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

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.

Clinical Trial Conditions for Gabapentin

Condition Name

Condition Name for Gabapentin
Intervention	Trials
Pain, Postoperative	36
Pain	34
Postoperative Pain	23
Healthy	17

Condition MeSH

Condition MeSH for Gabapentin
Intervention	Trials
Pain, Postoperative	89
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	712
Japan	45
Canada	42
Egypt	38
Brazil	17

Trials by US State

Trials by US State for Gabapentin
Location	Trials
California	55
New York	39
Florida	35
Texas	33
Ohio	32

Clinical Trial Progress for Gabapentin

Clinical Trial Phase

Clinical Trial Phase for Gabapentin
Clinical Trial Phase	Trials
Phase 4	162
Phase 3	93
Phase 2/Phase 3	26

Clinical Trial Status

Clinical Trial Status for Gabapentin
Clinical Trial Phase	Trials
Completed	283
Recruiting	73
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	527
Industry	143
NIH	59

Gabapentin: Clinical Trials, Market Analysis, and Projections

Introduction

Gabapentin, a medication belonging to the family of anticonvulsants, has been widely used for treating various conditions, including epilepsy, neuropathic pain, and several off-label indications. Here, we will delve into the current clinical trials, market analysis, and future projections for gabapentin.

Clinical Trials Update

Efficacy in Specific Conditions

Recent clinical trials have provided mixed results regarding the efficacy of gabapentin in different conditions. For instance, a randomized clinical trial examining the use of gabapentin for COVID-19–induced olfactory dysfunction found no statistically significant or clinically meaningful benefit over placebo. This study, conducted from January 2022 to February 2023, concluded that gabapentin is likely not an efficacious therapy for this specific condition[4].

Ongoing and Future Trials

While there are no groundbreaking new trials specifically focused on gabapentin, ongoing research continues to evaluate its efficacy and safety in various applications. For example, the focus on neuropathic pain management remains a significant area of study, given gabapentin's established role in this field.

Market Analysis

Current Market Size and Growth

The gabapentin market has shown steady growth in recent years. As of 2022, the global gabapentin market was valued at approximately USD 2.472 billion[3][5].

• North America: This region dominates the market, accounting for a significant share due to the high prevalence of chronic pain conditions and the widespread use of gabapentin in the United States and Canada[2][5].

Growth Drivers

Several factors are driving the growth of the gabapentin market:

• Increasing Prevalence of Neuropathic Pain: Conditions such as diabetic neuropathy, post-herpetic neuralgia, and trigeminal neuralgia are on the rise, necessitating effective pain management solutions[3][5].
• Growing Geriatric Population: The elderly are more prone to neurological disorders, contributing to the increased demand for gabapentin[3][5].
• Off-Label Usage: Gabapentin is often prescribed for conditions like anxiety, bipolar disorder, and nausea, expanding its market reach[2][5].

Regional Market Analysis

• Asia-Pacific (APAC): This region is expected to see significant growth due to increasing healthcare spending, growing awareness about gabapentin's benefits over opioids, and government initiatives[2][5].
• Latin America and Middle East & Africa: These regions also present opportunities for growth, driven by rising healthcare needs and increasing product approvals[5].

Market Projections

Forecasted Growth

The gabapentin market is projected to grow at a compound annual growth rate (CAGR) of around 4.8% to 5.35% from 2023 to 2030[2][5].

• By 2030, the market is expected to reach approximately USD 3.021 billion to USD 4.08 billion[3][5].

Segment Analysis

The market is segmented by dosage form, type, application, and distribution channel. The tablet segment is expected to dominate due to patient preference[3].

• Distribution Channels: Retail pharmacies, hospital pharmacies, and online pharmacies are key distribution channels, with retail pharmacies likely to remain the largest segment[2][5].

Challenges and Opportunities

Despite the growth prospects, the market faces several challenges:

• Side Effects and Regulatory Policies: Strict regulatory policies and side effects associated with gabapentin could hinder market growth[3].
• Emerging Markets and Untapped Opportunities: Developing countries and emerging markets offer significant opportunities for growth, driven by rising healthcare needs and increasing product approvals[3][5].

Competitive Landscape

The gabapentin market is highly competitive, with several key vendors operating globally. Companies are focusing on strategic initiatives such as product launches, research and development, and expanding their regional coverage to maintain market share[5].

Porter's Five Forces Analysis

A detailed Porter's Five Forces analysis reveals:

• Competitive Rivalry: High due to the presence of multiple players.
• Supplier Power: Moderate, as suppliers have some bargaining power but are not dominant.
• Buyer Power: High, as buyers have numerous options and can negotiate prices.
• Threat of Substitution: Moderate, as alternatives like opioids and new drugs (e.g., Ketamir-2) are available.
• Threat of New Entry: Low to moderate, as entering the market requires significant investment and regulatory approvals[5].

Key Takeaways

• Gabapentin's market is driven by its efficacy in managing neuropathic pain and its use in various off-label indications.
• The market is expected to grow significantly, driven by increasing prevalence of neurological disorders and a growing geriatric population.
• Regional growth, especially in APAC, is anticipated due to increasing healthcare spending and government initiatives.
• Despite growth prospects, the market faces challenges such as side effects and strict regulatory policies.

FAQs

What is the current market size of gabapentin?

The global gabapentin market was valued at approximately USD 2.472 billion in 2022[3].

What are the primary growth drivers for the gabapentin market?

The primary growth drivers include the increasing prevalence of neuropathic pain disorders, a growing geriatric population, and expanding off-label usage[3][5].

Which region is expected to dominate the gabapentin market?

North America is currently the dominant region, but the Asia-Pacific region is expected to see significant growth in the coming years[2][5].

What are the challenges facing the gabapentin market?

Challenges include side effects associated with gabapentin, strict regulatory policies, and the threat of substitution from alternative treatments[3].

What is the projected CAGR for the gabapentin market from 2023 to 2030?

The market is projected to grow at a CAGR of around 4.8% to 5.35% from 2023 to 2030[2][5].

How does gabapentin compare to new treatments like Ketamir-2?

Gabapentin faces competition from new treatments like Ketamir-2, which has shown superior efficacy in preclinical studies and is non-habit forming, addressing a critical gap in current treatments[1].

Sources

1. MIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA-Approved Treatments for Neuropathic Pain - Stock Titan
2. Gabapentin Market Size & Share, Growth Analysis 2037 - Research Nester
3. Gabapentin Market Size, Share, Scope & Industry Analysis By 2030 - Data Bridge Market Research
4. Efficacy of Gabapentin For Post–COVID-19 Olfactory Dysfunction - JAMA Otolaryngology
5. Gabapentin Market Size, Share, Growth Analysis - Industry Forecast - SkyQuest Technology Consulting Pvt. Ltd.