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Levetiracetam Tablets
Levetiracetam Tablets is a Small molecule drug developed by Gitte Moos Knudsen. It is currently in Phase 2 development. Also known as: Levetiracetam.
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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).
| 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 | Levetiracetam Tablets |
|---|---|
| Also known as | Levetiracetam |
| Sponsor | Gitte Moos Knudsen |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Levetiracetam Three Times Daily in Epilepsy (PHASE3)
- Evaluation of Levetiracetam's Effectiveness and Tolerability for Treating Epilepsy in Older Adults (PHASE4)
- Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects (PHASE1)
- LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome (PHASE3)
- Levetiracetam for Seizure Prevention After Brain Tumor Surgery (PHASE3)
- Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis (PHASE2)
- Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial) (PHASE4)
- Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) (PHASE4)
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:
- Levetiracetam Tablets CI brief — competitive landscape report
- Levetiracetam Tablets updates RSS · CI watch RSS
- Gitte Moos Knudsen portfolio CI
Frequently asked questions about Levetiracetam Tablets
What is Levetiracetam Tablets?
Who makes Levetiracetam Tablets?
Is Levetiracetam Tablets also known as anything else?
What development phase is Levetiracetam Tablets in?
Related
- Manufacturer: Gitte Moos Knudsen — full pipeline
- Also known as: Levetiracetam
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing