Drug

Fenfluramine hydrochloride

Approved · EMA

Late-stage development

Also known as Fintepla, Pondimin, fenfluramine (as hydrochloride), fenfluramine HCl.

RxNorm82018

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 3 Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study With Open-Label Extension to Evaluate the Efficacy And Safety of Fenfluramine Hydrochloride in Study Participants With Rett Syndrome

Clinical trial2026-07-10Results expected Q3 2028 · ClinicalTrials.gov

A Phase 1, Single-Center, Repeat-Dose, Open-Label, Fixed-Sequence Drug-Drug Interaction Study of ZX008 in Healthy Male Or Female Study Participants 18 To 55 Years Of Age

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

Using Fenfluramine to Test the Serotonin Deficiency Theory of Depression

Clinical trial2026-06-16Results expected Q3 2028 · ClinicalTrials.gov

An Open-Label Treatment of ZX008 (Fenfluramine Hydrochloride) in Pediatric and Adult Epilepsy Patients (Ages 4-25) With Sunflower Syndrome.

Clinical trial2024-11-06Results posted · ClinicalTrials.gov

Fenfluramine in CKDL5 Deficiency Disorder (CDD)

Clinical trial2023-10-04Results posted · ClinicalTrials.gov

Approval: Fintepla (EMA)

Regulatory2020-12-18EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Fenfluramine hydrochloride

Aliases & brands

FinteplaPondiminfenfluramine (as hydrochloride)fenfluramine HCl

RxNorm CUI

82018

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2020-12-18

Latest approval

2020-12-18

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2020-12-18Approval

Approval: Fintepla (EMA)

Indication: Treatment of seizures associated with Dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older. Fintepla is indicated for the… Show full indication

Treatment of seizures associated with Dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older. Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.