Last reviewed 2026-05-31 · How we verify

Levetriracetam

Duke University · Phase 2 active Small molecule ✓ Verified May 2026

Levetriracetam is a Small molecule drug developed by Duke University. It is currently in Phase 2 development. Also known as: Keppra.

Levetiracetam is a medication that has been studied in clinical trials for the treatment of Post-Traumatic Stress Disorder (PTSD). According to ClinicalTrials.gov, a double-blind discontinuation study (NCT00413296) was conducted to evaluate the efficacy of levetiracetam in treating PTSD.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Levetriracetam
Also known as	Keppra
Sponsor	Duke University
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Levetiracetam in Post-Traumatic Stress Disorder (PHASE2, 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:

Levetriracetam CI brief — competitive landscape report
Levetriracetam updates RSS · CI watch RSS
Duke University portfolio CI

Frequently asked questions about Levetriracetam

What is Levetriracetam?

Levetriracetam is a Small molecule drug developed by Duke University.

Who makes Levetriracetam?

Levetriracetam is developed by Duke University (see full Duke University pipeline at /company/duke-university).

Is Levetriracetam also known as anything else?

Levetriracetam is also known as Keppra.

What development phase is Levetriracetam in?

Levetriracetam is in Phase 2.

Manufacturer: Duke University — full pipeline
Therapeutic area: All drugs in Other
Also known as: Keppra

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