Dravet Syndrome (DS)
5
Pipeline Programs
3
Companies
4
Clinical Trials
1 recruiting
2
Approved Products
Pipeline by Development Stage
Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
1
4
Early DiscoveryClinical DevelopmentMarket
Drug Modality Breakdown
Small Molecule
1100%
+ 3 programs with unclassified modality
On Market (2)
Approved therapies currently available
U
FENFLURAMINEApproved
fenfluramine
Unknown Companyoral
UP
Competitive Landscape
3 companies ranked by most advanced pipeline stage
UP
UCB PharmaBelgium - Brussels
2 programs1
fenfluraminePhase 41 trial
Byteflies Remote patient monitoring solutionN/A1 trial
Active Trials
Jazz PharmaceuticalsCA - Palo Alto
1 program1
Epidiolex 100 mg/mL Oral SolutionPhase 41 trial
Active Trials
Trial Timeline
Clinical trial activity over time
2022
2023
2024
2025
2026
2027
2028
Jazz PharmaceuticalsEpidiolex 100 mg/mL Oral Solution
UCB Pharmafenfluramine
TakedaSoticlestat
UCB PharmaByteflies Remote patient monitoring solution
Clinical Trials (4)
Total enrollment: 409 patients across 4 trials
A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
Start: Feb 2026Est. completion: Dec 202825 patients
Phase 4Not Yet Recruiting
Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age
Start: Oct 2024Est. completion: Jul 202712 patients
Phase 4Recruiting
A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
Start: Mar 2022Est. completion: Sep 2025352 patients
Phase 3Terminated
Clinical Utility of Reduced EEG Home Monitoring in Fenfluramine Titration for Dravet and LGS
Start: Dec 2025Est. completion: Dec 202620 patients
N/ANot Yet Recruiting
Phase Legend
Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available
Key Insights
1 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 409 patients
3 companies competing in this space