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infliximab

Generic: infliximab·Brand: Avsola, Inflectra, Remicade, Renflexis, Zymfentra

infliximab: developed by 1 company · 7 clinical trials tracked · 1 FDA decision.

infliximab evidence translation

What we can confirm

1 FDA record · 7 tracked trials

What it means

Source-backed records connect infliximab to AMGN; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could infliximab → AMGN affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 3 study sponsors
Development Pipeline (1)
CompanyPhase
AMGEN INC (AMGN)Approved
Clinical Trials (7)

Phase 2 Study of Cytokine Release Syndrome Prophylaxis With Infliximab for Teclistamab/Talquetamab Therapy in Patients With Relapsed/Refractory Myeloma

NCT07657312·Phase 2
Recruiting

Primary endpoint: Incidence of all-grade cytokine release syndrome (CRS)

Interventionalopen35 targetStarted 2026-08Completion 2027-121 site · United StatesNaresh Bumma

A Randomized, Controlled Trial Investigating the Efficacy of Akkermansia Muciniphila Combined With Infliximab in Promoting Intestinal Mucosal Healing in Patients With Crohn's Disease

NCT07415473·Phase 4·ENTA
Not yet recruiting

Primary endpoint: Complete mucosal healing

InterventionalRandomizedopen400 targetStarted 2026-04Completion 2029-03Chinese Medical Association

A Randomized, Controlled Trial Investigating the Efficacy of Palmitoleic Acid Combined With Infliximab in Promoting Intestinal Mucosal Healing in Patients With Crohn's Disease

NCT07417696·Phase 4·ENTA
Not yet recruiting

Primary endpoint: Complete mucosal healing

InterventionalRandomizedopen400 targetStarted 2026-04Completion 2029-03Chinese Medical Association

Optimizing Immunosuppression for Steroid-Refractory Anti-PD-1/PD-L1 Pneumonitis

NCT04438382·Phase 2
Terminated

Primary endpoint: Pneumonitis Response Rate

InterventionalRandomizedopen1 enrolledStarted 2021-01Completion 2023-1218 sites · United StatesECOG-ACRIN Cancer Research Group

A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients (CATCO: Canadian Treatments for COVID-19), in Conjunction With the Public Health Emergency SOLIDARITY Trial (World Health Organization)

NCT04330690·Phase 3

Primary endpoint: Randomization WHO- Mortality

InterventionalRandomizedopen2,900 targetStarted 2020-03Completion 2024-0550 sites · CanadaSunnybrook Health Sciences Centre

A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

NCT03596645·Phase 3·GHRS
Active, not recruiting

Primary endpoint: Percentage of Participants With Clinical Remission at Week 6 as Assessed by the Mayo Score

InterventionalRandomizedopen84 targetStarted 2018-10Completion 2027-0250 sites · Belgium, Brazil, France, Israel…Janssen Research & Development, LLC

A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation (REACH3)

NCT03112603·Phase 3·INCY
Completed

Primary endpoint: Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit

InterventionalRandomizedopen330 enrolledStarted 2017-06Completion 2022-1250 sites · Australia, Austria, Belgium, United StatesIncyte Corporation
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE AVSOLA 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 : red(AMGN)FDA ↗
BLA761086StandardOtherInjectable

Frequently asked questions

Who is developing infliximab?

infliximab is being developed by AMGEN INC.

How many clinical trials involve infliximab?

BioSniper tracks 7 clinical trials involving infliximab.

What is infliximab's latest FDA decision?

The most recent tracked FDA decision for infliximab is Approval for 1 INDICATIONS AND USAGE AVSOLA 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 : red, dated December 6, 2019.