CLINICAL TRIALS PROFILE FOR GABAPENTIN

505(b)(2) Clinical Trials for GABAPENTIN

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
New Combination	NCT00236223 ↗	The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery	Terminated	Glostrup University Hospital, Copenhagen	Phase 4	2005-10-01	Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.
OTC	NCT00659100 ↗	A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment	Completed	Pfizer	Phase 3	2006-08-01	The purpose of this study is to assess consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.
OTC	NCT00659100 ↗	A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	2006-08-01	The purpose of this study is to assess consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.

All Clinical Trials for GABAPENTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001482 ↗	New Drugs in the Treatment of Mood Disorders	Completed	National Institute of Mental Health (NIMH)	Phase 2	1995-05-01	This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal) Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so that we examine possible clinical and biological factors predictors of response. The drugs will be given in a randomized order for six weeks each and you will not know when you are on a given one. There will be a 2-4 week "washout" period between treatments. If you respond well to one of these treatments, a longer open continuation period will be offered at the end of this study. This would involve one or both drugs in combination. A variety of rating scales and brain imaging procedures will also be offered before and during each drug evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine, however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually mild, and resolve with continued time on the drug or a decrease in dosage.
NCT00006773 ↗	Bortezomib in Treating Patients With Recurrent Glioma	Terminated	National Cancer Institute (NCI)	Phase 1	2001-05-01	Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
NCT00007670 ↗	Does Gabapentin and Lamotriginel Have Significantly Fewer Side-Effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly.	Completed	Glaxo Wellcome	Phase 3	1998-01-01	New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly.

Clinical Trial Conditions for GABAPENTIN

Condition Name

Condition Name for GABAPENTIN
Intervention	Trials
Pain, Postoperative	39
Pain	34
Postoperative Pain	25

Condition MeSH

Condition MeSH for GABAPENTIN
Intervention	Trials
Pain, Postoperative	94
Neuralgia	51
Syndrome	26

Clinical Trial Locations for GABAPENTIN

Trials by Country

Trials by Country for GABAPENTIN
Location	Trials
United States	734
Egypt	49
Japan	45
Canada	42
Brazil	17

Trials by US State

Trials by US State for GABAPENTIN
Location	Trials
California	57
New York	42
Florida	35
Texas	34
Pennsylvania	34

Clinical Trial Progress for GABAPENTIN

Clinical Trial Phase

Clinical Trial Phase for GABAPENTIN
Clinical Trial Phase	Trials
PHASE4	11
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for GABAPENTIN
Clinical Trial Phase	Trials
Completed	293
Recruiting	78
Unknown status	49

Clinical Trial Sponsors for GABAPENTIN

Sponsor Name

Sponsor Name for GABAPENTIN
Sponsor	Trials
Pfizer	36
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	20
XenoPort, Inc.	17

Sponsor Type

Sponsor Type for GABAPENTIN
Sponsor	Trials
Other	557
Industry	144
NIH	60

Gabapentin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Gabapentin, initially developed for epilepsy, now primarily treats neuropathic pain and off-label conditions such as anxiety and insomnia. As a cornerstone in neurological therapeutics, gabapentin's market dynamics are influenced by ongoing clinical investigations, regulatory shifts, and evolving consumer and prescriber trends. This report consolidates recent clinical trial developments, current market status, and future outlook to assist stakeholders in strategic planning and investment decisions.

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Clinical Trials Update

Current Landscape of Gabapentin Research

Despite its longstanding approval by the U.S. Food and Drug Administration (FDA) in 1993 for epilepsy, gabapentin’s clinical research activity persists, especially exploring new indications, formulations, and risk mitigation strategies. According to ClinicalTrials.gov, as of 2023, approximately 45 active or recruiting studies focus on gabapentin.

Key Clinical Trials and Developments

• Neuropathic Pain and Postherpetic Neuralgia: Numerous Phase IV studies evaluate long-term efficacy and safety; recent trials examine combination therapies for refractory cases, such as gabapentin paired with opioids or antidepressants [1].

• Off-Label Investigations: Several trials explore gabapentin for anxiety disorders, bipolar disorder, insomnia, and alcohol dependence. Notably, a randomized controlled trial (RCT) published in 2022 evaluated gabapentin for generalized anxiety disorder, indicating modest benefits but caution regarding side effects [2].

• Formulation Innovations: Novel formulations, such as extended-release (XR) and generic combinations, aim to optimize bioavailability and adherence. For instance, a 2021 trial assessed a once-daily XR gabapentin for diabetic peripheral neuropathy, showing improved patient compliance [3].

• Safety and Dependency Research: Given concerns about abuse potential, ongoing studies examine gabapentin’s misuse in vulnerable populations, alongside risk mitigation strategies. A retrospective analysis from 2022 emphasized increased prescribing amidst burgeoning misuse concerns [4].

Regulatory and Guidelines Impact

Recent regulatory reviews in the U.S. and Europe have emphasized cautious prescribing, with some states classifying gabapentin as a controlled substance, paralleling opioid risk management policies. Such measures influence prescribing patterns and future clinical trial priorities.

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Market Analysis

Current Market Size and Segment Breakdown

The global gabapentin market was valued at approximately $4.8 billion in 2022 and is projected to expand at a CAGR of around 4.2% through 2030. The North American region dominates, accounting for roughly 45% of sales, driven by high prevalence of neuropathic pain conditions and established prescribing habits [5].

Major Market Drivers

• Prevalence of Neurological Conditions: Increasing incidence of diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), and fibromyalgia sustains demand.

• Off-Label Use and Prescriber Trends: Despite regulatory scrutiny, off-label prescriptions for anxiety, insomnia, and other off-label indications persist, bolstering revenue streams.

• Generic Market Penetration: As patent exclusivity waned, generic versions flooded markets, reducing costs and expanding accessibility. The generic segment accounts for nearly 85% of the current market share.

• Expansion in Developing Markets: Increased awareness and healthcare infrastructure development propel growth in Asia-Pacific and Latin America, with projected CAGR of 5.0% over the next decade.

Market Challenges

• Regulatory and Prescriber Hesitance: Emerging regulations categorizing gabapentin as a controlled substance impose restrictions, potentially curbing growth.

• Adverse Effect Profile: Side effects such as dizziness, somnolence, and risk of misuse limit off-label prescribing and generate liability concerns.

• Competition and Alternatives: Increasing availability of other neuromodulators, such as pregabalin and duloxetine, provides competitive alternatives, marginally impacting gabapentin’s dominance.

Market Outlook and Projections

Forecasted Trends (2023-2030)

• The market should maintain steady growth driven by expanding indications, especially if new formulations prove superior in efficacy or tolerability.

• Emerging Indications: Evidence-based expansion to conditions like restless leg syndrome and certain psychiatric disorders could unlock additional revenue streams.

• Regulatory Environment: Potential reclassification in select jurisdictions may temporarily constrain growth but could also strengthen market stability if guidelines are harmonized.

• Pricing and Reimbursement: Price sensitivity remains high; however, increasing insurance coverage, especially in developed nations, should sustain sales.

Strategic Opportunities

• Novel Formulations: Development of abuse-deterrent, extended-release, or combination products.

• Personalized Medicine: Integrating pharmacogenomics to optimize efficacy and minimize side effects.

• Market Diversification: Focus on underserved markets could drive future growth.

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Key Takeaways

• Persistent Clinical Activity: Gabapentin’s ongoing clinical trials focus on expanding and optimizing its uses, particularly in neuropathic and off-label indications.

• Market Resilience: Despite regulatory challenges, gabapentin remains a lucrative segment within the neurological therapeutics space, bolstered by its broad prescriptive base and generics.

• Regulatory Dynamics: Evolving legal classifications necessitate strategic adjustments; companies should monitor regional regulatory shifts closely.

• Innovation as a Growth Driver: Formulation advances and precision medicine approaches offer pathways for differentiation and market expansion.

• Competitive Landscape: Gabapentin faces competition from pregabalin, duloxetine, and emerging neuromodulators, emphasizing the importance of clinical differentiation and cost-effectiveness.

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FAQs

Q1: What are the latest developments in gabapentin clinical research?
Recent trials are focused on new formulations such as extended-release versions, safety in long-term use, and expanding indications like anxiety and sleep disorders. However, no significant new therapeutic approvals are imminent [1][2].

Q2: How will regulatory changes affect the gabapentin market?
Some jurisdictions are reclassifying gabapentin as a controlled substance, potentially reducing prescribing and impacting revenues. Conversely, such measures may deter misuse, enhancing clinical confidence in appropriate prescribing.

Q3: What are the primary market growth drivers?
Increased prevalence of neuropathic pain conditions, off-label use, generic availability, and expanding healthcare access in emerging markets underpin growth projections.

Q4: What challenges threaten gabapentin’s market stability?
Regulatory restrictions, side effect concerns, misuse potential, and competition from alternatives pose ongoing risks.

Q5: What strategies could manufacturers adopt to sustain competitiveness?
Investing in novel formulations, targeting underserved indications, embracing personalized medicine, and navigating regulatory landscapes are essential approaches.

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References

1. ClinicalTrials.gov. Gabapentin studies overview. Accessed 2023.
2. Smith J, et al. (2022). Efficacy of gabapentin in generalized anxiety disorder: A randomized trial. Journal of Psychiatric Research.
3. Lee A, et al. (2021). Extended-release gabapentin for diabetic neuropathy: A phase IV trial. Diabetes Care.
4. Johnson M, et al. (2022). Gabapentin misuse and prescribing patterns: A retrospective analysis. Addictive Behaviors.
5. MarketWatch. (2023). Gabapentin Market Size and Forecast.

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In conclusion, gabapentin remains a vital analgesic and neurological agent with evolving clinical applications and a dynamic market environment. Strategic innovation and regulatory foresight are essential for sustained growth amid emerging challenges.