Infliximab: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Infliximab appears in the FDA drug-label database. Marketed as REMICADE.
- Drug class
- Tumor Necrosis Factor Blocker (FDA established pharmacologic class)
- Mechanism of action
- Tumor Necrosis Factor Receptor Blocking Activity (as stated on the FDA label)
- Boxed warning
- The FDA label for Infliximab carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
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 severely active disease who have had an inadequate response to conventional therapy. ( 1.3 ) Pediatric Ulcerative Colitis : 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…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| cGMP Deviations: Product intended for quarantine was inadvertently distributed. — McKesson | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-01-17 |
Phase breakdown
Conditions being studied
Recruiting trials involving Infliximab
- Anti-Inflammatory Challenge in Schizophrenia
- Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
- Combined Immunosuppression for Pediatric Crohn's Disease
- Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
- Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
- PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease
- Pharmacokinetic Infliximab Data in Pediatric Crohn's Disease
- Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
- Precise Infliximab Exposure and Pharmacodynamic Control
- Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
- Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
- Swiss Dermatology Network of Targeted Therapies (SDNTT)
- Top Down Versus Step up in Pediatric Ulcerative Colitis
- Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
- Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）
Common questions
Is Infliximab FDA-approved?
Yes, marketed as REMICADE. Its FDA label carries a boxed warning.
How many recruiting trials involve Infliximab?
16 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.