NDAORALCAPSULEPriority Review
Approved
Feb 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
16
Data completeness
5/8 — Partial
Priority Review
SKYCLARYS (omaveloxolone) by Biogen is cytochrome p450 3a4 inducers [moa]. First approved in 2023.
Drug data last refreshed 13h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SKYCLARYS (omaveloxolone) is an oral small-molecule cytochrome P450 3A4 inducer approved in February 2023 for Friedreich's ataxia, a rare inherited neurological disorder. The drug works by activating cellular stress response pathways to reduce oxidative damage and neuroinflammation in affected tissues.
$45.0MPart D
Peak6.8 years to LOEEarly-stage product in peak growth phase with strong Biogen backing; commercial team expansion likely as market penetration increases.
Mechanism of Action
Cytochrome P450 3A4 Inducers
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it During Pregnancy and/or During Breastfeeding and About the Health of Their Babies
Started Oct 2026
20 enrolled
Friedreich Ataxia
A Study to Learn How the Body Processes BIIB141 (Omaveloxolone) When Taken as a Capsule or as a Tablet Dissolved in Liquid, and to Learn About Its Safety in Healthy Adults Ages 18 to 55
Started Dec 2025
70 enrolled
Healthy Volunteer
A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55
Started Sep 2025
22 enrolled
Healthy Volunteer
A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55
Started Jun 2025
52 enrolled
Healthy Volunteer
A Study to Learn More About the Effects and Long-Term Safety of Omaveloxolone (BIIB141) in Children and Teens With Friedreich's Ataxia
Started Jun 2025
255 enrolled
Friedreich Ataxia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
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.