDE


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All Clinical Trials for Buspirone Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00021528 ↗ Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Completed National Institute of Mental Health (NIMH) Phase 4 2001-07-01 STAR*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated
NCT00029692 ↗ Effects of Ginseng and Ginkgo on Drug Disposition in Man Completed National Center for Complementary and Integrative Health (NCCIH) Phase 2 2002-03-01 This study will assess the effects of ginseng and ginkgo on 1) cognitive function, 2) enzymes that process drugs, and 3) enzymes that may help prevent cancer.
NCT00053846 ↗ Buspirone in Reducing Shortness of Breath in Patients With Cancer Completed National Cancer Institute (NCI) Phase 2/Phase 3 2002-11-01 RATIONALE: Buspirone may be effective in reducing dyspnea (shortness of breath) in patients with cancer who are undergoing chemotherapy. PURPOSE: Randomized clinical trial to study the effectiveness of buspirone in reducing shortness of breath in patients who are undergoing chemotherapy for cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Buspirone Hydrochloride

Condition Name

Condition Name for Buspirone Hydrochloride
Intervention Trials
Anxiety 6
Anxiety Disorders 4
Spinal Cord Injuries 4
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Condition MeSH

Condition MeSH for Buspirone Hydrochloride
Intervention Trials
Disease 17
Anxiety Disorders 11
Spinal Cord Injuries 7
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Clinical Trial Locations for Buspirone Hydrochloride

Trials by Country

Trials by Country for Buspirone Hydrochloride
Location Trials
United States 106
China 7
Canada 6
France 2
Germany 2
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Trials by US State

Trials by US State for Buspirone Hydrochloride
Location Trials
Massachusetts 13
Texas 9
Maryland 7
Ohio 7
New York 7
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Clinical Trial Progress for Buspirone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Buspirone Hydrochloride
Clinical Trial Phase Trials
Phase 4 17
Phase 3 8
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Buspirone Hydrochloride
Clinical Trial Phase Trials
Completed 45
Recruiting 9
Terminated 6
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Clinical Trial Sponsors for Buspirone Hydrochloride

Sponsor Name

Sponsor Name for Buspirone Hydrochloride
Sponsor Trials
National Institute on Drug Abuse (NIDA) 8
Massachusetts General Hospital 8
Medical University of South Carolina 3
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Sponsor Type

Sponsor Type for Buspirone Hydrochloride
Sponsor Trials
Other 70
NIH 18
Industry 17
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Buspirone Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Buspirone hydrochloride, a unique anxiolytic medication, has been a significant player in the treatment of generalized anxiety disorder (GAD) since its introduction. This article delves into the clinical trials, market analysis, and projections for buspirone hydrochloride, providing a comprehensive overview of its current and future standing in the pharmaceutical market.

Clinical Trials and Efficacy

Early Clinical Trials

Buspirone hydrochloride has been evaluated in several double-blind clinical trials, demonstrating its efficacy in alleviating symptoms of anxiety. These trials showed that buspirone, at doses of 15 to 30 mg/day, improves anxiety symptoms similarly to benzodiazepines like diazepam, clorazepate, alprazolam, and lorazepam[3].

Mechanism of Action and Delayed Onset

The therapeutic action of buspirone is primarily through its interaction with serotonin 5-HT1A autoreceptors. It acts as a potent agonist, initially causing activation and inhibition of 5-HT release, followed by desensitization of these autoreceptors, which enhances 5-HT release over time. This mechanism explains the delayed onset of action, typically observed within 2 to 4 weeks[4].

Long-Term Use and Safety

While the clinical effectiveness of long-term use (beyond 3 to 4 weeks) has not been extensively demonstrated in controlled trials, studies have shown no significant adverse events in patients receiving buspirone for up to a year[4].

Current Clinical Trials

Ongoing Studies

Several clinical trials are currently underway to further explore the efficacy and safety of buspirone hydrochloride. For instance, Johns Hopkins University and the University of Oxford are conducting Phase 2 trials, while Valenta Pharm JSC is involved in a Phase 3 trial[5].

Market Analysis

Global Market Size and Growth

The global buspirone hydrochloride market is anticipated to grow significantly. The anxiety disorder treatment market, which includes buspirone, is projected to reach $16.4 billion by 2031. This growth is driven by increasing awareness and diagnosis of anxiety disorders, as well as the expanding need for effective anxiolytic treatments[5].

Regional Analysis

The market analysis includes a detailed regional breakdown, highlighting the market size, share, and growth rate for each region. This analysis helps in identifying key markets and opportunities for buspirone hydrochloride[2].

Competitor Analysis

The global buspirone hydrochloride market is characterized by a competitive landscape with multiple players. The competitor analysis provides insights into the market share, strategies, and performance of key competitors, helping in understanding the market dynamics[2].

Market Projections

Forecast Period

The market forecast for buspirone hydrochloride extends from 2025 to 2031, with the base year being 2023. This period is expected to see significant growth driven by increasing demand and expanding market reach[2].

Drivers and Restraints

Key drivers for the market include the rising prevalence of anxiety disorders, the need for non-benzodiazepine anxiolytics, and the growing awareness of mental health. Restraints may include competition from other anxiolytic medications and regulatory challenges[2].

Segment Analysis

The market is segmented based on type, application, and region. By type, the market is divided into different formulations of buspirone hydrochloride, with tablets being the most common. The application segment includes various anxiety disorders, with GAD being the primary indication[2].

Technological and Regulatory Trends

Patent Analysis

Buspirone hydrochloride has several patent applications and entries, including 986 patent applications and 23 New Drug Applications (NDAs). This indicates ongoing research and development in the field[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market growth of buspirone hydrochloride. Compliance with regulatory standards and approvals from health authorities are essential for market expansion[5].

Consumer Behavior and ESG Analysis

Consumer Behavior

Consumer behavior analysis reveals an increasing preference for non-benzodiazepine anxiolytics due to their lower potential for abuse and dependence. This trend is expected to drive the demand for buspirone hydrochloride[2].

ESG Analysis

The Environmental, Social, and Governance (ESG) analysis highlights the sustainability and ethical practices of companies involved in the production and distribution of buspirone hydrochloride. This analysis is crucial for investors and stakeholders[2].

Key Takeaways

  • Efficacy and Safety: Buspirone hydrochloride is effective in treating GAD with a unique mechanism of action and a favorable safety profile.
  • Market Growth: The global market for buspirone hydrochloride is projected to grow significantly, driven by increasing demand and awareness of anxiety disorders.
  • Clinical Trials: Ongoing clinical trials are exploring the efficacy and safety of buspirone hydrochloride in various settings.
  • Regulatory and Technological Trends: The market is influenced by patent applications, regulatory approvals, and technological advancements.
  • Consumer Preferences: Consumers are increasingly preferring non-benzodiazepine anxiolytics, driving the demand for buspirone hydrochloride.

FAQs

What is the primary indication for buspirone hydrochloride?

Buspirone hydrochloride is primarily indicated for the treatment of Generalized Anxiety Disorder (GAD).

How does buspirone hydrochloride differ from benzodiazepines?

Buspirone hydrochloride lacks the hypnotic, anticonvulsant, and muscle relaxant properties of benzodiazepines and has a lower potential for abuse and dependence[3].

What is the typical dosage range for buspirone hydrochloride?

The typical dosage range for buspirone hydrochloride is 15 to 30 mg/day, often administered in divided doses[1].

What are the common side effects of buspirone hydrochloride?

Common side effects include nausea, vomiting, dizziness, and drowsiness, although these are generally less frequent and severe compared to benzodiazepines[4].

Is buspirone hydrochloride effective for long-term use?

While the long-term efficacy beyond 3 to 4 weeks has not been extensively demonstrated, studies have shown no significant adverse events in patients receiving buspirone for up to a year[4].

Sources

  1. DailyMed: BUSPIRONE HCL- buspirone hydrochloride tablet.
  2. Cognitive Market Research: Global Buspirone Hydrochloride Market Report 2024 Edition.
  3. PubMed: Buspirone. A preliminary review of its pharmacological properties.
  4. DrugBank: Buspirone: Uses, Interactions, Mechanism of Action.
  5. Drug Patent Watch: BUSPIRONE HYDROCHLORIDE - Generic Drug Details.

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