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Infantile Spasms

5
Pipeline Programs
5
Companies
8
Clinical Trials
1 recruiting
1
Approved Products

Pipeline by Development Stage

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

On Market (1)

Approved therapies currently available

Lundbeck
SABRILApproved
vigabatrin
Lundbeck
Anti-epileptic Agent [EPC]oral2009
18M Part D

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Lundbeck
LundbeckDenmark - Copenhagen
2 programs
1
VigabatrinPhase 41 trial
Sabril®N/A1 trial
Active Trials
NCT01073579Completed9,423
NCT01413711Withdrawn0
Marinus Pharmaceuticals
2 programs
2
GanaxolonePhase 21 trial
GanaxolonePhase 21 trial
Active Trials
NCT00441896Completed57Est. May 2008
NCT00442104Terminated54Est. Mar 2009
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
1
PrednisolonePhase 21 trial
Active Trials
NCT06819670Recruiting40Est. Jun 2028
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
2 programs
GWP42003-PPHASE_31 trial
GWP42003-PPHASE_31 trial
Active Trials
NCT02953548Completed9Est. May 2018
NCT02954887Completed9Est. Jun 2019
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
Genetic Studies in Patients and Families With Infantile SpasmsN/A1 trial
Active Trials
NCT01723787Completed63Est. Nov 2018

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
LundbeckVigabatrin
Jazz PharmaceuticalsGWP42003-P
Jazz PharmaceuticalsGWP42003-P
Angeles TherapeuticsPrednisolone
Marinus PharmaceuticalsGanaxolone
Marinus PharmaceuticalsGanaxolone
Colorado TherapeuticsGenetic Studies in Patients and Families With Infantile Spasms
LundbeckSabril®

Clinical Trials (8)

Total enrollment: 9,655 patients across 8 trials

NCT01413711LundbeckVigabatrin

An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms

Start: Jun 20120
Phase 4Withdrawn
NCT02954887Jazz PharmaceuticalsGWP42003-P

Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)

Start: May 2017Est. completion: Jun 20199 patients
Phase 3Completed
NCT02953548Jazz PharmaceuticalsGWP42003-P

Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)

Start: Apr 2017Est. completion: May 20189 patients
Phase 3Completed
NCT06819670Angeles TherapeuticsPrednisolone

A Study to Prevent Infantile Spasms Relapse

Start: May 2025Est. completion: Jun 202840 patients
Phase 2Recruiting
NCT00441896Marinus PharmaceuticalsGanaxolone

A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms

Start: Jan 2007Est. completion: May 200857 patients
Phase 2Completed
NCT00442104Marinus PharmaceuticalsGanaxolone

Open-label Extension to Protocol 1042-0500

Start: Jan 2007Est. completion: Mar 200954 patients
Phase 2Terminated
NCT01723787Colorado TherapeuticsGenetic Studies in Patients and Families With Infantile Spasms

Genetic Studies in Patients and Families With Infantile Spasms

Start: Mar 2013Est. completion: Nov 201863 patients
N/ACompleted
NCT01073579LundbeckSabril®

Sabril Patient Registry

Start: Aug 20099,423 patients
N/ACompleted

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 actively recruiting trials targeting 9,655 patients
5 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.