CLINICAL TRIALS PROFILE FOR LYRICA CR

505(b)(2) Clinical Trials for LYRICA CR

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 CR

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.
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.
NCT00288639 ↗	Lyrica (Pregabalin) Administered as an Add-on Therapy for Partial Seizures (LEADER).	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	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.
NCT00291148 ↗	Neuropathic Pain Assessment Comparing Pregabalin and Paroxetine in Management of MS-induced Neuropathic Pain	Completed	University of Manitoba	Phase 3	2006-03-01	This is a comparative drug trial involving patients with clinically definite Multiple Sclerosis and documented neuropathic pain. Patients will be randomized to receive treatment with either paroxetine or pregabalin. After dose titration, participants will complete various pain scale assessments at several points during the study in order to determine the effectiveness of their assigned pain medication.

Clinical Trial Conditions for LYRICA CR

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for LYRICA CR

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for LYRICA CR

Clinical Trial Phase

Clinical Trial Phase for LYRICA CR
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	43

Clinical Trial Status

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

Clinical Trial Sponsors for LYRICA CR

Sponsor Name

Sponsor Name for LYRICA CR
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 CR
Sponsor	Trials
Other	132
Industry	118
NIH	8

Lyrica CR (pregabalin extended-release) clinical trials update, market analysis and revenue projection (2026)

Last updated: July 28, 2026

What clinical trials have reported results for Lyrica CR (pregabalin extended-release)?

Answer: No complete, reliably attributable “Lyrica CR-specific” late-stage trial result set can be finalized from the information available in this chat.

Which Lyrica CR studies matter for regulatory and market access?

For pregabalin extended-release products, the decision-critical evidence typically clusters into:

• Bioequivalence and pharmacokinetic bridging versus immediate-release pregabalin
• Proof of symptom efficacy in neuropathic pain indications used by prescribers (diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury-related neuropathic pain)
• Long-term safety extensions (tolerability, discontinuation rates, weight gain, dizziness, somnolence)
• Abuse-deterrence and misuse monitoring where applicable to extended-release formats

What endpoints drive adoption for CR products?

• Durable pain reduction over maintenance periods
• Functional improvement (sleep interference and patient-reported interference measures where studied)
• Tolerability profile that supports dose persistence and switching reduction

How does Lyrica CR’s market size and demand profile look vs immediate-release pregabalin?

Answer: No complete, source-verifiable market sizing for “Lyrica CR” as a standalone SKU can be produced from the information available here.

What typically differentiates CR from immediate-release in the market?

Extended-release pregabalin is usually positioned for:

• Reduced dosing frequency versus immediate-release formulations
• Improved adherence in chronic neuropathic pain populations
• Potential reduction in peak-trough related adverse events for some patients, depending on study design

Where substitution risk is highest?

• Payer formularies that default to “preferred pregabalin” without forcing ER-specific use
• Generic immediate-release uptake that pressures ER premium pricing
• Pharmacy benefit designs that restrict ER coverage absent step therapy

When does Lyrica CR lose exclusivity and what drives generic timing?

Answer: No Orange Book–anchored exclusivity or patent-expiration timeline for “Lyrica CR” can be finalized without specific listed patents and FDA attachment identifiers.

What events typically control generic entry for ER products?

• Composition-of-matter patent expiry on pregabalin (active ingredient)
• Additional protection for ER formulation, excipients, particle engineering, and release mechanisms
• Method-of-use protection for specific neuropathic pain indications where applicable
• FDA exclusivities tied to listed drug references, if any (rare for older molecules unless tied to new clinical/marketed forms)

What is the Orange Book status of Lyrica CR and which patents cover it?

Answer: This chat does not contain Orange Book listings required to enumerate Lyrica CR’s listed patents, their expiration dates, and whether they are formulation, method-of-use, or device-related.

How many patents typically cover an ER pregabalin listed drug?

ER products commonly have:

• Several formulation and release-profile patents
• A smaller subset of method-of-use patents
• Potential manufacturing-process patents

What matters most for Paragraph IV decision-making?

• Listed patent type (formulation vs method-of-use)
• Remaining term by jurisdiction
• Whether any patent is enforceable against generic labeling or product characteristics

Are there any biosimilar or biologics-like risks for Lyrica CR?

Answer: None. Lyrica CR is a small molecule (pregabalin), so “biosimilar” frameworks do not apply.

What replacement categories compete with Lyrica CR?

• Small-molecule generics of pregabalin immediate-release and extended-release
• Therapeutic alternatives for neuropathic pain: gabapentinoids and non-gabapentinoid analgesics used in payer pathways

What formulation patents protect Lyrica CR (pregabalin extended-release)?

Answer: No formulation patent set for Lyrica CR can be enumerated from the information in this chat.

How formulation patents usually block generic ER entry

• Release kinetics claims tied to polymer matrices and drug load ranges
• Manufacturing method claims controlling particle size distribution, blending, granulation, and coating
• In vitro dissolution profiles required to meet claimed ranges

What patent litigation affects Lyrica CR?

Answer: This chat does not include case captions, court dockets, or settlement agreements necessary to identify active or resolved Lyrica CR patent disputes.

What to monitor in ER small-molecule patent litigation

• Injunction scope tied to specific asserted claims
• Dismissal outcomes tied to design-around strategies (different release matrix)
• “Carve-outs” on labeling changes versus structural product requirements

What generic entry risks exist for Lyrica CR?

Answer: No generic entry risk can be quantified without Orange Book term, Paragraph IV filing history, and court outcomes.

How risk is typically assessed for CR generics

• Remaining patent term and strength (claim construction likelihood)
• Whether ANDA challenges method-of-use versus formulation patents
• Expected launch design-around success (release profile compliance and dissolution equivalence)

How does Lyrica CR compare with competing pregabalin products (ER and IR) on exclusivity and expected launch pressure?

Answer: A comparative exclusivity and launch-forecast grid cannot be completed without identified competitors’ listed patents, FDA status, and launch dates.

What drivers usually pressure premium ER pricing?

• Immediate-release pregabalin generic availability
• ER generic adoption after patent cliffs
• Payer step edits that narrow ER coverage

FDA regulatory status: is Lyrica CR approved for which indications and what pathway does it follow?

Answer: This chat does not contain Lyrica CR FDA approval/labeling details necessary to map approvals, indication scope, and regulatory pathways.

What information typically matters for commercial projections

• Label breadth across neuropathic pain indications
• Whether ER is interchangeable with IR in labeling
• Safety communications affecting persistence (somnolence, dizziness, weight gain)

Commercial projection: what revenue trajectory is realistic for Lyrica CR?

Answer: This chat does not include baseline revenue, market share, unit demand, price history, or country-by-country sales required for a quantified projection.

What a defensible projection model needs (and what this chat lacks)

A projection that withstands investment or licensing scrutiny requires:

• Current sales by geography and formulation strength
• Generic penetration rates and expected ER replacement cadence
• WAC-to-net price evolution by payer mix
• Patent cliff timing and expected litigation/settlement outcomes

Key data grid (required for investment-grade projection)

Category	Lyrica CR requirement	Present in chat
FDA listed drug identifiers	NDA/BLA number, strength, label	Not provided
Orange Book patent list	Patent numbers, types, expiration dates	Not provided
Exclusivity	Listed exclusivity with start/end	Not provided
Paragraph IV history	ANDA number, filer, filing date, certifications	Not provided
Litigation	Case numbers, courts, asserted claims, outcomes	Not provided
Sales baseline	Revenue, units, net price, payer mix	Not provided
Forecast inputs	Patent cliff schedule, generic penetration curve	Not provided

Because the required primary inputs are absent, no defensible timeline, litigation posture, or revenue forecast can be produced.

Key Takeaways

• A “clinical trials update” for Lyrica CR cannot be completed with attribution quality from the information available here.
• Orange Book status, patent expiration, and Paragraph IV risk for Lyrica CR cannot be enumerated without the listed-drug identifier and patent list.
• A quantitative market analysis and revenue projection cannot be produced without baseline sales, payer dynamics, and patent cliff inputs.

FAQs

1. How can Lyrica CR’s extended-release mechanism affect generic dissolution-equivalence challenges?
2. What patent claim types (formulation vs method-of-use) most often drive ANDA Paragraph IV settlements for ER gabapentinoids?
3. How do payer step edits typically shift demand from pregabalin ER to pregabalin IR after generic launches?
4. What label changes related to CNS adverse events most influence patient persistence for pregabalin products?
5. What datasets are required to build a court-to-commercial forecast after patent litigation for ER small molecules?

References

1. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, U.S. FDA. (No Orange Book entries for Lyrica CR were provided in this chat.)
2. FDA Drug Trials Snapshots and labeling databases, U.S. FDA. (No Lyrica CR identifiers or snapshots were provided in this chat.)
3. CourtListener / PACER dockets, USPTO Patent Center. (No case captions were provided in this chat.)