Golimumab
drug drugOn this page
Also known as CNTO 148CNTO-148Simponi
Summary
Golimumab (CHEMBL1201833) is an approved antibody (ATC L04AB06); indicated across 15 conditions including rheumatoid arthritis and ulcerative colitis.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: L04AB06
- Indications: 15 conditions
- Clinical trials: 89
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1201833 |
| Name | Golimumab |
| Type | Antibody |
| Max phase | 4 |
| ATC | L04AB06 |
Also known as: CNTO 148, CNTO-148, Golimumab, Simponi, GOLIMUMAB
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
6 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).
| Indication | Phase | MONDO | EFO |
|---|---|---|---|
| rheumatoid arthritis | 4 | MONDO:0008383 | EFO:0000685 |
| ulcerative colitis | 4 | MONDO:0005101 | EFO:0000729 |
| ankylosing spondylitis | 4 | MONDO:0005306 | EFO:0003898 |
| psoriatic arthritis | 4 | MONDO:0011849 | EFO:0003778 |
| immune system disorder | 4 | MONDO:0005046 | EFO:0000540 |
| spondylitis | 4 | MONDO:0003937 | MONDO:0003937 |
9 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.
| Disease (in trials) | Phase | MONDO | EFO |
|---|---|---|---|
| spondyloarthropathy | 3 | MONDO:0005095 | EFO:0000706 |
| juvenile idiopathic arthritis | 3 | MONDO:0011429 | EFO:0002609 |
| osteoarthritis | 3 | MONDO:0005178 | MONDO:0005178 |
| Crohn disease | 2 | MONDO:0005011 | EFO:0000384 |
| asthma | 2 | MONDO:0004979 | MONDO:0004979 |
| type 1 diabetes mellitus | 2 | MONDO:0005147 | MONDO:0005147 |
| sarcoidosis | 2 | MONDO:0019338 | MONDO:0019338 |
| prostate adenocarcinoma | 2 | MONDO:0005082 | EFO:0000673 |
| prostate carcinoma | 2 | MONDO:0005159 | EFO:0001663 |
Clinical trials
Total trials: 89.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 30 |
| PHASE4 | 19 |
| Not specified | 17 |
| PHASE2 | 15 |
| PHASE1 | 5 |
| PHASE2/PHASE3 | 1 |
| PHASE1/PHASE2 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT01212653 | PHASE4 | COMPLETED | Effect of Anti-TNF (Alpha) Treatment on Vascular Stiffness in Ankylosing Spondylitis (AS) |
| NCT01295151 | PHASE4 | COMPLETED | SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug. |
| NCT01602302 | PHASE4 | TERMINATED | Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis |
| NCT01668004 | PHASE4 | COMPLETED | The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) |
| NCT01718951 | PHASE4 | COMPLETED | Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial |
| NCT01804166 | PHASE4 | 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) |
| NCT02092285 | PHASE4 | COMPLETED | Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) |
| NCT02186886 | PHASE4 | UNKNOWN | Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab |
| NCT02318667 | PHASE4 | COMPLETED | Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). |
| NCT02412085 | PHASE4 | UNKNOWN | Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission |
| NCT02425865 | PHASE4 | COMPLETED | Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET |
| NCT02687724 | PHASE4 | UNKNOWN | Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis |
| NCT02758782 | PHASE4 | COMPLETED | NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis |
| NCT03100253 | PHASE4 | TERMINATED | Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation |
| NCT03124121 | PHASE4 | COMPLETED | Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels |
| NCT03253796 | PHASE4 | COMPLETED | Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038) |
| NCT03669029 | PHASE4 | UNKNOWN | Optimization of Golimumab Treatment in Ulcerative Colitis |
| NCT03733925 | PHASE4 | COMPLETED | A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis |
| NCT05164198 | PHASE4 | UNKNOWN | REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST) |
| NCT03414502 | PHASE3 | RECRUITING | Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response |
| NCT03596645 | PHASE3 | ACTIVE_NOT_RECRUITING | A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT05669833 | PHASE3 | RECRUITING | Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients |
| NCT00264550 | PHASE3 | COMPLETED | An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy |
| NCT00265083 | PHASE3 | COMPLETED | A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis |
| NCT00265096 | PHASE3 | COMPLETED | A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis |
| NCT00299546 | PHASE3 | COMPLETED | A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s) |
| NCT00361335 | PHASE3 | COMPLETED | A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy |
| NCT00487539 | PHASE2/PHASE3 | COMPLETED | An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT00488631 | PHASE3 | COMPLETED | An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT00727987 | PHASE3 | COMPLETED | A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy |
| NCT00771251 | PHASE3 | COMPLETED | A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA) |
| NCT00973479 | PHASE3 | COMPLETED | An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy |
| NCT01004432 | PHASE3 | COMPLETED | Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA) |
| NCT01248780 | PHASE3 | COMPLETED | Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy |
| NCT01248793 | PHASE3 | COMPLETED | Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis |
| NCT01426815 | PHASE3 | COMPLETED | Exploration of TNF-alpha Blockade With Golimumab in the Induction of Clinical Remission in Patients With Early Peripheral Spondyloarthritis (SpA) According to ASAS-criteria |
| NCT01453725 | PHASE3 | COMPLETED | Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006) |
| NCT01863771 | PHASE3 | COMPLETED | A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis. |
| NCT01871649 | PHASE3 | COMPLETED | Initial Treatment With Golimumab in Early PsA |
| NCT01962974 | PHASE3 | TERMINATED | A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) |
| NCT02065713 | PHASE3 | COMPLETED | Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients |
| NCT02181673 | PHASE3 | COMPLETED | A Study of Golimumab in Participants With Active Psoriatic Arthritis |
| NCT02186873 | PHASE3 | COMPLETED | A Study of Golimumab in Participants With Active Ankylosing Spondylitis |
| NCT02277444 | PHASE3 | COMPLETED | A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy |
| NCT02437162 | PHASE3 | TERMINATED | A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis |
| NCT02438787 | PHASE3 | TERMINATED | A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis |
| NCT03270501 | PHASE3 | COMPLETED | Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation |
| NCT04108468 | PHASE3 | COMPLETED | GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA |
| NCT04610476 | PHASE3 | UNKNOWN | Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis |
| NCT05842213 | PHASE3 | COMPLETED | Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX |
| NCT05242471 | PHASE2 | ACTIVE_NOT_RECRUITING | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn’s Disease |
| NCT05242484 | PHASE2 | ACTIVE_NOT_RECRUITING | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT05960578 | PHASE2 | ACTIVE_NOT_RECRUITING | Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study |
| NCT07138898 | PHASE2 | NOT_YET_RECRUITING | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT00207714 | PHASE2 | COMPLETED | An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis |
| NCT00675649 | PHASE2 | WITHDRAWN | A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma |
| NCT00955279 | PHASE2 | COMPLETED | A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis |
| NCT01217814 | PHASE2 | TERMINATED | Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers |
| NCT01526174 | PHASE1/PHASE2 | TERMINATED | Intratympanic Injection for Autoimmune Inner Ear Disease |
| NCT01715896 | PHASE2 | COMPLETED | A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis |
| NCT01988961 | PHASE2 | COMPLETED | A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis |
| NCT02846545 | PHASE2 | COMPLETED | A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes |
| NCT03182166 | PHASE2 | COMPLETED | Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization |
| NCT04218565 | PHASE2 | TERMINATED | Golimumab for the Treatment of Refractory Behcet’s Uveitis |
| NCT04729296 | PHASE2 | WITHDRAWN | Anti-TNFα to Delay or Prevent Progression to Stage 3 T1D |
| NCT05071664 | PHASE2 | COMPLETED | A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis |
| NCT01288157 | PHASE1 | COMPLETED | A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects |
| NCT01362153 | PHASE1 | COMPLETED | A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA) |
| NCT01900574 | PHASE1 | COMPLETED | A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis |
| NCT03298542 | PHASE1 | COMPLETED | A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes |
| NCT05632211 | PHASE1 | COMPLETED | A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants |
| NCT03632759 | EARLY_PHASE1 | COMPLETED | Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D |
| NCT04725422 | Not specified | RECRUITING | CHronic Nonbacterial Osteomyelitis International Registry |
| NCT01081717 | Not specified | COMPLETED | Golimumab Safety and Surveillance Program Using the Ingenix NHI Database |
| NCT02390700 | Not specified | TERMINATED | Observational Study of Golimumab Intravenous Infusion |
| NCT02414984 | Not specified | TERMINATED | Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab |
| NCT02728934 | Not specified | COMPLETED | Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis |
| NCT02841176 | Not specified | TERMINATED | Thermography in Assessing Treatment Response to Golimumab in Psoriatic Arthritis |
| NCT03016260 | Not specified | TERMINATED | RABIOPRED - a Validation Study of Theranostic Test to PREDict Treatment Response of Anti-TNFα BIologicals in Rheumatoid Arthritis |
| NCT03018925 | Not specified | COMPLETED | Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis |
| NCT03557853 | Not specified | COMPLETED | Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab |
| NCT03729349 | Not specified | COMPLETED | Golimumab for Adherence in Rheumatoid Arthritis |
| NCT03945903 | Not specified | NO_LONGER_AVAILABLE | Pre-Approval Access to Golimumab Subcutaneous for the Treatment of Stage 3 Type-1 Diabetes Mellitus in Children and Young Adults |
| NCT03955861 | Not specified | COMPLETED | Ultrasound Enthesitis Response in Psoriatic Arthritis |
| NCT04156425 | Not specified | UNKNOWN | The Role of PKC Activation in the Immune-inflammatory Mechanism of Major Depressive Depression |
| NCT04188249 | Not specified | UNKNOWN | Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis |
| NCT04200833 | Not specified | COMPLETED | Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab |
| NCT04531423 | Not specified | UNKNOWN | PKC as Serum Biomarkers for Depression |
| NCT05530122 | Not specified | COMPLETED | Prognosis in UC After First Biological |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Indicated for: rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, immune system disorder, spondylitis
- In clinical trials for: spondyloarthropathy, juvenile idiopathic arthritis, osteoarthritis, Crohn disease, asthma, type 1 diabetes mellitus, sarcoidosis, prostate adenocarcinoma, prostate carcinoma