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Skyclarys (OMAVELOXOLONE)
Skyclarys (generic name: OMAVELOXOLONE) is a Small molecule drug developed by Biogen Us. It is currently FDA-approved (first approved 2023) for Friedreich’s ataxia.
Skyclarys works by activating the Nrf2 pathway to increase the production of antioxidant proteins that protect cells from damage.
Skyclarys, also known as omaveloxolone, is a small molecule that activates nuclear factor erythroid 2-related factor 2. It is being studied in clinical trials for conditions such as Friedreich Ataxia and is also being tested for its safety and pharmacokinetics in healthy adults.
At a glance
| Generic name | OMAVELOXOLONE |
|---|---|
| Sponsor | Biogen Us |
| Target | Nuclear factor erythroid 2-related factor 2 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2023 |
| Annual revenue | 300 |
Mechanism of action
The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreichs ataxia is unknown. Omaveloxolone have been shown to activate the Nuclear factor (erythroid-derived 2)-like (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress.
Approved indications
- Friedreich’s ataxia
Common side effects
- Elevated liver enzymes (AST/ALT)
- Headache
- Nausea
- Abdominal pain
- Fatigue
- Diarrhea
- Musculoskeletal pain
- Oropharyngeal pain
- Influenza
- Vomiting
- Muscle spasms
- Back pain
Key clinical trials
- 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) (PHASE3)
- Cardiac Output and Fatigue in Friedreich's Ataxia (NA)
- 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 (PHASE1)
- A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia (PHASE2)
- 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 (PHASE1)
- 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 (PHASE1)
- 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 (PHASE1)
- 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
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Skyclarys CI brief — competitive landscape report
- Skyclarys updates RSS · CI watch RSS
- Biogen Us portfolio CI
Frequently asked questions about Skyclarys
What is Skyclarys?
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When was Skyclarys approved?
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What are the side effects of Skyclarys?
What is Skyclarys's annual revenue?
What does Skyclarys target?
Related
- Target: All drugs targeting Nuclear factor erythroid 2-related factor 2
- Manufacturer: Biogen Us — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Friedreich’s ataxia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing