FINTEPLA (fenfluramine hydrochloride)
FINTEPLA is indicated for the treatment of Dravet Syndrome; Lennox-Gastaut Syndrome; Seizures.
How FINTEPLA Works
The precise mechanism by which fenfluramine exerts its therapeutic effects in treating seizures is currently unknown. Fenfluramine and its metabolite, norfenfluramine, function as agonists at serotonin 5-HT2 receptors. While this activity contributes to its clinical effect, the activation of 5-HT2B receptors is also associated with risks of valvular heart disease and pulmonary arterial hypertension.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-06-25
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- SOLUTION
FINTEPLA Approval History
What FINTEPLA Treats
3 indicationsFINTEPLA is approved for 3 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dravet Syndrome
- Lennox-Gastaut Syndrome
- Seizures
FINTEPLA 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 )
FINTEPLA 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 FINTEPLA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 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 |
| NCT07503444 | EP0247 2025-523157-34 | Ph 3 | not yet recruiting | A Phase 3 Study of Fenfluramine Hydrochloride in Rett 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 |
| NCT03790137 results posted | 12112018 | Ph 3 | completed | Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25). |
| NCT03861871 results posted | 18-01530 | Ph 2 | completed | Fenfluramine in CDKL5 Deficiency Disorder (CDD) |
| 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.
FINTEPLA FDA Label Details
Indications & Usage
FDA Label (PDF)FINTEPLA 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 ...
FINTEPLA Patents & Exclusivity
Patents (27 active)
Exclusivity
Pro Intelligence Preview
Deep insights for FINTEPLA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 30 active patents
Trial Analysis
- • 3 total trials
- • Stage: Expansion
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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