Remicade
An anti-TNF infusion biologic for inflammatory bowel disease and arthritis.
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), 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Infliximab. 9 are current, and 9 of these recommend it for at least some patients. 4 older appraisals were replaced or withdrawn.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.
What Remicade is used for
REMICADE is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.1 ) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease. ( 1.1 ) Pediatric Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active disease who have had an inadequate response to conventional therapy. ( 1.2 ) Ulcerative Colitis : reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to se…
How it works
12.1 Mechanism of Action Infliximab neutralizes the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibits binding of TNFα with its receptors. Infliximab does not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα. Biological activities attributed to TNFα include: induction of pro-inflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and …
Related clinical trials recruiting now
Compare Remicade with
Explore more
How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 9 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.