Infliximab
Highest phase reached
Approved
Drug type
Antibody
First approval year
1998
- First approval year
- 1998
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Infliximab
- flixabi
- Flixabi
- inflectra
- Inflectra
- remicade
- Remicade
- remsima
- Remsima
- zessly
- Zessly
- abp 710
- ABP 710
- Abp-710
- avsola
- Avsola
- bow 015
- Bow-015
- bow015
- BOW015
- ct p 13
- ct p13
- Ct p13
- CT P13 [WHO-DD]
- ct p13 who dd
- Ct-p-13
- Ct-p13
- CT-P13
- CT-P13 SC (Infliximab)
- ctp 13
- CTP-13
- ctp13
- CTP13
- IMMUNOGLOBULIN G (HUMAN-MOUSE MONOCLONAL CA2 HEAVY CHAIN ANTI-HUMAN TUMOR NECROSIS FACTOR), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL CA2 LIGHT CHAIN, DIMER
- immunoglobulin g human mouse monoclonal ca2 heavy chain anti human tumor necrosis factor disulfide with human mouse monoclonal ca2 light chain dimer
- infimab
And 119 more, listed on the interactive page.
- ATC classification codes
- L04AB02
Sources for recorded values
- CAS registry numbers
- 170277-31-3
- ChEMBL ID
- CHEMBL1201581
- FDA ingredient codes (UNII)
- B72HH48FLU
- 191831
- 1790539
- Applicant
- CENTOCOR INC
- Approval date
- 24 Aug 1998
- Application number
- BLA103772
- Status
- Authorised
- Status date
- 13 Aug 1999
- Authorisation date
- 13 Aug 1999
- Approved indications
- Rheumatoid arthritis Remicade, 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 Remicade 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 Remicade 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. Remicade has been studied only in combination with conventional immunosuppressive therapy. Ulcerative colitis Remicade 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 Remicade is indicated for treatment of severely active ulcerative colitis, in paediatric patients 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 Remicade is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy. Psoriatic arthritis Remicade is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Remicade should be administered: in combination with methotrexate; or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated. Remicade 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 Remicade 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 ultraviolet A (PUVA).
- Product number
- EMEA/H/C/000240
- Authorisation holder
- Janssen Cilag International NV
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 3
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Psoriatic
- Arthritis, Rheumatoid
- Colitis, Ulcerative
- Crohn Disease
- Psoriasis
- Spondylitis, Ankylosing
European medicines record
- Patents
- 0
- Designations
- 4
- Earliest recorded loss of exclusivity
- 23 Sept 2018
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- infliximab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- tumour necrosis factor shed form
- Gene symbol
- tumour necrosis factor shed form
- Median affinity
- 8.74
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- TNF-alpha inhibitor
- Action type
- Inhibitor
- Target
- Tumor necrosis factor
- Protein identifier
- P01375
Open Targets mechanisms
- Mechanism
- TNF-alpha inhibitor
- Action type
- Inhibitor
- Target
- Tumor necrosis factor
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Crohn Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Dermatomyositis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000398
- Subject identifier
- D003882
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Psoriasis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000676
- Subject identifier
- D011565
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Spondylarthropathies
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000706
- Subject identifier
- D025242
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Myositis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000783
- Subject identifier
- D009220
- Condition
- Endometriosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001065
- Subject identifier
- D004715
- Condition
- Macular Degeneration
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001365
- Subject identifier
- D008268
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002609
- Subject identifier
- D001171
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002617
- Subject identifier
- D008545
- Condition
- Reperfusion Injury
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002687
- Subject identifier
- D015427
- Condition
- Hepatitis C
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003047
- Subject identifier
- D006526
- Condition
- Polymyositis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003063
- Subject identifier
- D017285
- Condition
- Inflammatory Bowel Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003767
- Subject identifier
- D015212
- Condition
- Arthritis, Psoriatic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003778
- Subject identifier
- D015535
- Condition
- Behcet Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003780
- Subject identifier
- D001528
- Condition
- Colitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003872
- Subject identifier
- D003092
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Hepatitis C, Chronic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004220
- Subject identifier
- D019698
- Condition
- Eosinophilic Esophagitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004232
- Subject identifier
- D057765
- Condition
- Mucocutaneous Lymph Node Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004246
- Subject identifier
- D009080
And 29 more, listed on the interactive page.
- Condition identifier
- EFO_0000198
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000341
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000384
- Condition identifier
- EFO_0000398
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000676
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0000706
- Condition identifier
- EFO_0000729
- Condition identifier
- EFO_0000783
- Condition identifier
- EFO_0001065
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002609
- Highest recorded phase
- 3
- Condition identifier
- EFO_0002687
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003047
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003063
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003767
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003778
- Condition identifier
- EFO_0003780
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003872
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003898
- Condition identifier
- EFO_0004220
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004232
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004246
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004276
- Condition identifier
- EFO_0004599
- Highest recorded phase
- 2
And 105 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Warning
- Black Box Warning
- Effect
- infectious disease
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Event
- abdominal discomfort
- Reports
- 3,458
- Reporting signal score
- 2,939.96
- Event
- alopecia
- Reports
- 4,077
- Reporting signal score
- 3,993.37
- Event
- anti-cyclic citrullinated peptide antibody positive
- Reports
- 1,280
- Reporting signal score
- 3,534.22
- Event
- arthralgia
- Reports
- 32,083
- Reporting signal score
- 15,936
- Event
- arthropathy
- Reports
- 2,848
- Reporting signal score
- 3,706.86
- Event
- blood pressure fluctuation
- Reports
- 2,749
- Reporting signal score
- 5,749.3
- Event
- colitis ulcerative
- Reports
- 2,155
- Reporting signal score
- 3,499.01
- Event
- condition aggravated
- Reports
- 9,161
- Reporting signal score
- 8,633.67
- Event
- crohn's disease
- Reports
- 9,339
- Reporting signal score
- 8,429.23
- Event
- drug intolerance
- Reports
- 4,450
- Reporting signal score
- 4,564.71
- Event
- glossodynia
- Reports
- 2,060
- Reporting signal score
- 4,361.42
- Event
- hand deformity
- Reports
- 1,825
- Reporting signal score
- 4,362.81
- Event
- infusion related reaction
- Reports
- 8,660
- Reporting signal score
- 17,589.9
- Event
- injection site bruising
- Reports
- 10,119
- Reporting signal score
- 8,961.8
- Event
- injection site erythema
- Reports
- 28,046
- Reporting signal score
- 30,429.7
- Event
- injection site pain
- Reports
- 36,582
- Reporting signal score
- 33,558.3
- Event
- injection site pruritus
- Reports
- 15,404
- Reporting signal score
- 17,113.1
- Event
- injection site reaction
- Reports
- 14,682
- Reporting signal score
- 13,838.5
- Event
- injection site swelling
- Reports
- 15,132
- Reporting signal score
- 15,546.7
- Event
- injection site warmth
- Reports
- 7,246
- Reporting signal score
- 8,837.08
- Event
- joint swelling
- Reports
- 14,075
- Reporting signal score
- 10,318.3
- Event
- lupus-like syndrome
- Reports
- 1,566
- Reporting signal score
- 3,261.59
- Event
- nasopharyngitis
- Reports
- 13,404
- Reporting signal score
- 6,696.15
- Event
- pain
- Reports
- 28,914
- Reporting signal score
- 8,203.82
- Event
- pemphigus
- Reports
- 2,512
- Reporting signal score
- 6,570.81
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And 185 more, listed on the interactive page.
- Dose
- 5 mg/kg
- Route
- Intravenous
- How often
- At 0, 2, and 6 weeks, then every 8 weeks
- Administer by infusion for at least 2 hours
- Administer with an in-line filter (pore size 1.2 μm or less)
- Prepare infusion solution within 3 hours of reconstitution and dilution
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 0069-0809
- 55513-670
- 57894-030
- 57894-160
- 72606-025
- 72606-047
- 78206-162
Related records
Trials (477)
- "Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission: the SIMILAR Trial"
- 12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression
- 3D Evaluation of Postoperative Edema After Third Molar Surgery
- A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit
- A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
- A Clinical Trial of Infliximab for Childhood Uveitis
- A Clinical Trial of Infliximab for Uveitis
- A Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram in Depression
- A Cohort Study Comparing IFX to CS for Moderate to Severe UC
- A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study
- A Direct Head-to-head Comparison of Ustekinumab with Infliximab for the Treatment of Ulcerative Colitis
- A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)
- A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients
- A Long-term Safety Study of Infliximab (Remicade)
- A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence
- A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease
- A Multicentered Prospective Cohort Study of Chinese IBD Patients
- A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
- A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
- A Phase 2 Trial of Infliximab in Coronavirus Disease 2019 (COVID-19).
Approved for (7)
- Ankylosing spondylitis
- Crohn disease
- Immune system disorder
- Psoriasis
- Psoriatic arthritis
- Rheumatoid arthritis
- Ulcerative colitis
In development for (43)
- Age-related macular degeneration Phase 2
- Asthma Phase 3
- Behcet disease Phase 3
- Bipolar disorder Phase 2
- Choroidal neovascularization Phase 2
- Chronic beryllium disease Phase 1
- Chronic granulomatous disease Phase 1
- Chronic hepatitis C virus infection Phase 3
- Chronic obstructive pulmonary disease Phase 3
- Colitis Phase 3
- COVID-19 Phase 3
- Dermatomyositis Phase 2
- Endometriosis Phase 2
- Eosinophilic esophagitis Phase 2
- Glaucoma Phase 1
- Graft versus host disease Phase 3
- Granulomatosis with polyangiitis Phase 2
- Hepatitis C virus infection Phase 2
- Hidradenitis suppurativa Phase 2
- Inflammatory bowel disease Phase 3
Other linked conditions (2)
- Diabetic macular edema
- Uveitis
Targets (1)
- TNF TNF-alpha inhibitor