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.

Clinical Trial Conditions for LYRIca

Condition Name

Condition Name for LYRIca
Intervention	Trials
Healthy	11
Pain	10
Neuropathic Pain	9

Condition MeSH

Condition MeSH for LYRIca
Intervention	Trials
Neuralgia	29
Pain, Postoperative	23
Peripheral Nervous System Diseases	14

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
Terminated	19
Recruiting	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

Lyrica (pregabalin) Clinical Trials Update, Market Analysis, and Projection

Last updated: May 3, 2026

What is Lyrica and what is the current clinical-trial posture?

Lyrica is pregabalin, an oral alpha-2-delta (α2δ) calcium-channel subunit ligand, marketed for multiple indications including neuropathic pain and partial-onset seizures (with adjunctive use). Patent and regulatory timelines determine near-term R&D economics, while ongoing clinical work typically focuses on label expansion, special populations, formulation performance, and comparative effectiveness rather than new-mechanism breakthroughs.

Current trial activity profile (what to track) Clinical programs for established branded molecules like Lyrica usually cluster into:

• New dosing regimens and titration strategies (lower tolerability risk, regimen adherence)
• Special populations (renal impairment, elderly, comorbidities)
• Comparative effectiveness and real-world linked endpoints (symptom scales, functionality, patient-reported outcomes)
• Formulation and bioequivalence rather than de novo efficacy discovery

Regulatory label and indication anchor points Pfizer’s U.S. prescribing information lists the approved indications and core safety framing for Lyrica (pregabalin) and informs which trial types are commercially relevant (patient selection and endpoints tied to label). [1]

Which clinical programs most influence near-term value for pregabalin?

For a legacy brand, value impact comes less from early-phase novelty and more from:

1. Any late-stage work that can drive new claims (for example, additional pain subtypes or sequencing in treatment algorithms).
2. Evidence packages that strengthen payer coverage in jurisdictions where formularies tighten.
3. Switch-to-generic risk management via lifecycle strategies (often centered on formulations, dosing convenience, or subgroup wins).

A practical decision lens for investors and R&D sponsors is whether a trial can plausibly change:

• Coverage criteria
• Guideline positioning
• Formulary tiering
• Relative use vs competitors (gabapentinoids and pain therapeutics)

What market does Lyrica address, and how does the competitive set shape pricing power?

Pregabalin’s market sits within the neuropathic pain category and overlapping chronic pain markets. Lyrica competes primarily with:

• Other gabapentinoids (notably gabapentin)
• Alternative neuropathic pain agents (SNRIs, TCAs, topical agents, opioids in selected pathways)
• Condition-specific standard-of-care depending on country and guideline updates

Demand drivers

• High prevalence of neuropathic pain conditions
• Long duration of therapy in real-world practice (tolerance and discontinuation rates matter)
• Payer preference for lower-cost generics once exclusivity lapses

Supply and pricing reality

Once pregabalin reached generic entry in key markets, branded Lyrica pricing power typically shifts toward:

• Brand premium in selected formularies
• Patient-level inertia (tolerability history, prescriber familiarity)
• Switch barriers (documentation, physician-managed cross-titration)

How is the global market for pregabalin trending, and what does that imply for revenue?

The commercial trajectory for pregabalin typically follows a branded-to-generic transition curve. That curve impacts:

• Revenue stability in mature markets (volume may hold while price erodes)
• New growth concentration in emerging geographies where generic entry may lag
• Therapeutic substitution dynamics with adjacent neuropathic pain agents

Given the absence of any credible, current primary data in the provided materials about trial-by-trial enrolment, completion, and results for pregabalin beyond the label anchor, projection work must be constrained to the structural market model of a mature generics-exposed drug rather than a claim-driven growth model.

What is the projection for Lyrica over the next 3 to 5 years?

This projection framework separates brand Lyrica economics from class pregabalin demand.

Base-case projection logic (structural model)

• Class demand: Stable-to-slow growth in chronic neuropathic pain patient populations, offset by switching to other neuropathic pain mechanisms and competing products.
• Brand share: Declines unless lifecycle strategies maintain differentiation.
• Price: Continues downward under generic competition and volume contracting by payer management.
• Net effect: Brand revenue growth is unlikely in mature markets; total market value can rise modestly if emerging markets add volume, but branded share usually shrinks.

Scenario set (directional, decision-grade)

Horizon	Base case (most likely)	Bear case	Bull case
12-24 months	Brand revenue flattens then drifts down; volume stable in pockets	Further payer push to lowest WAC/cheapest generic; faster share erosion	Targeted contracting maintains premium pricing longer; slower conversions
3-5 years	Continued net erosion with modest market volume growth	Stronger substitution toward non-gabapentinoid options; steeper discontinuation	New label/data support expands payer adoption in a subgroup that resists switching

What clinical trial outcomes would change this projection fastest?

The highest-impact outcomes for a mature drug are those that:

• Sustain or improve discontinuation rates (tolerability improvements can preserve persistence and payer confidence)
• Demonstrate differentiated effectiveness in a specific neuropathic pain subgroup aligned with guideline gaps
• Support new reimbursement pathways (health-economic endpoints, reduced rescue medication use, improved function)

Absent such differentiated outcomes, the market behaves like a classic legacy molecule: price compression dominates and R&D spend shifts from efficacy discovery to lifecycle and evidence maintenance.

Which endpoints and safety data matter most in Lyrica trials?

Across pregabalin trials, endpoints that drive payer and guideline alignment typically include:

• Pain intensity reduction scales (baseline-to-endpoint change)
• Functional outcomes and patient-reported measures
• Sleep and quality-of-life measures in neuropathic pain programs
• Treatment-emergent adverse events with focus on:
  • Dizziness
  • Somnolence
  • Peripheral edema
  • Weight gain
• Dose titration tolerability and discontinuation rates

These safety and monitoring priorities are anchored in the U.S. prescribing information for Lyrica, which drives how trials design inclusion criteria and risk management. [1]

What regulatory and labeling items should guide a clinical-trial readout?

Label constraints define trial credibility:

• Dosing titration and renal impairment considerations
• Concomitant medication guidance
• Adverse reaction monitoring and contraindication context

These are embedded in the approved product information and influence the acceptability of results to regulators and payers. [1]

How should investors and business leaders interpret ongoing pregabalin trials?

For mature molecules, the signal is not “trial completion.” The signal is whether the trial delivers a commercially actionable claim:

• A new indication that maps to unmet payer coverage criteria
• A subgroup effect that is stable across endpoints and replicates in practice
• A health economic narrative that supports formulary exceptions or tier placement
• A formulation advantage that reduces discontinuations or improves adherence

If a trial only replicates known efficacy without a differentiator, it typically does not halt branded premium erosion in generic-heavy markets.

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Key Takeaways

• Lyrica is a mature, generics-exposed pregabalin franchise where near-term value depends more on lifecycle evidence and payer contracting than on new mechanism breakthroughs.
• Clinical-trial impact is highest for differentiated tolerability, subgroup efficacy, and reimbursement-linked endpoints that preserve persistence and reduce switching.
• Market economics for pregabalin are structurally characterized by ongoing price compression in mature geographies, with only modest growth potential tied to volume expansion and localized brand resilience.
• Over 3 to 5 years, the most likely outcome is continued branded revenue erosion with possible stabilizers only if trials support commercially actionable claims.

FAQs

1. What is Lyrica approved for?
   Lyrica’s approved indications include neuropathic pain and adjunctive treatment of partial-onset seizures, as listed in the U.S. prescribing information. [1]

2. What determines whether Lyrica trial results move the market?
   Results matter if they change payer coverage, guideline positioning, or persistence through differentiated tolerability or clinically meaningful subgroup outcomes. [1]

3. Does pregabalin have a “new mechanism” pipeline?
   The pregabalin mechanism is fixed; for a branded legacy molecule, most measurable upside usually comes from lifecycle and evidence packages rather than new mechanism discovery.

4. How does generic competition typically affect Lyrica revenue?
   Generic entry drives price compression and share erosion; branded revenue usually drifts down unless lifecycle differentiation slows switching.

5. Which safety signals are most monitored in Lyrica studies?
   Dizziness, somnolence, peripheral edema, weight gain, and discontinuation due to adverse reactions are core monitored safety areas reflected in labeling. [1]

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References

[1] Pfizer Inc. (n.d.). Lyrica (pregabalin) prescribing information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/spl/