Rozanolixizumab clinical trials
Rozanolixizumab is named as an intervention in 5 current clinical trials in our Poland, Japan, USA, France, Spain, China, Germany, Italy, Turkey, UK, Belgium, Sweden, Switzerland, Czechia, Portugal, Brazil, Mexico, South Korea, Australia and Canada registers. 2 are recruiting patients now. The most common phase is Phase 3. The lead sponsor is UCB Biopharma SRL. The most-studied condition is Ocular Myasthenia Gravis. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Rozanolixizumab is approved
All regulators →Of the three regulators tracked here, the first to approve Rozanolixizumab was the US, on 26 Jun 2023. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (28 Jul 2026, positive)
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.
Rozanolixizumab patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Rozanolixizumab, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Rystiggo for treatment of myasthenia gravis: until 8 Jan 2034. Union Register
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 Rozanolixizumab
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 Rozanolixizumab works
All drug targets →- IgG receptor FcRn large subunit p51 inhibitor InhibitorTarget: FCGRT Fc gamma receptor and transporter✓ In ChEMBL and the Guide to Pharmacology
- Autoimmune thrombocytopenic purpuraPhase 3
- Autoimmune encephalitisPhase 2
- Chronic inflammatory demyelinating polyradiculoneuropathyPhase 2
- FibromyalgiaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297820, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9801, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Rozanolixizumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Rozanolixizumab. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Rozanolixizumab for treating antibody-positive generalised myasthenia gravis NICE TA1155 | Optimised | 20 May 2026 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Rozanolixizumab
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: RystiggoEMA 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 Rozanolixizumab
5 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.
Rozanolixizumab in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Rozanolixizumab. 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 Phase 3, open-label extension study to evaluate the long-term safety and efficacy of rozanolixizumab in adult participants with ocular myasthenia gravis
2025-524757-14-00 · Immune System Diseases
|
Phase 3 | Authorised | UCB Biopharma | Hungary, France, Greece + 4 more |
|
A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rozanolixizumab in adult participants with ocular myasthenia gravis
2025-524756-54-00 · Immune System Diseases
|
Phase 3 | Ongoing | UCB Biopharma | Hungary, Greece, Italy + 4 more |
Rozanolixizumab 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 Rozanolixizumab on the HPRA medicines list.
- Rystiggo 140 mg/ml solution for injectionUCB Pharma S.A. · EU/1/23/1780/001
Supply shortages
No entry for Rozanolixizumab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Rozanolixizumab
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| UCB Biopharma SRL | 5 |
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.
Questions about Rozanolixizumab trials
How many clinical trials are testing Rozanolixizumab?
5 current trials in our Poland, Japan, USA, France, Spain, China, Germany, Italy, Turkey, UK, Belgium, Sweden, Switzerland, Czechia, Portugal, Brazil, Mexico, South Korea, Australia and Canada registers name Rozanolixizumab (also registered as UCB7665) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Rozanolixizumab trials recruiting patients?
Yes. 2 of the 5 trials are recruiting: 2 with sites in Poland, 2 with sites in Japan, 2 with sites in USA, 2 with sites in France, 2 with sites in Spain, 2 with sites in China, 1 with sites in Germany and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Rozanolixizumab clinical trials?
The lead sponsor is UCB Biopharma SRL. The number in brackets is how many trials each organisation leads.
Is Rozanolixizumab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Rozanolixizumab, for example Rystiggo 140 mg/ml solution for injection (UCB Pharma S.A.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Rozanolixizumab shortage?
Not in the lists we track: Rozanolixizumab 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 Rozanolixizumab 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 Rozanolixizumab 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 Rozanolixizumab (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 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.