Filgotinib clinical trials
Filgotinib is named as an intervention in 10 current clinical trials in our UK, Germany, France, Spain, Italy, Belgium, Netherlands, Poland, Ireland, Norway, Czechia, South Korea, Portugal, Austria and Taiwan registers. 6 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Alfasigma S.p.A (6). The most-studied condition is Ulcerative Colitis. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
Where Filgotinib is approved
All regulators →Of the three regulators tracked here, the first to approve Filgotinib was the EU, on 24 Sep 2020.
- 1 EU safety letter (DHPC), latest: referral - article 20 procedure for Cibinqo / Jyseleca / Olumiant / Rinvoq / Xeljanz, 21 Feb 2023
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 Filgotinib
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 Filgotinib works
All drug targets →- Tyrosine-protein kinase JAK1 inhibitor InhibitorTarget: JAK1 Janus kinase 1✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase JAK2 inhibitor InhibitorTarget: JAK2 Janus kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase TYK2 inhibitor InhibitorTarget: TYK2 tyrosine kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase JAK3 inhibitor InhibitorTarget: JAK3 Janus kinase 3✓ In ChEMBL and the Guide to Pharmacology
- Crohn diseasePhase 3
- Ankylosing spondylitisPhase 3
- Juvenile idiopathic arthritisPhase 3
- Psoriatic arthritisPhase 3
- SpondyloarthropathyPhase 3
- Ulcerative colitisPhase 3
- Behcet diseasePhase 2
- Sjogren syndromePhase 2
- Cutaneous lupus erythematosusPhase 2
- Idiopathic inflammatory myopathyPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3301607, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7913, 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 Filgotinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Filgotinib. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Filgotinib for treating moderately to severely active ulcerative colitis NICE TA792 | Recommended | 1 Jun 2022 | Current |
| Filgotinib for treating moderate to severe rheumatoid arthritis NICE TA676 | Optimised | 24 Feb 2021 | 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 Filgotinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: JyselecaEMA 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.
Reference identifiers for Filgotinib
- ChEMBL
- CHEMBL3301607
- DrugBank
- DB14845
- PubChem CID
- 49831257
- CAS number
- 1206161-97-8
- FDA UNII
- 3XVL385Q0M
- Wikidata
- Q19904163
- Wikipedia
- Filgotinib
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 Filgotinib
10 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.
Filgotinib in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Filgotinib. 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 |
|---|---|---|---|---|
|
Optimising Arthritis Strategies in Elderly patients (≥70 years) with rheumatoid arthritis in sustained low disease activity (the OASE study): A Prospective Target Trial Emulation Study Evaluating Tapering of Disease-Modifying Anti-Rheumatic Drugs vs. Usual Care Based on Patient Preference
2026-525221-21-01 · Musculoskeletal Diseases
|
Phase 4 | Authorised | Aalborg University Hospital, Aalborg University Hospital | Denmark |
|
STOP - Safety and efficacy of a STOPping strategy versus classical maintenance dose of JAK inhibitors in deep remission patients with ulcerative colitis: a randomized controlled trial
2026-525643-32-00 · Digestive System Diseases
|
Phase 4 | Authorised | Centre Hospitalier Regional De Marseille | France |
|
FirST lines of biologics in pAtients with ulceRaTivE colitis: a Randomised controlled trial
2024-514964-24-00 · CTIS ↗ · Digestive System Diseases
|
Phase 3 | Authorised | University Hospital Of Clermont-Ferrand | France |
Filgotinib 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)
2 single-substance products containing Filgotinib on the HPRA medicines list.
- Jyseleca 100 mg film-coated tabletsAlfasigma S.p.A · EU/1/20/1480/001-002
- Jyseleca 200 mg film-coated tabletsAlfasigma S.p.A · EU/1/20/1480/003-004
Supply shortages
No entry for Filgotinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Filgotinib
9 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Alfasigma S.p.A | 6 |
| University Hospital, Toulouse | 1 |
| UMC Utrecht | 1 |
| R.Bos | 1 |
| Eisai Korea Inc | 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 Filgotinib trials
How many clinical trials are testing Filgotinib?
10 current trials in our UK, Germany, France, Spain, Italy, Belgium, Netherlands, Poland, Ireland, Norway, Czechia, South Korea, Portugal, Austria and Taiwan registers name Filgotinib (also registered as GS-6034) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Filgotinib trials recruiting patients?
Yes. 6 of the 10 trials are recruiting: 3 with sites in UK, 3 with sites in Germany, 4 with sites in France, 2 with sites in Spain, 2 with sites in Italy, 2 with sites in Belgium, 2 with sites in Netherlands, 2 with sites in Poland, 1 with sites in Ireland, 1 with sites in Norway, 1 with sites in Czechia and 1 with sites in Portugal. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Filgotinib clinical trials?
Alfasigma S.p.A (6), University Hospital, Toulouse (1), UMC Utrecht (1) and R.Bos (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Filgotinib 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 Filgotinib licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Filgotinib, for example Jyseleca 100 mg film-coated tablets (Alfasigma S.p.A). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Filgotinib shortage?
Not in the lists we track: Filgotinib 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 Filgotinib 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 Filgotinib 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 Filgotinib (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.