SKYCLARYS (omaveloxolone)
SKYCLARYS is indicated for the treatment of Friedreich's Ataxia.
How SKYCLARYS Works
The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreich's ataxia is unknown. The drug has been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in humans and animals. This biological pathway is involved in the cellular response to oxidative stress.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-02-28
- Patent Cliff
- 2033
- Revenue
- $145M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
SKYCLARYS Approval History
What SKYCLARYS Treats
1 indicationsSKYCLARYS is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Friedreich's Ataxia
SKYCLARYS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06054893 BOLD | 408-C-2001 | Ph 1 | active not recruiting | A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old |
| NCT07297199 | 296HV102 | Ph 1 | completed | 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 |
| NCT06953583 BRAVE | 296FA301 2025-520896-13 | Ph 3 | recruiting | A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old (BRAVE) |
| NCT07149415 | 296HV104 | Ph 1 | completed | 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 |
| NCT07019064 | 296HV103 | Ph 1 | completed | 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 |
| NCT03664453 | 408-C-1703 | Ph 1 | completed | A Pharmacokinetic Study of Omaveloxolone in Healthy Volunteers |
| NCT05927649 | 408-C-2201 | Ph 1 | completed | A TQTc Study for Omaveloxolone |
| NCT05909644 | 408-C-2202 | Ph 1 | completed | An Open-label DDI Study of Omaveloxolone in Healthy Subjects |
| NCT04008186 | 408-C-1806 | Ph 1 | completed | A Clinical Drug-Drug Interaction (DDI) Study With Omaveloxolone |
| NCT02029729 DISCOVER | RTA 408-C-1303 | Ph 1 | completed | RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER |
| NCT06612879 | 296HV101 | Ph 1 | completed | A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SKYCLARYS FDA Label Details
Indications & Usage
FDA Label (PDF)SKYCLARYS is indicated for the treatment of Friedreich's Ataxia.
SKYCLARYS Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for SKYCLARYS
Revenue Insights
- • Q4-2025: $145M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 8 active patents
Trial Analysis
- • 11 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment