FENFLURAMINE
FENFLURAMINE is indicated for the treatment of Dravet Syndrome; Lennox-Gastaut Syndrome; Seizures.
How FENFLURAMINE Works
The precise mechanism by which fenfluramine exerts its therapeutic effects in treating seizures is unknown. Fenfluramine and its metabolite, norfenfluramine, function as agonists at serotonin 5-HT2 receptors. While this serotonergic activity is central to its function, activation of the 5-HT2B receptor subtype is also associated with risks such as valvular heart disease and pulmonary arterial hypertension.
Development Insights
Details
- Status
- Prescription
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- SOLUTION
FENFLURAMINE Approval History
What FENFLURAMINE Treats
3 indicationsFENFLURAMINE is approved for 3 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dravet Syndrome
- Lennox-Gastaut Syndrome
- Seizures
FENFLURAMINE Boxed Warning
VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension [see Warnings and Precautions (5.1) ]. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. The benefits versus the risks of initiating or continuing FINTEPLA must be considered, based on echocardiogram findings [see Dosage and Administration (2.1 , 2.6 ) and Warnings and Precautions (5.1) ]. Because of the risks of valvula...
WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension [see Warnings and Precautions (5.1) ]. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. The benefits versus the risks of initiating or continuing FINTEPLA must be considered, based on echocardiogram findings [see Dosage and Administration (2.1 , 2.6 ) and Warnings and Precautions (5.1) ]. Because of the risks of valvular heart disease and pulmonary arterial hypertension, FINTEPLA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the FINTEPLA REMS [see Warnings and Precautions (5.2) ]. WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION See full prescribing information for complete boxed warning. FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension. ( 5.1 ) Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. ( 2.1 , 2.6 , 5.1 ) FINTEPLA is available only through a restricted program called the FINTEPLA REMS. ( 5.2 )
FENFLURAMINE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to FENFLURAMINE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05560282 | 21-5681 | Ph 3 | terminated | Fenfluramine for Adult Dravet Patients |
| NCT05064878 GEMZ | ZX008-2103/EP0216 2021-003222-76, 2023-506269-78-00 | Ph 3 | active not recruiting | A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder. |
| NCT04289467 | ZX008-IS | Ph 2 | recruiting | Treatment of Refractory Infantile Spasms With Fenfluramine |
| NCT06118255 ORCHID | EP0213 2022-502359-75, U1111-1289-2867 | Ph 3 | active 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 |
| NCT06598449 | 21-3972 | Ph 4 | recruiting | Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age |
| NCT05026398 FEN&Cognition | FenCog | Ph 4 | completed | Fenfluramine and Cognition |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FENFLURAMINE FDA Label Details
Indications & Usage
FENFLURAMINE is indicated for the treatment of Dravet Syndrome; Lennox-Gastaut Syndrome; Seizures.
WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION FINTEPLA can cause valvular heart disease and pulmonary arterial hypertension [see Warnings and Precautions (5.1) ]. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. The benefits versus the ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment