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	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)".
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)".

All Clinical Trials for LYRICA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00288639 ↗	Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).	Completed	Pfizer	Phase 4	2005-12-01	The objective of study is to assess the clinical improvement (change in seizure frequency), safety, and tolerability of subjects with partial seizures following adjunctive therapy of pregabalin BID (150 to 600 mg/day titration) in addition to existing standards AEDs.
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.

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	13
Diabetic Neuropathies	11

Clinical Trial Locations for LYRICA

Trials by Country

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Trials by Country for LYRICA
Location	Trials
United States	496
India	36
Canada	34
China	25
United Kingdom	21

Trials by US State

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−

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
Phase 4	43
Phase 3	39
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for LYRICA
Clinical Trial Phase	Trials
Completed	97
Terminated	19
Recruiting	18

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	131
Industry	116
NIH	8

LYRICA (Pregabalin): Clinical Trials, Market Analysis, and Projections

Introduction to LYRICA (Pregabalin)

LYRICA, known generically as pregabalin, is a medication widely used for the treatment of various neurological and psychiatric conditions. It is particularly effective in managing neuropathic pain, epilepsy, fibromyalgia, and generalized anxiety disorder.

Clinical Trials and Efficacy

Neuropathic Pain and Fibromyalgia

Clinical trials have consistently demonstrated the efficacy of LYRICA in treating neuropathic pain and fibromyalgia. For instance, a double-blind, placebo-controlled study involving 529 patients with fibromyalgia showed that LYRICA significantly reduced pain, improved sleep quality, and decreased fatigue compared to the placebo group[1].

Generalized Anxiety Disorder

LYRICA has also shown promising results in treating generalized anxiety disorder. Phase I and II placebo-controlled clinical studies involving over 1,200 patients indicated that LYRICA provided rapid relief from both psychic and somatic symptoms, often outperforming other treatments like venlafaxine[1].

Epilepsy

LYRICA is used as an adjunctive therapy for partial-onset seizures in patients with epilepsy. Its efficacy in reducing seizure frequency has been well-documented, making it a valuable option for managing this condition.

Market Analysis

Market Size and Growth

The pregabalin market is projected to grow at a Compound Annual Growth Rate (CAGR) of 5% from 2025 to 2030. This growth is driven by the increasing prevalence of epilepsy, neuropathic pain, and anxiety disorders. The World Health Organization estimates that about 50 million people worldwide suffer from epilepsy, with a significant portion residing in low- and middle-income countries[2].

Regional Market Share

North America holds the largest market share for pregabalin, primarily due to the high prevalence of epilepsy and related disorders in the region. The Asia Pacific region is expected to be the fastest-growing market, driven by increasing awareness and the growing need for effective treatments[2].

Key Players

Major players in the pregabalin market include Teva Pharmaceuticals, Cipla Limited, Medley Pharmaceuticals Limited, Viatris Inc., and Amneal Pharmaceuticals LLC. These companies are instrumental in driving market growth through the introduction of generic pregabalin products, which enhance affordability and accessibility[2].

Market Projections

Forecast Period

The pregabalin market is forecasted to continue growing from 2025 to 2030, driven by several factors:

• Increasing Prevalence of Epilepsy and Related Disorders: The growing number of epilepsy cases, particularly in low- and middle-income countries, is expected to increase the demand for pregabalin.
• Generic Market Entry: The approval and launch of generic pregabalin products, such as those by Lupin Pharmaceuticals, are anticipated to drive market growth due to their cost-effectiveness and increased availability[2].

Challenges and Restraints

Despite the positive growth projections, the pregabalin market faces several challenges:

• Alternative Treatments: The availability of alternative treatments could restrain market growth.
• Adverse Effects: Pregabalin is associated with several adverse effects, which may deter some patients.
• Regulatory Policies: Stringent regulatory policies can also impact the market's growth trajectory[2].

Emerging Competitors

Ketamir-2

A new competitor, Ketamir-2, is being developed by MIRA Pharmaceuticals. Preclinical studies have shown that Ketamir-2 is up to 112% more effective than pregabalin and 70% more effective than gabapentin in treating neuropathic pain. Additionally, Ketamir-2 is non-habit forming, addressing a critical gap in current treatments like pregabalin. While still in the preclinical stage, Ketamir-2 has the potential to significantly impact the market if its efficacy and safety are confirmed in human trials[3].

Regional Market Insights

China

In China, the pregabalin market has seen significant growth, with a Compound Annual Growth Rate (CAGR) of 40.55% from 2016 to 2020. The sales value of pregabalin in the Chinese market was approximately CNY186 million in 2020. Key players in the Chinese market include Pfizer Ltd (LYRICA), Chongqing Saiwei Pharmaceutical Co., Ltd. (Laireike), and Qilu Pharmaceutical (Hainan) Co., Ltd. (Xisiping)[5].

Key Takeaways

• Clinical Efficacy: LYRICA has demonstrated strong efficacy in treating neuropathic pain, fibromyalgia, generalized anxiety disorder, and epilepsy.
• Market Growth: The pregabalin market is expected to grow at a CAGR of 5% from 2025 to 2030, driven by increasing prevalence of related disorders and the introduction of generic products.
• Regional Dynamics: North America holds the largest market share, while the Asia Pacific region is expected to be the fastest-growing market.
• Emerging Competitors: Ketamir-2, a new drug in development, could pose a significant challenge to pregabalin if it proves effective and safe in human trials.

FAQs

What conditions is LYRICA primarily used to treat?

LYRICA is primarily used to treat neuropathic pain, fibromyalgia, generalized anxiety disorder, and epilepsy.

What is the projected CAGR for the pregabalin market from 2025 to 2030?

The pregabalin market is expected to grow at a CAGR of 5% from 2025 to 2030.

Which region holds the largest market share for pregabalin?

North America holds the largest market share for pregabalin.

What are the key factors driving the growth of the pregabalin market?

The growth is driven by the increasing prevalence of epilepsy and related disorders, the introduction of generic pregabalin products, and the rising geriatric population.

What is the potential impact of Ketamir-2 on the pregabalin market?

Ketamir-2, if proven effective and safe in human trials, could significantly impact the market due to its superior efficacy and non-habit forming nature compared to pregabalin.

Sources

1. Clinical Trials Arena: Lyrica (Pregabalin) for the Treatment of Neuropathic Pain, USA.
2. Mordor Intelligence: Pregabalin Market Size & Share Analysis - Growth Trends.
3. Stock Titan: MIRA Pharmaceuticals Announces Ketamir-2 Outperforms Current FDA Treatments.
4. Singularity Hub: Four Clinical Trials We're Watching That Could Change Medicine in 2025.
5. Research and Markets: Investigation Report on China's Pregabalin Market 2021-2025.