What Was Approved?
On September 30, 2025, the U.S. Food and Drug Administration approved Rhapsido (remibrutinib) for adults with chronic spontaneous urticaria, or CSU, who remain symptomatic despite treatment with an H1 antihistamine.
Rhapsido is not indicated for other forms of urticaria.
What Is Chronic Spontaneous Urticaria?
CSU is a condition in which hives, itching, or swelling can occur repeatedly without a specific external trigger being identified.
Symptoms may continue for weeks or longer and can significantly affect daily life.
How Does Rhapsido Work?
Rhapsido is a kinase inhibitor.
It inhibits Bruton’s tyrosine kinase, or BTK, which is involved in immune-cell signaling pathways associated with allergic and inflammatory responses.
How Is Rhapsido Taken?
The recommended dose is:
25 mg by mouth twice daily, with or without food.
The tablets should be swallowed whole and should not be split, crushed, or chewed.
What Did the Clinical Trials Show?
FDA approval was supported by two randomized, placebo-controlled trials involving 912 adults with CSU whose symptoms remained inadequately controlled with antihistamine treatment.
Patients receiving Rhapsido had greater improvement in measures of itching and hives compared with placebo at Week 12.
These trial results do not guarantee the same response for every patient.
What Are the Main Safety Concerns?
The FDA-approved label warns about an increased risk of bleeding.
Patients should be monitored for signs of bleeding, and treatment may need to be temporarily interrupted around surgery. Use with antithrombotic medicines may further increase bleeding risk.
The label also recommends avoiding live or live-attenuated vaccines during treatment.
What Are Common Side Effects?
The most common adverse reactions were:
- Nasopharyngitis
- Bleeding
- Headache
- Nausea
- Abdominal pain
Are Drug Interactions Important?
Yes.
The FDA label recommends avoiding Rhapsido with strong or moderate CYP3A4 inhibitors or inducers because they may significantly affect drug exposure.
Patients should review all prescription medicines, over-the-counter products, and supplements with their healthcare professional.
Bottom Line
Rhapsido (remibrutinib) is an FDA-approved oral treatment for adults with chronic spontaneous urticaria who continue to have symptoms despite H1 antihistamine therapy.
It is taken twice daily and provides another treatment option for CSU, but bleeding risk, drug interactions, and vaccination considerations should be reviewed before and during treatment.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2025.
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Rhapsido.
- U.S. Food and Drug Administration (FDA) — Rhapsido (remibrutinib) Prescribing Information, September 2025.