REMICADE (infliximab)
REMICADE (infliximab) is a tumor necrosis factor (TNF) blocker used to treat various chronic inflammatory conditions in adult and pediatric patients. It is primarily indicated for patients with moderately to severely active Crohn’s disease or ulcerative colitis who have had an inadequate response to conventional therapy. The medication is also utilized to manage symptoms and inhibit structural damage in adults with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis.
How REMICADE Works
Infliximab neutralizes the biological activity of TNFα by binding with high affinity to both its soluble and transmembrane forms, which prevents the cytokine from binding to its receptors. This action inhibits the inflammatory cascade, including the induction of pro-inflammatory cytokines and the enhancement of leukocyte migration. By blocking these pathways, the drug reduces the production of tissue-degrading enzymes and can lead to the lysis of cells expressing transmembrane TNFα.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-08-24
- Patent Cliff
- 2018
- Revenue
- $269M (Q4-2016)
- Routes
- N/A
- Dosage Forms
- VIAL
REMICADE Approval History
What REMICADE Treats
8 indicationsREMICADE is approved for 8 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Crohn's Disease
- Pediatric Crohn's Disease
- Ulcerative Colitis
- Pediatric Ulcerative Colitis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Psoriatic Arthritis
- Plaque Psoriasis
REMICADE Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. ( 5.1 ) Discontinue REMICADE if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB ...
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. ( 5.1 ) Discontinue REMICADE if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting REMICADE. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( 5.1 ) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including REMICADE. ( 5.2 ) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including REMICADE. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of REMICADE cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. ( 5.2 ) SERIOUS INFECTIONS Patients treated with REMICADE are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. REMICADE should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before REMICADE use and during therapy. Treatment for latent infection should be ini
REMICADE Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
REMICADE Biosimilars
4 FDA-approvedThese 4 alternatives require prescriber approval to substitute for REMICADE.
What are biosimilars? Lower-cost alternatives to REMICADE with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
REMICADE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in REMICADE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications REMICADE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to REMICADE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
105 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05660746 REMODEL-CD | 2022-0071 R01DK132408-01 | Ph 2, Ph 3 | recruiting | Precise Infliximab Exposure and Pharmacodynamic Control |
| NCT05205603 | 2021ZSLYEC-456 | Ph 4 | completed | Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis |
| NCT07550673 | KY20252556-F-1-2 | Ph 4 | recruiting | Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE） |
| NCT03596645 PURSUIT 2 results posted | CR108499 CNTO148UCO3003, 2017-004496-31 | Ph 3 | active not recruiting | A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT04438382 results posted | EAQ172 NCI-2018-02825, EAQ172 | Ph 2 | terminated | Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis |
| NCT05043870 | Combined therapy in CD | Ph 4 | recruiting | Combined Immunosuppression for Pediatric Crohn's Disease |
| NCT03819296 | 2018-0383 NCI-2018-03437, 2018-0383 | Ph 1 | recruiting | Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer |
| NCT04835506 | 2021P000391 | Ph 4 | active not recruiting | Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial |
| NCT07417696 | POA-IFX-CD-2026 | Ph 4 | not yet recruiting | Palmitoleic Acid Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease |
| NCT07415473 | AKK-IFX-CD-2026 | Ph 4 | not yet recruiting | Akkermansia Muciniphila Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease |
| NCT06941376 PROSECT RP | VCRC5565 | Ph 2 | recruiting | An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis |
| NCT04305145 | 19-763 | Ph 2 | active not recruiting | Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT05034536 | 21-077 | Ph 2 | active not recruiting | PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma |
| NCT06646016 EPIC | MNK60052002 | Ph 2 | withdrawn | EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis |
| NCT07297069 | CINTO 1 | Ph 2 | not yet recruiting | Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial |
| NCT04407247 | 2019-0276 NCI-2019-04986, 2019-0276 | Ph 1, Ph 2 | active not recruiting | Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma |
| NCT04898231 MISTIC results posted | 202109 | Ph 2, Ph 3 | completed | MIS-C Comparative Effectiveness Study |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT03112603 results posted | INCB 18424-365 (REACH3) CINC424D2301, 2016-004432-38 | Ph 3 | completed | A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3) |
| NCT02638701 | 15-16893 | Ph 1, Ph 2 | recruiting | Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms |
| NCT00463580 Infliximab results posted | IRB00011734 1R21MH077172-01A2 | Ph 4 | completed | A Study of Infliximab for Treatment Resistant Major Depression |
| NCT03679546 EFFICACI | 35RC17_8841_EFFICACI 2018-002673-21, 2018-66-PP | Ph 4 | completed | EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis |
| NCT05168475 BIOVAS results posted | BIOVAS | Ph 2 | terminated | Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis |
| NCT05906576 | C008CDIV | Ph 4 | recruiting | Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients |
| NCT06453317 COMBO-UC | Combo/2022/3 2023-506452-25 | Ph 2 | recruiting | Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis |
| NCT06136546 | 2023p002988 | Ph 2 | recruiting | Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab |
| NCT03937609 TITRATE | 6746101818 | Ph 4 | terminated | TITRATE (inducTIon for acuTe ulceRATivE Colitis) |
| NCT01804166 results posted | CR100938 CR100938 | Ph 4 | completed | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) |
| NCT02566889 ADAPT results posted | CR108044 C0168IBD4020, 2015-001653-32 | Ph 4 | terminated | An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease |
| NCT04646187 FREE | 202000261 2020-001811-26 | Ph 4 | enrolling by invitation | De-escalation of Anti-TNF Therapy in Inflammatory Bowel Disease |
| NCT04982172 MODIFI | S64521 | Ph 4 | completed | Model-informed Dose De-escalation of Infliximab in Patients With Inflammatory Bowel Diseases |
| NCT02770040 PREDICT UC | HREC/14/Austin/595 | Ph 4 | completed | Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis |
| NCT06614387 VEDI-UC | CT 2023-509775-16 | Ph 3 | not yet recruiting | Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab |
| NCT05552287 ProRAPID | ProRAPID | Ph 4 | recruiting | Pharmacokinetic Infliximab Data in Pediatric Crohn's Disease |
| NCT05340764 results posted | 202007200 | Ph 4 | completed | Safety of Reduced Infliximab Infusion Time |
| NCT02251041 CAPITL results posted | CAPITL RCT | Ph 2 | completed | Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL) |
| NCT06113913 AMARETTO | BIRD2023001 | Ph 4 | recruiting | Subcutaneous Infliximab After A Previous Intravenous Dose Optimization |
| NCT05823532 | STUDY00004430 R01MH131910-01 | Ph 4 | recruiting | Anti-Inflammatory Challenge in Schizophrenia |
| NCT02517684 TISKids | NL52030.078.15 2014-005702-37, MEC-2015-080 | Ph 4 | completed | Top-down Infliximab Study in Kids With Crohn's Disease |
| NCT04999228 | UC1.1 | Ph 4 | recruiting | Top Down Versus Step up in Pediatric Ulcerative Colitis |
| NCT03704610 EFIRTES | P141205J 2017-001809-32 | Ph 3 | completed | Efficacy of Remission-induction Regimen With Infliximab for Severe Extrathoracic Sarcoidosis (EFIRTES) |
| NCT03004443 results posted | IRB00090667 1R01MH112076-01 | Ph 4 | terminated | Inflammation-Induced CNS Glutamate Changes in Depression |
| NCT04593940 ACTIV-1 IM results posted | Pro00106301 | Ph 3 | completed | Immune Modulators for Treating COVID-19 |
| NCT05947669 iCaD | The ICaD Study | Ph 3 | recruiting | Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis |
| NCT04922827 INFLIXCOVID | ZKSJ0137_INFLIXCOVID 2021-002098-25 | Ph 2 | completed | Infliximab in the Treatment of Patients With Severe COVID-19 Disease |
| NCT03371095 ITAC | P160932J | Ph 3 | completed | Induction Therapy With Anti-TNFα vs Cyclophosphamide in Severe Behçet Disease |
| NCT02425852 ACTIVE | GETAID 2015-02 | Ph 4 | completed | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis |
| NCT05813860 | 2023ZSLYEC-123 | Ph 4 | not yet recruiting | HLADQA1*05 Genotype and the Efficacy of Treatment With Infliximab in Chinese Population Crohn's Disease |
| NCT02990806 results posted | NI071F2 | Ph 3 | completed | A Phase 3 Study of NI-071 in Participants With Rheumatoid Arthritis (RADIANCE) |
Showing 50 of 105 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REMICADE FDA Label Details
Indications & Usage
FDA Label (PDF)REMICADE is indicated for the treatment of Crohn's Disease; Pediatric Crohn's Disease; Ulcerative Colitis; Pediatric Ulcerative Colitis; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Plaque Psoriasis.
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such...
Pro Intelligence Preview
Deep insights for REMICADE
Revenue Insights
- • Q4-2016: $269M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2018
- • Generic/biosimilar risk
Trial Analysis
- • 115 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment