Golimumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2009
- First approval year
- 2009
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Golimumab
- simponi
- Simponi
- adalimumab certolizumab etanercept golimumab infliximab
- adalimumab infliximab ustekinumab golimumab and vedolizumab
- cnto 148
- CNTO 148
- CNTO 148 (Golimumab)
- CNTO 148 / Golimumab
- CNTO-148
- golimumab
- Golimumab
- GOLIMUMAB
- Golimumab (GLM)
- Golimumab (GOL)
- Golimumab (Optimization)
- GOLIMUMAB [EMA EPAR]
- GOLIMUMAB [HSDB]
- golimumab [INN]
- GOLIMUMAB [JAN]
- GOLIMUMAB [MART.]
- GOLIMUMAB [MI]
- GOLIMUMAB [PURPLE BOOK CDER]
- GOLIMUMAB [USAN]
- GOLIMUMAB [VANDF]
- Golimumab [WHO-DD]
- Golimumab 100 mg
- Golimumab 200 mg
And 34 more, listed on the interactive page.
- ATC classification codes
- L04AB06
Sources for recorded values
- CAS registry numbers
- 476181-74-5
- ChEMBL ID
- CHEMBL1201833
- RxNorm IDs (RxCUI)
- 819300
- FDA ingredient codes (UNII)
- 91X1KLU43E
- Applicant
- CENTOCOR ORTHO BIOTECH INC
- Approval date
- 24 Apr 2009
- Application number
- BLA125289
- Status
- Authorised
- Status date
- 1 Oct 2009
- Authorisation date
- 1 Oct 2009
- Approved indications
- Rheumatoid arthritis (RA) Simponi, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function. For information regarding the polyarticular juvenile idiopathic arthritis indication, please see the Simponi 50 mg SmPC. Psoriatic arthritis (PsA) Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Axial spondyloarthritis Ankylosing spondylitis (AS) Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non radiographic axial spondyloarthritis (nr Axial SpA) Simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ulcerative colitis (UC) Simponi 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. Ulcerative colitisPaediatric ulcerative colitis (pUC)Simponi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, 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. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis (pJIA) Simponi in combination with methotrexate (MTX) is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX. Rheumatoid arthritis (RA) Simponi, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease modifying anti rheumatic drug (DMARD) therapy including MTX has been inadequate. the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX. Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function. Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis (pJIA) Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX. Psoriatic arthritis (PsA) Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function. Axial spondyloarthritis Ankylosing spondylitis (AS) Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non radiographic axial spondyloarthritis (nr Axial SpA) Simponi is indicated for the treatment of adults with severe, active non radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Ulcerative colitis (UC) Simponi 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.
- Product number
- EMEA/H/C/000992
- Authorisation holder
- Janssen Cilag International NV
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 2
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Psoriatic
- Arthritis, Rheumatoid
- Colitis, Ulcerative
- Spondylitis, Ankylosing
European medicines record
- Patents
- 0
- Designations
- 1
- Earliest recorded loss of exclusivity
- 7 Oct 2032
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- golimumab
- 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
- 10.74
- Affinity units
- pIC50
- 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
- Crohn Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Spondylarthropathies
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000706
- Subject identifier
- D025242
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001663
- Subject identifier
- D011471
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002609
- Subject identifier
- D001171
- Condition
- Arthritis, Psoriatic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003778
- Subject identifier
- D015535
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Spondylitis
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0003937
- Subject identifier
- D013166
- Condition
- Asthma
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004979
- Subject identifier
- D001249
- Condition
- Diabetes Mellitus, Type 1
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005147
- Subject identifier
- D003922
- Condition
- Osteoarthritis
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0005178
- Subject identifier
- D010003
- Condition
- Sarcoidosis
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0019338
- Subject identifier
- D012507
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0000706
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000729
- Condition identifier
- EFO_0002609
- Condition identifier
- EFO_0003767
- Condition identifier
- EFO_0003778
- Condition identifier
- EFO_0003898
- Condition identifier
- MONDO_0002009
- Condition identifier
- MONDO_0002050
- Condition identifier
- MONDO_0003937
- Condition identifier
- MONDO_0003937
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004979
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005011
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005046
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005083
- Condition identifier
- MONDO_0005095
- Condition identifier
- MONDO_0005101
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005147
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005265
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005306
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0007191
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008315
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008383
- Highest recorded phase
- 4
And 9 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
- 2,391
- Reporting signal score
- 4,329.16
- Event
- alopecia
- Reports
- 2,649
- Reporting signal score
- 5,038.18
- Event
- anti-cyclic citrullinated peptide antibody positive
- Reports
- 1,124
- Reporting signal score
- 4,555.29
- Event
- arthralgia
- Reports
- 32,083
- Reporting signal score
- 15,936
- Event
- arthropathy
- Reports
- 2,004
- Reporting signal score
- 4,660.2
- Event
- crohn's disease
- Reports
- 9,339
- Reporting signal score
- 8,429.23
- Event
- discomfort
- Reports
- 1,306
- Reporting signal score
- 2,982.57
- Event
- drug intolerance
- Reports
- 3,016
- Reporting signal score
- 6,030.97
- Event
- glossodynia
- Reports
- 2,047
- Reporting signal score
- 7,226.44
- Event
- hand deformity
- Reports
- 1,673
- Reporting signal score
- 6,233.01
- Event
- hypersensitivity
- Reports
- 1,869
- Reporting signal score
- 2,293.15
- 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
- lower respiratory tract infection
- Reports
- 1,582
- Reporting signal score
- 3,745.43
- Event
- muscle injury
- Reports
- 618
- Reporting signal score
- 2,173.48
- 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
- 2,175
- Reporting signal score
- 8,497.54
- Event
- pericarditis
- Reports
- 1,049
- Reporting signal score
- 2,938.63
And 10 more, listed on the interactive page.
- NCT00207714
- NCT00264537
- NCT00264550
- NCT00299546
- NCT00361335
- NCT00727987
- NCT00771251
- NCT00973479
- NCT00975130
- NCT01004432
- NCT01217814
- NCT01248780
- NCT01295151
- NCT01362153
- NCT01602302
- NCT01715896
- NCT01962974
- NCT02242474
- NCT02862574
- NCT03100253
- NCT03414502
- NCT03915964
- NCT04086745
- NCT00207740
- NCT00675649
And 52 more, listed on the interactive page.
- Dose
- 50 mg
- Route
- Subcutaneous
- How often
- Once a month
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 57894-070
- 57894-071
- 57894-350
Related records
Trials (116)
- A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma
- A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)
- A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)
- 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)
- A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab
- A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.
- A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
- A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
- A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
- A Study of Golimumab in Participants With Active Ankylosing Spondylitis
- A Study of Golimumab in Participants With Active Psoriatic Arthritis
- A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
- A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis
- A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis
- A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
- A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes
- A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects
- A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
Approved for (6)
- Ankylosing spondylitis
- Immune system disorder
- Psoriatic arthritis
- Rheumatoid arthritis
- Spondylitis
- Ulcerative colitis
In development for (9)
- Asthma Phase 2
- Crohn disease Phase 2
- Juvenile idiopathic arthritis Phase 3
- Osteoarthritis Phase 3
- Prostate adenocarcinoma Phase 2
- Prostate carcinoma Phase 2
- Sarcoidosis Phase 2
- Spondyloarthropathy Phase 3
- Type 1 diabetes mellitus Phase 2
Other linked conditions (3)
- Autoimmune inner ear disease
- Inflammatory bowel disease
- Major depressive disorder
Targets (1)
- TNF TNF-alpha inhibitor