Recent Updates
Recently added Catalysts

Levetiracetam

Phase 4FDA approved

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Jun 14, 2010

Levetiracetam development status

FDA approval on record Dec 20, 2018 as Elepsia Xr
Approval holderTripoint
ApplicationNDA204417
Highest phase Phase 4 run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (NCT00855738)
Phase scored for RDYPhase 1
Registered trials 14 across 9 sponsors since Aug 2006

Levetiracetam target and mechanism

Molecular targetCACNA1B, SV2A
Target classBlocker
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment48

FDA Designations

No designations recorded

Levetiracetam clinical trials

Levetiracetam · 2 trials · 1 indication

Phase 1 2
NCT01131897Bioavailability Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fasting Conditions.Healthy
COMPLETED24 Analytics
NCT01132352Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed ConditionsHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Bioavailability Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fasting Conditions.
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioavailability based on Cmax and AUC parameters
3 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LevetiracetamEXPERIMENTALLevetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Keppra®ACTIVE_COMPARATORKeppra® 750 mg Tablets of UCB Pharma Inc.,

Interventions

NameTypeDescription
LevetiracetamDRUGLevetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult male volunteers, 18 to 55 years of age; * Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Wights of Adults", Metropolitan Life Insurance Company, 1983); * Medically healthy subjects with clinically normal laboratory profiles and...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Levetiracetam

What is Levetiracetam?

Levetiracetam is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied in Phase 1 clinical trials. The specific medical conditions it is intended to treat have not been disclosed. It belongs to the therapeutic area classified as Other.

What does Levetiracetam target?

Levetiracetam targets CACNA1B and SV2A. It acts as a blocker of these targets. CACNA1B is a calcium channel, and SV2A is a synaptic vesicle protein. This mechanism is under investigation in early-stage clinical trials.

Who is developing Levetiracetam?

Levetiracetam is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company that trades under the ticker symbol RDY. The company is responsible for the clinical development of this small molecule drug.

What phase is Levetiracetam in?

Levetiracetam is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The two completed Phase 1 trials were bioequivalence and bioavailability studies conducted in healthy male volunteers.

What clinical trials is Levetiracetam in?

Levetiracetam has been studied in two completed Phase 1 trials: NCT01132352, a bioequivalence study under fed conditions, and NCT01131897, a bioavailability study under fasting conditions. Both enrolled 24 healthy male volunteers in the United States and are now completed.