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GM1 Gangliosidosis

2
Pipeline Programs
6
Companies
3
Clinical Trials
0
Approved Products

Pipeline by Development Stage

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

Competitive Landscape

5 companies ranked by most advanced pipeline stage

BioTherapeutics Inc
BioTherapeutics IncVA - Blacksburg
1 program
1
PBGM01Phase 1/2
GEMMA Biotherapeutics
GEMMA BiotherapeuticsPA - Philadelphia
1 program
1
PBGM01Phase 1/21 trial
Active Trials
NCT04713475Active Not Recruiting26Est. Feb 2029
Azafaros
AzafarosNetherlands - DC Naarden
1 program
GM1 and GM2 Gangliosidosis PROspective Neurological Disease TrajectOry Study (PRONTO)N/A1 trial
Active Trials
NCT05109793Completed31Est. Sep 2025
Biocorp
BiocorpFrance - Issoire
1 program
Natural History Study of Infantile and Juvenile GM1 Gangliosidosis (GM1) PatientsN/A1 trial
Active Trials
NCT04041102Completed31Est. May 2024
Passage Bio
Passage BioPA - Philadelphia
1 program
Natural History Study of Infantile and Juvenile GM1 Gangliosidosis (GM1) PatientsN/A

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
GEMMA BiotherapeuticsPBGM01
AzafarosGM1 and GM2 Gangliosidosis PROspective Neurological Disease TrajectOry Study (PRONTO)
BiocorpNatural History Study of Infantile and Juvenile GM1 Gangliosidosis (GM1) Patients

Clinical Trials (3)

Total enrollment: 88 patients across 3 trials

Study of Safety, Tolerability and Efficacy of PBGM01 in Pediatric Participants With GM1 Gangliosidosis

Start: Mar 2021Est. completion: Feb 202926 patients
Phase 1/2Active Not Recruiting
NCT05109793AzafarosGM1 and GM2 Gangliosidosis PROspective Neurological Disease TrajectOry Study (PRONTO)

GM1 and GM2 Gangliosidosis PROspective Neurological Disease TrajectOry Study (PRONTO)

Start: Feb 2022Est. completion: Sep 202531 patients
N/ACompleted
NCT04041102BiocorpNatural History Study of Infantile and Juvenile GM1 Gangliosidosis (GM1) Patients

Natural History Study of Infantile and Juvenile GM1 Gangliosidosis (GM1) Patients

Start: Jun 2020Est. completion: May 202431 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

6 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.