Natalizumab clinical trials
Natalizumab is named as an intervention in 4 current clinical trials in our USA, Ireland, UK, Germany, Spain, Switzerland, Australia and China registers. 2 are recruiting patients now. All registered phases are Observational. The sponsor with the most trials is Biogen (3). The most-studied condition is Multiple Sclerosis. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Natalizumab is approved
All regulators →Of the three regulators tracked here, the first to approve Natalizumab was the US, on 23 Nov 2004. It is approved in 3 of the 3 regulators tracked here.
- 1 FDA-approved biosimilar: Tyruko
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.
What health systems spend on Natalizumab
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 Natalizumab works
All drug targets →- Integrin alpha-4/beta-7 inhibitor InhibitorTarget: Integrin alpha-4/beta-7✓ In ChEMBL and the Guide to Pharmacology
- Integrin alpha-4/beta-1 inhibitor InhibitorTarget: Integrin alpha-4/beta-1✓ In ChEMBL and the Guide to Pharmacology
- Acute graft versus host diseasePhase 2
- Focal epilepsyPhase 2
- Ischemic strokePhase 2
- Rheumatoid arthritisPhase 2
- OsteosarcomaPhase 1/2
- Plasma cell myelomaPhase 1/2
- Inclusion body myositisPhase 1
- Psychotic disorderPhase 1
- SchizophreniaPhase 1
- Sickle cell diseasePhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201607, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6591, 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 Natalizumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Natalizumab. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Natalizumab (originator and biosimilar) for treating highly active relapsing–remitting multiple sclerosis after disease-modifying therapy NICE TA1126 | Optimised Not recommended | 28 Jan 2026 | Current |
| Natalizumab for treating rapidly evolving severe relapsing–remitting multiple sclerosis NICE TA127 | Optimised | 22 Aug 2007 Updated 21 May 2024 | 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 Natalizumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- 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.
Reference identifiers for Natalizumab
- ATC code
- L04AA23
- ChEMBL
- CHEMBL1201607
- DrugBank
- DB00108
- CAS number
- 189261-10-7
- FDA UNII
- 3JB47N2Q2P
- Wikidata
- Q386119
- Wikipedia
- Natalizumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Natalizumab
4 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.
Natalizumab in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Natalizumab. 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 |
|---|---|---|---|---|
|
Phase 1/2 Open-Label Trial to Evaluate the Safety, Tolerability, Biological Activity, and Clinical Efficacy of intracisterna Magna administration of an AAV9 Vector Encoding Human ASAH1 (GNT0009) in Patients with Spinal Muscular Atrophy with Progressive Myoclonic Epilepsy (SMA-PME)
2026-527323-10-00 · CTIS ↗ · Nervous System Diseases
|
Phase 1 | Authorised | Genethon | France |
Natalizumab 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)
3 single-substance products containing Natalizumab on the HPRA medicines list.
- Tyruko 300 mg concentrate for solution for infusionPolpharma Biologics S.A. · EU/1/23/1745/001
- Tysabri 150 mg solution for injection in pre-filled syringeBiogen Netherlands B.V. · EU/1/06/346/002
- Tysabri 300 mg concentrate for solution for infusionBiogen Netherlands B.V. · EU/1/06/346/001
Supply shortages
No entry for Natalizumab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Natalizumab
4 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Biogen | 3 |
| Beijing Tiantan Hospital | 1 |
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 Natalizumab trials
How many clinical trials are testing Natalizumab?
4 current trials in our USA, Ireland, UK, Germany, Spain, Switzerland, Australia and China registers name Natalizumab (also registered as BG00002) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Natalizumab trials recruiting patients?
Yes. 2 of the 4 trials are recruiting: 1 with sites in USA, 1 with sites in Ireland, 1 with sites in UK, 1 with sites in Germany, 1 with sites in Spain, 1 with sites in Switzerland, 1 with sites in Australia and 1 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Natalizumab clinical trials?
Biogen (3) and Beijing Tiantan Hospital (1). The number in brackets is how many trials each organisation leads.
Are there Natalizumab clinical trials in Ireland?
Yes. 1 trial 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 Natalizumab licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Natalizumab, for example Tyruko 300 mg concentrate for solution for infusion (Polpharma Biologics S.A.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Natalizumab shortage?
Not in the lists we track: Natalizumab 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 Natalizumab 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 Natalizumab 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 Natalizumab (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.