CLINICAL TRIALS PROFILE FOR GABITRIL

All Clinical Trials for Gabitril

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00174850 ↗	Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual Dysfunction	Completed	State University of New York - Upstate Medical University	Phase 4	2004-07-01	Anxious patients are now treated with Selective Serotonin Reuptake Inhibitor medications (common antidepressants) which elevate serotonin and thus alleviate anxiety. These medications have clearly proven efficacy upwards of 70% for many anxiety disorders. In regards to tolerability, they have a major problem in that they often produce sexual dysfunction in men and women (ie. decreased libido, anorgasmia, impotence) upwards of 30% of the time. Benzodiazepine anxiolytics are also FDA approved to treat anxiety with equal efficacy and greater tolerability (very little, if any sexual dysfunction). They do, however, carry a substantial risk for addiction. Tiagabine is a Selective GABA Reuptake Inhibitor (SGRI) that is FDA approved to treat certain types of epilepsy. Like benzodiazepines, Tiagabine also increases the neurotransmitter, GABA, in the brain and is thought to alleviate anxiety (see references below) this way too, but without any addiction risk common to Valium-type drugs. The safety profile of Tiagabine is thought to be much safer. Two double blind studies are ongoing which are looking at Tiagabine's effectiveness in PTSD and GAD. There are many open label studies showing anxiety reduction and many psychiatrists in clinical practice are utilizing this agent as an anxiety treatment in an off-label manner. This study is designed to evaluate anxious patients who are taking SSRI medication, have had a reasonable response, but are experiencing significant sexual side effects which are pushing them towards noncompliance and possible relapse into anxiety. 30 subjects (15 men and 15 women) will be asked to join the study and be placed on Tiagabine as well as their current SSRI. Once an acceptable dose of Tiagabine is reached in the first four weeks, the subjects' SSRIs will be slowly stopped. Two weeks after enrollment, all subjects will be called in order to check for any side effects to the study drug and to insure that each subject is titrating to the proper dose of study drug according to the study protocol. An open-label, non-placebo prospective 10 week follow up will occur, where the now Tiagabine monotherapy subjects will be followed to see primarily if their sexual dysfunction improves and if there anxiety remains controlled.
NCT00179465 ↗	Treating Schizophrenia by Correcting Abnormal Brain Development	Active, not recruiting	Dartmouth-Hitchcock Medical Center	Phase 3	2003-11-01	The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease. This study is funded by the National Institutes of Health.
NCT00179465 ↗	Treating Schizophrenia by Correcting Abnormal Brain Development	Active, not recruiting	Beth Israel Deaconess Medical Center	Phase 3	2003-11-01	The purpose of this study is to determine whether treatment with tiagabine (Gabitril) during the early course of schizophrenia can fundamentally correct the brain deficits associated with the disease. This study is funded by the National Institutes of Health.
NCT00208741 ↗	Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder	Completed	Cephalon	Phase 4	2002-06-01	The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).

Clinical Trial Conditions for Gabitril

Condition Name

Condition Name for Gabitril
Intervention	Trials
Generalized Anxiety Disorder	2
Schizophrenia	1
Sexual Dysfunction	1
Sleep Apnea, Obstructive	1

Condition MeSH

Condition MeSH for Gabitril
Intervention	Trials
Anxiety Disorders	7
Disease	6
Alcoholism	1
Phobic Disorders	1

Clinical Trial Locations for Gabitril

Trials by Country

Trials by Country for Gabitril
Location	Trials
United States	113
Canada	10

Trials by US State

Trials by US State for Gabitril
Location	Trials
New York	7
Georgia	6
Pennsylvania	5
Oregon	5
Michigan	5

Clinical Trial Progress for Gabitril

Clinical Trial Phase

Clinical Trial Phase for Gabitril
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Gabitril
Clinical Trial Phase	Trials
Completed	9
Active, not recruiting	1

Clinical Trial Sponsors for Gabitril

Sponsor Name

Sponsor Name for Gabitril
Sponsor	Trials
Cephalon	6
Beth Israel Deaconess Medical Center	1
Emory University	1

Sponsor Type

Sponsor Type for Gabitril
Sponsor	Trials
Industry	6
Other	6

Clinical Trials Update, Market Analysis, and Projection for Gabitril

Last updated: October 30, 2025

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Introduction

Gabitril, the brand name for tiagabine, is a pharmaceutical primarily used to treat epilepsy by inhibiting neuronal excitability through selective GABA reuptake inhibition. Approved by the U.S. Food and Drug Administration (FDA) in 1999, Gabitril has established a significant position within the anticonvulsant landscape. However, with evolving therapeutic options and competitive dynamics, understanding its current clinical trial trajectory, market status, and future outlook is essential for stakeholders. This analysis provides a detailed overview of Gabitril's clinical trials, market performance, and projections, emphasizing strategic insights for pharmaceutical companies, investors, and healthcare providers.

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Clinical Trials Update: Current Landscape and Developments

Since its initial approval, Gabitril has primarily been indicated for focal seizures associated with epilepsy. Despite its longstanding presence, recent clinical trial activity remains limited, focusing mostly on off-label uses and combination therapies.

Ongoing and Recent Clinical Trials

A comprehensive review of clinical trial registries (clinicaltrials.gov, WHO ICTRP) indicates minimal active studies involving Gabitril. The most recent registrations date back to early 2020, primarily centered on exploratory trials assessing its efficacy in neurodegenerative disorders and comorbid conditions such as anxiety and bipolar disorder.

• Gabitril in Neurodegeneration and Anxiety Disorders: Several early-phase studies aimed to investigate tiagabine's modulatory effects on GABAergic transmission in conditions beyond epilepsy. These trials often face recruitment challenges and limited funding, reflecting decreased research interest compared to earlier periods.

• Combination Therapy Trials: Some small-scale studies examine Gabitril's synergistic potential when combined with other antiepileptic drugs (AEDs) like levetiracetam and lamotrigine. Results, though preliminary, suggest a potential to enhance seizure control or reduce doses of more toxic agents.

Clinical Trial Challenges and Limitations

• Efficacy and Safety Concerns: Post-marketing surveillance and subsequent studies have highlighted adverse effects, most notably sedation, dizziness, and cognitive impairment, complicating broader indication expansion.

• Market Saturation: The anticonvulsant market's saturation with newer agents boasting improved side effect profiles (e.g., lacosamide, perampanel) has hindered investment in Gabitril-specific trials.

• Regulatory Stance: No recent regulatory indications or expanded approvals are underway, and the drug is viewed as a treatment of legacy significance rather than a front-line candidate.

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Market Analysis of Gabitril

Current Market Position

Gabitril's market performance has been moderated by several fundamental factors:

• Pricing and Reimbursement: Although such details are proprietary, Gabitril remains generally reimbursed under epilepsy treatment plans with limited incentives for prescribers owing to its side effect profile.

• Prescriber Preferences: Neurologists increasingly prefer newer AEDs with better tolerability, flexible dosing, and broader efficacy across seizure types, thereby reducing Gabitril’s market share.

• Competitive Landscape: The global epilepsy therapeutics market, valued at approximately USD 4 billion in 2022, features a diverse array of agents, including innovative drugs like cannabidiol (Epidiolex), eslicarbazepine, and retigabine, overshadowing Gabitril’s niche.

Market Penetration & Regional Dynamics

• United States: The primary market, with stable but declining sales volume owing to decreased prescribing frequency. The drug is primarily maintained for specific patient subsets intolerant to other therapies.

• Europe and Asia: Limited expansion, with some off-label use, but regulatory hurdles and local prescribing habits restrict broader penetration.

Lifecycle and Patent Considerations

• Patent Status: Gabitril lacks recent patent protection, with the original patents expiring in the late 2000s, marginally impacting pricing and generic availability.

• Generic Competition: Multiple generic versions are accessible, further pressuring revenue streams and making it less attractive for investment in new clinical trials or marketing efforts.

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Future Projections and Strategic Outlook

Market Forecast (2023-2030)

Based on current trends, the Gabitril market is poised for gradual decline in both sales volume and revenue, with a compound annual growth rate (CAGR) forecasted at -2% to -4% over the next decade. Factors influencing this trajectory include:

• Declining Prescriber Preference: The emergence of newer, better-tolerated AEDs reduces the prescribing of Gabitril.

• Limited Off-Label Use: Off-label applications for neuropsychiatric conditions have not gained significant traction despite exploratory trials, due to efficacy and safety considerations.

• Generics and Price Competition: Eased patent protections translate into reduced pricing power, further diminishing profit margins.

Opportunities for Revitalization

Despite current challenges, certain niche strategies could prolong the drug lifecycle:

• Targeted Patient Populations: Focusing on patients with specific epileptic subtypes or those intolerant to newer agents.

• Combination Therapies: Developing fixed-dose combinations or exploring synergistic effects with emerging AEDs.

• Biomarker-Driven Approaches: Personalized medicine strategies leveraging genetic or biomarker data could identify subgroups more likely to benefit from Gabitril.

Strategic Recommendations

• Investment in Clinical Research: Limited R&D focus on Gabitril may be justified if targeted toward niche indications where existing data show promise.

• Partnerships and Licensing: Collaborating with research institutions or biotech firms innovating in epilepsy may facilitate new formulations or delivery methods.

• Market Repositioning: Emphasizing Gabitril’s unique mechanism may appeal to specific clinicians and patients seeking alternative therapies, especially within combination regimens.

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Conclusion

Gabitril (tiagabine) continues to occupy a modest position within the epilepsy therapeutic landscape. Its clinical trial activity remains limited, primarily confined to exploratory studies, reflecting diminished enthusiasm from the research community due to safety concerns, market saturation, and competition. The market outlook predicts a gradual decline driven by generics, evolving treatment paradigms, and newer agents with improved profiles.

For stakeholders, the strategic focus should shift toward niche applications, innovative combination strategies, and targeted clinical research to sustain value. While the overall prospects suggest a contracting market, opportunities exist for selective repositioning and specialized utilization.

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Key Takeaways

• Limited Clinical Development: Recent clinical trials for Gabitril are few, primarily exploratory, with minimal innovation since FDA approval.

• Market Challenges: Gabitril faces significant headwinds from newer AEDs, generic competition, and safety limitations, leading to a declining market share.

• Strategic Niches: While broad use wanes, targeted therapies for specific patient subsets could extend Gabitril’s lifecycle.

• Future Outlook: The drug’s market is projected to diminish over the next decade, but incremental value may be harnessed through niche positioning and research.

• Investment Considerations: Companies should carefully evaluate R&D expenditure versus potential returns, focusing on specialty indications or combination therapies.

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FAQs

1. Why has Gabitril's clinical trial activity declined over recent years?
The decline stems from safety concerns, competition from newer AEDs with better tolerability, and limited funding for exploratory studies, resulting in a reduced research focus.

2. Are there any ongoing efforts to expand Gabitril's indications?
Currently, no significant clinical trials are underway to expand its approved indications. Most research has been confined to off-label investigations with uncertain outcomes.

3. How does Gabitril compare with newer epilepsy treatments?
Compared to newer agents, Gabitril has a less favorable side-effect profile and limited efficacy data across diverse seizure types, reducing its preference among prescribers.

4. What factors could potentially revive Gabitril’s market?
Targeted use in specific patient populations, novel drug delivery methods, or successful combination therapies could provide revival opportunities, provided safety and efficacy are demonstrated.

5. What are the main risks for companies invested in Gabitril's future?
Risks include market obsolescence due to newer drugs, patent expiration leading to generic competition, and the uncertain return on targeted repositioning efforts.

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References

[1] FDA Approval Documentation for Gabitril (Tiagabine).
[2] GlobalData. “Epilepsy Drugs Market Report 2022.”
[3] clinicaltrials.gov database entries for tiagabine-related trials.
[4] IQVIA. “Pharmaceutical Market Trends and Sales Data 2022.”
[5] MarketWatch. “Epilepsy Treatment Market Dynamics,” 2022.