FINTEPLA

Peak

fenfluramine

NDAORALSOLUTIONPriority Review
Approved
Jun 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10

Mechanism of Action

Lennox-Gastaut syndrome is unknown. Fenfluramine and the metabolite, norfenfluramine, exhibit agonist activity at serotonin 5-HT2 receptors. There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine and norfenfluramine, and valvular heart…

Clinical Trials (5)

NCT07225231N/ANot Yet Recruiting

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)
NCT06598449Phase 4Recruiting

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
NCT06118255Phase 3Active Not Recruiting

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
NCT06422377Phase 3Terminated

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)
NCT05026398Phase 4Completed

Fenfluramine and Cognition

Started Apr 2021
56 enrolled
Cognitive Function

Loss of Exclusivity

LOE Date
Dec 29, 2038
156 months away
Patent Expiry
Dec 29, 2038
Exclusivity Expiry
Sep 25, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
10478442
May 3, 2033
U-2860
12097206
May 3, 2033
U-4013
9549909
May 3, 2033
U-2858
9610260
May 3, 2033
U-2858
10478441
May 3, 2033
U-2860