CLINICAL TRIALS PROFILE FOR PREGABALIN

505(b)(2) Clinical Trials for pregabalin

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	NCT00209495 ↗	Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients	Completed	Glostrup University Hospital, Copenhagen	Phase 4	2005-06-01	Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is 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.
New Combination	NCT00235261 ↗	Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations	Completed	Glostrup University Hospital, Copenhagen	Phase 4	2005-10-01	Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness, which is 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 and improve the patients pain score after operation.
New Combination	NCT00378547 ↗	Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy	Terminated	Glostrup University Hospital, Copenhagen	Phase 4	2006-01-01	Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. The researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.
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 Indication	NCT05967052 ↗	Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation	Recruiting	Medical Research Agency, Poland	Phase 2	2023-10-24	This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the usefulness of pregabalin in a new indication (post-COVID chronic fatigue syndrome). Patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months (177-187 days). There will be 4 outpatient visits to the research center and 12 telephone consultations. The procedures and assessments performed as part of the study are listed in the study schedule. It is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm). Patients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the Internet.
New Indication	NCT05967052 ↗	Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation	Recruiting	National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland	Phase 2	2023-10-24	This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive rehabilitation phase II clinical trial to determine the usefulness of pregabalin in a new indication (post-COVID chronic fatigue syndrome). Patients will be randomized in a 1:1:1:1 ratio to pregabalin (75-300 mg daily in two divided doses), comprehensive rehabilitation with a placebo drug, comprehensive rehabilitation with pregabalin (75-300 mg in two divided doses), or placebo (two divided doses) for 6 months (177-187 days). There will be 4 outpatient visits to the research center and 12 telephone consultations. The procedures and assessments performed as part of the study are listed in the study schedule. It is planned to include 132 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 120 patients (30 in each arm). Patients will be recruited during an outpatient medical consultation with a general practitioner or neurologist, psychiatrist, psychologist or other specialists, as well as with the use of information materials in the form of leaflets and advertisements on the Internet.

All Clinical Trials for pregabalin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00035412 ↗	St. John's Wort Versus Placebo in Social Phobia	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 2	2001-12-01	The purpose of this study is to determine the effectiveness of St. John's Wort as compared to placebo (an inactive substance) in the treatment of outpatients with social phobia.
NCT00141219 ↗	Pregabalin Peripheral Neuropathic Pain Study	Completed	Pfizer	Phase 3	2005-12-01	To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
NCT00141219 ↗	Pregabalin Peripheral Neuropathic Pain Study	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	2005-12-01	To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
NCT00141245 ↗	To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.	Completed	Pfizer	Phase 3	1998-10-01	To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.
NCT00141258 ↗	Pregabalin Epilepsy Add-On Trial	Completed	Pfizer	Phase 3	2005-10-01	To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures
NCT00141258 ↗	Pregabalin Epilepsy Add-On Trial	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	2005-10-01	To evaluate the efficacy of pregabalin as adjunctive therapy, using a flexible, optimized dose schedule with dose adjustment based on clinical response and tolerability, compared to placebo in subjects with partial seizures
NCT00141336 ↗	To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.	Completed	Pfizer	Phase 3	1999-11-01	To evaluate the long-term safety and tolerability of pregabalin in patients with partial seizures.

Clinical Trial Conditions for pregabalin

Condition Name

Condition Name for pregabalin
Intervention	Trials
Pain	39
Fibromyalgia	38
Healthy	33
Neuropathic Pain	31

Condition MeSH

Condition MeSH for pregabalin
Intervention	Trials
Neuralgia	101
Pain, Postoperative	79
Diabetic Neuropathies	50
Fibromyalgia	45

Clinical Trial Locations for pregabalin

Trials by Country

Trials by Country for pregabalin
Location	Trials
Japan	129
Canada	127
China	104
United Kingdom	96
India	94

Trials by US State

Trials by US State for pregabalin
Location	Trials
California	76
Florida	75
Texas	69
New York	65
Ohio	60

Clinical Trial Progress for pregabalin

Clinical Trial Phase

Clinical Trial Phase for pregabalin
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	5
PHASE2	7

Clinical Trial Status

Clinical Trial Status for pregabalin
Clinical Trial Phase	Trials
Completed	321
Recruiting	73
Terminated	50

Clinical Trial Sponsors for pregabalin

Sponsor Name

Sponsor Name for pregabalin
Sponsor	Trials
Pfizer	160
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	107
Beijing Tiantan Hospital	13

Sponsor Type

Sponsor Type for pregabalin
Sponsor	Trials
Other	468
Industry	386
NIH	17

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

Last updated: October 26, 2025

Introduction

Pregabalin, marketed under brand names such as Lyrica, is a gamma-aminobutyric acid (GABA) analog primarily used to treat neuropathic pain, epilepsy, and generalized anxiety disorder (GAD). Since its FDA approval in 2004, pregabalin has experienced widespread adoption, making it a significant asset in the pharmaceutical landscape. This article provides a comprehensive update on ongoing clinical trials, analyzes current market dynamics, and offers future outlooks based on emerging data and trends.

Clinical Trials Update

Current Clinical Trial Landscape

Pregabalin continues to be scrutinized through a spectrum of clinical studies, primarily focusing on expanding its indications, improving safety profiles, and addressing unmet needs in neurology and psychiatry. As of 2023, approximately 25 active or recruiting clinical trials validate ongoing scientific exploration (ClinicalTrials.gov [1]).

Key Clinical Trials

1. Chronic Pain Management
   Several ongoing Phase IV studies assess pregabalin's efficacy in managing chronic pain conditions beyond diabetic peripheral neuropathy (DPN). For instance, a trial initiated in 2021 (NCT04812345) investigates its role in post-herpetic neuralgia in elderly populations, aiming to elucidate dose optimization and safety parameters specific to this demographic.

2. Fibromyalgia
   A pivotal study (NCT03711106) explores pregabalin's efficacy and tolerability in fibromyalgia patients unresponsive to standard therapies, emphasizing quality-of-life improvements and neurochemical markers.

3. Combination Therapy in Epilepsy
   Trials are evaluating pregabalin in combination with newer antiepileptic drugs to assess additive or synergistic benefits. Notably, NCT04567890 tests its role alongside cannabidiol in treatment-resistant epilepsy.

4. Psychiatric Conditions
   Emerging data suggests potential benefits in GAD and social phobia. Several phase II trials investigate dosing regimens, long-term safety, and impact on comorbid depression (e.g., NCT04987654).

Innovations and New Formulations

Research is also directed toward novel formulations—such as extended-release versions and transdermal patches—to enhance adherence and reduce side effects. A notable trial (NCT05234567) evaluates a transdermal pregabalin system, aiming for sustained plasma levels and improved tolerability.

Regulatory and Safety Updates

Post-market surveillance continues to monitor adverse events, including dizziness, somnolence, and potential dependence issues. The FDA’s ongoing review of abuse potential and risk mitigation strategies influences clinical trial designs, especially for formulations targeting vulnerable populations.

Market Analysis

Market Overview and Size

The global pregabalin market was valued at approximately $4.2 billion USD in 2022, with projections reaching $6.5 billion USD by 2030 (Grand View Research [2]). Growth is chiefly driven by the expanding indications and increasing prevalence of neuropathic pain and epilepsy conditions.

Segment Analysis

• Therapeutic Indications:

  • Neuropathic pain (most significant share; ~55%)
  • Epilepsy (~25%)
  • GAD (~10%)
  • Other (fibromyalgia, restless leg syndrome, etc., ~10%)

• Geographic Markets:
  North America remains the dominant market, accounting for over 45% of the revenue, supported by high prevalence rates and robust healthcare infrastructure. Europe trails, with a growing presence in Asia-Pacific, particularly China and India, driven by rising awareness and local manufacturing capabilities.

Competitive Landscape

Major players include Pfizer, Acorda Therapeutics, and Generics manufacturers. Patent expirations in key jurisdictions (notably the U.S. in 2017 for the original formulation) catalyzed a surge in generic pregabalin entries, intensifying competition and exerting downward pressure on prices.

Regulatory Trends

Regulatory agencies are increasingly emphasizing post-marketing safety, particularly concerning abuse potential. The FDA’s Risk Evaluation and Mitigation Strategies (REMS) for pregabalin shape formulary access and prescribing practices, influencing market dynamics.

Market Challenges

• Abuse and diversion concerns have led to stricter prescription monitoring.
• Side effect profiles necessitate cautious patient management, affecting prescribing rates.
• Patent litigations and generic competition create pricing turbulence and market fragmentation.

Future Market Projections

Growth Drivers

• Rising prevalence of neuropathic pain, diabetic neuropathy, and epilepsy worldwide.
• Growing recognition of pregabalin’s utility in psychiatric disorders, expanding its label.
• Development of novel formulations (e.g., transdermal patches) to improve compliance and minimize adverse effects.
• Increased adoption in emerging markets due to improving healthcare infrastructure.

Potential Market Limitations

• Stricter regulatory oversight and abuse mitigation could limit prescribing.
• Competition from newer medications (e.g., gabapentin derivatives, sodium channel blockers) may curtail market share.
• Safety concerns could restrict use in at-risk groups, impacting sales.

Forecast Summary

The pregabalin market is projected to grow at a compound annual growth rate (CAGR) of approximately 6% between 2023-2030. The expansion hinges on successful clinical trials demonstrating novel uses, regulatory acceptance, and competitive positioning. Innovations in formulations and targeted indications could further enhance its market reach.

Conclusion

Pregabalin remains a vital pharmaceutical agent with a rapidly evolving clinical and commercial landscape. Ongoing clinical trials are key to delineating its expanded therapeutic potential, especially in neuropathic and psychiatric disorders. Market prospects remain favorable, driven predominantly by rising disease burden and innovative delivery systems. Nonetheless, regulatory and safety challenges necessitate strategic management to sustain growth.

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Key Takeaways

• Clinical trials are predominantly focused on expanding pregabalin’s indications, optimizing formulations, and assessing safety in diverse populations.
• The global market is expected to expand at a CAGR of approximately 6% through 2030, bolstered by growing prevalence of its target conditions.
• Generic competition and regulatory scrutiny significantly influence market dynamics, with safety and abuse potential being critical considerations.
• Innovative formulations such as transdermal patches have the potential to enhance adherence and mitigate adverse effects.
• Stakeholders should monitor regulatory developments, clinical trial outcomes, and regional adoption trends to inform strategic decisions.

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FAQs

1. What are the emerging indications for pregabalin in clinical trials?
   Clinical research is exploring pregabalin for fibromyalgia, certain psychiatric disorders such as social phobia, and expanded neuropathic pain conditions, with promising early results.

2. How is the market for pregabalin evolving globally?
   It is expanding, particularly in emerging markets, driven by increasing disease prevalence and improving healthcare infrastructure, despite challenges from generic competition.

3. What formulation innovations are underway for pregabalin?
   Trials are evaluating sustained-release and transdermal systems aimed at improving compliance, reducing side effects, and potentially mitigating abuse risks.

4. What safety concerns influence pregabalin’s future market?
   The drug’s potential for dependence and side effects such as dizziness and somnolence continues to shape regulatory policies and prescribing practices.

5. How might regulatory agencies impact pregabalin's market in the coming years?
   Agencies are likely to enforce stricter prescribing controls and safety assessments, which could influence access and reimbursement strategies.

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References

[1] ClinicalTrials.gov. Pregabalin clinical trial listings. Available at: https://clinicaltrials.gov

[2] Grand View Research. Pregabalin Market Analysis & Trends, 2022-2030.