New Pill for Chronic Hives Not Controlled by Antihistamines

Who this is for

Next clinical step

Health Canada and the US Food and Drug Administration (FDA) have approved this medicine. In Canada, the United States, the United Kingdom, Japan, Australia, Switzerland and the European Union, ask your doctor or a specialist whether it suits you. They can write a prescription. Insurance or public drug plan coverage is not guaranteed. In Japan and Switzerland, it is authorised but may not be on sale yet.

Ways to access this treatment

• Canada · Prescription

  Canada prescription (Health Canada NOC, DIN 02570076)

  https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=107225

• United States · Prescription

  US prescription (FDA-labelled)

  https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e5e89bff-6ced-4165-acc5-fb13136b3a3d

• United Kingdom · Prescription

  UK prescription (MHRA-authorised)

  https://www.gov.uk/government/news/mhra-approves-remibrutinib-for-adults-with-chronic-spontaneous-urticaria

• European Union · Prescription

  EU prescription (EC marketing authorisation)

  https://www.ema.europa.eu/en/medicines/human/EPAR/rhapsido

• Australia · Prescription

  Australia prescription (ARTG-registered)

  https://www.tga.gov.au/resources/artg/485465

• United States, European Union · Recruiting clinical trial

  Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

  Tests this treatment. Remibrutinib vs placebo in chronic urticaria: CSU cohort plus a chronic inducible urticaria (CINDU) cohort whose arm description includes symptomatic dermographism (phase 2).

  https://clinicaltrials.gov/study/NCT06865651

• Japan · Recruiting clinical trial

  Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks

  Tests this treatment. Remibrutinib 25 mg twice daily in adult CSU inadequately controlled by H1 antihistamines; omalizumab added at Week 12 only if control is inadequate (phase 3). CSU only, not dermographism.

  https://clinicaltrials.gov/study/NCT07816328

Search all trials on ClinicalTrials.gov: https://clinicaltrials.gov/search?cond=chronic%20spontaneous%20urticaria&intr=remibrutinib&aggFilters=status:rec

Possible routes (not confirmed)

• Company expanded-access programme · Applicability unknown

  Novartis Global Managed Access Program NCT05170724 (CSU refractory to H1 antihistamines and omalizumab)

  Managed-access record lists no sites (last verified 2025-12); such programmes usually serve countries without commercial supply, and every chip country has an authorisation.

  https://clinicaltrials.gov/study/NCT05170724

• Switzerland · Prescription · Applicability unknown

  Switzerland prescription (Swissmedic authorisation no. 70227)

  Authorised by Swissmedic (19 Jun 2026), but Swiss marketing and Specialities List (SL) reimbursement are not confirmed.

  https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/new-medicines/rhapsido-filmtabletten-remibrutinibum.html

• Japan · Prescription · Applicability unknown

  Japan prescription (ラプシド錠25 mg, MHLW approval)

  Approved in Japan (19 Jun 2026), but National Health Insurance (NHI) price listing and launch are not confirmed.

  https://www.pmda.go.jp/files/000281577.pdf

General resources for further research

• Canadian Clinical Trial Search Portal (Health Canada)

  Health Canada's public search of the drug and biologic clinical trials it has authorised in Canada (phase 1 to 3, since April 2013). Search by condition, drug, or trial status and see where trials are running. It replaced the Health Canada Clinical Trials Database in July 2026. A listing is not enrolment, and Health Canada does not recruit patients: ask your clinician and contact the trial sponsor.

  https://clinical-trials-search.canada.ca/en/home

• ClinicalTrials.gov

  US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.

  https://clinicaltrials.gov/

• Human Research Switzerland (HumRes) trial search

  Public Swiss clinical-trial search on Human Research Switzerland (HumRes). Search studies taking place in Switzerland. A listing is not Swissmedic authorisation and is not enrolment.

  https://www.humanforschung-schweiz.ch/en/trial-search/

• CTIS (EU Clinical Trials Information System)

  European Union public portal for clinical trials submitted under the Clinical Trials Regulation. Search by medicine, condition, and member state. A CTIS record is not an EMA marketing authorisation and is not enrolment.

  https://euclinicaltrials.eu/

• jRCT (Japan Registry of Clinical Trials)

  Japan Registry of Clinical Trials, the public registry used under Japanese clinical-trial rules. Search studies by condition and location. A jRCT listing is not PMDA approval and is not enrolment.

  https://jrct.mhlw.go.jp/en-top