Skyclarys (omaveloxolone)
An approved treatment for Friedreich Ataxia.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Omaveloxolone wherever you encounter it, plus the key facts at a glance.
- Generic name
- Omaveloxolone
- Brand name
- Skyclarys
- Development code
- RTA 408
- Drug class
- Nrf2 activator
- Manufacturer
- Biogen
- How it's taken
- Taken by mouth once a day as 3 capsules of 50mg, for a total of 150mg.
A once-daily pill and the first FDA-approved treatment for Friedreich ataxia, approved on February 28, 2023 for people 16 and older. In its main trial, people on Skyclarys scored better on a physical function scale after 48 weeks than people on placebo.
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Where Omaveloxolone fits
The first and only FDA-approved drug for Friedreich ataxia. Before 2023, care relied on physical therapy, heart care and treatment of scoliosis and diabetes, and those remain part of care alongside Skyclarys.
How Omaveloxolone works
People with Friedreich ataxia make too little frataxin, a protein that mitochondria need to make energy. Without enough of it, cells build up harmful oxidative stress, and nerve cells in the spinal cord and brain are hit hardest. Omaveloxolone switches on Nrf2, a protein that turns on the cell's own antioxidant and repair genes. The label notes that the exact way this slows Friedreich ataxia is not known, and the drug does not replace the missing frataxin.
Side effects and safety
- Raised liver enzymes. Liver tests before starting, every month for the first 3 months, then from time to time. The doctor stops Skyclarys if these liver enzymes pass 5 times the normal limit, or 3 times with signs of liver trouble.
- Raised BNP, a heart-strain marker. Heart disease is common in Friedreich ataxia, and it is unclear whether the BNP rises came from the drug. Call the doctor about a weight gain of 3 pounds in 1 day or 5 pounds in 1 week, swelling, a racing heartbeat or shortness of breath.
- Cholesterol changes. LDL cholesterol went up by about 23.5mg/dL on average at 48 weeks, and HDL went down slightly. Cholesterol is checked before and during treatment.
- Hormonal birth control. Skyclarys can make birth control pills, patches, rings, implants and progestin-only pills work less well. Use a non-hormonal method, or add one such as condoms, during treatment and for 28 days after stopping.
- Liver enzymes and bilirubin before starting, monthly for 3 months, then periodically
- BNP before starting, and again if signs of fluid buildup appear
- Cholesterol before starting and during treatment
Skyclarys has no boxed warning and no contraindications. Its 3 warnings are about liver enzymes, a heart-strain marker called BNP and cholesterol. In the main trial, 31% of people on Skyclarys had liver enzymes above 3 times the upper limit of normal, and 16% above 5 times. These rises peaked within 12 weeks, usually caused no symptoms and went away after stopping the drug.
BNP rose above normal in 14% of people on Skyclarys against 4% on placebo, and LDL cholesterol rose in 16% against 8%. The most common side effects were raised liver enzymes, headache, nausea, stomach pain, tiredness, diarrhea and muscle pain.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Omaveloxolone
Taken by mouth once a day as 3 capsules of 50mg, for a total of 150mg. It goes on an empty stomach, at least 1 hour before or 2 hours after eating. Capsules are swallowed whole, or opened and stirred into 2 tablespoons of applesauce and eaten right away. The contents should not be mixed with milk or orange juice or given through a feeding tube.
People with moderate liver impairment take 100mg, and people with severe liver impairment should not take it. Grapefruit and many drugs that affect the liver enzyme CYP3A4 change the dose or should be avoided. A missed dose is skipped, and the next one is taken at the usual time the next day. Skyclarys comes from a specialty pharmacy, not a retail pharmacy.
Availability and cost
Only available as the brand-name product.
Help paying for Skyclarys
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Insurance and case manager help
After the doctor submits a Start Form, a Family Access Manager helps with prior authorization and insurance, and a Lead Case Manager coordinates shipments from the specialty pharmacy, Biologics.
The official page does not say who qualifies. Ask the program. · source - Copay help
Eligible commercially insured patients may pay as little as $0; Biogen says 95% did as of February 2026. Annual cap applies. Not available to people covered by Medicare, Medicaid, VA, DoD or other federal plans.
For: private insurance · source
Good to know: Call Biogen REACH at 1-844-987-3224, weekdays 8:30am-8pm ET. People without insurance should call REACH to ask about financial assistance options; the page does not name a free medicine program.
- From a charity · Muscular Dystrophy AssociationMDA Durable Medical Equipment (DME) Grant Program fundApply directly
Pays for: Medical equipment (wheelchairs, lifts, canes and other DME), up to $1,000 per year.
The foundation says: “Status not shown on page”
Access and eligibility
Approved for people 16 and older with Friedreich ataxia. Its safety and effectiveness under 16 are not known. The main trial enrolled people aged 16-40 who could do an exercise test and whose heart pumping strength was at least 40%. It left out people with significant liver disease.
Source: Biogen REACH (Skyclarys access support)
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
Approval rested on the MOXIe trial (NCT02255435), which randomly assigned 103 people aged 16-40 with Friedreich ataxia to Skyclarys or placebo for 48 weeks. The main result came from the 82 people without pes cavus, a high-arched foot that can skew the balance tests. Their scores on the modified Friedreich Ataxia Rating Scale (mFARS), where lower means less impairment, improved by 1.56 points on Skyclarys and worsened by 0.85 points on placebo.
The difference of 2.41 points had about a 1 in 70 chance of being a fluke (p=0.0138). Across all 103 people, the difference was 1.94 points. A later comparison with untreated people from a natural history study suggested slower decline over 3 years, but the label says that analysis should be read with caution.
Development history
Reata Pharmaceuticals developed omaveloxolone, and the FDA approved it on February 28, 2023 as the first treatment for Friedreich ataxia. It came through a priority review with orphan drug and fast track status. Biogen acquired Reata later in 2023 and now sells Skyclarys. Later label updates defined an empty stomach as 1 hour before or 2 hours after eating. They also added a pregnancy registry and reports of hives and rash.
Explore Friedreich Ataxia trials
Common questions about Omaveloxolone
▸What is Omaveloxolone (Skyclarys)?
A once-daily pill and the first FDA-approved treatment for Friedreich ataxia, approved on February 28, 2023 for people 16 and older. In its main trial, people on Skyclarys scored better on a physical function scale after 48 weeks than people on placebo.
▸How does Omaveloxolone work?
People with Friedreich ataxia make too little frataxin, a protein that mitochondria need to make energy. Without enough of it, cells build up harmful oxidative stress, and nerve cells in the spinal cord and brain are hit hardest. Omaveloxolone switches on Nrf2, a protein that turns on the cell's own antioxidant and repair genes. The label notes that the exact way this slows Friedreich ataxia is not known, and the drug does not replace the missing frataxin.
▸What are the side effects of Omaveloxolone?
Skyclarys has no boxed warning and no contraindications. Its 3 warnings are about liver enzymes, a heart-strain marker called BNP and cholesterol. In the main trial, 31% of people on Skyclarys had liver enzymes above 3 times the upper limit of normal, and 16% above 5 times. These rises peaked within 12 weeks, usually caused no symptoms and went away after stopping the drug. BNP rose above normal in 14% of people on Skyclarys against 4% on placebo, and LDL cholesterol rose in 16% against 8%. The most common side effects were raised liver enzymes, headache, nausea, stomach pain, tiredness, diarrhea and muscle pain.
▸How is Omaveloxolone taken?
Taken by mouth once a day as 3 capsules of 50mg, for a total of 150mg. It goes on an empty stomach, at least 1 hour before or 2 hours after eating. Capsules are swallowed whole, or opened and stirred into 2 tablespoons of applesauce and eaten right away. The contents should not be mixed with milk or orange juice or given through a feeding tube. People with moderate liver impairment take 100mg, and people with severe liver impairment should not take it. Grapefruit and many drugs that affect the liver enzyme CYP3A4 change the dose or should be avoided. A missed dose is skipped, and the next one is taken at the usual time the next day. Skyclarys comes from a specialty pharmacy, not a retail pharmacy.
▸Is Omaveloxolone FDA approved?
Yes, Omaveloxolone (Skyclarys) is FDA approved (2023) for the treatment of Friedreich Ataxia.
▸Does Skyclarys stop Friedreich ataxia from getting worse?
It is not a cure. Over 48 weeks, scores improved slightly on average on Skyclarys and worsened on placebo, a gap of about 2.4 points on a 99-point ataxia scale. Results vary from person to person, so ask your neurologist how they will measure whether it is helping you.
▸Can people under 16 take Skyclarys?
The FDA approved Skyclarys for people 16 and older, because the main trial enrolled ages 16-40. Its safety and effectiveness in younger children are not known, so ask your child's neurologist about trials that include younger ages.
▸What blood tests do I need on Skyclarys?
Liver tests before starting, every month for the first 3 months and then from time to time. Your doctor also checks BNP, a marker of heart strain, before you start, and cholesterol before and during treatment.
▸Does Skyclarys affect birth control?
Yes, it can make hormonal birth control less effective, including pills, patches, rings, implants and progestin-only pills. The patient information advises a non-hormonal method or an added barrier method during treatment and for 28 days after stopping.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-04-06. SKYCLARYS (omaveloxolone) capsules: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2709e870-df3d-f30f-e063-6394a90aeda1
- U.S. Food and Drug Administration. Drugs@FDA: SKYCLARYS approval history (NDA 216718). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216718
- U.S. Food and Drug Administration · 2023-02-28. FDA approves first treatment for Friedreich's ataxia. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-friedreichs-ataxia
- ClinicalTrials.gov. A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia. https://clinicaltrials.gov/study/NCT02255435
- Biogen. Get support for accessing SKYCLARYS with Biogen REACH. https://www.skyclarys.com/en-us/home/resources-and-support/biogen-reach.html