Hereditary Inclusion Body Myopathy

3
Pipeline Programs
1
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
0
1
0
2
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

1 companies ranked by most advanced pipeline stage

Ultragenyx Pharmaceutical
3 programs
1
2
Aceneuramic Acid Extended-Release TabletsPhase 31 trial
aceneuramic acid extended-releasePhase 31 trial
Aceneuramic Acid Extended-ReleasePhase 21 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

Clinical Trials (3)

Total enrollment: 274 patients across 3 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

Phase Legend

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

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
1 companies competing in this space