New Oral Treatment for Chronic Spontaneous Urticaria: BTK Inhibitor

Antihistamines are the first-line treatment for chronic hives (also called chronic urticaria). But some people with the condition may still have symptoms despite taking antihistamines. What can they do?

Advanced chronic urticaria medicines are now available, including a new class of medication called a Bruton’s tyrosine kinase (BTK) inhibitor. It blocks or slows the release of histamine, stopping the hives before they can start. The medication is only for people with a chronic spontaneous urticaria diagnosis.

Rhapsido® (remibrutinib) earned U.S. Food and Drug Administration (FDA) approval on Sept. 30, 2025. It is the first BTK inhibitor approved to treat chronic spontaneous urticaria (CSU) in the United States. The drug manufacturer is Novartis.

CSU causes itchy, inflamed, red welts on the skin that keep coming back for six weeks or longer. They often occur without an obvious trigger. When there’s no clear trigger, it’s CSU. (Chronic inducible urticaria is defined by specific triggers.) This is a serious disease that can severely impact quality of life.

Rhapsido is approved for adults 18 years of age and older who have CSU symptoms despite taking H1 antihistamines. It may be recommended by your doctor when your current CSU medication is not controlling symptoms.

Rhapsido is a 25 mg tablet taken as an oral therapy twice daily. It has previously been prescribed for rheumatoid arthritis and to treat immune-related conditions.

Talk with your doctor about your CSU treatment plan. Discuss whether it’s working or if you need to consider more advanced medications.

How does Rhapsido work as a BTK inhibitor chronic urticaria medicine?

Rhapsido is a type of medicine called a BTK inhibitor. It works by blocking a protein in the body called Bruton’s tyrosine kinase (BTK). BTK helps certain immune cells – like mast cells and B cells – send signals that cause the release of histamine and other chemicals. These chemicals cause the itching, swelling and redness that happen with hives.

When BTK becomes too active, it can make the immune system overreact and cause too much inflammation. Rhapsido helps by blocking BTK. This calms down overactive immune cells. It reduces the release of histamine and other substances that cause hives.

BTK is part of the body’s normal defense system. It becomes active when immune cells respond to things like allergens, viruses, or bacteria. In CSU, this pathway can stay active even when there’s no real threat, leading to ongoing hives and itching.

Medicines that block BTK, like Rhapsido, are called targeted therapies because they focus on a specific part of the immune system. In addition to CSU, doctors use these medicines to help treat some blood cancers, such as leukemia and lymphoma.

Listen to our podcast on BTK inhibitor medication for CSU below:

How can Rhapsido help people with CSU?

In clinical trials for treating CSU patients, people who used Rhapsido reported fewer hives, less itching, and better overall control of their symptoms.

The medication may help patients with CSU by…

• reducing or preventing inflammation and flare-ups
• making the skin feel more comfortable
• improving sleep and daily quality of life

By targeting a specific pathway that drives inflammation in immune cells, Rhapsido may provide longer-lasting relief for people whose chronic hives don’t improve with antihistamines – without suppressing the immune system.

What are the side effects of Rhapsido?

Rhapsido may cause serious side effects, including the risk of bleeding. Studies show about 9% of people who take the medication experience bleeding. The risk may be higher if you’re taking a blood thinner medicine. Signs and symptoms of bleeding may include bruising, red or purple skin marks, nosebleeds or bleeding gums.

Other common side effects may include a runny nose, nasal congestion, sore throat, headache, nausea and abdominal pain.

How do I obtain Rhapsido?

Rhapsido is available only as a prescription medication. It can be prescribed by your doctor. To find out if Rhapsido is right for you, it may be best to see a specialist such as an allergist or dermatologist. Be sure to come to the appointment with information about how your current medication is working.

How much does Rhapsido cost?

In general, Rhapsido is an expensive medication. However, most patients will not pay the list price. The actual cost will vary based on your insurance coverage.

Novartis, the manufacturer of the drug, offers support through its Novartis Patient Support program. Eligible patients with commercial insurance may pay as little as $0 through Novartis’s Co-Pay Plus.