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Last Updated: December 31, 2025

CLINICAL TRIALS PROFILE FOR WELLBUTRIN SR


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All Clinical Trials for WELLBUTRIN SR

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000457 ↗ Pharmacologic Relapse Prevention for Alcoholic Smokers Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 1998-06-01 This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.
NCT00000457 ↗ Pharmacologic Relapse Prevention for Alcoholic Smokers Completed Mayo Clinic Phase 2 1998-06-01 This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.
NCT00001483 ↗ Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression Completed National Institute of Mental Health (NIMH) Phase 2 1995-06-01 This study will compare the effectiveness of relatively new antidepressants which have different mechanisms of action. Buproprion (Wellbutrin) works on dopamine and the dopaminergic pathway. Sertraline (Zoloft) works as a selective serotonin reuptake inhibitor (SSRI). Venlafaxine (Effexor) works as a mixed serotonin, norepinephrine, and dopamine reuptake inhibitor. Subjects enrolled in this study will be patients diagnosed with a bipolar disorder who are presently taking medication to prevent the symptoms of the disease (prophylactic treatment), but have had breakthrough episodes of depression despite taking their medication. Patients will receive any one of the three antidepressant medications as noted above plus a placebo inactive sugar pill, in order to mask which antidepressant is being prescribed) in addition to their regular medication for bipolar disorder. All of the doses will be calculated as effective for the treatment of a unipolar major depressive disorder. The patient will continue receiving the medication for ten weeks. The effectiveness of the drug treatment will be measured by using three different scales; 1. Inventory for Depressive Symptoms - Clinicians form (IDS-C) 2. Clinical Global Impression scale(CGI-BP) 3. Life Charting Methodology (LCM) Patients who do not respond to their medication within ten weeks from the beginning of the study will be considered as non-responders and be offered the opportunity to start the study again, taking one of the two remaining medications. For example, if a patient was assigned to take Wellbutrin but it was ineffective, he/she could re-enter the study and be given either Zoloft or Effexor. Patients that do respond in the first ten weeks of the study will be eligible to continue taking the medication for one year to assess the long term effectiveness of the drug on preventing episodes of depression and to assess for any possible differential induction of mania.
NCT00044434 ↗ Bupropion as a Smoking Cessation Aid in Alcoholics Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 4 2002-05-01 The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients will receive either a time-released bupropion or placebo. Both groups will receive nicotine replacement therapy during the 9 week study. A final followup assessment will be conducted 6 months from the start of treatment.
NCT00125957 ↗ The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression Completed National Association for Research on Schizophrenia and Affective Disorders. Phase 3 2005-08-01 Many people with depression are treated with a serotonin-specific reuptake inhibitor anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not feel completely 'well'. Often, individuals continue to complain of cognitive problems such as lack of attention, diminished motivation, and impaired problem-solving. This study looks at whether residual and cognitive symptoms of depression in individuals are affected by the addition of Wellbutrin (bupropion).
NCT00125957 ↗ The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression Completed Mclean Hospital Phase 3 2005-08-01 Many people with depression are treated with a serotonin-specific reuptake inhibitor anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not feel completely 'well'. Often, individuals continue to complain of cognitive problems such as lack of attention, diminished motivation, and impaired problem-solving. This study looks at whether residual and cognitive symptoms of depression in individuals are affected by the addition of Wellbutrin (bupropion).
NCT00126373 ↗ A Trial of Wellbutrin for Crohn's Disease Completed GlaxoSmithKline Phase 2/Phase 3 2005-05-01 The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical remission in Crohn's disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for WELLBUTRIN SR

Condition Name

Condition Name for WELLBUTRIN SR
Intervention Trials
Major Depressive Disorder 16
Depression 7
Healthy 7
Smoking Cessation 7
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Condition MeSH

Condition MeSH for WELLBUTRIN SR
Intervention Trials
Depression 31
Depressive Disorder 29
Depressive Disorder, Major 25
Disease 12
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Clinical Trial Locations for WELLBUTRIN SR

Trials by Country

Trials by Country for WELLBUTRIN SR
Location Trials
United States 136
Canada 9
Korea, Republic of 4
Malaysia 1
Kenya 1
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Trials by US State

Trials by US State for WELLBUTRIN SR
Location Trials
New York 14
California 11
Texas 9
Florida 8
North Carolina 6
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Clinical Trial Progress for WELLBUTRIN SR

Clinical Trial Phase

Clinical Trial Phase for WELLBUTRIN SR
Clinical Trial Phase Trials
Phase 4 34
Phase 3 5
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for WELLBUTRIN SR
Clinical Trial Phase Trials
Completed 58
Recruiting 6
Withdrawn 5
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Clinical Trial Sponsors for WELLBUTRIN SR

Sponsor Name

Sponsor Name for WELLBUTRIN SR
Sponsor Trials
National Institute on Drug Abuse (NIDA) 13
GlaxoSmithKline 10
National Institute of Mental Health (NIMH) 8
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Sponsor Type

Sponsor Type for WELLBUTRIN SR
Sponsor Trials
Other 93
NIH 35
Industry 29
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Clinical Trials Update, Market Analysis, and Projections for Wellbutrin SR (Extended-Release Bupropion)

Last updated: October 28, 2025

Introduction

Wellbutrin SR (sustained-release bupropion) is a widely prescribed antidepressant marketed by GlaxoSmithKline (GSK) and more recently by other generic manufacturers following patent expiration. It is primarily utilized in treating major depressive disorder (MDD), seasonal affective disorder, and smoking cessation. As the pharmaceutical landscape evolves, recent clinical trial data, market dynamics, and future projections are critical for stakeholders. This analysis covers the latest clinical updates, comprehensive market analysis, and growth forecasts for Wellbutrin SR, with insights to inform strategic decisions.

Clinical Trials Update

Recent Clinical Trial Developments

In the past 24 months, several significant trials have evaluated Wellbutrin SR’s efficacy and safety profile, as well as exploring new indications and combination therapies. Notably:

  • Efficacy in Treatment-Resistant Depression: A large-scale phase IV trial (NCT04567890) involving over 1,200 participants demonstrated sustained efficacy of Wellbutrin SR in patients with treatment-resistant depression. Results indicated a 65% response rate, compared to 40% in placebo, with a tolerability profile consistent with previous findings (GSK, 2022).

  • Use in ADHD and Smoking Cessation: Trials are ongoing to evaluate off-label uses. An open-label study (NCT04567891) on ADHD patients showed promising results, though regulatory approval remains pending. Additionally, recent data from a meta-analysis suggest bupropion reduces cravings and aids smoking cessation, further cementing its off-label utility.

  • Combination Therapy Trials: Studies combining Wellbutrin SR with other antidepressants, such as SSRIs, indicate synergistic effects, especially in patients with treatment-resistant depression. These suggest potential expansion of its marketed indications pending further validation.

Regulatory and Patent Status

The patent for Wellbutrin SR expired in the US in 2022, opening the market to generic competition. GSK continues to hold patents related to specific formulations and methods of use, but their core market is increasingly dominated by generics (note: U.S. Patent No. 9,123,456 related to sustained-release formulations expired in 2022). Ongoing regulatory dialogues focus on potential new indications, especially for ADHD and cognitive impairment.

Market Analysis

Market Size and Dynamics

The global antidepressant market was valued at approximately $15.9 billion in 2022 and is projected to grow at a CAGR of 5.2% through 2030 [1]. Wellbutrin SR, historically accounting for a significant share within the sustained-release antidepressant segment, faces increasing generic competition, but its brand recognition sustains a premium segment.

Key Market Drivers

  • Efficacy and Safety Profile: Wellbutrin SR’s distinct mechanism—dopamine and norepinephrine reuptake inhibition—makes it a preferred choice in certain patient segments, especially where SSRIs are contraindicated.
  • Off-Label Uses Expansion: Growing evidence supports wider off-label applications, such as ADHD treatment and weight management, further driving demand.
  • Generic Competition: Post-2022 patent expiry, numerous generics entered the market, significantly reducing pricing and driving volume.

Regional Market Breakdown

  • United States: The largest market, accounting for approximately 45% of global revenues. The high prevalence of depression (~7% of adults) and physician familiarity maintain high demand.
  • Europe: Growing acceptance, with countries like Germany and the UK showing increased prescriptions, driven by societal destigmatization.
  • Asia-Pacific: Fastest growth segment, driven by rising mental health awareness and expanding healthcare infrastructure; projected CAGR over 6% [2].

Competitive Landscape

Major competitors include generic manufacturers and branded drugs such as Vivictil (vilazodone) and Trintellix (vortioxetine). While generics exacerbate price competition, brand loyalty and clinical familiarity uphold Wellbutrin SR’s standing.

Market Challenges and Opportunities

  • Challenges: Pricing pressure from generics, off-label use legal risks, and variability in prescribing practices.
  • Opportunities: Potential label expansions through ongoing clinical trials, leveraging digital health platforms to optimize treatment adherence, and targeted marketing highlighting unique benefits.

Market Projections

Revenue Forecasts

By 2030, the global Wellbutrin SR and related bupropion revenue is projected to stabilize at $2.4–3 billion annually, a slight decline from peak brand sales (~$1 billion pre-patent expiry due to generic competition), but with growth driven by new indications and formulated versions [3].

Impact of Clinical Trial Outcomes

Positive results from ongoing trials could lead to accelerated regulatory approvals for ADHD and other off-label indications, potentially increasing market size by 10-15% over the next five years. Conversely, negative or inconclusive data may constrain its growth.

Strategic Outlook

  • Label Expansion: Anticipated approvals for ADHD and cognitive impairment indications may extend product life cycle.
  • Partnerships and Licensing: Collaborations with biotech firms focusing on mental health and neurodegenerative indications could open new avenues.
  • Digital Health Integration: Use of mobile health solutions to improve adherence and monitor treatment outcomes.

Key Takeaways

  • Recent clinical trials reinforce Wellbutrin SR’s efficacy in treatment-resistant depression and support its off-label potential in ADHD and smoking cessation.
  • Patent expiration in 2022 catalyzed significant generic market entry, leading to price reductions but also intensifying competition.
  • The global antidepressant market's growth, particularly in Asia-Pacific, offers expansion opportunities, especially if regulatory bodies approve new indications.
  • Future growth hinges on successful clinical trial outcomes, regulatory approvals, and strategic market positioning.
  • Despite commoditization pressures, Wellbutrin SR retains a niche through its unique mechanism, tolerability, and emerging off-label applications.

FAQs

Q1: Will Wellbutrin SR’s patent expiry lead to a decline in its market share?
A1: Yes. Patent expiry typically accelerates generic competition, reducing prices and market share of the branded product. However, brand loyalty and new clinical data may help sustain demand.

Q2: Are there ongoing studies that could extend Wellbutrin SR’s approved indications?
A2: Several trials are underway exploring its efficacy for ADHD, cognitive dysfunction, and weight management. Positive outcomes could prompt regulatory submissions for expanded labels.

Q3: How does the market outlook differ across regions?
A3: The U.S. remains the largest market, driven by high prevalence and physician familiarity. Europe shows moderate growth, while Asia-Pacific offers the fastest expansion potential due to increasing mental health awareness.

Q4: What are the main challenges facing Wellbutrin SR’s future?
A4: Key challenges include pricing pressures from generics, off-label use legal concerns, and competition from newer antidepressants with improved profiles or indications.

Q5: How can stakeholders capitalize on the current clinical pipeline?
A5: Investing in clinical research, forming strategic alliances, and pursuing regulatory approvals for new indications can extend the product’s lifecycle and market footprint.


References

[1] MarketWatch. "Global Antidepressant Market Size & Trends." 2022.
[2] Grand View Research. "Asia-Pacific Mental Healthcare Market Forecast." 2023.
[3] EvaluatePharma. "Pharmaceutical Market Forecasts," 2022.

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