NDAORALTABLET, EXTENDED RELEASE
Approved
Dec 2018
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
5/8 — Partial
ELEPSIA XR (levetiracetam) by VentriPoint Diagnostics is mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. First approved in 2018.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELEPSIA XR is an extended-release oral tablet formulation of levetiracetam, an antiepileptic agent approved in 2018. The drug binds to synaptic vesicle protein SV2A, thought to regulate vesicle exocytosis and suppress seizure activity, though its precise mechanism remains incompletely understood. It is indicated for epilepsy management in patients requiring extended-release dosing.
LOE Approaching1.1 years to LOE
With LOE approaching in late 2027 and high competitive pressure (15 competitors), the brand team is likely in defensive mode focused on retention and market share stabilization rather than expansion.
Mechanism of Action
mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. A saturable and stereoselective neuronal binding site in rat brain tissue has been described for levetiracetam. Experimental data indicate that this binding site is the synaptic vesicle protein SV2A, thought to be…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy
Started May 2021
110 enrolled
Focal Onset Seizures
An Investigation of Levetiracetam in Alzheimer's Disease
Started Oct 2018
8 enrolled
Alzheimer DiseaseEpilepsy
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
Started Nov 2017
38 enrolled
Partial Seizures
Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage
Started Jan 2016
15 enrolled
Subarachnoid Hemorrhage
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
Started Nov 2015
13 enrolled
Healthy Volunteers
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.