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IV Lacosamide
IV Lacosamide is a Small molecule drug developed by Le Bonheur Children's Hospital. It is currently in Phase 3 development. Also known as: Vimpat.
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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).
| 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 | IV Lacosamide |
|---|---|
| Also known as | Vimpat |
| Sponsor | Le Bonheur Children's Hospital |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
- Functional gastrointestinal disorder
- Pyrexia
- Respiratory tract infection
- Respiratory tract infection viral
- Blood triglycerides increased
- Blood cholesterol increased
Key clinical trials
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures (PHASE2)
- A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 (PHASE2)
- Study to Investigate Safety and Tolerability of Intravenous Lacosamide in Children. (PHASE2, PHASE3)
- IV Lacosamide: The Safety of Intravenous Lacosamide (PHASE3)
- The Safety of Intravenous Lacosamide (PHASE4)
- Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures (PHASE3)
- Cognitive and Behavioral Effects of Lacosamide (PHASE4)
- Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures (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:
- IV Lacosamide CI brief — competitive landscape report
- IV Lacosamide updates RSS · CI watch RSS
- Le Bonheur Children's Hospital portfolio CI
Frequently asked questions about IV Lacosamide
What is IV Lacosamide?
Who makes IV Lacosamide?
Is IV Lacosamide also known as anything else?
What development phase is IV Lacosamide in?
What are the side effects of IV Lacosamide?
Related
- Manufacturer: Le Bonheur Children's Hospital — full pipeline
- Also known as: Vimpat
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing