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Hereditary Inclusion Body Myopathy

2
Pipeline Programs
3
Companies
4
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
2
0
0
0
0
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
Immune GlobulinPhase 1
Genome & Company
Genome & CompanyKorea - Suwon
1 program
1
Immune GlobulinPhase 11 trial
Active Trials
NCT00195637Completed4Est. Jul 2006
Ultragenyx Pharmaceutical
3 programs
Aceneuramic Acid Extended-ReleasePHASE_21 trial
Aceneuramic Acid Extended-Release TabletsPHASE_31 trial
aceneuramic acid extended-releasePHASE_31 trial
Active Trials
NCT02731690Terminated42Est. Jan 2018
NCT02736188Terminated143Est. Jan 2018
NCT02377921Completed89Est. Jun 2017

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Ultragenyx PharmaceuticalAceneuramic Acid Extended-Release Tablets
Ultragenyx Pharmaceuticalaceneuramic acid extended-release
Ultragenyx PharmaceuticalAceneuramic Acid Extended-Release
Genome & CompanyImmune Globulin

Clinical Trials (4)

Total enrollment: 278 patients across 4 trials

NCT02736188Ultragenyx PharmaceuticalAceneuramic Acid Extended-Release Tablets

Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

Start: May 2016Est. completion: Jan 2018143 patients
Phase 3Terminated
NCT02377921Ultragenyx Pharmaceuticalaceneuramic acid extended-release

Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Sialic Acid in Patients With Glucosamine (UDP-N-acetyl)-2-epimerase Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

Start: May 2015Est. completion: Jun 201789 patients
Phase 3Completed
NCT02731690Ultragenyx PharmaceuticalAceneuramic Acid Extended-Release

A Study to Evaluate the Safety of Aceneuramic Acid Extended Release (Ace-ER; UX001) Tablets in Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) Myopathy (GNEM) (Also Known as Hereditary Inclusion Body Myopathy [HIBM]) Patients With Severe Ambulatory Impairment

Start: Apr 2016Est. completion: Jan 201842 patients
Phase 2Terminated

Intravenous Immune Globulin to Treat Hereditary Inclusion Body Myopathy

Start: Sep 2005Est. completion: Jul 20064 patients
Phase 1Completed

Phase Legend

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

Key Insights

3 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.