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.
OTC	NCT00666575 ↗	A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness	Completed	Pfizer	Phase 3	2004-12-01	The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
OTC	NCT00666575 ↗	A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	2004-12-01	The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness

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.
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	Parke-Davis	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.
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	US Department of Veterans Affairs	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	37
Postoperative Pain	26
Restless Legs Syndrome	17

Condition MeSH

Condition MeSH for gabapentin
Intervention	Trials
Pain, Postoperative	95
Neuralgia	51
Syndrome	26
Restless Legs Syndrome	25

Clinical Trial Locations for gabapentin

Trials by Country

Trials by Country for gabapentin
Location	Trials
United States	734
Egypt	50
Japan	45
Canada	43
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	297
Recruiting	81
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	564
Industry	144
NIH	60

Gabapentin Market Analysis and Financial Projection

Last updated: April 24, 2026

Gabapentin: Clinical Trials Update, Market Analysis, and 10-Year Projection

What is the current clinical-trials footprint for gabapentin?

Gabapentin (active ingredient; multiple marketed products) is a mature, off-patent small molecule with a persistent clinical-trials presence focused on new indications, new formulations, and comparative effectiveness. Trial activity is concentrated in neurology, pain, and epilepsy research, with periodic randomized studies that refine patient subgroups and care pathways rather than establishing entirely new therapeutic classes.

Clinical development pattern (observed across public registries):

• Indication focus: neuropathic pain (including post-herpetic neuralgia), seizure disorders (adjunctive therapy), and pain syndromes with gabapentin-containing regimens.
• Study type mix: randomized controlled trials, pragmatic trials in real-world care settings, and formulation-focused comparisons.
• Geographic coverage: multi-region recruitment is common, with enrollment often concentrated in Europe and North America for label-relevant endpoints, and broader global distribution for comparative effectiveness and real-world studies.
• Endpoints: pain intensity scales, responder rates, opioid-sparing outcomes, seizure control metrics, quality of life, and tolerability.

Practical read-through for investment/R&D:

• The majority of ongoing gabapentin studies are aimed at incremental claims: specific patient populations, co-therapies, and regimen optimization.
• The probability-weighted path to meaningful market share is typically tied to differentiated formulations (bioavailability, dosing convenience), clear payer-friendly endpoints, or new-label positioning in defined subgroups.

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What do recent trial results and ongoing studies indicate for product strategy?

Across the gabapentin research landscape, the same clinical questions recur:

• Can optimized dosing improve pain responder rates while reducing discontinuations?
• Do standardized titration protocols reduce adverse events, particularly somnolence and dizziness?
• Do new formulations (extended-release or gastro-retentive concepts) shift exposure to improve adherence or outcomes?

Common competitive implications:

• If a new sponsor cannot demonstrate a clinically meaningful improvement in pain/seizure outcomes or tolerability versus existing gabapentin, differentiation usually shifts to process outcomes (fewer doses per day, simpler titration) and endpoint selection aligned with payer policy.
• Studies that align endpoints with reimbursement rules (for example, patient-reported outcomes that map to health technology assessment frameworks) tend to be the most commercially actionable.

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Where does gabapentin sit in the competitive landscape?

Gabapentin is widely available as a generic. Competitive pressure is primarily price and channel-based, while clinical differentiation tends to occur only where formulation and dosing design generate measurable exposure and adherence benefits.

Key competitive buckets:

1. Immediate-release generics: price and supply dominate.
2. Combination regimens using gabapentin-containing pathways: value depends on comparative outcomes and tolerability.
3. Formulation innovation: extended-release and other delivery concepts attempt to shift the adherence and exposure profile.

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How big is the gabapentin market and what drives demand?

Gabapentin demand is anchored in:

• Chronic neuropathic pain prevalence and long-term therapy behavior.
• Epilepsy adjunctive therapy usage in clinical practice.
• Broad inclusion in formularies due to decades of safety and effectiveness evidence, and because many payers treat gabapentin as a low-cost option relative to newer agents.

Market reality for projections:

• Pricing is constrained by generic competition.
• Growth comes from volume and utilization management (switching among generics, adherence effects, and formulary positioning) rather than net price expansion.

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Market analysis: sizing, growth drivers, and supply dynamics

What are the core growth and headwinds?

Growth drivers

• Persistent incidence of neuropathic pain conditions.
• Long treatment durations with stable prescribing patterns.
• Ongoing adoption in specific subgroups where gabapentin remains a preferred low-cost option.

Headwinds

• Generic price compression across key geographies.
• Payer shift toward utilization management and step edits for non-first-line pain use.
• Safety and tolerability concerns that create discontinuation risk, particularly in older populations and polypharmacy settings.

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How does reimbursement risk shape adoption economics?

In markets with strict formularies, gabapentin utilization is less about novelty and more about administrative fit:

• Evidence packages that support clinical guidelines alignment and cost-effectiveness drive payer comfort.
• Trials that demonstrate patient-relevant improvement and tolerability improvements are more likely to support formulary retention or preferred status.

For any sponsor of a differentiated gabapentin formulation, economic viability typically depends on securing:

• Preferential formulary placement
• Evidence of reduced discontinuations
• Demonstrated improvement in responder rates or reduced resource use

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10-year market projection (scenario-based)

What does a 10-year projection look like for gabapentin?

A precise forecast requires current market-size baselines by geography and product segment. The gabapentin market is largely generic and varies widely across sources; however, the direction is consistent:

• Near-term: stable-to-low single-digit volume growth offset by continued price compression.
• Mid-term: modest revenue growth where differentiated formulations capture premium segments, while pure generics track utilization.
• Long-term: constrained by generic equilibrium pricing and substitution dynamics, with growth limited to demographic trends and ongoing clinical use.

Projection framework (revenue drivers, not price assumptions):

• Demand: driven by neuropathic pain management and epilepsy adjunct use.
• Supply: generics maintain availability; formulation differentiation can shift mix.
• Policy: step edits and guideline adherence determine utilization.

Base-case qualitative forecast

• Units: grow modestly with demographics and persistent indication use.
• Net revenue: grows slower than units because of price erosion.
• Premium share: increases only if a differentiated product produces repeatable payer-relevant clinical or adherence outcomes.

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Clinical development implications for business planning

What trial themes are most likely to move market share?

The trials most likely to matter commercially are those that:

• Demonstrate improved responder rates in neuropathic pain endpoints that are compatible with payer decision frameworks.
• Produce a tolerability advantage that reduces discontinuation.
• Validate dosing convenience claims with real-world adherence metrics.

Where sponsors tend to win in practice

• Differentiation that changes dosing frequency.
• Clear titration protocols that reduce adverse-event-driven discontinuation.
• Evidence that supports clinician and payer confidence in long-term use.

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Key Takeaways

• Gabapentin clinical trial activity is ongoing but is mostly incremental, focused on optimization, subgroups, and formulation-driven differentiation rather than class-defining breakthroughs.
• Market demand remains anchored by neuropathic pain and epilepsy adjunct use, but revenue growth is constrained by generic price compression.
• Commercial upside is most achievable through formulation differentiation tied to payer-relevant endpoints and adherence or tolerability improvements.
• A 10-year outlook is best modeled as modest unit growth with slower revenue growth, with premium share gains only where differentiated clinical evidence supports payer uptake.

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FAQs

1) Is gabapentin still actively studied in clinical trials?

Yes. The ongoing global trial landscape continues to include randomized and pragmatic studies focused on pain outcomes, epilepsy adjunctive settings, and formulation or regimen optimization.

2) What differentiates clinical trials for gabapentin from trials for newer neuro-pain drugs?

Gabapentin studies typically emphasize incremental improvements such as responder rates, tolerability, titration protocols, and real-world adherence rather than novel mechanism-based efficacy claims.

3) What is the biggest market risk for gabapentin revenue?

Generic price erosion and payer-driven utilization management.

4) What type of evidence supports formulary retention or preferred status for gabapentin products?

Patient-relevant outcomes aligned with reimbursement decisions plus evidence that reduces discontinuations or improves adherence.

5) How does a differentiated formulation change the economics?

It can shift the product mix from lower-cost generics to a premium segment if trials show consistent improvements in tolerability, dosing convenience, or clinically meaningful endpoints.

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References

[1] ClinicalTrials.gov. (n.d.). Search results for gabapentin studies. https://clinicaltrials.gov/
[2] European Medicines Agency. (n.d.). Gabapentin-related assessment information and public documents. https://www.ema.europa.eu/
[3] U.S. Food and Drug Administration. (n.d.). Gabapentin drug product information and labeling resources. https://www.fda.gov/