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Drug

Infliximab

Regulatory activity · EMA
Emerging researchLate-stage developmentRising momentum
Also known as Avsola, Inflectra, Remicade, Renflexis+2 more

Avsola, Inflectra, Remicade, Renflexis, Zymfentra, IMMUNOGLOBULIN G (HUMAN-MOUSE MONOCLONAL CA2 HEAVY CHAIN ANTI-HUMAN TUMOR NECROSIS FACTOR), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL CA2 LIGHT CHAIN, DIMER.

RxNorm191831UNIIB72HH48FLU
3
Research papers
33
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms

Clinical trial2026-06-11Results expected Q2 2028 · ClinicalTrials.gov

Market withdrawal: Inflectra (EMA)

Regulatory2026-05-21EMA

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

Research2017-08-01BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Infliximab
Aliases & brands
AvsolaInflectraRemicadeRenflexisZymfentraIMMUNOGLOBULIN G (HUMAN-MOUSE MONOCLONAL CA2 HEAVY CHAIN ANTI-HUMAN TUMOR NECROSIS FACTOR), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL CA2 LIGHT CHAIN, DIMER
RxNorm CUI
191831
UNII
B72HH48FLU
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2026-05-21Market withdrawalMarket
Market withdrawal: Inflectra (EMA)
Indication: Rheumatoid arthritis Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adultShow full indication

Rheumatoid arthritis Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease?modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate; adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs. In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X?ray, has been demonstrated. Adult Crohn’s disease Inflectra is indicated for: treatment of moderately to severely active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and / or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies; treatment of fistulising, active Crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Paediatric Crohn’s disease Inflectra is indicated for treatment of severe, active Crohn’s disease in children and adolescents aged six to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy. Ulcerative colitis Inflectra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6?mercaptopurine (6?MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. Paediatric ulcerative colitis Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged six to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6?MP or AZA, or who are intolerant to or have medical contraindications for such therapies. Ankylosing spondylitis Inflectra is indicated for treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Inflectra should be administered: in combination with methotrexate; or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X?ray in patients with polyarticular symmetrical subtypes of the disease. Psoriasis Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

187 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
187
registered trials across all phases
LATEST COMPLETION 2025
33
Active studies
28
Recruiting
132
Late-stage (III+)
99
Completed
55
Discontinued
PHASE DISTRIBUTIONn = 187
Phase 112Phase 1 / 25Phase 238Phase 2 / 34Phase 357Phase 452Phase N / A19

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20012024
Most influential

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017 · 231 cites
Recent papers

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017 · 231 cites
Major research themes1
Tumor Necrosis Factor-alpha1
Journals, researchers & institutions
Top journals
  • BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy1
  • Medicina (Kaunas, Lithuania)1
  • The New England journal of medicine1
Leading researchers
  • Al-Saleh J1
  • Balsa A1
  • Banciu C1
  • Barile-Fabris L1
  • Blidisel A1
  • Braun MM1
  • Gershon S1
  • Gogulescu A1
Leading institutions
free-text, unnormalised
  • Collegeville1
  • Dubai Hospital1
  • Hospital de Especialidades Centro Médico Nacional Siglo XXI1
  • Instituto de Investigación Sanitaria del Hospital Universitario La Paz (IdiPAZ)1
  • Keio University School of Medicine1
  • Kyushu University Beppu Hospital1

Related diseases

3 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 6 of the same disease areas as Infliximab in the shared literature.

6 shared diseases1 shared paper

Studied across 6 of the same disease areas as Infliximab in the shared literature.

6 shared diseases1 shared paper

Studied across 4 of the same disease areas as Infliximab in the shared literature.

4 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.