NDAORALSOLUTIONPriority Review
Approved
Jun 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FINTEPLA (fenfluramine) is an oral solution small molecule approved in June 2020 for rare seizure disorders, specifically Dravet syndrome and Lennox-Gastaut syndrome. It is a serotonin 5-HT1A and 5-HT7 receptor agonist that reduces seizure frequency in these severe pediatric epilepsy populations. The drug represents a significant therapeutic advance for patients with limited treatment options.
$18.0MPart D
Peak12.3 years to LOEProduct is in peak commercial phase with modest Part D spending (~$18M in 2023), indicating a niche orphan drug positioning; teams are likely focused on maximizing penetration within the rare epilepsy patient base.
Mechanism 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 (13)
A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome
Started Jul 2026
200 enrolled
Rett Syndrome
EEG Dynamics in Lennox-Gastaut Syndrome Patients Undergoing Fenfluramine Treatment
Started May 2026
20 enrolled
Lennox Gastaut Syndrome (LGS)
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
5 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
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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.