Treats seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). Sold as Fintepla. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Fenfluramine Hydrochloride (sold as Fintepla), first approved Jun 25, 2020, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Fintepla | Part D | $61.1M | +49% | 417 |
| Program | Updated |
|---|---|
| Fintepla REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled | May 22, 2026 |
| Using Fenfluramine to Test the Serotonin Deficiency Theory of DepressionDepression - Major Depressive Disorder · Imperial College Healthcare NHS Trust | Not applicable | Not yet recruiting | Jun 16, 2026 |
| EEG Dynamics in Lennox-Gastaut Syndrome Patients Undergoing Fenfluramine TreatmentLennox Gastaut Syndrome (LGS) · University of Chicago | — | Enrolling by invitation | Apr 29, 2026 |
| A Phase 3 Study of Fenfluramine Hydrochloride in Rett SyndromeRett Syndrome · UCB BIOSCIENCES, Inc. | Phase 3 | Recruiting | Mar 31, 2026 |
| Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGSDravet Syndrome (DS), Lennox Gastaut Syndrome (LGS) · Byteflies | Not applicable | Enrolling by invitation | Nov 6, 2025 |
| The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome ProjectDravet Syndrome · The University of Texas Health Science Center, Houston | Phase 4 | Recruiting | Aug 8, 2025 |
| Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of AgeDravet Syndrome (DS), Children Under 2 Years · University of Colorado, Denver | Phase 4 | Recruiting | Sep 19, 2024 |
| A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure · Zogenix, Inc. | Phase 3 | Active, not recruiting | Oct 1, 2021 |
| Treatment of Refractory Infantile Spasms With FenfluramineInfantile Spasm · Children's Hospital of Orange County | Phase 2 | Recruiting | Feb 28, 2020 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
