Infliximab clinical trials
Infliximab is named as an intervention in 28 current clinical trials in our China, Belgium, Canada, Netherlands, South Korea, Israel, France, Spain, Italy, Poland, USA, Brazil, Taiwan, India, Denmark, Switzerland, Turkey, Mexico and Egypt registers. 16 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Shanghai 10th People's Hospital (2). The most-studied condition is Crohn Disease. The EU clinical trials register (CTIS) separately lists 8 authorised or ongoing trials.
Where Infliximab is approved
All regulators →Of the three regulators tracked here, the first to approve Infliximab was the US, on 24 Aug 1998. It is approved in 3 of the 3 regulators tracked here.
- 4 FDA-approved biosimilars: Avsola, Inflectra, Ixifi, Renflexis
- 1 EU orphan designation, most recently for treatment of Kawasaki disease (20 May 2026, positive)
- 2 EU safety letters (DHPC), latest: new contraindication for Remsima, 8 Dec 2025
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 Infliximab
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 Infliximab works
All drug targets →- TNF-alpha inhibitor InhibitorTarget: TNF tumor necrosis factorChEMBL only
- Behcet diseasePhase 3
- COVID-19Phase 3
- FeverPhase 3
- Hemolytic anemiaPhase 3
- Kawasaki diseasePhase 3
- Low back painPhase 3
- SciaticaPhase 3
- AsthmaPhase 3
- Chronic bronchitisPhase 3
- Chronic graft versus host diseasePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201581, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5004, 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 Infliximab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 13 technology appraisals of Infliximab. 9 are current, and 9 of these recommend it for at least some patients. 4 older appraisals were replaced or withdrawn.
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 Infliximab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 7 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 Infliximab
- ATC code
- L04AB02
- ChEMBL
- CHEMBL1201581
- DrugBank
- DB00065
- CAS number
- 170277-31-3
- FDA UNII
- B72HH48FLU
- Wikidata
- Q415264
- Wikipedia
- Infliximab
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 Infliximab
28 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.
Infliximab in the EU trials register (CTIS)
8 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Infliximab. 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.
Infliximab 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)
7 single-substance products containing Infliximab on the HPRA medicines list.
- Flixabi 100 mg powder for concentrate for solution for infusionSamsung Bioepis NL B.V. · EU/1/16/1106/001
- Remicade 100 mg Powder for concentrate for solution for infusionJanssen-Cilag International NV · EU/1/99/116/001-5
- Remsima 100 mg powder for concentrate for solution for infusionCelltrion Healthcare Hungary Kft. · EU/1/13/853/001
- Remsima 120 mg solution for injection in pre-filled penCelltrion Healthcare Hungary Kft. · EU/1/13/853/012-014
- Remsima 120 mg solution for injection in pre-filled syringeCelltrion Healthcare Hungary Kft. · EU/1/13/853/006-011
Supply shortages
No entry for Infliximab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Infliximab
32 conditionsAll 32 conditions
| Condition (as registered) | Trials |
|---|---|
| Crohn Disease | 9 |
| Ulcerative Colitis | 5 |
| Inflammatory Bowel Diseases | 4 |
| Colitis, Ulcerative | 2 |
| Acute Severe Ulcerative Colitis | 2 |
| Infliximab | 2 |
| Inflamatory Bowel Disease | 1 |
| Crohn Disease (CD) | 1 |
| Immunosuppression | 1 |
| Children, Only | 1 |
| Cardiac Arrest (CA) | 1 |
| Post Cardiac Arrest Syndrome | 1 |
| Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis) | 1 |
| Fecal Microbiota Transplantation | 1 |
| Children | 1 |
| Crohn's Diseases | 1 |
| Crohn's Disease in Pediatric Patient | 1 |
| Inflammatory Disease | 1 |
| Disease Crohn | 1 |
| Bowel Disease | 1 |
| Colitis | 1 |
| Psoriasis | 1 |
| Takayasu Arteritis | 1 |
| Glaucoma Following Surgery | 1 |
| Sjogren Syndrome | 1 |
| Sjogren Syndrome With Keratoconjunctivitis | 1 |
| Dry Eye Disease (DED) | 1 |
| Crohn's Disease | 1 |
| Rheumatoid Arthritis | 1 |
| Ankylosing Spondylitis | 1 |
| Psoriatic Arthritis | 1 |
| Ulcerative Colitis (UC) | 1 |
Sponsors
lead sponsor per trial+ 11 more sponsors in the trial list above.
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 Infliximab trials
How many clinical trials are testing Infliximab?
28 current trials in our China, Belgium, Canada, Netherlands, South Korea, Israel, France, Spain, Italy, Poland, USA, Brazil, Taiwan, India, Denmark, Switzerland, Turkey, Mexico and Egypt registers name Infliximab (also registered as CMAB008) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Infliximab trials recruiting patients?
Yes. 16 of the 28 trials are recruiting: 5 with sites in China, 2 with sites in Belgium, 1 with sites in Canada, 1 with sites in Netherlands, 2 with sites in South Korea, 1 with sites in Israel, 1 with sites in Italy, 1 with sites in Poland, 1 with sites in Denmark, 1 with sites in Switzerland and 1 with sites in Turkey. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Infliximab clinical trials?
Shanghai 10th People's Hospital (2), Children's Hospital of Fudan University (2), Janssen Research & Development, LLC (1) and Asian Institute of Gastroenterology, India (1), among 26 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Infliximab licensed in Ireland?
Yes. The HPRA medicines list includes 7 single-substance products containing Infliximab, for example Flixabi 100 mg powder for concentrate for solution for infusion (Samsung Bioepis NL B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Infliximab shortage?
Not in the lists we track: Infliximab 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 Infliximab 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 Infliximab 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 Infliximab (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.