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Fintepla (FENFLURAMINE)
Fintepla works by binding to the Alpha-1B adrenergic receptor, which helps regulate the activity of certain neurons in the brain.
Fintepla (Fenfluramine) is a small molecule drug developed by UCB Inc, targeting the Alpha-1B adrenergic receptor. It is FDA-approved for the treatment of Dravet syndrome, seizures associated with Dravet syndrome, and obesity. Fintepla is a fenfluramine drug, patented by UCB Inc, with a half-life of 20 hours. The commercial status of Fintepla is patented, with no generic manufacturers available. Key safety considerations include the potential for serotonin syndrome and other cardiovascular risks.
At a glance
| Generic name | FENFLURAMINE |
|---|---|
| Sponsor | UCB |
| Drug class | fenfluramine |
| Target | Alpha-1B adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
The mechanisms by which fenfluramine exerts its therapeutic effects in the treatment of seizures associated with Dravet syndrome are unknown. Fenfluramine and the metabolite, norfenfluramine, increase extracellular levels of serotonin through interaction with serotonin transporter proteins, and exhibit agonist activity at serotonin 5HT-2 receptors.
Approved indications
- Dravet syndrome
- Obesity
- Seizures associated with Dravet syndrome
Boxed warnings
- 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 )
Common side effects
- Decreased appetite
- Somnolence, sedation, lethargy
- Diarrhea
- Constipation
- Abnormal echocardiogram
- Fatigue, malaise, asthenia
- Ataxia, balance disorder, gait disturbance
- Blood pressure increased
- Drooling, salivary hypersecretion
- Pyrexia
- Upper respiratory tract infection
- Vomiting
Drug interactions
- isocarboxazid
- pargyline
- phenelzine
- selegiline
- tranylcypromine
Key clinical trials
- A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome (PHASE3)
- 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 (PHASE3)
- A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder (PHASE3)
- A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome (PHASE3)
- Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS (NA)
- A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine (PHASE3)
- An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome (PHASE3)
- A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fintepla CI brief — competitive landscape report
- Fintepla updates RSS · CI watch RSS
- UCB portfolio CI