Fenfluramine Hydrochloride

Phase 3Small molecule

NNYU Langone Health

Fenfluramine Hydrochloride is one of 25 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 SyndromeNot yet recruiting

Rett SyndromePhase 3

Not yet recruiting

Competition

Competitive Landscape

30 competitors in Rett Syndrome

#DrugCompanyPhaseTrials

Epidiolex

Jazz Pharmaceuticals

Approved

—2

Norpramin

VValidus Pharmaceuticals

Risperdal

GWP42003-P

2 5

Donepezil Hydrochloride

Eisai

Phase 3

1 6

Robitussin

Pfizer

Phase 2

4 7

Copaxone

Teva

Phase 2

2 8

Dojolvi

Ultragenyx

Phase 2

1 9

Ketalar

AAultman Health Foundation

Phase 2

1 10

Altoprev

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 2

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

Timeline

Expected Milestones

Q4 2030

Phase 3Not yet recruiting

Rett Syndrome

NCT07503444

Clinical

Trials by Indication[1]

ESS1 trial

ZX008 Expanded Access Protocol

Approved for marketing·ZZogenix, Inc.··NCT03780127

CDKL5 Deficiency Disorder1 trial

Fenfluramine in CDKL5 Deficiency Disorder (CDD)

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

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

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

Not yet 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

Q4 2030

Trials by Indication[1]

ESS1 trial

CDKL5 Deficiency Disorder1 trial

Treatment1 trial

Rett syndrome1 trial

References

Drug Info

Quick Facts

Related News