Last reviewed 2026-04-23 · How we verify

Lévétiracetam

Hospices Civils de Lyon · Phase 3 active Small molecule

Lévétiracetam is a Antiepileptic agent Small molecule drug developed by Hospices Civils de Lyon. It is currently in Phase 3 development for Epilepsy (adjunctive therapy for partial-onset seizures), Epilepsy (adjunctive therapy for myoclonic seizures), Epilepsy (adjunctive therapy for primary generalized tonic-clonic seizures).

Levetiracetam reduces neuronal excitability by binding to synaptic vesicle protein SV2A, thereby modulating neurotransmitter release and preventing seizure propagation.

Levetiracetam reduces neuronal excitability by binding to synaptic vesicle protein SV2A, thereby modulating neurotransmitter release and preventing seizure propagation. Used for Epilepsy (adjunctive therapy for partial-onset seizures), Epilepsy (adjunctive therapy for myoclonic seizures), Epilepsy (adjunctive therapy for primary generalized tonic-clonic seizures).

Likelihood of approval

55.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Lévétiracetam
Sponsor	Hospices Civils de Lyon
Drug class	Antiepileptic agent
Target	SV2A (synaptic vesicle protein 2A)
Modality	Small molecule
Therapeutic area	Neurology
Phase	Phase 3

Mechanism of action

Levetiracetam is a pyrrolidone derivative that binds to the synaptic vesicle protein SV2A, which is involved in vesicle exocytosis and neurotransmitter release. This binding reduces the release of excitatory neurotransmitters and stabilizes neuronal membranes, preventing the spread of seizure activity. The exact mechanism remains incompletely understood, but SV2A binding is considered the primary molecular action responsible for its anticonvulsant effects.

Approved indications

Epilepsy (adjunctive therapy for partial-onset seizures)
Epilepsy (adjunctive therapy for myoclonic seizures)
Epilepsy (adjunctive therapy for primary generalized tonic-clonic seizures)

Common side effects

Somnolence
Asthenia/fatigue
Dizziness
Headache
Behavioral changes/mood changes
Ataxia
Infection

Key clinical trials

Prevention of Epileptic Seizures in Acute intraCerebral Haemorrhage (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Lévétiracetam CI brief — competitive landscape report
Lévétiracetam updates RSS · CI watch RSS
Hospices Civils de Lyon portfolio CI

Frequently asked questions about Lévétiracetam

What is Lévétiracetam?

Lévétiracetam is a Antiepileptic agent drug developed by Hospices Civils de Lyon, indicated for Epilepsy (adjunctive therapy for partial-onset seizures), Epilepsy (adjunctive therapy for myoclonic seizures), Epilepsy (adjunctive therapy for primary generalized tonic-clonic seizures).

How does Lévétiracetam work?

Levetiracetam reduces neuronal excitability by binding to synaptic vesicle protein SV2A, thereby modulating neurotransmitter release and preventing seizure propagation.

What is Lévétiracetam used for?

Lévétiracetam is indicated for Epilepsy (adjunctive therapy for partial-onset seizures), Epilepsy (adjunctive therapy for myoclonic seizures), Epilepsy (adjunctive therapy for primary generalized tonic-clonic seizures).

Who makes Lévétiracetam?

Lévétiracetam is developed by Hospices Civils de Lyon (see full Hospices Civils de Lyon pipeline at /company/hospices-civils-de-lyon).

What drug class is Lévétiracetam in?

Lévétiracetam belongs to the Antiepileptic agent class. See all Antiepileptic agent drugs at /class/antiepileptic-agent.

What development phase is Lévétiracetam in?

Lévétiracetam is in Phase 3.

What are the side effects of Lévétiracetam?

Common side effects of Lévétiracetam include Somnolence, Asthenia/fatigue, Dizziness, Headache, Behavioral changes/mood changes, Ataxia.

What does Lévétiracetam target?

Lévétiracetam targets SV2A (synaptic vesicle protein 2A) and is a Antiepileptic agent.

Drug class: All Antiepileptic agent drugs
Target: All drugs targeting SV2A (synaptic vesicle protein 2A)
Manufacturer: Hospices Civils de Lyon — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Epilepsy (adjunctive therapy for partial-onset seizures)
Indication: Drugs for Epilepsy (adjunctive therapy for myoclonic seizures)
Indication: Drugs for Epilepsy (adjunctive therapy for primary generalized tonic-clonic seizures)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing