CLINICAL TRIALS PROFILE FOR LAMOTRIGINE

505(b)(2) Clinical Trials for lamotrigine

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	NCT00214877 ↗	Methylene Blue for Cognitive Dysfunction in Bipolar Disorder	Completed	Stanley Medical Research Institute	Phase 3	2003-11-01	While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.
OTC	NCT00214877 ↗	Methylene Blue for Cognitive Dysfunction in Bipolar Disorder	Completed	Nova Scotia Health Authority	Phase 3	2003-11-01	While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine. Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.

All Clinical Trials for lamotrigine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000192 ↗	Neurobiology of Opioid Dependence: 1 - 1	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
NCT00000192 ↗	Neurobiology of Opioid Dependence: 1 - 1	Withdrawn	Yale University	Phase 2	1993-01-01	The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
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.

Clinical Trial Conditions for lamotrigine

Condition Name

Condition Name for lamotrigine
Intervention	Trials
Bipolar Disorder	54
Epilepsy	44
Healthy	20
Bipolar Depression	12

Condition MeSH

Condition MeSH for lamotrigine
Intervention	Trials
Bipolar Disorder	67
Epilepsy	55
Disease	41
Depression	39

Clinical Trial Locations for lamotrigine

Trials by Country

Trials by Country for lamotrigine
Location	Trials
United States	605
Germany	41
Canada	34
Italy	24
China	20

Trials by US State

Trials by US State for lamotrigine
Location	Trials
Texas	38
Ohio	33
New York	32
California	27
Pennsylvania	24

Clinical Trial Progress for lamotrigine

Clinical Trial Phase

Clinical Trial Phase for lamotrigine
Clinical Trial Phase	Trials
PHASE3	2
PHASE1	3
Phase 4	59

Clinical Trial Status

Clinical Trial Status for lamotrigine
Clinical Trial Phase	Trials
Completed	158
Terminated	19
Recruiting	15

Clinical Trial Sponsors for lamotrigine

Sponsor Name

Sponsor Name for lamotrigine
Sponsor	Trials
GlaxoSmithKline	59
National Institute of Mental Health (NIMH)	14
Dr. Reddy's Laboratories Limited	8

Sponsor Type

Sponsor Type for lamotrigine
Sponsor	Trials
Other	194
Industry	122
NIH	23

Lamotrigine: Clinical Trials Update and Market Outlook (2026-2031)

Last updated: April 23, 2026

What is lamotrigine and where is it used clinically?

Lamotrigine is an oral antiepileptic drug (AED) marketed globally for multiple indications, with the core commercial demand tied to epilepsy. It is also used in bipolar disorder and other seizure-related settings depending on local labeling.

Key commercial use cases

• Epilepsy: adjunctive therapy and monotherapy across seizure types depending on jurisdictional approvals.
• Bipolar disorder: relapse prevention (maintenance) in bipolar I disorder in several major markets (labeling varies by country).
• Other seizure syndromes: use is expanding in line with guideline adoption and local regulatory approvals.

What does the patent and regulatory landscape imply for near-term competition?

Lamotrigine is an older, widely generically available product in major markets. The practical implication for investors and R&D decision-makers is that incremental clinical entrants depend on differentiated formulations, dosing convenience, or new combination strategies, not on baseline API monopoly economics.

Regulatory and market structure

• The drug is widely off-patent for API in most jurisdictions, enabling broad generic competition.
• Brand survival generally depends on formulation differentiation (when present), contract manufacturing capacity, and payer economics rather than exclusivity.

What is the current clinical trials update for lamotrigine?

No current, specific, high-certainty global late-stage program identifiers for lamotrigine can be confirmed from the information provided in this request. The dataset required for a complete, accurate “clinical trials update” (trial IDs, phase distribution, enrollment status, readout windows, and endpoints) is not present.

How does market demand typically behave for lamotrigine?

Lamotrigine demand is structurally driven by:

• Chronic use (patients remain on therapy for long durations if effective and tolerated).
• Dose titration sensitivity (adherence and tolerability influence persistence).
• Payer switching behavior (generics dominate spend; switching is shaped by formulary status and pharmacy benefit design).
• Guideline adherence for epilepsy management and bipolar maintenance.

Market demand drivers vs. constraints

Driver	Commercial impact
Chronic epilepsy and bipolar maintenance	Converts new patient launches into long-duration revenue streams even when generics dominate
Generic market depth	Increases volume but pressures price realization
Tolerability and titration	Supports persistence in responders; tolerability side effects can reduce adherence
Formularies and payer contracting	Determines rapid uptake among generics and subsequent price compression

What is the market analysis: pricing power, share, and competitive dynamics?

Lamotrigine faces intense competition from multiple generics in most markets. As a result:

• Price is the primary lever for market share.
• Differentiation shifts to formulation bioequivalence robustness, patient support programs (where still used), and product packaging/availability.
• In markets where originator brands persist, they typically do so through brand equity and contracting, not through exclusivity.

Competitive dynamics by channel

• Retail and institutional formularies: generics dominate; formulary tiering reduces pricing and limits upside.
• Hospital use (where relevant): purchase tends to follow procurement contracts and inventory availability.
• Neurology-led prescribing: tends to maintain continuity for stable patients, creating a slower churn curve once a product is established.

What market projections can be made for 2026-2031?

A complete and accurate five-year market projection requires baseline market size, regional split, and a quantified forecast model (unit growth, price erosion, and penetration). Those inputs are not included in the request.

Result: A defensible numeric projection cannot be produced without risking fabricated figures.

Where can value still be created for lamotrigine assets?

With API competition already entrenched, value creation concentrates in these areas:

• Line extensions: patient-friendly dosing formats (where not already normalized).
• Combination products: branded fixed-dose combinations can differentiate and protect gross margin if payers accept them.
• Digital adherence support: limited ROI impact but can improve persistence and reduce discontinuation in tolerated responders.
• New use-case evidence packages: real-world effectiveness and safety in specific subpopulations can support guideline adoption and formulary inclusion, though this does not remove generic pricing pressure.

Key Takeaways

• Lamotrigine is a mature, widely generic antiepileptic with commercial demand anchored in chronic treatment and payer formulary contracting.
• Patent-driven exclusivity upside is limited; near-term market outcomes are dominated by generic pricing, contracting, and product supply rather than novel API exclusivity.
• A precise “clinical trials update” and quantified 2026-2031 market projection cannot be delivered from the information provided in this request.
• Value creation in new lamotrigine programs, if any, would likely depend on differentiated formulations or combination strategies rather than baseline molecule novelty.

FAQs

1. Is lamotrigine currently dominated by generics?
   Yes in major markets; generic availability constrains pricing and shifts competition to formulary and contracting dynamics.

2. What drives lamotrigine persistence for payers?
   Stable seizure control and tolerability determine long-term continuation, which supports demand even under price pressure.

3. Can new lamotrigine entrants win share?
   They typically can only do so with differentiated value: formulation convenience, combination products, or strong payer contracting.

4. Do clinical trial outcomes materially change lamotrigine market economics?
   In a generic-heavy environment, clinical evidence can change adoption and guideline alignment, but it usually cannot fully offset structural price erosion.

5. What would support a credible market projection for lamotrigine?
   A projection requires baseline market size (units and revenue), regional segmentation, price erosion assumptions, and competitive penetration paths across channels.

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References

[1] US Food and Drug Administration. Lamictal (lamotrigine) prescribing information. FDA.
[2] European Medicines Agency. Lamictal (lamotrigine) product information. EMA.
[3] World Health Organization. WHO model list of essential medicines: lamotrigine. WHO.