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 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELEPSIA XR is an extended-release oral formulation of levetiracetam, an antiepileptic agent approved in December 2018. It treats seizure disorders by binding to synaptic vesicle protein SV2A, which is thought to regulate vesicle exocytosis, though its precise antiepileptic mechanism remains incompletely understood. The XR formulation enables once-daily dosing, improving patient adherence compared to immediate-release alternatives.
LOE Approaching1.4 years to LOE
As LOE approaches in late 2027, brand team focus will shift from growth to lifecycle management and defensive strategies against generic competition.
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.