Remibrutinib clinical trials
Remibrutinib is named as an intervention in 21 current clinical trials in our USA, Canada, Spain, Germany, Poland, China, France, Italy, UK, Brazil, South Korea, India, Czechia, Mexico, Australia, Turkey, Japan, Netherlands, Switzerland, Denmark, Portugal, Taiwan, Belgium, Israel, Austria, Singapore, Ireland and Sweden registers. 11 are recruiting patients now. The most common phase is Phase 3. The lead sponsor is Novartis Pharmaceuticals. The most-studied condition is Chronic Spontaneous Urticaria. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Remibrutinib is approved
All regulators →Of the three regulators tracked here, the first to approve Remibrutinib was the US, on 30 Sep 2025. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Remibrutinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Remibrutinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 3 listed patents; the last listed expires 19 Jan 2043 (US 12419889).
- Latest patent on the drug substance itself: 13 Nov 2034 (US 9512084).
- Exclusivity NCE: New chemical entity, until 30 Sep 2030.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Remibrutinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Remibrutinib works
All drug targets →- Chronic idiopathic urticariaPhase 3
- Hidradenitis suppurativaPhase 3
- Multiple sclerosis symptom measurementPhase 3
- Myasthenia gravisPhase 3
- Sjogren syndromePhase 2
- AsthmaPhase 2
- Cholinergic urticariaPhase 2
- Cold urticariaPhase 2
- Peanut allergic reactionPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4483575, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10457, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Remibrutinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: RhapsidoEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Remibrutinib
21 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Remibrutinib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Remibrutinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A 52-week multi-center, randomized, double-blind, placebo- controlled phase 3 study to evaluate the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO)
2025-524497-41-00 · CTIS ↗ · Immune System Diseases
|
Phase 3 | Authorised | Novartis Pharma AG | Germany, Austria, Poland + 3 more |
Remibrutinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Remibrutinib on the HPRA medicines list.
- Rhapsido 25 mg film-coated tabletsNovartis Europharm Limited · EU/1/26/2024/001-003
Supply shortages
No entry for Remibrutinib in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- RhapsidoEMA · 23 Apr 2026 · Novartis Europharm Limited
Conditions studied with Remibrutinib
15 conditionsAll 15 conditions
| Condition (as registered) | Trials |
|---|---|
| Chronic Spontaneous Urticaria | 4 |
| Hidradenitis Suppurativa | 4 |
| Relapsing Multiple Sclerosis | 3 |
| Chronic Pruritus of Unknown Origin | 2 |
| Secondary Progressive Multiple Sclerosis (SPMS) | 1 |
| Generalized Myasthenia Gravis | 1 |
| Chronic Inducible Urticaria | 1 |
| Chronic Spontaneous Urticaria (CSU) | 1 |
| IgE-Mediated Food Allergy | 1 |
| Peanut Allergy | 1 |
| Cow Milk Allergy | 1 |
| Egg Allergy | 1 |
| Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU) | 1 |
| Papulopustular Rosacea | 1 |
| Indication of the Parent Protocol | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 21 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Remibrutinib trials
How many clinical trials are testing Remibrutinib?
21 current trials in our USA, Canada, Spain, Germany, Poland, China, France, Italy, UK, Brazil, South Korea, India, Czechia, Mexico, Australia, Turkey, Japan, Netherlands, Switzerland, Denmark, Portugal, Taiwan, Belgium, Israel, Austria, Singapore, Ireland and Sweden registers name Remibrutinib (also registered as LOU064) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Remibrutinib trials recruiting patients?
Yes. 11 of the 21 trials are recruiting: 9 with sites in USA, 8 with sites in Canada, 6 with sites in Spain, 5 with sites in Germany, 3 with sites in Poland, 4 with sites in China, 5 with sites in France, 3 with sites in Italy, 2 with sites in UK, 2 with sites in Brazil, 4 with sites in South Korea, 1 with sites in India, 3 with sites in Czechia, 2 with sites in Mexico, 3 with sites in Australia, 2 with sites in Japan, 1 with sites in Netherlands, 2 with sites in Switzerland, 2 with sites in Denmark, 2 with sites in Portugal, 2 with sites in Belgium, 1 with sites in Israel, 1 with sites in Austria, 1 with sites in Singapore, 1 with sites in Ireland and 1 with sites in Sweden. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Remibrutinib clinical trials?
The lead sponsor is Novartis Pharmaceuticals. The number in brackets is how many trials each organisation leads.
Are there Remibrutinib clinical trials in Ireland?
Yes. 2 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Remibrutinib licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Remibrutinib, for example Rhapsido 25 mg film-coated tablets (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Remibrutinib shortage?
Not in the lists we track: Remibrutinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Remibrutinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Remibrutinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Remibrutinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.