Lyrica
(Pregabalin)ApprovedSmall molecule
Pregabalin is used to treat nerve pain from diabetes or shingles, and it also helps reduce seizures and anxiety. It works by calming overactive nerves in the body that cause pain and other symptoms.[2] Lyrica is currently approved and in use across 74 indications[4].[1]
Lyrica is one of 855 small molecule programs targeting Pruritus. It is currently in Approved.
74
Indications
418
Total Trials
19
Active Trials
854
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
6
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 69 indications
Competition
Competitive Landscape
744 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Lyrica
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Approved
Methylthioninium Chloride
PProvepharm SAS
Preclinical
Duragesic-100
CCephalon
Preclinical
MS Contin
HHikma Pharmaceuticals LLC
Preclinical
Nubain
AAultman Health Foundation
Preclinical
Vfend
PPrism Pharmaceuticals
Preclinical
Systemic Therapy
Bristol-Myers SquibbPreclinical
Rilvegostomig
AstraZenecaPreclinical
Vit D
PPost Graduate Institute of Medical Education and Research, Chandigarh
Preclinical
Beta Blocker
WWeill Medical College of Cornell University
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Pregabalin38 trials
Show 35 more trials
A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01080612·24 enrolled
Preemptive Pregabalin in Myringoplasty
Withdrawn·—·N/A·NCT03603626
Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia
Unknown status·—·Phase 2/3·NCT05389813·150 enrolled
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01220219·24 enrolled
Pregabalin vs. Gabapentin on Reducing Opioid Usage
Completed·—·Phase 4·NCT04705480·109 enrolled
The Effect of Oral Pregabalin on Epidural-induced Shivering and Epidural Characteristics
Completed·—·N/A·NCT03721432·77 enrolled
A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT01727791·10 enrolled
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01257516·18 enrolled
Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in Chinese Healthy Subject
Recruiting·—·Phase 1·NCT06935721·10 enrolled
Fibromyalgia16 trials
Efficacy and Safety of Pregabalin/Tizanidine vs. Pregabalin in Patients With Fibromyalgia
Not yet recruiting·—·N/A·NCT07382921·164 enrolled
Pregabalin In Adolescent Patients With Fibromyalgia
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT01020526·63 enrolled
The Efficacy and Safety of Pregabalin and Crisugabalin in Patients With Fibromyalgia
Recruiting·—·N/A·NCT07196657·1,116 enrolled
Show 13 more trials
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00830128·106 enrolled
Adolescent Fibromyalgia Study
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT01020474·107 enrolled
The Effect of Sympathetic Dysfunction on Muscle Spindle in Fibromyalgia
Unknown status·IIstanbul Physical Medicine Rehabilitation Training and Research Hospital·N/A·NCT05704374·36 enrolled
Exploration the Mechanism of Ba-Duan-Jin Therapy in the Management of Fibromyalgia
Completed·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·N/A·NCT03890133·60 enrolled
Comparison of Ba-Duan-Jin and Pregabalin in Patients with Fibromyalgia
Completed·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·N/A·NCT03797560·104 enrolled
Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00333866·747 enrolled
A Safety Study Of Pregabalin In Fibromyalgia
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00282997·500 enrolled
The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia
Recruiting·—·N/A·NCT07208357·384 enrolled
Neuropathic Pain15 trials
Pregabalin Peripheral Neuropathic Pain Study
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00141219·241 enrolled
Show 12 more trials
Efficacy of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain at Variable Dose
Unknown status·—·Phase 1·NCT05292066·126 enrolled
Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00219544·158 enrolled
Pregabalin Trial In HIV Neuropathic Pain
Terminated·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT01145417·217 enrolled
A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00301223·309 enrolled
Peripheral Neuropathy12 trials
Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00159731·160 enrolled
Show 9 more trials
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT01057693·633 enrolled
A Study To Evaluate Pregabalin In Patients With Painful Diabetic Peripheral Neuropathy (DPN)
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00156078·450 enrolled
The Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy
Completed·—·Phase 3·NCT02927951·44 enrolled
Post Operative Pain6 trials
Does Pregabalin Improve Post-operative Pain After C-section Delivery
Completed·—·N/A·NCT04259073·138 enrolled
Show 3 more trials
the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery
Unknown status·—·Phase 2·NCT05083793·90 enrolled
Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery
Completed·—·Phase 4·NCT03604354·95 enrolled
75 more indications
Postherpetic Neuralgia6 trials
A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00394901·372 enrolled
Single Dose5 trials
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following Various Sized Lunches As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01270815·28 enrolled
An Investigation Of The Absorption And Pharmacokinetics Of A Single Dose Of A Controlled Release (CR) Pregabalin Tablet Following A Low, Medium, And High-Fat Evening Meal As Compared To A Single Dose Of The Immediate Release (IR) Pregabalin Capsule In Healthy Volunteers
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01257529·28 enrolled
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01321671·24 enrolled
Show 2 more trials
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted At Bedtime Or Immediately Following A 400-500 or 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01291524·24 enrolled
Seizure4 trials
Once-A-Day Pregabalin For Partial Seizures
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT01262677·325 enrolled
Hysterectomy4 trials
Postoperative Analgesia3 trials
Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia
Recruiting·—·Phase 1·NCT05150795·80 enrolled
Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia
Completed·—·N/A·NCT03530280·51 enrolled
Restless Legs Syndrome3 trials
Total Knee Arthroplasty3 trials
Anxiety3 trials
Post-thoracotomy Pain2 trials
Partial Epilepsy2 trials
Chronic pain2 trials
Alcohol Dependence2 trials
Pregabalin for Alcohol Dependence
Completed·SSt. Petersburg Bekhterev Research Psychoneurological Institute·Phase 4·NCT02205879·100 enrolled
Medication2 trials
Safety and Efficacy2 trials
Breast Cancer2 trials
After Cardiac Surgery2 trials
Spinal Cord Injury2 trials
Prophylactic Pregabalin Treatment Following Spinal Cord Injury
Recruiting·—·N/A·NCT06066918·50 enrolled
Efficacy and Safety2 trials
A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00631943·112 enrolled
Essential Tremor2 trials
Pregabalin in the Treatment of Essential Tremor
Completed·—·Phase 1·NCT00646451·20 enrolled
Sevoflurane2 trials
Neuropathy2 trials
Preoperative2 trials
Cognition1 trial
Pain Control1 trial
Preoperative Pain Control in Liver Surgery Patients
Completed·—·N/A·NCT01923948·40 enrolled
Chronic Pancreatitis1 trial
Pain and Chronic Pancreatitis - Clinical End Experimental Studies
Completed·—·Phase 2/3·NCT00755573·64 enrolled
Osteoarthritis1 trial
Effectiveness1 trial
Neuralgia1 trial
Tooth Sensitivity1 trial
Burning Mouth Syndrome1 trial
Opioid Withdrawal1 trial
Total Knee Replacement1 trial
Effect of Perioperative Oral Pregabalin in Total Knee Replacement
Unknown status·—·Phase 4·NCT06187922·120 enrolled
Surgery1 trial
Management of Pain Associated With Failed Back Surgery Syndrome
Completed·—·Phase 4·NCT05324761·60 enrolled
Laparoscopic Sleeve Gastrectomy (LSG)1 trial
Interaction1 trial
Dacryocystorhinostomy1 trial
Clinical Trial1 trial
Abuse Potential1 trial
Epilepsy1 trial
Shoulder pain1 trial
Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy
Completed·—·Phase 4·NCT03241875·90 enrolled
Acute Postoperative Pain1 trial
Pregabalin is an Effective Treatment for Acute Postoperative Pain Following Spinal Surgery Without Major Side Effects
Unknown status·—·Phase 4·NCT05478382·132 enrolled
Magnesium Sulfate1 trial
Pruritus1 trial
Efficacy of Pregabalin for Diabetic Pruritus - A Randomized Controlled Study.
Recruiting·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT06790537·46 enrolled
Head and Neck Cancer1 trial
Pre-Operative Pregabalin for Post-Operative Pain in Head and Neck Cancer Surgery
Withdrawn·—·Phase 4·NCT03714867
Intravenous1 trial
Oral Pregabalin Effect to the Intravenous Morphine in Multiple Fracture Ribs
Unknown status·—·Phase 1·NCT03473093·80 enrolled
Immunodeficiency1 trial
Opioids1 trial
Adult1 trial
Pancreatic Cancer1 trial
Anxiety Disorder1 trial
Thoracotomy1 trial
Duloxetine vs Pregabalin for Thoracotomy Pain
Unknown status·—·Phase 4·NCT04782310·75 enrolled
Bone pain1 trial
A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
Terminated·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00381095·152 enrolled
Prevention1 trial
Analgesic1 trial
Muscle Cramp1 trial
Diabetic Neuropathy1 trial
Withdrawal Syndrome1 trial
Pregabalin for Opiate Withdrawal Syndrome
Completed·SSt. Petersburg Bekhterev Research Psychoneurological Institute·Phase 4·NCT03017430·100 enrolled
Hot flashes1 trial
Irritable Bowel Syndrome1 trial
Unspecified2 trials
Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00631696·222 enrolled
Regulatory
FDA Approval Timeline[5]
Dec 30, 2004
LYRICA
NDA NDA021446
Jan 4, 2010
LYRICA
NDA NDA022488
Oct 11, 2017
LYRICA CR
NDA NDA209501
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Lyrica drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Pregabalin. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Lyrica. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
Patent Landscape[6]
Patent Cliff
Nov 2, 2026
Earliest patent expiration — generic entry possible after this date
Patent #Expires
10022447Nov 2, 2026
8945620Nov 2, 2026
9144559Nov 2, 2026
9144559*PEDMay 2, 2027
10022447*PEDMay 2, 2027
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8945620*PEDMay 2, 2027