Keppra

(Levetiracetam)

ApprovedSmall molecule

Levetiracetam is used to treat and prevent seizures in people with epilepsy. It can be used alone or combined with other seizure medications.[2] Keppra is currently approved and in use across 65 indications[4].[1]

Keppra is one of 1199 small molecule programs targeting Bilateral tonic-clonic seizure. It is currently in Approved.

Indications

214

Total Trials

Active Trials

1,198

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Bilateral Tonic-Clonic SeizureActive, not recruiting

Epilepsy With Generalized Tonic-Clonic SeizuresApproved

MetastasisActive, not recruiting

Partial EpilepsyApproved

ParagangliomaApproved

Migraine DisorderActive, not recruiting

Generalized Non-Motor (absence) SeizureApproved

Drug-Induced DyskinesiaApproved

Cognitive ImpairmentActive, not recruiting

StrokeActive, not recruiting

Bilateral Tonic-Clonic SeizureApproved

Active, not recruiting

Epilepsy With Generalized Tonic-Clonic SeizuresApproved

Approved

MetastasisPhase 2

Active, not recruiting

Partial EpilepsyApproved

Approved

ParagangliomaApproved

Approved

Migraine DisorderPreclinical

Active, not recruiting

Generalized Non-Motor (absence) SeizureApproved

Approved

Drug-Induced DyskinesiaApproved

Approved

Cognitive ImpairmentPhase 2

Active, not recruiting

StrokePhase 3

Active, not recruiting

Showing 10 of 63 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Keppra

UCB

Approved

1 2

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 3

Norvir

AbbVie

Preclinical

1 4

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 5

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 6

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 7

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

PEG-Intron

1 9

CAR-T

HHebei Senlang Biotechnology Inc., Ltd.

Preclinical

3 10

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Seizure

NCT07284498

Q2 2027

Post-ApprovalRecruiting

Brain Injury

NCT06866691

Phase 3Not yet recruiting

Seizure

NCT07239115

Q3 2027

Recruiting

Infants

NCT03511118

Q1 2028

Phase 3Not yet recruiting

Brain Injury

NCT04573803

Post-ApprovalRecruiting

Seizure

NCT07072624

Clinical

Trials by Indication[1]

Epilepsy45 trials

A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures

Completed· UCB logo

UCB·Phase 3·NCT00367432·398 enrolled

Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

Completed· UCB logo

UCB·Phase 4·NCT00643500·342 enrolled

Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy

Completed· UCB logo

UCB·Phase 2·NCT00535392·33 enrolled

Show 42 more trials

Levetiracetam for Benign Rolandic Epilepsy

Completed·JJohns Hopkins University·Phase 4·NCT00181116·6 enrolled

Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT00160628·100 enrolled

An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures

Completed· UCB logo

UCB·Phase 2·NCT01407523·16 enrolled

Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy

Completed· UCB logo

UCB·Phase 4·NCT00630630·3 enrolled

Comparison of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Epilepsy

Completed·RRESnTEC, Institute of Research·N/A·NCT07163585·102 enrolled

Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures

Completed· UCB logo

UCB·Phase 3·NCT00160550·154 enrolled

A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)

Completed· UCB logo

UCB·Phase 3·NCT01228747·361 enrolled

Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy

Completed· UCB logo

UCB·Phase 2·NCT00505934·19 enrolled

Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT00175903·1,701 enrolled

Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

Completed· UCB logo

UCB·Phase 3·NCT00291655·130 enrolled

Second-Line Treatment Choice for Epilepsy

Unknown status·DDutch Epilepsy Clinics Foundation·N/A·NCT00208520·60 enrolled

A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil

Completed· UCB logo

UCB·Phase 1·NCT03695094·31 enrolled

Lamotrigine Versus Levetiracetam in the Initial Monotherapy of Epilepsy

Completed·PPhilipps University Marburg·Phase 3·NCT00242606·409 enrolled

A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02201251·63 enrolled

Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy

Completed· UCB logo

UCB·Phase 4·NCT00160654·251 enrolled

Levetiracetam Three Times Daily in Epilepsy

Recruiting·WWaad Alkathiri·Phase 3·NCT07490769·120 enrolled

Levetiracetam to Prevent Post-Traumatic Epilepsy

Completed·PPavel Klein·Phase 2·NCT01463033·126 enrolled

Levetiracetam Versus Valproate in Idiopathic Generalized Epilepsy

Completed·MMazandaran University of Medical Sciences··NCT06393309·169 enrolled

Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

Completed· UCB logo

UCB·Phase 3·NCT00150813·66 enrolled

Carisbamate Retention Study (CaReS): Comparative Study on the Long Term Effectiveness, Safety and Tolerability of Carisbamate Compared to Two Other Frequently Prescribed Anti-epileptic Drugs (AEDs) in Patients With Epilepsy.

Terminated·SSK Life Science, Inc.·Phase 3·NCT00563459·89 enrolled

Levetiracetam for Alzheimer's Disease Neuropsychiatric Symptoms Related to Epilepsy Trial (LAPSE)

Unknown status·WWalter Reed National Military Medical Center·Phase 2·NCT04004702·65 enrolled

Precision Medicine in the Treatment of Epilepsy

Recruiting·GGitte Moos Knudsen··NCT05450822·550 enrolled

Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT00150735·580 enrolled

Modified Atkins Diet Versus Levetiracetam for Refractory Childhood Epilepsy

Unknown status·LLady Hardinge Medical College·Phase 2/3·NCT04172311·90 enrolled

Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)

Unknown status·BBeijing Pins Medical Co., Ltd··NCT02603991·1 enrolled

An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures

Completed· UCB logo

UCB·Phase 3·NCT01398956·44 enrolled

A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT00150709·223 enrolled

Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

Completed· UCB logo

UCB·Phase 3·NCT00150787·250 enrolled

Changing Agendas on Sleep, Treatment and Learning in Epilepsy

Terminated·KKing's College London·Phase 4·NCT04610879·5 enrolled

Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method

Completed· UCB logo

UCB·Phase 2·NCT00600509·216 enrolled

Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy.

Completed· UCB logo

UCB·Phase 4·NCT00245713·40 enrolled

Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)

Terminated·EEmory University·Phase 3·NCT01891890·72 enrolled

Characterization of Epilepsy Patients BEEP 2b

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT02707965·21 enrolled

Post-stroke Epilepsy: Primary Prophylaxis Study

Unknown status·NNational Cheng Kung University·N/A·NCT04858841·180 enrolled

S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Completed· UCB logo

UCB·Phase 4·NCT00630968·1,541 enrolled

Modification of Epilepsy Screen Questionnaire and Treatment Feasibility Evaluation

Unknown status·NNational Taiwan University Hospital·N/A·NCT04939675·40 enrolled

Evaluation of Levetiracetam's Effectiveness and Tolerability for Treating Epilepsy in Older Adults

Completed·NNasim Tabrizi·Phase 4·NCT07422233·137 enrolled

Improvement Effect of Lacosamide and Levetiracetam on Cognitive in Alzheimer's Disease Patients With Epilepsy

Unknown status·XXiangya Hospital of Central South University·Phase 4·NCT05969054·140 enrolled

A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

Completed· UCB logo

UCB·Phase 3·NCT00280696·352 enrolled

Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT00150748·217 enrolled

A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy

Completed· UCB logo

UCB·Phase 4·NCT00631150·35 enrolled

An Open Label Study of Levetiracetam Monotherapy in Patients With Newly Diagnosed Focal Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT01506882·71 enrolled

Seizure29 trials

A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures

Completed· UCB logo

UCB·Phase 2·NCT00545012·4 enrolled

Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention

Completed·UUniversity of Cincinnati·Phase 4·NCT00618436·52 enrolled

Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors

Completed·DDr Andrea Rossetti·Phase 2·NCT00629889·52 enrolled

Show 26 more trials

Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

Completed· UCB logo

UCB·Phase 3·NCT00160615·154 enrolled

Pregabalin Versus Levetiracetam In Partial Seizures

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00537238·509 enrolled

Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)

Recruiting·—·Phase 4·NCT07072624·1,260 enrolled

Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary Generalization

Completed·AAche Laboratorios Farmaceuticos S.A.·Phase 3·NCT01392768·126 enrolled

Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures

Completed· UCB logo

UCB·Phase 3·NCT01954121·436 enrolled

Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures

Completed· UCB logo

UCB·Phase 3·NCT00615615·216 enrolled

The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A Multicentric Randomized Controlled Study

Completed·YYonsei University·Phase 4·NCT02208492·75 enrolled

Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study

Withdrawn·MMedical University of South Carolina·Phase 2·NCT00627133

Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

Completed· UCB logo

UCB·Phase 4·NCT01229735·343 enrolled

Treatment of Seizures in Neonate With HIE

Not yet recruiting·MMansoura University·Phase 4·NCT07284498·66 enrolled

Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures

Completed· UCB logo

UCB·Phase 2·NCT00610454·25 enrolled

Seizure Treatment in Glioma

Recruiting·LLeiden University Medical Center·Phase 4·NCT03048084·120 enrolled

Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

Withdrawn·NNorthwestern University·N/A·NCT00415376

Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children

Completed·—·Phase 1·NCT01521130·108 enrolled

Trial of Levetiracetam in Patients With Primary Brain Tumors and Symptomatic Seizures Who Undergo Surgery

Completed·UUniversity Hospital Tuebingen·Phase 4·NCT00571155·30 enrolled

A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures.

Completed· UCB logo

UCB·Phase 3·NCT00175890·116 enrolled

Levetiracetam for Seizure Prevention After Brain Tumor Surgery

Not yet recruiting·—·Phase 3·NCT07239115·558 enrolled

Clinical Trial : TROCC (Quick Oral Treatment of Cluster Epileptic Seizures)

Terminated·UUniversity Hospital, Grenoble·Phase 3·NCT00376766·112 enrolled

A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures

Completed· UCB logo

UCB·Phase 3·NCT01292837·13 enrolled

An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures

Completed· UCB logo

UCB·Phase 3·NCT01063764·73 enrolled

A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age

Completed· UCB logo

UCB·Phase 3·NCT03340064·38 enrolled

Prevention of Post-traumatic Seizures With Levetiracetam

Terminated·RRennes University Hospital·Phase 3·NCT00566046·23 enrolled

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Completed·MMazandaran University of Medical Sciences·Phase 4·NCT03940326·103 enrolled

Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure

Not yet recruiting·NNebraska Methodist Health System·Phase 3·NCT07220902·1,240 enrolled

A Safety and Feasibility Study of Enteral LVT vs. Standard of Care for Seizure Control in Pediatric CM

Completed·UUniversity of Rochester·Phase 2·NCT01982812·44 enrolled

Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures

Completed· UCB logo

UCB·Phase 3·NCT00152516·255 enrolled

Status Epilepticus9 trials

Established Status Epilepticus Treatment Trial

Completed·UUniversity of Virginia·Phase 3·NCT01960075·478 enrolled

Effectiveness of Combined Levetiracetam and Midazolam in Generalized Convulsive Status Epilepticus in Children

Completed·SSohag University·Phase 2·NCT04926844·144 enrolled

Levetiracetam, Lacosamide and Ketamine as Adjunctive Treatment of Refractory Status Epilepticus

Withdrawn·MMid-Atlantic Epilepsy and Sleep Center, LLC·Phase 3·NCT02726867

Show 6 more trials

Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children

Recruiting·SSohag University·Phase 2/3·NCT07046611·124 enrolled

Efficacy Comparison Between Levetiracetam and Valproic Acid in Pediatric Patients With Status Epilepticus

Completed·RRESnTEC, Institute of Research·N/A·NCT07052136·138 enrolled

Efficacy of Phenytoin vs Levetiracetam in Status Epilepticus at Institute of Child Health,Faisalabad

Completed·SShaheed Zulfiqar Ali Bhutto Medical University·N/A·NCT06067412·70 enrolled

Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus

Completed·—·Phase 2·NCT02920060·80 enrolled

The Efficacy and Safety of Levetiracetam Versus Fosphenytoin in Convulsive Status Epilepticus

Enrolling by invitation·—·Phase 4·NCT06403150·62 enrolled

Safety and Tolerability Study of Levetiracetam to Treat Patients With Status Epilepticus

Unknown status·MMedical Center Haaglanden·Phase 2·NCT00362141·12 enrolled

Fasting Conditions6 trials

Levetiracetam 1000 mg Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00859521·30 enrolled

Levetiracetam 1000 mg Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00859430·22 enrolled

Levetiracetam 750 mg Tablets Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00849485·22 enrolled

Show 3 more trials

Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00826865·27 enrolled

Bioavailability Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fasting Conditions.

Completed·—·Phase 1·NCT01131897·24 enrolled

Levetiracetam 750 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00849862·22 enrolled

Neonatal seizure6 trials

Levetiracetam Versus Phenobarbitone for the Treatment of Neonatal Seizures in a Tertiary Care Hospital.

Completed·HHayat Abad Medical Complex, Peshawar·N/A·NCT07401433·260 enrolled

Efficacy of Keppra for Neonatal Seizures

Terminated·—··NCT01475656·2 enrolled

Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG

Unknown status·—·Phase 4·NCT03107507·40 enrolled

Show 3 more trials

Efficacy of Intravenous Levetiracetam in Neonatal Seizures

Completed·RRichard H. Haas·Phase 1/2·NCT01720667·280 enrolled

Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study

Completed·UUniversity Hospital, Tours·Phase 2·NCT02229123·18 enrolled

Levetiracetam Treatment of Neonatal Seizures

Terminated·—·Phase 1/2·NCT02550028·60 enrolled

75 more indications

Treatment4 trials

Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA)

Unknown status·OOslo University Hospital·Phase 4·NCT00393614·30 enrolled

Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder (PMDD)

Completed·—·N/A·NCT00518570·7 enrolled

Cognitive Effects of Treatment of Interictal Discharges

Completed·MMassachusetts General Hospital·N/A·NCT00916149·31 enrolled

Show 1 more trial

Comparison of Keppra and Clonidine in the Treatment of Tics

Completed·—·Phase 4·NCT00370838·12 enrolled

Brain Injury4 trials

Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?

Unknown status·LLoyola University·Phase 4·NCT03054285·2,300 enrolled

Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide

Recruiting·WWake Forest University Health Sciences·Phase 4·NCT06866691·600 enrolled

Pharmacological Management of Seizures Post Traumatic Brain Injury

Not yet recruiting·—·Phase 3·NCT04573803·1,649 enrolled

Show 1 more trial

Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

Terminated·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT06081283·5 enrolled

Parkinson's Disease4 trials

Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias

Completed· UCB logo

UCB·Phase 2·NCT00160576·30 enrolled

Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease

Unknown status·—·Phase 2·NCT00291733·50 enrolled

Keppra IV for the Treatment of Motor Fluctuations in Parkinson's Disease

Withdrawn·UUniversity of South Florida·Phase 4·NCT00584025

Show 1 more trial

Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease

Completed·TTechnische Universität Dresden·Phase 4·NCT00307450·34 enrolled

Fed3 trials

Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00826787·29 enrolled

Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00827320·26 enrolled

Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions

Completed·—·Phase 1·NCT01132352·24 enrolled

Drug3 trials

Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam

Completed· UCB logo

UCB·Phase 1·NCT00736931·20 enrolled

Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Completed·—··NCT00612235·80 enrolled

Antiepileptic Drugs and Vascular Risk Markers

Terminated·TThomas Jefferson University·N/A·NCT00774306·52 enrolled

Tardive Dyskinesia2 trials

Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

Completed· UCB logo

UCB·Phase 2·NCT00175955·70 enrolled

Levetiracetam Treatment of Tardive Dyskinesia

Completed·YYale University·Phase 3·NCT00291213·50 enrolled

Intravenous2 trials

An Open-label, Bioequivalence Study to Evaluate LEV Administered as a 45-min Intravenous Infusion and Same Dosage LEV Oral Tablet in Chinese

Completed· UCB logo

UCB·Phase 1·NCT01618903·24 enrolled

Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects

Completed· UCB logo

UCB·Phase 1·NCT01394224·25 enrolled

Brain Tumor2 trials

Levetiracetam Prophylaxis in Brain Tumor Resection Pilot

Not yet recruiting·HHamilton Health Sciences Corporation·Phase 3·NCT05897658·70 enrolled

1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients

Completed·UUniversity of Florida·Phase 4·NCT02334722·81 enrolled

Double-blind2 trials

Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS

Completed· UCB logo

UCB·Phase 3·NCT00152373·192 enrolled

A Randomized, Double-blind, Pharmacokinetics Study to Assess Safety, Tolerability of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of Bid Dosing in Chinese Healthy Volunteers

Completed· UCB logo

UCB·Phase 1·NCT01618877·24 enrolled

Dementia2 trials

Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia

Completed·—·Phase 4·NCT01318408·24 enrolled

Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease

Recruiting·TThe University of Queensland·Phase 2·NCT04643327·28 enrolled

Stroke2 trials

Levetiracetam Versus Carbamazepine in Post-Stroke Late Onset Crisis

Unknown status·SScienze Neurologiche Ospedaliere·Phase 3·NCT00542802·630 enrolled

Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial

Recruiting·SShanghai East Hospital·Phase 3·NCT06773364·2,423 enrolled

Psychosis2 trials

Levetiracetam in Early Psychosis

Completed·NNYU Langone Health·Phase 2·NCT03129360·48 enrolled

Investigating the Effect of a Single-dose of Levetiracetam on Brain Function, Chemistry and Cognitive Performance in Psychosis Risk

Recruiting·KKing's College London·N/A·NCT06224530·69 enrolled

Methadone2 trials

Efficacy of Levetiracetam in Cocaine-Abusing Methadone Maintained Patients

Completed·YYale University·Phase 2·NCT00577005·28 enrolled

Levetiracetam (Keppra) Tolerability in Cocaine Abusing Methadone-maintained Patients.

Completed·YYale University·Phase 2·NCT00593125·15 enrolled

Alzheimer's Disease2 trials

Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability

Completed·UUniversity of Minnesota·Phase 2·NCT02002819·34 enrolled

An Investigation of Levetiracetam in Alzheimer's Disease

Completed·UUniversity of Oxford·Phase 2·NCT03489044·8 enrolled

Aneurysm2 trials

Seizure Prophylaxis in Aneurysm Repair

Terminated·IIndiana University·Phase 4·NCT01974700·17 enrolled

Seizure Prophylaxis in Aneurysm Repair

Completed·UUniversity of Michigan·Phase 4·NCT01801072·82 enrolled

Polyneuropathy2 trials

Levetiracetam for Painful Polyneuropathy

Completed·OOdense University Hospital·Phase 4·NCT00286260·40 enrolled

A Study to Determine if Levetiracetam Will Assist Those Suffering From Chronic Idiopathic Axonal Polyneuropathy.

Completed·VVanderbilt University·Phase 2·NCT00156689·30 enrolled

Schizophrenia2 trials

Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia

Completed·UUniversity of Colorado, Denver·N/A·NCT02647437·18 enrolled

Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

Completed·VVA Office of Research and Development·Phase 1/2·NCT03034356·67 enrolled

TED2 trials

Bioequivalency Study of Levetiracetam 1g Under Fasted Conditions

Completed·RRoxane Laboratories·N/A·NCT00826722·30 enrolled

Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects

Completed· Roche logo

Roche·Phase 1·NCT07393022·20 enrolled

Spinal Cord Injury1 trial

Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

Completed·—·Phase 4·NCT00252954·36 enrolled

Panic Disorder1 trial

Levetiracetam Treatment of Panic Disorder and Lactate-Induced Panic Attacks

Completed·LLindner Center of HOPE·Phase 3·NCT00279617·15 enrolled

Adolescent1 trial

Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults

Completed· UCB logo

UCB·Phase 3·NCT00150774·116 enrolled

Bipolar Depression1 trial

Levetiracetam in the Management of Bipolar Depression

Completed·YYale University·N/A·NCT00566150·35 enrolled

Effectiveness1 trial

Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

Completed·—·Phase 4·NCT00265109·17 enrolled

Lymphoma1 trial

Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma

Completed· Gilead logo

Gilead·Phase 1/2·NCT02348216·307 enrolled

Neuroblastoma1 trial

Therapy for Children With Advanced Stage Neuroblastoma

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT01857934·153 enrolled

Malaria1 trial

Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria

Completed·UUniversity of Rochester·Phase 1/2·NCT01660672·7 enrolled

Obsessive-Compulsive Disorder1 trial

Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

Terminated·—·Phase 2/3·NCT00299611·12 enrolled

Fibromyalgia1 trial

Levetiracetam for Treatment of Pain Associated With Fibromyalgia

Completed·UUniversity of California, San Francisco·N/A·NCT00254657·66 enrolled

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03196466·753 enrolled

Alcohol Dependence1 trial

Levetiracetam for the Treatment of Alcohol Dependence and Anxiety

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00141115·3 enrolled

Convulsion1 trial

Intermittent Levetricetam in Treatment of Febrile Convulsions

Unknown status·—·N/A·NCT05860153·100 enrolled

Elderly Patients1 trial

Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs

Completed·JJohannes Gutenberg University Mainz·Phase 4·NCT00438451·361 enrolled

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 enrolled

Neuralgia1 trial

A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN)

Completed· UCB logo

UCB·Phase 2·NCT00160511·170 enrolled

Essential Tremor1 trial

Efficacy of Levetiracetam in Essential Tremor

Completed·SSouthern California Institute for Research and Education·Phase 1/2·NCT00620165·10 enrolled

Refractory AML1 trial

T-Cell Depleted Double UCB for Refractory AML

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT01464359·3 enrolled

Newly Diagnosed1 trial

Validation of the Role of Levetiracetam for Newly Diagnosed GBM Patients

Unknown status·SSeoul National University Hospital·Phase 2·NCT02815410·73 enrolled

Childhood Absence Epilepsy1 trial

A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy

Completed·TThe Cleveland Clinic·N/A·NCT00361010·20 enrolled

Kidney Disease1 trial

Study on the Population Pharmacokinetics of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease

Unknown status·TThe Second Hospital of Shandong University··NCT05330390·50 enrolled

Brain Tumors1 trial

Short Versus Long-term Levetiracetam in Brain Tumors

Recruiting·TTata Memorial Centre·Phase 3·NCT06442748·604 enrolled

Pilot Study1 trial

Pilot Study of Levetiracetam (Keppra® (Registered Trademark)) for Bipolar Illness

Completed·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00015769·30 enrolled

Headache1 trial

A Clinical Study Examining the Safety and Effectiveness of a New Medication (Keppra®) for the Prevention of Migraine Headaches

Completed·TThomas Jefferson University·N/A·NCT00203216·31 enrolled

Pregnancy1 trial

Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding

Recruiting·UUniversity of Pittsburgh··NCT05450978·60 enrolled

Post-Traumatic Stress Disorder1 trial

Levetiracetam in Post-Traumatic Stress Disorder

Completed·—·Phase 2/3·NCT00413296·16 enrolled

Epileptics1 trial

Pharmacokinetics of Antiepileptics in Patients on CRRT

Completed·UUniversity of Maryland, Baltimore··NCT03632915·18 enrolled

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06345495·30 enrolled

CAR1 trial

Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide

Terminated· UCB logo

UCB·Phase 3·NCT01375374·11 enrolled

Dystonia1 trial

Efficacy of Levetiracetam in Oromandibular and Cranial Dystonia

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT02199509·8 enrolled

Imaging1 trial

A Brain Imaging Study With Positron Emission Tomography and the Radiotracer [11C]UCB-J to Estimate How Fast Brivaracetam and Levetiracetam Enter the Brain in Healthy Volunteers

Completed· UCB logo

UCB·Phase 1·NCT02602860·13 enrolled

Alcoholism1 trial

Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism

Terminated·—·Phase 2·NCT00862563·85 enrolled

Tics1 trial

Pharmacokinetics of Levetiracetam (Keppra) in Neonates

Completed·—··NCT01261416·18 enrolled

Hematoma1 trial

Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas

Unknown status·UUniversité de Sherbrooke·Phase 4·NCT04759196·56 enrolled

Alcohol Withdrawal1 trial

Efficacy and Safety of Levetiracetam in the Inpatient Treatment of Alcohol Withdrawal Syndrome

Completed·—·Phase 3·NCT00146471·120 enrolled

Social Anxiety Disorder1 trial

Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type)

Completed· UCB logo

UCB·Phase 2·NCT00612859·217 enrolled

Partial Epilepsy1 trial

Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy

Completed·KKorea UCB Co., Ltd.·Phase 4·NCT01498822·353 enrolled

Multiple Sclerosis1 trial

Levetiracetam in Central Pain in Multiple Sclerosis(MS)

Completed·OOdense University Hospital·Phase 4·NCT00423527·30 enrolled

Motor Neuron Disease1 trial

Levetiracetam for Cramps, Spasticity and Neuroprotection in Motor Neuron Disease

Completed·—·Phase 2·NCT00324454·20 enrolled

Metastasis1 trial

Seizure Prophylaxis in Patients With Glioma or Brain Metastasis

Terminated·—·Phase 2·NCT03436433·4 enrolled

Canavan disease1 trial

rAAV-Olig001-ASPA Gene Therapy for Treatment of Children With Typical Canavan Disease

Enrolling by invitation·MMyrtelle Inc.·Phase 1/2·NCT04833907·24 enrolled

Alcohol1 trial

The Effects of Levetiracetam on Alcohol Dependent Subjects

Completed·—·Phase 4·NCT00325182·40 enrolled

Acceptability1 trial

Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam

Completed· UCB logo

UCB··NCT00319605·600 enrolled

Pediatric1 trial

Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old

Completed· UCB logo

UCB·Phase 2·NCT00544050·13 enrolled

Transplantation1 trial

MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

Recruiting·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT05735717·70 enrolled

Cognition1 trial

A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures

Completed· UCB logo

UCB·Phase 2·NCT00105040·87 enrolled

Monotherapy1 trial

Add on Lacosamide Versus High Dose Monotherapy

Completed·—·Phase 3·NCT01345058·56 enrolled

Trial1 trial

Photosensitivity Proof of Concept Trial

Completed·TThe Epilepsy Study Consortium·Phase 2·NCT00894010·6 enrolled

MPA1 trial

Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients

Completed· UCB logo

UCB·Phase 4·NCT01491113·30 enrolled

Elderly1 trial

Effects of Keppra on Thinking, Emotions, and Balance in Elderly Healthy Volunteers

Completed·UUniversity Hospitals Cleveland Medical Center·N/A·NCT00221988·40 enrolled

Alcohol Consumption1 trial

Effects of Levetiracetam (Keppra) on Alcohol Consumption

Completed·UUniversity of California, San Francisco·N/A·NCT01168687·46 enrolled

Mastectomy1 trial

The Effect of Levetiracetam on the Postmastectomy Pain Syndrome

Completed·OOdense University Hospital·N/A·NCT00262262·25 enrolled

Cognitive impairment1 trial

Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)

Completed·JJohns Hopkins University·Phase 2·NCT01044758·96 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Levetiracetam in Prevention of Alcohol Relapse in Recently Detoxified Alcohol Dependent Patients

Completed·—·Phase 3·NCT00758277·201 enrolled

Unspecified5 trials

Dosing of Levetiracetam (Keppra) in Neonates

Completed·—·Phase 1/2·NCT01239212·7 enrolled

Treating Hyperexcitability in AD With Levetiracetam

Recruiting·—·Phase 2·NCT03875638·85 enrolled

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Show 2 more trials

A Bioequivalence Study of Levetiracetam Versus Keppra

Completed·TTri-Service General Hospital·N/A·NCT00926302·26 enrolled

Human Pharmacology Study (Keppra Dry Syrup Bioequivalence Study)

Completed· UCB logo

UCB·Phase 1·NCT00985348·26 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 15, 2003

KEPPRA

NDA NDA021505

Jan 6, 2006

KEPPRA

NDA NDA021035

Jul 31, 2006

KEPPRA

NDA NDA021872

Sep 12, 2008

KEPPRA XR

NDA NDA022285

Nov 9, 2011

LEVETIRACETAM IN SODIUM CHLORIDE

NDA NDA202543

Jul 31, 2015

SPRITAM

NDA NDA207958

Dec 20, 2018

ELEPSIA XR

NDA NDA204417

Sources

References

[1]
ClinicalTrials.gov — 214 trial records for Levetiracetam. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Keppra drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Levetiracetam compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Levetiracetam. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204417). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Keppra. U.S. Food & Drug Administration.
[7]
SEC EDGAR — UCB company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Voltage-Gated N-Type Calcium Channel Alpha-1b Subunit Blocker; Synaptic Vesicle Glycoprotein 2a Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: UCB

Patent Landscape[6]

Patent Cliff

Sep 3, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8535717Feb 22, 2026

8425938Feb 22, 2026

8163306Sep 3, 2027

8431156Oct 31, 2027

8470367Oct 31, 2027

6 more patents

7858122Sep 17, 2028

8802142Jun 7, 2031

8802142*PEDDec 7, 2031

11160786Mar 14, 2034

9669009Mar 14, 2034

9339489Mar 14, 2034

Keppra

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q1 2028

Trials by Indication[1]

Epilepsy45 trials

Seizure29 trials

Status Epilepticus9 trials

Fasting Conditions6 trials

Neonatal seizure6 trials

Treatment4 trials

Brain Injury4 trials

Parkinson's Disease4 trials

Fed3 trials

Drug3 trials

Tardive Dyskinesia2 trials

Intravenous2 trials

Brain Tumor2 trials

Double-blind2 trials

Dementia2 trials

Stroke2 trials

Psychosis2 trials

Methadone2 trials

Alzheimer's Disease2 trials

Aneurysm2 trials

Polyneuropathy2 trials

Schizophrenia2 trials

TED2 trials

Spinal Cord Injury1 trial

Panic Disorder1 trial

Adolescent1 trial

Bipolar Depression1 trial

Effectiveness1 trial

Lymphoma1 trial

Neuroblastoma1 trial

Malaria1 trial

Obsessive-Compulsive Disorder1 trial

Fibromyalgia1 trial

Pediatrics1 trial

Alcohol Dependence1 trial

Convulsion1 trial

Elderly Patients1 trial

Infants1 trial

Neuralgia1 trial

Essential Tremor1 trial

Refractory AML1 trial

Newly Diagnosed1 trial

Childhood Absence Epilepsy1 trial

Kidney Disease1 trial

Brain Tumors1 trial

Pilot Study1 trial

Headache1 trial

Pregnancy1 trial

Post-Traumatic Stress Disorder1 trial

Epileptics1 trial

Subarachnoid Hemorrhage1 trial

Anemia1 trial

Myelofibrosis1 trial

CAR1 trial

Dystonia1 trial

Imaging1 trial

Alcoholism1 trial

Tics1 trial

Hematoma1 trial

Alcohol Withdrawal1 trial

Social Anxiety Disorder1 trial

Partial Epilepsy1 trial

Multiple Sclerosis1 trial

Motor Neuron Disease1 trial

Metastasis1 trial

Canavan disease1 trial

Alcohol1 trial

Acceptability1 trial

Pediatric1 trial

Transplantation1 trial

Cognition1 trial