LYRICA (pregabalin)
Lyrica (pregabalin) is a medication indicated for the management of several chronic pain conditions and as an adjunctive treatment for epilepsy. It is used to treat neuropathic pain associated with diabetic peripheral neuropathy and spinal cord injury, as well as postherpetic neuralgia and fibromyalgia. Additionally, the drug is approved as an add-on therapy for partial onset seizures in adult and pediatric patients aged four years and older.
How LYRICA Works
Pregabalin binds with high affinity to the alpha 2-delta subunit of voltage-gated calcium channels within the central nervous system. This binding is thought to reduce the calcium-dependent release of pro-nociceptive neurotransmitters, potentially by disrupting channel trafficking or reducing calcium currents. While it is a structural derivative of the neurotransmitter GABA, it does not bind directly to GABA receptors or affect sodium channels, opiate receptors, or the reuptake of dopamine and serotonin.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-12-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE, SOLUTION
LYRICA Approval History
What LYRICA Treats
6 indicationsLYRICA is approved for 6 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neuropathic Pain
- Diabetic Peripheral Neuropathy
- Postherpetic Neuralgia
- Partial Onset Seizures
- Fibromyalgia
- Spinal Cord Injury
LYRICA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LYRICA
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
160 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07275762 | Y-4-LC-04 | Ph 2 | recruiting | Y-4 to Treat the Postherpetic Neuralgia |
| NCT07567924 | SIUT-ERC-2024/A-475 | Ph 4 | active not recruiting | Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome |
| NCT03794388 CAPTRANE results posted | ICO-A-2018-10 | Ph 3 | completed | Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery |
| NCT06628908 | VX24-548-110 | Ph 3 | recruiting | Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy |
| NCT06614322 | STUDY00009806 | Ph 2 | recruiting | SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy. |
| NCT06619860 | VX24-993-103 2024-514689-38-01 | Ph 2 | recruiting | Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy |
| NCT07451431 | #5739 | Ph 4 | recruiting | Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain |
| NCT05488847 results posted | 15592 | Ph 4 | active not recruiting | Opioid-Free Pain Protocol After Shoulder Arthroplasty |
| NCT04862845 | N-39-2021 | Ph 1 | completed | Combination of Duloxetine and Pregabalin to Improve Postoperative Pain |
| NCT07288528 FORTITUDE | FORTITUDE-01 | Ph 4 | not yet recruiting | A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough |
| NCT03216187 PREVENT | PREVENT | Ph 3 | terminated | Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery |
| NCT05660538 results posted | VX21-548-103 | Ph 2 | completed | Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN) |
| NCT05640453 | 35912/10/22 | Ph 4 | recruiting | Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting |
| NCT06766916 CRYSTAL | SYSKY-2024-1020-02 | Ph 2 | recruiting | Crisugabalin for Radiotherapy-Related Neuropathic Pain |
| NCT04322305 GABI2 | 7977 R21AA028371 | Ph 2 | suspended | Pregabalin Trial for the Treatment of Alcohol Use Disorder |
| NCT05974501 results posted | 20230147 | Ph 4 | completed | Pre vs Post Block in Total Knee Arthroplasty (TKA) |
| NCT03928093 | 1000060628 | Ph 3 | completed | Pregabalin Treatment for RDEB Pain and Itch |
| NCT05640479 | 35913/10/22 | Ph 4 | completed | Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery |
| NCT06512155 | Sleep disorders-1 | Ph 1 | completed | Improving Perioperative Sleep Disorders |
| NCT01480765 | Reda 007583 2010-024462-21, 11/H0703/7 | Ph 4 | completed | Preventing Pain After Heart Surgery |
| NCT06367998 | PC24MISV0017 | Ph 4 | not yet recruiting | Effect of Pregabalin on Shoulder Pain in Patients With Central Sensitization After Arthroscopic Rotator Cuff Repair |
| NCT04015908 results posted | 121505 | Ph 4 | completed | A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery |
| NCT06077786 | 20435A 2023-503987-18-00 | Ph 1 | completed | A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult Participants |
| NCT05967052 POSTCOVID | NIGRIR_001POSTCOVID | Ph 2 | recruiting | Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation |
| NCT04766996 results posted | STUDY00002021 | Ph 4 | terminated | PROUD Study - Preventing Opioid Use Disorders |
| NCT05221151 | 1/2022ANET3-B | Ph 4 | completed | Melatonin vs Pregabalin for Anxiolysis and Sedation |
| NCT04641273 | 20887 2020-002066-14 | Ph 2 | terminated | A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic Pain |
| NCT01801189 results posted | H001 | Ph 4 | completed | Preoperative Pain Control in Gastric Bypass Surgery Patients |
| NCT05370716 | CG100651-1-01 | Ph 1 | completed | Drug-Drug Interaction Study of "CG-651" in Healthy Volunteer |
| NCT04246619 BLOSSOM | KCT 11/2017 2017-004341-24 | Ph 4 | terminated | Efficacy of Pregabalin and Duloxetine in Patients With PDPN: the Effect of Pain on Cognitive Function, Sleep and Quality of Life |
| NCT04495283 results posted | CP-NVK009-0005 | Ph 2 | completed | A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy |
| NCT00599638 results posted | B0261002 | Ph 2 | completed | A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia |
| NCT00853229 results posted | CCF 08-195 | Ph 2 | terminated | Pregabalin for the Treatment of Vulvodynia |
| NCT01939366 results posted | KF6005/08 2013-000473-68, U1111-1151-4331 | Ph 2 | completed | Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves |
| NCT03472469 MAST results posted | HSC-MS-18-0036 KL2TR000370, UL1TR000371 | Ph 4 | completed | MAST Trial: Multi-modal Analgesic Strategies in Trauma |
| NCT03348735 PELICAN | R017007 | Ph 4 | terminated | Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment |
| NCT01846182 REGIONS results posted | SPLD-016-12F 6125 | Ph 2 | terminated | Research Examining Gulf War Illness in Our Nations Service Members |
| NCT00991276 results posted | A0081185 | Ph 3 | completed | Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance |
| NCT00676403 results posted | A0081183 | Ph 2 | completed | Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients |
| NCT01701362 results posted | A0081279 2012-003304-12 | Ph 3 | completed | Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain |
| NCT01387607 results posted | A0081241 | Ph 3 | completed | A Study For Pregabalin In Patients With Fibromyalgia |
| NCT01202227 results posted | A0081252 | Ph 3 | completed | An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain |
| NCT01332149 results posted | A0081265 | Ph 3 | completed | Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy |
| NCT01049217 results posted | A0081244 | Ph 3 | terminated | Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy |
| NCT00905437 results posted | A0081229 | Ph 3 | terminated | Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement |
| NCT01455415 results posted | A0081268 2011-002743-10 | Ph 3 | completed | Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain |
| NCT01474772 results posted | A0081269 2011-003266-32 | Ph 3 | completed | Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN) |
| NCT01020526 results posted | A0081231 2010-020300-29 | Ph 4 | completed | Pregabalin In Adolescent Patients With Fibromyalgia |
| NCT00624780 results posted | A0081147 | Ph 4 | completed | Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder |
| NCT01270828 results posted | A0081224 2009-016766-86 | Ph 3 | completed | Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia |
Showing 50 of 160 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LYRICA FDA Label Details
Indications & Usage
FDA Label (PDF)LYRICA is indicated for the treatment of Neuropathic Pain; Diabetic Peripheral Neuropathy; Postherpetic Neuralgia; Partial Onset Seizures; Fibromyalgia; Spinal Cord Injury.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment