Wednesday, July 8, 2026

Drug profile · INN

levetiracetam

levetiracetam (APO-LEVETIRACETAM) is a synaptic vesicle glycoprotein 2a modulator. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Nervous system (N03) N03AX14
US status approved
Patents linked 1
Pipeline programs 12
News articles 0
Drug details — levetiracetam
US status
approved
Class
Nervous system (N03)
Route
ORAL
Patents
1
Programs
12
Data quality
0.89

Quick answer

levetiracetam (APO-LEVETIRACETAM) is a synaptic vesicle glycoprotein 2a modulator. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN levetiracetam
Brand APO-LEVETIRACETAM
Mechanism Synaptic vesicle glycoprotein 2A modulator
Target Synaptic vesicle glycoprotein 2A
Therapeutic class Nervous system (N03)
Route ORAL
Formulation TABLET
ATC code N03AX14

Mechanism of action

Synaptic vesicle glycoprotein 2A modulator

Primary target: Synaptic vesicle glycoprotein 2A

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. ALL2820 Phase 3 · Telethon Foundation · Adult Philadelphia Chromosome-Positive Acute Lymphoblastic L
  2. APHP200068 Phase 3 · PARItec · Adult ICU patients with septic shock
  3. Levetiracetam Phase 3 · Ucb Pharma S.P.A · Epilepsy
  4. Levetiracetam NORMON comprimidos recubiertos... Phase 3 · George Institute for · Down syndrome, Alzheimer's Disease
  5. NXPLEVE/24/P3-6 Phase 3 · NEURAXPHARM AUSTRALIA PTY · Refractory Partial Onset Epilepsy
  6. 20180257 Phase 2 · Amgen · Relapsed or Refractory B cell Precursor Acute Lymphoblastic
  7. Levact 2 for Relapsed/refractory large B-cel… Phase 2 · George Institute for · Relapsed/refractory large B-cell non-Hodgkin lymphoma, mantl
  8. Oral levetiracetam Phase 2 · Chinese Academy of · Neonatal Seizures

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. US 8512746

    Extended release pharmaceutical compositions of levetiracetam

    Expires Mon Aug 15 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is levetiracetam?

levetiracetam (APO-LEVETIRACETAM) is a synaptic vesicle glycoprotein 2a modulator. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for levetiracetam?

APO-LEVETIRACETAM is a marketed brand name for levetiracetam. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of levetiracetam?

levetiracetam has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.