Lisraya (brepocitinib)
An approved treatment for Dermatomyositis.
The same compound appears under different names depending on the context. Here is how to identify Brepocitinib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Brepocitinib
- Brand name
- Lisraya
- Development code
- PF-06700841
- Drug class
- JAK/TYK2 inhibitor
- Manufacturer
- Priovant Therapeutics
- How it's taken
- Lisraya is taken as one 30 mg pill by mouth once a day.
The first and only targeted therapy approved for dermatomyositis. A once-daily pill that blocks two enzymes (TYK2 and JAK1) driving the overactive immune signaling behind the disease. Approved by the FDA in August 2026 for adults.
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Where Brepocitinib fits
The first targeted therapy approved for dermatomyositis. It can be used as an alternative or an add-on to the steroids, non-specific immunomodulators, and IVIG that have been the mainstay of care, with no restrictions based on disease activity, presentation, or prior treatment. Its steroid-sparing effect is a large part of the point, since long-term high-dose steroids carry their own serious harms.
How Brepocitinib works
Lisraya blocks two enzymes called TYK2 and JAK1 that carry inflammatory signals inside immune cells. These signals run too hot in dermatomyositis. Turning them down reduces the inflammation behind both the muscle weakness and the skin rash. Most other treatments for the disease either suppress the immune system broadly or replace missing antibodies; this one targets the specific biology of the disease.
Mechanism: Selective TYK2/JAK1 inhibitor that blocks interferon signaling
Side effects and safety
Lisraya carries a boxed warning for serious infections, death, cancer, major heart problems (heart attack and stroke), and blood clots, which is standard for this class of medicine. Tell your doctor about any infection, chest pain, shortness of breath, or swelling and pain in a leg. Your doctor will test you for tuberculosis before you start and will check your blood counts, cholesterol, and liver during treatment. The most common side effects were upper respiratory infection, headache, fatigue, urinary tract infection, nausea, bronchitis, joint pain, diarrhea, back pain, falls, flu, and acne. Live vaccines should be avoided during treatment, and it may cause harm to an unborn baby. Your doctor will check whether you are pregnant before you start, and women who can become pregnant should use effective birth control during treatment and for 3 days after the last dose. The label also warns about serious allergic reactions, tears in the stomach or intestines (report new belly pain right away), low blood sugar in people with diabetes, and hepatitis B or C flaring up, so you will be screened for hepatitis before starting.
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 Brepocitinib
Lisraya is taken as one 30 mg pill by mouth once a day. It can be used on its own or added to existing treatment. It is not recommended together with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs, or in people with severe liver or kidney problems. It is dispensed through a limited network of specialty pharmacies.
Availability and cost
Only available as the brand-name product.
Help paying for Lisraya
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.
- Copay help
My Compass Support Copay Savings Program: eligible privately insured patients may pay as little as $0 per month. Not valid with Medicare, Medicaid, VA or TRICARE.
For: private insurance · source - Insurance and case manager help
A dedicated Patient Access Liaison checks benefits, helps with insurance approval and coordinates specialty pharmacy home delivery.
The official page does not say who qualifies. Ask the program. · source - Other support
For people with Medicare or Medicaid, the liaison can help identify independent charities that may help with costs.
For: Medicare, Medicaid · source
Good to know: Run by Priovant Therapeutics. Enroll online, text LISRAYA to 37538, call 1-888-736-9788 or email mcs@priovant.com. No manufacturer free-drug program for uninsured patients is described on the official site.
- From a charity · The Assistance FundMyositis fundOpen
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “OPEN — Accepting New Patients. TAF is currently accepting new patient enrollments for this program.”
Clinical trial results
The FDA approved Lisraya on August 27, 2026, based on the Phase 3 VALOR trial, the largest dermatomyositis study ever run. Improvement on the Total Improvement Score showed up as early as week 4 and held through 52 weeks. By the end of the study, 55% of patients on Lisraya had both meaningful improvement and minimal or no steroid use, compared with 30% on placebo. Among patients taking at least 7.5 mg of steroids a day at the start, 62% tapered to minimal or no steroids versus 38% on placebo, and 45% came off steroids entirely versus 29%. Patients rated their own disease activity as improving more than 4 times as much as those on placebo. Results were published in the New England Journal of Medicine in March 2026, with skin-specific results in JAMA Dermatology in August 2026.
Development history
Brepocitinib was originally discovered by Pfizer. Priovant Therapeutics was formed by Roivant and Pfizer in September 2021, when Pfizer licensed brepocitinib to Priovant and kept a 25% stake in the company. The FDA granted it Orphan Drug Designation and Priority Review, then approved it as Lisraya on August 27, 2026, making it the first targeted therapy for dermatomyositis in decades. Priovant is also studying brepocitinib in Phase 3 for non-infectious uveitis and cutaneous sarcoidosis, and in Phase 2b/3 for lichen planopilaris.
Explore Dermatomyositis trials
Other Dermatomyositis treatments
Common questions about Brepocitinib
▸What is Brepocitinib (Lisraya)?
The first and only targeted therapy approved for dermatomyositis. A once-daily pill that blocks two enzymes (TYK2 and JAK1) driving the overactive immune signaling behind the disease. Approved by the FDA in August 2026 for adults.
▸How does Brepocitinib work?
Lisraya blocks two enzymes called TYK2 and JAK1 that carry inflammatory signals inside immune cells. These signals run too hot in dermatomyositis. Turning them down reduces the inflammation behind both the muscle weakness and the skin rash. Most other treatments for the disease either suppress the immune system broadly or replace missing antibodies; this one targets the specific biology of the disease.
▸What are the side effects of Brepocitinib?
Lisraya carries a boxed warning for serious infections, death, cancer, major heart problems (heart attack and stroke), and blood clots, which is standard for this class of medicine. Tell your doctor about any infection, chest pain, shortness of breath, or swelling and pain in a leg. Your doctor will test you for tuberculosis before you start and will check your blood counts, cholesterol, and liver during treatment. The most common side effects were upper respiratory infection, headache, fatigue, urinary tract infection, nausea, bronchitis, joint pain, diarrhea, back pain, falls, flu, and acne. Live vaccines should be avoided during treatment, and it may cause harm to an unborn baby. Your doctor will check whether you are pregnant before you start, and women who can become pregnant should use effective birth control during treatment and for 3 days after the last dose. The label also warns about serious allergic reactions, tears in the stomach or intestines (report new belly pain right away), low blood sugar in people with diabetes, and hepatitis B or C flaring up, so you will be screened for hepatitis before starting.
▸How is Brepocitinib taken?
Lisraya is taken as one 30 mg pill by mouth once a day. It can be used on its own or added to existing treatment. It is not recommended together with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs, or in people with severe liver or kidney problems. It is dispensed through a limited network of specialty pharmacies.
▸Is Brepocitinib FDA approved?
Yes, Brepocitinib (Lisraya) is FDA approved (2026) for the treatment of Dermatomyositis.
▸What type of drug is brepocitinib?
Brepocitinib (brand name Lisraya) is a dual TYK2/JAK1 inhibitor, meaning it blocks two related enzymes involved in inflammatory signaling. This dual action targets the specific immune pathways that drive dermatomyositis.
▸What is the current development status?
The FDA approved brepocitinib as Lisraya on August 27, 2026 for adults with dermatomyositis, and it became available in the U.S. immediately. It is the first and only targeted therapy approved for the condition.
▸How does brepocitinib differ from other dermatomyositis treatments?
Dermatomyositis has long been treated with corticosteroids, broad immunosuppressants, and IVIG, none of which target the underlying biology. Lisraya blocks the specific TYK2 and JAK1 signaling involved in the disease, in a once-daily pill, and in its trial let most patients cut back or stop steroids entirely.
▸What side effects have been reported?
Lisraya has a boxed warning for serious infections, death, cancer, major cardiovascular events, and blood clots, which applies to this whole class of medicine. The most common side effects in the VALOR trial were upper respiratory infection, headache, fatigue, urinary tract infection, nausea, bronchitis, joint pain, diarrhea, back pain, falls, flu, and acne. Your doctor will screen you for tuberculosis first and monitor blood counts, lipids, and liver tests during treatment.
▸Can Lisraya help me get off steroids?
That was one of the main things the trial measured. Among patients taking at least 7.5 mg a day of prednisone-equivalent steroids at the start, 62% tapered to minimal or no steroids by week 52 on Lisraya compared with 38% on placebo, and 45% stopped steroids completely compared with 29%. Any change to your steroid dose should be planned with your doctor.
▸What help is available paying for Lisraya?
LISRAYA My Compass Support assigns a dedicated Patient Access Liaison to help with insurance coverage, financial assistance programs, and ongoing support. Priovant says eligible patients may pay as little as $0 per month. Lisraya is dispensed through a limited network of specialty pharmacies.