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GNE Myopathy

5
Pipeline Programs
4
Companies
6
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
1
4
0
0
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Genome & Company
Genome & CompanyKorea - Suwon
3 programs
2
ManNAcPhase 2
ManNAcPhase 2
A Natural History Study of Patients With GNE Myopathy and GNE-Related DiseasesN/A
Human BioSciences
Human BioSciencesWV - Martinsburg
3 programs
2
ManNAcPhase 21 trial
ManNAcPhase 21 trial
A Natural History Study of Patients With GNE Myopathy and GNE-Related DiseasesN/A1 trial
Active Trials
NCT01417533Completed78
NCT02346461Completed12Est. Nov 2018
NCT04231266Active Not Recruiting54Est. Oct 2025
Ultragenyx Pharmaceutical
3 programs
1
UX016Phase 1/21 trial
SA-ER 500 mgPHASE_21 trial
Sialic Acid Extended ReleasePHASE_21 trial
Active Trials
NCT01830972Completed59Est. Feb 2017
NCT01517880Completed46Est. Nov 2013
NCT07511556Not Yet Recruiting24Est. Dec 2028
Leadiant Biosciences
Leadiant BiosciencesMD - Rockville
1 program
ManNAcPHASE_2

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Human BioSciencesManNAc
Human BioSciencesManNAc
Ultragenyx PharmaceuticalSA-ER 500 mg
Ultragenyx PharmaceuticalSialic Acid Extended Release
Ultragenyx PharmaceuticalUX016
Human BioSciencesA Natural History Study of Patients With GNE Myopathy and GNE-Related Diseases

Clinical Trials (6)

Total enrollment: 273 patients across 6 trials

Multi-Center Study of ManNAc for GNE Myopathy

Start: Apr 2022Est. completion: Oct 202554 patients
Phase 2Active Not Recruiting

An Open Label Phase 2 Study of ManNAc in Subjects With GNE Myopathy

Start: Feb 2015Est. completion: Nov 201812 patients
Phase 2Completed

An Open Label Phase 2 Extension Study of Higher Dose Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy

Start: Jun 2013Est. completion: Feb 201759 patients
Phase 2Completed
NCT01517880Ultragenyx PharmaceuticalSialic Acid Extended Release

A Phase 2 Study to Evaluate the Dose and Pharmacodynamic Efficacy of Sialic Acid-Extended Release (SA-ER) Tablets in Patients With GNE Myopathy or Hereditary Inclusion Body Myopathy

Start: May 2012Est. completion: Nov 201346 patients
Phase 2Completed

First-in-human Study of UX016 in GNEM

Start: Oct 2026Est. completion: Dec 202824 patients
Phase 1/2Not Yet Recruiting
NCT01417533Human BioSciencesA Natural History Study of Patients With GNE Myopathy and GNE-Related Diseases

A Natural History Study of Patients With GNE Myopathy and GNE-Related Diseases

Start: Sep 201178 patients
N/ACompleted

Phase Legend

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

Key Insights

4 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.