Overview
Levetiracetam is a drug within the pyrrolidine class that is used to treat various types of seizures stemming from epileptic disorders. It was first approved for use in the United States in 1999 and is structurally and mechanistically unrelated to other anti-epileptic drugs (AEDs). Levetiracetam possesses a wide therapeutic index and little-to-no potential to produce, or be subject to, pharmacokinetic interactions - these characteristics make it a desirable choice over other AEDs, a class of drugs notorious for having generally narrow therapeutic indexes and a propensity for involvement in drug interactions.
Indication
Levetiracetam is indicated as an adjunctive therapy in the treatment of partial onset seizures in epileptic patients who are one month of age and older. Additionally, it is indicated as an adjunct in the treatment of myoclonic seizures in patients with juvenile myoclonic epilepsy who are 12 years of age and older, and in primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy who are 6 years of age and older. Levetiracetam is also available as an orally dissolvable tablet that is indicated as an adjunct in the treatment of partial onset seizures in patients with epilepsy who are 4 years of age and older and weigh more than 20kg.
Associated Conditions
- Epilepsies
- Generalized Tonic-Clonic Seizures
- Partial-Onset Seizures
- Myoclonic seizures
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2007/11/30 | Phase 3 | Terminated | Rennes University Hospital | ||
2007/11/26 | Phase 3 | Terminated | |||
2007/10/16 | Phase 2 | Completed | |||
2007/10/16 | Phase 2 | Completed | |||
2007/10/12 | Phase 3 | UNKNOWN | Scienze Neurologiche Ospedaliere | ||
2007/10/01 | Phase 3 | Completed | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | ||
2007/09/26 | Phase 2 | Completed | |||
2007/08/20 | Not Applicable | Completed | |||
2007/08/02 | Phase 4 | Completed | |||
2007/07/25 | Phase 2 | Completed |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| American Health Packaging | 68084-882 | ORAL | 750 mg in 1 1 | 12/8/2023 | |
| SOHM, Inc. | 50405-301 | ORAL | 500 mg in 1 1 | 5/1/2023 | |
| SOHM, Inc. | 50405-300 | ORAL | 250 mg in 1 1 | 5/1/2023 | |
| ACI Healthcare USA, Inc. | 71093-125 | ORAL | 750 mg in 1 1 | 1/17/2023 | |
| REMEDYREPACK INC. | 70518-3769 | ORAL | 100 mg in 1 mL | 3/29/2024 | |
| Baxter Healthcare Corporation | 36000-354 | IONTOPHORESIS, INTRAVENOUS | 15 mg in 1 mL | 5/6/2024 | |
| NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7977 | ORAL | 500 mg in 1 1 | 11/8/2023 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-4142 | ORAL | 500 mg in 1 1 | 7/17/2020 | |
| TRIPOINT THERAPEUTICS, LLC | 80705-100 | ORAL | 1000 mg in 1 1 | 3/25/2024 | |
| BluePoint Laboratories | 68001-404 | ORAL | 750 mg in 1 1 | 12/20/2023 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.