Levetiracetam
Approved · FDA / EMAAlso known as Elepsia, Keppra, Roweepra, Spritam+3 more
Elepsia, Keppra, Roweepra, Spritam, Levetiracetame, Lévétiracetam, Levetiracetamum.
Recent clinical, regulatory, research and industry developments relating to this drug.
A Phase IIb Dose Escalation Study of Levetiracetam for the Treatment of Neonatal Seizures
Approval: LEVETIRACETAM (ANDA215465)
Antiepileptic Strategies for Patients with Primary and Metastatic Brain Tumors.
Approval: Levetiracetam Hospira (EMA)
Approval: Levetiracetam Sun (EMA)
Approval: Levetiracetam Actavis Group (EMA)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of… Show full indicationShow less
Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Hospira is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.
Indication: Levetiracetam Sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly… Show full indicationShow less
Levetiracetam Sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Sun is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. Levetiracetam Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.
Indication: Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with… Show full indicationShow less
Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Levetiracetam Actavis Group is indicated as adjunctive therapy: in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from 1 month of age with epilepsy; in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy; in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Treatment of Seizures in Neonate With Hypoxic Ischemic Encephalopathy
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes3
Journals, researchers & institutions
- Epilepsy & behavior : E&B2
- Archives of neurology1
- Brain and nerve = Shinkei kenkyu no shinpo1
- Current treatment options in oncology1
- Epilepsia1
- Epilepsia open1
- Atabaki SM3
- He J3
- Klein P3
- McCarter R3
- Pearl PL3
- Sandoval F3
- Tsuchida T3
- van den Anker J3
- MedStar Research Institute2
- 1State University of New York at Buffalo1
- Asahigawaso Rehabilitation and Medical Center Okayama Japan.1
- Biomagnetic Imaging Laboratory1
- Children's National Medical Center1
- Department of Neurology 1st Affiliated Hospital of Chongqing Medical University Chongqing China.1
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.