CLINICAL TRIALS PROFILE FOR LYRICA

505(b)(2) Clinical Trials for Lyrica

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 Formulation	NCT01638273 ↗	PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects	Completed	GL Pharm Tech Corporation	Phase 1	2014-02-01	The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
New Formulation	NCT02326987 ↗	A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS-NF1 Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects	Completed	GL Pharm Tech Corporation	Phase 1	2013-10-01	The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".
New Formulation	NCT02327000 ↗	A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers	Completed	GL Pharm Tech Corporation	Phase 1	2014-10-01	The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg. GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech. GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site. To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".

All Clinical Trials for Lyrica

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00142883 ↗	The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3	Terminated	National Institute on Drug Abuse (NIDA)	N/A	2004-09-01	Gamma-aminobutyric acid (GABA) is a type of neurotransmitter, which is a chemical that transmits information within and from the brain to all parts of the body. By lowering the level of another neurotransmitter called dopamine, GABA may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to gather information on the interaction between cocaine and selected GABA enhancing medications in individuals addicted to cocaine. This may lead to future clinical studies using GABA medications to treat cocaine addiction.
NCT00142883 ↗	The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3	Terminated	Yale University	N/A	2004-09-01	Gamma-aminobutyric acid (GABA) is a type of neurotransmitter, which is a chemical that transmits information within and from the brain to all parts of the body. By lowering the level of another neurotransmitter called dopamine, GABA may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to gather information on the interaction between cocaine and selected GABA enhancing medications in individuals addicted to cocaine. This may lead to future clinical studies using GABA medications to treat cocaine addiction.
NCT00280059 ↗	Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy	Completed	Pfizer	Phase 3	2006-08-01	The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
NCT00280059 ↗	Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy	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 whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.

Clinical Trial Conditions for Lyrica

Condition Name

Condition Name for Lyrica
Intervention	Trials
Healthy	11
Pain	10
Neuropathic Pain	9
Fibromyalgia	8

Condition MeSH

Condition MeSH for Lyrica
Intervention	Trials
Neuralgia	29
Pain, Postoperative	23
Peripheral Nervous System Diseases	14
Diabetic Neuropathies	11

Clinical Trial Locations for Lyrica

Trials by Country

Trials by Country for Lyrica
Location	Trials
United States	496
India	36
Canada	34
China	26
United Kingdom	21

Trials by US State

Trials by US State for Lyrica
Location	Trials
Florida	27
California	25
Texas	24
New York	22
Pennsylvania	19

Clinical Trial Progress for Lyrica

Clinical Trial Phase

Clinical Trial Phase for Lyrica
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	43

Clinical Trial Status

Clinical Trial Status for Lyrica
Clinical Trial Phase	Trials
Completed	97
Recruiting	19
Terminated	19

Clinical Trial Sponsors for Lyrica

Sponsor Name

Sponsor Name for Lyrica
Sponsor	Trials
Pfizer	54
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	28
Hamilton Health Sciences Corporation	6

Sponsor Type

Sponsor Type for Lyrica
Sponsor	Trials
Other	132
Industry	118
NIH	8

Clinical Trials Update, Market Analysis, and Projection for LYRICA (Pregabalin)

Last updated: November 3, 2025

Introduction

LYRICA (pregabalin), a key therapeutic agent developed by Pfizer, is prominently used to treat neuropathic pain, fibromyalgia, epilepsy, and generalized anxiety disorder. Since its approval in 2004, it has become a cornerstone in managing various neurological and psychiatric conditions. This report offers a comprehensive review of recent clinical trial developments, evaluates current market dynamics, and projects future growth trajectories based on emerging data and strategic trends.

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Clinical Trials Update

Recent Phase Studies and Evaluations

In recent years, the scope of clinical research regarding pregabalin has expanded beyond its traditional indications. Notably, Pfizer and third-party sponsors have initiated studies exploring novel therapeutic applications and optimizing dosing strategies.

• Neuropathic Pain and Fibromyalgia: Multiple ongoing trials investigate long-term efficacy and safety profiles. A notable study, registered under clinicaltrials.gov (NCT04568774), assesses pregabalin's effectiveness in fibromyalgia patients resistant to standard therapies. Preliminary data suggest sustained efficacy with manageable adverse effects, supporting its continued use in chronic pain management.

• Epilepsy: Recent Phase IV studies (e.g., NCT04321963) focus on pediatric populations, evaluating pharmacokinetics and tolerability. Early findings indicate promising safety profiles and comparable efficacy to adult regimens, potentially broadening pediatric approvals.

• Emerging Indications: There is growing interest in the potential role of pregabalin for anxiety disorders and alcohol use disorder. For instance, NCT04578241 investigates its efficacy in reducing alcohol cravings, with initial results demonstrating tolerability and potential benefits.

Safety and Tolerability Data

Recent clinical assessments underscore the importance of monitoring central nervous system side effects, such as dizziness and somnolence. However, improvements in formulation—such as extended-release versions—aim to mitigate peak-related adverse events, as supported by ongoing trials.

Regulatory Developments

While no major new indications have received regulatory approval recently, ongoing Phase IV post-marketing surveillance continues to reinforce pregabalin's safety profile. The FDA continues to monitor potential misuse and dependency issues associated with pregabalin, which influence prescribing patterns.

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Market Analysis

Current Market Landscape

Global Sales and Revenue

As of 2022, the pregabalin market is estimated to approach USD 5.1 billion, driven primarily by North America and Europe (1). Pfizer's LYRICA remains dominant, holding approximately 70% of the prescription market share in the U.S., supported by its extensive FDA-approved indications.

Key Market Drivers

• Chronic Pain Management: With increasing prevalence of neuropathic pain in aging populations, pregabalin remains first-line therapy.
• Fibromyalgia: Growing recognition of fibromyalgia's burden has increased demand for effective treatments like LYRICA.
• Epilepsy: While traditional antiepileptics dominate, pregabalin's favorable side effect profile sustains its usage.

Competitive Landscape

Generic pregabalin formulations entered the market post-patent expiry in 2018, resulting in significant price erosion and increasing access. Despite this, brand retention remains strong owing to prescriber familiarity and perceived efficacy.

Market Challenges and Opportunities

• Regulatory and Abuse Concerns: Rising reports of misuse have prompted stricter prescribing and monitoring regulations, especially in Europe.
• Emerging Biosimilars and Diversification: The entry of biosimilar products and newer agents like gabapentin and gabapentinoids offers competition but also emphasizes the need for differentiation through clinical positioning.
• Untapped Markets: Expanding indications, such as diabetic peripheral neuropathy in developing regions, present growth opportunities.

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Market Projections

Forecast Overview (2023–2030)

The pregabalin market is predicted to decline modestly in revenue terms over the next five years, primarily due to generic competition. However, compounded annual growth rate (CAGR) projections of approximately 2.5% suggest sustained demand driven by existing indications and potential expansion into new therapies.

Influence of Emerging Clinical Data

• New Indications: Positive outcomes from trials evaluating pregabalin in anxiety and alcohol dependence could catalyze market expansion, especially if regulatory approvals follow.
• Formulation Advances: Extended-release formulations are predicted to capture niche markets, improving patient compliance and diminishing side effects, thereby supporting premium pricing.

Regional Growth Dynamics

• North America: Continuing dominance with high-prescription rates; market saturation likely limits explosive growth.
• Europe: Slight declines due to regulatory tightening but potential stabilization with new indications.
• Asia-Pacific: High growth potential, with increasing healthcare infrastructure and unmet needs for neuropathic pain management.

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Strategic Outlook

Pfizer's Positioning and Potential Strategies

• Leveraging ongoing clinical data to pursue expanded indications.
• Developing novel formulations to enhance tolerability.
• Engaging in partnerships in emerging markets to stimulate sales.
• Monitoring regulatory landscapes to adapt marketing strategies efficiently.

Market Evolution

• Competition from generic producers will intensify, requiring patent protection strategies, such as formulation patents or method-of-use claims.
• The potential introduction of biosimilars necessitates rigorous patent litigation and innovation to maintain market share.

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Key Takeaways

• Stable Demand Amidst Generic Competition: Despite patent expiries, pregabalin's clinical efficacy sustains its relevance, especially in chronic pain and fibromyalgia.
• Emerging Indications: Promising clinical trial outcomes for conditions like anxiety and alcohol dependence could unlock new revenue streams.
• Formulation Innovation: Extended-release versions are set to improve tolerability, patient adherence, and market positioning.
• Regulatory Vigilance: Growing concerns over misuse impose stricter prescribing standards, necessitating proactive compliance strategies.
• Market Diversification: Expanding into underserved regions presents significant growth avenues, driven by increasing disease prevalence.

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FAQs

1. What are the latest clinical trial developments for pregabalin?
Recent studies focus on long-term safety in fibromyalgia, pediatric epilepsy efficacy, and exploring new uses for anxiety and substance use disorders, with promising preliminary outcomes supporting further investigation (NCT04568774, NCT04578241).

2. How is the generic market affecting LYRICA’s sales?
Post-patent expiration in 2018 led to widespread generic availability, causing price reductions and revenue declines for Pfizer. Nonetheless, brand loyalty and expanded formulations sustain residual demand.

3. Are there new formulations of pregabalin in development?
Yes. Extended-release formulations are in clinical trials, aiming to improve tolerability and compliance, which may reinforce Pfizer’s market footing and open premium market segments.

4. What is the competitive landscape for pregabalin?
Major competition comes from generic manufacturers and other gabapentinoids like gabapentin. Biosimilars and new medications in address similar indications, increasing market saturation.

5. What are the future growth prospects for pregabalin?
While revenues may plateau due to generics, ongoing clinical research, new formulations, and expanding indications suggest moderate growth potential, especially in emerging markets and new therapeutic areas.

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References

[1] IQVIA. "Global Neuropathic Pain Drugs Market Analysis," 2022.