Lennox Gastaut Syndrome

6
Pipeline Programs
5
Companies
7
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
0
0
2
2
Early DiscoveryClinical DevelopmentMarket

On Market (1)

Approved therapies currently available

Jazz Pharmaceuticals
EPIDIOLEXApproved
cannabidiol
Jazz Pharmaceuticals
oral2018

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
2 programs
1
CannabidiolPhase 41 trial
Epidiolex 100 mg/mL Oral SolutionN/A1 trial
Active Trials
NCT05485831Recruiting100Est. Feb 2027
NCT05044819Active Not Recruiting154Est. Mar 2028
Harmony Biosciences
Harmony BiosciencesPLYMOUTH MEETING, PA
1 program
1
Clemizole HClPhase 31 trial
Active Trials
NCT05066217RecruitingEst. Nov 2029
UP
UCB PharmaBelgium - Brussels
1 program
1
ZX008 0.2 or 0.8 mg/kg/dayPhase 31 trial
Active Trials
NCT03355209Completed296Est. May 2024
SK Life Science
SK Life ScienceNJ - Paramus
2 programs
2
CarisbamatePhase 11 trial
CarisbamatePhase 11 trial
Active Trials
NCT04062981CompletedEst. Dec 2022
NCT03731715CompletedEst. Jun 2022
E
EisaiChina - Liaoning
1 program
RufinamideN/A1 trial
Active Trials
NCT03778424Available

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Jazz PharmaceuticalsCannabidiol
Harmony BiosciencesClemizole HCl
UCB PharmaZX008 0.2 or 0.8 mg/kg/day
SK Life ScienceCarisbamate
SK Life ScienceCarisbamate
Jazz PharmaceuticalsEpidiolex 100 mg/mL Oral Solution

Clinical Trials (7)

Total enrollment: 550 patients across 7 trials

NCT05044819Jazz PharmaceuticalsCannabidiol

Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

Start: Jul 2021Est. completion: Mar 2028154 patients
Phase 4Active Not Recruiting
NCT05066217Harmony BiosciencesClemizole HCl

An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

Start: Apr 2025Est. completion: Nov 2029
Phase 3Recruiting
NCT03355209UCB PharmaZX008 0.2 or 0.8 mg/kg/day

A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

Start: Nov 2017Est. completion: May 2024296 patients
Phase 3Completed
NCT04062981SK Life ScienceCarisbamate

Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome

Start: May 2019Est. completion: Dec 2022
Phase 1Completed
NCT03731715SK Life ScienceCarisbamate

Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome

Start: Feb 2019Est. completion: Jun 2022
Phase 1Completed
NCT03778424EisaiRufinamide

An Extended Access Program (EAP) for Participants Who Have Completed Rufinamide Study E2080-G000-303

N/AAvailable
NCT05485831Jazz PharmaceuticalsEpidiolex 100 mg/mL Oral Solution

Epidyolex® in Lennox Gastaut, Dravet Syndrome and Tuberous Sclerosis Complex: an Observational Study in ITALY

Start: Feb 2025Est. completion: Feb 2027100 patients
N/ARecruiting

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

2 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 550 patients
5 companies competing in this space