Data updated: May 26, 2026
KEPPRA (levetiracetam)
CNS
Approved 1999-11-30
KEPPRA is indicated for the treatment of Partial-Onset Seizures; Myoclonic Seizures; Primary Generalized Tonic-Clonic Seizures.
Source: FDA Label • UCB INC
How KEPPRA Works
The precise mechanism by which levetiracetam exerts its antiepileptic effect is unknown. The drug binds to the synaptic vesicle protein SV2A, which is thought to be involved in the regulation of vesicle exocytosis. Evidence indicates that levetiracetam’s affinity for SV2A correlates with its antiseizure potency in animal models, suggesting that this interaction significantly contributes to its therapeutic mechanism of action.
11
Indications
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Phase 3 Trials
2
Priority Reviews
26
Years on Market
Details
- Status
- Prescription
- First Approved
- 1999-11-30
- Patent Cliff
- 2031
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- TABLET, SOLUTION, INJECTABLE
KEPPRA Approval History
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Original
New Indication
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Label Update
268 FDA actions from 1999 to 2024 · 5 indication expansions
Feb 2016 SUPPL
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Label
What KEPPRA Treats
3 indicationsKEPPRA is approved for 3 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
- Myoclonic Seizures
- Primary Generalized Tonic-Clonic Seizures
Source: FDA Label
KEPPRA Competitive Set
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Direct competitors
2
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Indication competitors
10
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Drugs Similar to KEPPRA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
FYCOMPA
PERAMPANEL
CATALYST PHARMS
Shared indications:
Partial-Onset SeizuresPrimary Generalized Tonic-Clonic Seizures
PERAMPANEL
PERAMPANEL
MSN
Shared indications:
Partial-Onset SeizuresPrimary Generalized Tonic-Clonic Seizures
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Clinical Trial Registry
66 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06866691 SEIZE-TBI | IRB00123210 | Ph 4 | recruiting | Seizure Prevention in Traumatic Brain Injury With Levetiracetam and Lacosamide |
| NCT01857934 results posted | NB2012 NCI-2013-00034 | Ph 2 | completed | Therapy for Children With Advanced Stage Neuroblastoma |
| NCT01345058 results posted | 2010-P-001630 | Ph 3 | completed | Add on Lacosamide Versus High Dose Monotherapy |
| NCT03875638 LeAD | 2019P000091 | Ph 2 | completed | Treating Hyperexcitability in AD With Levetiracetam |
| NCT05735717 | 2021LS061 | Ph 2 | recruiting | MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies |
| NCT07490769 LEVTID | SCTR25011502 | Ph 3 | recruiting | Levetiracetam Three Times Daily in Epilepsy |
| NCT06345495 | 2023-0899 NCI-2024-02814 | Ph 2 | recruiting | High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly |
| NCT06442748 LIBRA | 4385 | Ph 3 | recruiting | Short Versus Long-term Levetiracetam in Brain Tumors |
| NCT07284498 HIE | MDP.25.01.179 | Ph 4 | not yet recruiting | Treatment of Seizures in Neonate With HIE |
| NCT07239115 PREVENT | KY2025-213-02 | Ph 3 | not yet recruiting | Levetiracetam for Seizure Prevention After Brain Tumor Surgery |
| NCT04833907 CAN-GT | CAN-GT | Ph 1, Ph 2 | enrolling by invitation | rAAV-Olig001-ASPA Gene Therapy for Treatment of Children With Typical Canavan Disease |
| NCT06081283 results posted | 23-0157 | Ph 4 | terminated | Antiseizure Medication in Seizure Networks at Early Acute Brain Injury |
| NCT07220902 LEVMag | 1559 | Ph 3 | not yet recruiting | Levetiracetam Compared to Magnesium Sulfate for Prevention of Eclamptic Seizure |
| NCT07072624 E-PTS | AIIMS/IEC/2024/4889 IIRPIG-2023-0001210 | Ph 4 | recruiting | Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial) |
| NCT03034356 results posted | MHBB-006-16S I01CX001414 | Ph 1, Ph 2 | completed | Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia |
| NCT07046611 KLaSSEC | Soh-Med-25-6-2PD | Ph 2, Ph 3 | recruiting | Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children |
| NCT06773364 EAST | 2024-228 | Ph 3 | recruiting | Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial |
| NCT02201251 results posted | CR104425 TOPMATEPY4067, 2012-001552-19 | Ph 3 | completed | A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy |
| NCT01228747 results posted | N01159 2014-004401-32 | Ph 3 | completed | A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures) |
| NCT03048084 STING | 77353 | Ph 4 | recruiting | Seizure Treatment in Glioma |
| NCT01801072 SPAR results posted | HUM00064523 | Ph 4 | completed | Seizure Prophylaxis in Aneurysm Repair |
| NCT05897658 LeviTaTe Pilot | 14147 | Ph 3 | not yet recruiting | Levetiracetam Prophylaxis in Brain Tumor Resection Pilot |
| NCT04643327 TRIP | HREC/2020/QRBW/69379 | Ph 2 | recruiting | Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease |
| NCT03340064 PEACH results posted | EP0100 | Ph 3 | completed | 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 |
| NCT02348216 ZUMA-1 results posted | KTE-C19-101 2015-005007-86 | Ph 1, Ph 2 | completed | Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Participants With Refractory Aggressive Non-Hodgkin Lymphoma |
| NCT03489044 ILiAD | IRAS 203849 2016-003109-32 | Ph 2 | completed | An Investigation of Levetiracetam in Alzheimer's Disease |
| NCT03436433 results posted | Pro00081334 | Ph 2 | terminated | Seizure Prophylaxis in Patients With Glioma or Brain Metastasis |
| NCT03129360 results posted | 17-00266 | Ph 2 | completed | Levetiracetam in Early Psychosis |
| NCT04926844 | Soh-Med-21-06-07 | Ph 2 | completed | Effectiveness of Combined Levetiracetam and Midazolam in Generalized Convulsive Status Epilepticus in Children |
| NCT02002819 LEV-AD results posted | NEUR-2017-25879 PCTRB-13-288476 | Ph 2 | completed | Levetiracetam for Alzheimer's Disease-Associated Network Hyperexcitability |
| NCT03940326 results posted | LEVIGS | Ph 4 | completed | Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures |
| NCT02334722 results posted | IRB201400876 OCR14673 | Ph 4 | completed | 1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients |
| NCT01239212 results posted | 101335 | Ph 1, Ph 2 | completed | Dosing of Levetiracetam (Keppra) in Neonates |
| NCT01960075 ESETT results posted | 18078 119756, U01NS088034 | Ph 3 | completed | Established Status Epilepticus Treatment Trial |
| NCT04573803 MAST | A095460 | Ph 3 | not yet recruiting | Pharmacological Management of Seizures Post Traumatic Brain Injury |
| NCT04610879 CASTLE | CASTLE 2018-003893-29, RP-PG-0615-20007 | Ph 4 | terminated | Changing Agendas on Sleep, Treatment and Learning in Epilepsy |
| NCT03695094 results posted | UP0070 2018-001941-16 | Ph 1 | completed | A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil |
| NCT00489281 results posted | J0676 P30CA006973, P01CA015396 | Ph 2 | terminated | Non-Myeloablative Bone Marrow Transplant for Patients With Sickle Cell Anemia and Other Blood Disorders |
| NCT00627133 | K17644 | Ph 2 | withdrawn | Efficacy of Keppra in Acute Alcohol Related Seizure Control--A Pilot Study |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01464359 results posted | MT2011-15 | Ph 2 | terminated | T-Cell Depleted Double UCB for Refractory AML |
| NCT01521130 FIRST | R01NS065840-01 R01NS065840-01 | Ph 1 | completed | Imaging the Effect of Centrotemporal Spikes and Seizures on Language in Children |
| NCT01935908 SPLASH - Pilot | SPLASH-P1 | Ph 4 | withdrawn | Seizure Prophylaxis With Levetiracetam in Aneurysmal Subarachnoid Hemorrhage - Pilot Study |
| NCT02602860 | EP0074 | Ph 1 | completed | 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 |
| NCT01891890 COPE results posted | IRB00066541 PCORI 527 | Ph 3 | terminated | Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE) |
| NCT02726867 | MAES-003 | Ph 3 | withdrawn | Levetiracetam, Lacosamide and Ketamine as Adjunctive Treatment of Refractory Status Epilepticus |
| NCT01375374 VICTOR results posted | SP0978 2010-022534-84 | Ph 3 | terminated | Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide |
| NCT01398956 results posted | N01361 | Ph 3 | completed | An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures |
| NCT01954121 results posted | N01364 | Ph 3 | completed | Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures |
| NCT01229735 results posted | N01353 | Ph 4 | completed | Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures |
Showing 50 of 66 trials
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Trial Timeline
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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.
KEPPRA FDA Label Details
Indications & Usage
FDA Label (PDF)KEPPRA is indicated for the treatment of Partial-Onset Seizures; Myoclonic Seizures; Primary Generalized Tonic-Clonic Seizures.
View full patent landscape →
2 OB patents · 1 families ·
35 international docs across 26 countries
KEPPRA Patents & Exclusivity
Latest Patent: Dec 2031
Patents (2 active)
US8802142*PED
Expires Dec 7, 2031
US8802142
Expires Jun 7, 2031
Source: FDA Orange Book
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Patent Timeline
- • Cliff: 2031
- • 32 active patents
Trial Analysis
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Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.