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GM2 Gangliosidosis

2
Pipeline Programs
2
Companies
6
Clinical Trials
4 recruiting
0
Approved Products

Pipeline by Development Stage

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

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Azafaros
AzafarosNetherlands - DC Naarden
1 program
1
AZ-3102Phase 25 trials
Active Trials
NCT07399704Recruiting21Est. Aug 2030
NCT07054515Recruiting147Est. Nov 2027
NCT07082543Recruiting75Est. Nov 2027
+2 more trials
IntraBio
IntraBioTX - Austin
1 program
1
IB1001Phase 21 trial
Active Trials
NCT03759665Completed30Est. Jan 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
AzafarosAZ-3102
AzafarosAZ-3102
AzafarosAZ-3102
AzafarosAZ-3102
AzafarosAZ-3102
IntraBioIB1001

Clinical Trials (6)

Total enrollment: 358 patients across 6 trials

A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease, GM1 Gangliosidosis or GM2 Gangliosidosis

Start: Jun 2025Est. completion: Nov 2027147 patients
Phase 3Recruiting

A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of GM1 Gangliosidosis or GM2 Gangliosidosis

Start: Jun 2025Est. completion: Nov 202775 patients
Phase 3Recruiting

A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease (NPC)

Start: Jun 2025Est. completion: Nov 202772 patients
Phase 3Recruiting

A Study to Evaluate the Safety and Efficacy of Nizubaglustat (AZ-3102) in Patients With GM2 Gangliosidosis or Niemann-Pick Type C Disease

Start: Feb 2026Est. completion: Aug 203021 patients
Phase 2Recruiting

Phase 2 Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZ-3102 in Patients With GM2 Gangliosidosis or Niemann-Pick Type C Disease

Start: Apr 2023Est. completion: May 202613 patients
Phase 2Completed

N-Acetyl-L-Leucine for GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease)

Start: Jun 2019Est. completion: Jan 202330 patients
Phase 2Completed

Phase Legend

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

Key Insights

4 actively recruiting trials targeting 358 patients
2 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.