Levetiracetam ER is under clinical development by AgeneBio and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Levetiracetam ER’s likelihood of approval (LoA) and phase transition for Mild Cognitive Impairment took place on 11 Aug 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Levetiracetam ER Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Levetiracetam ER overview

Levetiracetam ER (AGB-101) is under development for the treatment of amnestic mild cognitive impairment (aMCI) due to Alzheimer’s dementia. The drug candidate is once-daily, extended-release capsule and tablet formulation of levetiracetam administered through oral route. It acts by targeting synaptic vesicle protein (SV2A) ligand.

AgeneBio overview

AgeneBio is a pharmaceutical company that develops therapies for psychiatric and neurological diseases. The company’s therapy is targeted to prevent neurodegeneration and preserve and restore cognitive function for unserved patients. Its lead candidate AGB101 is under phase 3 of clinical trials for the treatment of mild cognitive impairment (aMCI) and can delay progression to Alzheimer’s dementia and can target hippocampus overactivity. AgeneBio’s other pipeline product is GABAA alpha5 a small molecule program is being developed for the treatment of aMCI, autism and schizophrenia, among others. The company partners with Johns Hopkins University and leading research centers worldwide. AgeneBio is headquartered in Baltimore, Maryland, the US.

Quick View Levetiracetam ER LOA Data

Report Segments
  • Innovator
Drug Name
  • Levetiracetam ER
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
Key Developers
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.