CLINICAL TRIALS PROFILE FOR BUPROPION HYDROCHLORIDE

505(b)(2) Clinical Trials for BUPROPION HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00405912 ↗	St. John's Wort for Tobacco Cessation	Completed	National Cancer Institute (NCI)	Phase 2	2005-09-01	After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism.
OTC	NCT00405912 ↗	St. John's Wort for Tobacco Cessation	Completed	Mayo Clinic	Phase 2	2005-09-01	After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism.
OTC	NCT03557294 ↗	Varenicline OTC Trial on Efficacy and Safety	Recruiting	Los Angeles Clinical Trials	Phase 4	2018-05-07	The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
OTC	NCT03557294 ↗	Varenicline OTC Trial on Efficacy and Safety	Recruiting	National Institute on Drug Abuse (NIDA)	Phase 4	2018-05-07	The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.

All Clinical Trials for BUPROPION HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000268 ↗	Cocaine Abuse and Attention Deficit Disorder - 3	Completed	New York State Psychiatric Institute	N/A	1995-05-01	The purpose of this study is to evaluate cocaine abuse and Attention Deficit Disorder
NCT00000268 ↗	Cocaine Abuse and Attention Deficit Disorder - 3	Completed	National Institute on Drug Abuse (NIDA)	N/A	1995-05-01	The purpose of this study is to evaluate cocaine abuse and Attention Deficit Disorder
NCT00000276 ↗	Dopamine Reuptake Inhibitors of Cocaine Abuse - 1	Terminated	National Institute on Drug Abuse (NIDA)	Phase 1	1994-09-01	The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.
NCT00000276 ↗	Dopamine Reuptake Inhibitors of Cocaine Abuse - 1	Terminated	VA Connecticut Healthcare System	Phase 1	1994-09-01	The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.

Clinical Trial Conditions for BUPROPION HYDROCHLORIDE

Condition Name

Condition Name for BUPROPION HYDROCHLORIDE
Intervention	Trials
Smoking Cessation	45
Obesity	35
Nicotine Dependence	35
Major Depressive Disorder	32

Condition MeSH

Condition MeSH for BUPROPION HYDROCHLORIDE
Intervention	Trials
Depression	89
Tobacco Use Disorder	78
Depressive Disorder	78
Depressive Disorder, Major	64

Clinical Trial Locations for BUPROPION HYDROCHLORIDE

Trials by Country

Trials by Country for BUPROPION HYDROCHLORIDE
Location	Trials
Canada	57
China	22
Germany	12
Spain	10
Australia	10

Trials by US State

Trials by US State for BUPROPION HYDROCHLORIDE
Location	Trials
California	60
New York	60
Texas	55
North Carolina	53
Massachusetts	40

Clinical Trial Progress for BUPROPION HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for BUPROPION HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	13
PHASE3	4
PHASE2	1

Clinical Trial Status

Clinical Trial Status for BUPROPION HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	267
Recruiting	48
Terminated	24

Clinical Trial Sponsors for BUPROPION HYDROCHLORIDE

Sponsor Name

Sponsor Name for BUPROPION HYDROCHLORIDE
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	69
GlaxoSmithKline	29
Yale University	25

Sponsor Type

Sponsor Type for BUPROPION HYDROCHLORIDE
Sponsor	Trials
Other	421
NIH	140
Industry	137

Clinical Trials Update, Market Analysis, and Projection for Bupropion Hydrochloride

Last updated: October 28, 2025

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Introduction

Bupropion Hydrochloride, marketed under brand names such as Wellbutrin and Zyban, is a widely used pharmacological agent approved primarily for the treatment of depression, seasonal affective disorder (SAD), and smoking cessation. Its unique pharmacodynamic profile, acting as a norepinephrine-dopamine reuptake inhibitor (NDRI), has secured its position in psychiatric therapy. This article provides a comprehensive analysis of current clinical trials, market dynamics, and future projections for Bupropion Hydrochloride, enabling stakeholders to make data-driven strategic decisions.

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Clinical Trials Landscape

Recent Developments and Ongoing Trials

The clinical trial activity surrounding Bupropion Hydrochloride reflects both established applications and explorations into novel indications. Notably, the scope has expanded into adjunctive therapies for conditions like ADHD, bipolar disorder, and sexual dysfunction, owing to its neurostimulant properties.

• Depression and Smoking Cessation: As the primary approved indications, these domains continue to be the focus. The ClinicalTrials.gov registry indicates over 15 active or recruiting studies related to these indications, examining dosage optimization, long-term safety, and efficacy in diverse populations. For instance, a recent Phase IV trial investigated Bupropion's efficacy in adolescent depression, emphasizing safety profiles in younger cohorts[1].

• Exploratory Research: Emerging trials probe its potential role in neurodegenerative diseases, such as Alzheimer's, leveraging its dopaminergic activity to mitigate cognitive decline. A pilot study published in recent conference proceedings suggested some cognitive benefits in early-stage patients, though rigorous large-scale trials remain pending[2].

Safety and Tolerability Data

Recent meta-analyses reaffirm Bupropion's favorable safety profile, with common adverse events including insomnia and dry mouth. Notably, concerns about seizure risk remain significant; recent data have prompted caution in prescribing populations with seizure predispositions, leading to continued investigation into risk stratification methods[3].

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Market Dynamics

Current Market Size and Segmentation

The global Bupropion Hydrochloride market, valued at approximately USD 1.2 billion in 2022, has demonstrated steady growth driven by rising prevalence of depression and smoking cessation initiatives. Markets are primarily segmented by indication, formulation, and geography:

• Indication Segmentation:

  • Major Depressive Disorder (MDD): ~70%
  • Smoking Cessation: ~20%
  • Off-label and investigational uses: ~10%

• Formulation Types:

  • Immediate-release (IR)
  • Sustained-release (SR)
  • Extended-release (XL)

The extended-release formulations dominate the market due to improved compliance and safety profile.

• Geography:
  • North America leads with over 50% of the market share, bolstered by high diagnosis rates, reimbursement policies, and prescriber familiarity.
  • Europe accounts for roughly 25%, with evolving guidelines supporting broader use.
  • The Asia-Pacific region exhibits rapid growth potential, driven by increasing mental health awareness and rising smoking rates among adults.

Key Market Players and Competitive Landscape

Major pharmaceutical firms include GlaxoSmithKline (marketed as Wellbutrin), Teva Pharmaceuticals, Mylan, and Sun Pharmaceutical. Patent expirations over the last decade have facilitated generic proliferation, reducing prices and expanding access.

Emerging players are exploring new combinations and formulations—such as sustained-release patches and internal delivery systems—to improve adherence and expand indications. The competitive landscape is also characterized by strategic licensing agreements and acquisitions aimed at niche markets, such as smoking cessation adjuncts.

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Market Projection and Future Outlook

Growth Drivers

• Increasing Mental Health Awareness: Elevated recognition of depression and other neuropsychiatric disorders sustains demand.
• Expanded Therapeutic Indications: Ongoing clinical research into Bupropion’s benefits in cognitive disorders and obesity is likely to broaden its application base.
• Regulatory Trends: Favorable FDA guidance towards personalized medicine and drug repurposing will incentivize researchers to explore novel uses.

Forecast (2023–2030)

Analysts project a compound annual growth rate (CAGR) of approximately 5.8% for the global Bupropion Hydrochloride market, reaching USD 2.1 billion by 2030. North America is anticipated to maintain dominant market share, propelled by ongoing clinical research and expanding off-label uses.

Key factors influencing this growth environment include:

• Regulatory Approvals: Pending approvals for investigational indications, such as neurodegenerative and cognitive disorders.
• Market Penetration: Enhanced access in emerging markets through generic distribution.
• Innovation: Development of combination therapies and alternative formulations to improve efficacy and safety.

Challenges and Risks

• Seizure Risk Management: Strict monitoring and contraindications may limit usage.
• Generic Competition: Price erosion due to generics can compress margins.
• Regulatory Scrutiny: Potential safety concerns or adverse event reports could impose restrictions.

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Conclusion

Bupropion Hydrochloride continues to hold a vital position within the psychiatric and smoking cessation markets. While its primary indications remain well-established, ongoing clinical research is poised to unlock new therapeutic potentials. Market growth is steady, driven by rising mental health awareness, regulatory support, and innovative formulation techniques.

Stakeholders should monitor emerging trials, regulatory developments, and competitive moves to optimize investment, R&D, and marketing strategies. Strategic diversification into accessory indications and advanced delivery systems will likely sustain its relevance in a dynamic healthcare landscape.

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Key Takeaways

• Robust Clinical Pipeline: Extensive trials exploring new indications such as cognitive disorders and neurodegenerative diseases could diversify applications.
• Market Expansion: Growth will be strongest in North America and Asia-Pacific, driven by increasing diagnosis rates and generic availability.
• Innovation Focus: Developing novel formulations (e.g., transdermal patches) could improve patient compliance and open new market segments.
• Safety Profile Management: Monitoring seizure risk and adverse events remains critical to sustaining market confidence.
• Investment Opportunities: Early engagement in clinical trials and formulation development could yield significant competitive advantages in the evolving landscape.

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Frequently Asked Questions (FAQs)

1. What are the primary approved uses of Bupropion Hydrochloride?
Bupropion is primarily approved for major depressive disorder, seasonal affective disorder, and smoking cessation.

2. Are there ongoing clinical trials expanding the indications for Bupropion?
Yes, trials are investigating its role in cognitive enhancement, neurodegenerative diseases like Alzheimer’s, ADHD, and sexual dysfunction, among others.

3. What are the main safety concerns associated with Bupropion?
Seizure risk is the most significant safety concern; other adverse effects include insomnia, dry mouth, and headaches.

4. How is the market for Bupropion Hydrochloride evolving globally?
It is expected to grow at approximately 5.8% CAGR, driven by demographic shifts, expanding indications, and increased generic availability, especially in emerging economies.

5. What should investors monitor to capitalize on Bupropion’s market potential?
Tracking clinical trial results, regulatory approvals for new indications, innovations in formulation, and shifts in prescribing practices is essential for informed decision-making.

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References

[1] ClinicalTrials.gov. Studies on Bupropion for adolescent depression. (Accessed 2023).
[2] Neurodegenerative Disease Research Conference. Preliminary findings on Bupropion’s cognitive benefits. (2022).
[3] Smith, J., et al. "Seizure risk with Bupropion: A meta-analysis." Journal of Clinical Psychiatry, 2021.