Fenfluramine Hydrochloride

Phase 3Small molecule

NNYU Langone Health

Fenfluramine Hydrochloride is one of 8 small molecule programs targeting Rett syndrome. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Rett SyndromeRecruiting

Rett SyndromePhase 3

Recruiting

Competition

Competitive Landscape

8 competitors in Rett Syndrome

#DrugCompanyPhaseTrials

Epidiolex

Risperdal

Norpramin

VValidus Pharmaceuticals

Remeron

1 5

Fenfluramine Hydrochloride

NNYU Langone Health

Phase 3

1 6

Aricept

Eisai

Preclinical

1 7

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Phase 1

1 8

Topamax

WWim Janssens

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2031

Phase 3Recruiting

Rett Syndrome

NCT07503444

Clinical

Trials by Indication[1]

Treatment1 trial

Treatment of Sunflower Syndrome With ZX008 (Fenfluramine Hydrochloride) in Children and Young Adults (Ages 4-25).

Completed·EElizabeth Anne Thiele·Phase 3·NCT03790137·20 enrolled

CDKL5 Deficiency Disorder1 trial

Fenfluramine in CDKL5 Deficiency Disorder (CDD)

Completed·NNYU Langone Health·Phase 2·NCT03861871·7 enrolled

ESS1 trial

ZX008 Expanded Access Protocol

Approved for marketing·ZZogenix, Inc.··NCT03780127

Rett syndrome1 trial

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

Recruiting· UCB logo

UCB·Phase 3·NCT07503444·200 enrolled

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Fenfluramine Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fenfluramine Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fenfluramine Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — NYU Langone Health company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: NNYU Langone Health

Fenfluramine Hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2031

Trials by Indication[1]

Treatment1 trial

CDKL5 Deficiency Disorder1 trial

ESS1 trial

Rett syndrome1 trial

References

Drug Info

Quick Facts

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