NDAORALSOLUTIONPriority Review
Approved
Jun 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FINTEPLA (fenfluramine) is an oral solution small molecule approved by the FDA on June 25, 2020, for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older. The drug works through agonist activity at serotonin 5-HT2 receptors, though the exact mechanism in seizure control remains unclear. FINTEPLA is a niche orphan/rare disease product addressing severe, treatment-resistant epilepsy syndromes with limited therapeutic alternatives.
$0.0BPart D
12.7 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome
Started Mar 2026
200 enrolled
Rett Syndrome
Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS
Started Dec 2025
20 enrolled
Dravet Syndrome (DS)Lennox Gastaut Syndrome (LGS)
Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age
Started Oct 2024
12 enrolled
Dravet Syndrome (DS)Children Under 2 Years
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome
Started May 2024
25 enrolled
Dravet Syndrome
A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine
Started Apr 2024
1 enrolled
Dravet Syndrome (DS)Lennox-Gastaut Syndrome (LGS)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.