omaveloxolone
omaveloxolone: sourced relationships with 1 company · 7 clinical trials tracked · 1 FDA decision.
omaveloxolone evidence translation
What we can confirm
1 FDA record · 7 tracked trials
What it means
What to watch
Prepared research question
How could omaveloxolone → BIIB affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| BIOGEN INC. (BIIB) Friedreich's ataxia | Approved |
| BIOGEN INC. (BIIB) Reported 2023-02-28 · Current development: unknownSource Friedreich Ataxia; Healthy Adult Subjects; Healthy Volunteer | Phase 3 |
Clinical Trial Registry Records (7)
A Post-marketing, Observational, Descriptive Study to Assess the Risk Associated With Pregnancy, the Maternal Complications, and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Omaveloxolone During Pregnancy and/or Lactation
Primary endpoint: Number of Major Congenital Malformations (MCMs)
A Phase 1, Randomized, Open-Label, Single-Dose, Crossover, Bioequivalence Study of Omaveloxolone Tablets for Oral Suspension Versus Capsules in Healthy Adult Participants
Primary endpoint: Maximum Observed Plasma Concentration (Cmax) of Omaveloxolone
A Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omaveloxolone (BIIB141) in Participants With Friedreich's Ataxia Aged 2 to < 16 Years
Primary endpoint: Part 1: Change From Baseline in Upright Stability Score (USS) Subscale E of Modified Friedreich's Ataxia Rating Scale (mFARS) at Week 52
An Observational, Multinational, Post-Marketing Registry of Omaveloxolone-Treated Patients With Friedreich's Ataxia
Primary endpoint: Omaveloxolone Naive Cohort: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
An Open-Label, Phase 1, Study to Evaluate the Pharmacokinetics, Safety, Tolerability, Pharmacodynamics, and Efficacy of Omaveloxolone in Participants ≥2 to <16 Years of Age With Friedreich's Ataxia
Primary endpoint: Part 1: Apparent Clearance (CL/F) of Omaveloxolone
A Single Sequence, 2-Period, Open-label Crossover Study in Healthy Subjects to Determine the Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of Omaveloxolone
Primary endpoint: Maximum concentration (Cmax) of omaveloxolone
A Phase 2 Study of the Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich's Ataxia (MOXIe)
Primary endpoint: Part 1: Change From Baseline in Peak Work During Maximal Exercise Testing at Week 12
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with omaveloxolone?
omaveloxolone has dated SEC/FDA relationship records for BIOGEN INC..
How many clinical trials involve omaveloxolone?
BioSniper tracks 7 clinical trials involving omaveloxolone.
What is omaveloxolone's latest FDA decision?
The most recent tracked FDA decision for omaveloxolone is Approval for 1 INDICATIONS AND USAGE SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. ( 1 ), dated February 28, 2023.