SIMPONI (golimumab)
SIMPONI is indicated for the treatment of Rheumatoid arthritis; Psoriatic arthritis; Ankylosing spondylitis; Ulcerative colitis.
How SIMPONI Works
Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα. This binding prevents TNFα from interacting with its receptors, thereby inhibiting the biological activity of this proinflammatory cytokine. By blocking TNFα, the drug modulates the expression of adhesion proteins responsible for leukocyte infiltration and reduces the secretion of other proinflammatory cytokines. While this mechanism addresses the articular inflammation characteristic of several chronic diseases, the exact mechanism for treating ulcerative colitis is unknown.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-04-24
- Patent Cliff
- 2024
- Revenue
- $171M (Q4-2024)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SIMPONI Approval History
What SIMPONI Treats
4 indicationsSIMPONI is approved for 4 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Ulcerative colitis
SIMPONI Boxed Warning
SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ( 5.1 ) Discontinue SIMPONI if a patient develops a serious infection or sepsis ( 5.1 ) Perform test for latent TB; if positive, start trea...
WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ( 5.1 ) Discontinue SIMPONI if a patient develops a serious infection or sepsis ( 5.1 ) Perform test for latent TB; if positive, start treatment for TB prior to starting SIMPONI ( 5.1 ) 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 TNF blockers, of which SIMPONI is a member ( 5.2 ) SERIOUS INFECTIONS Patients treated with SIMPONI are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI if a patient develops a serious infection. Reported infections with TNF blockers, of which SIMPONI is a member, include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before SIMPONI use and during therapy. Initiate treatment for latent TB prior to SIMPONI use. Invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at ri
SIMPONI 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.
SIMPONI 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 SIMPONI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SIMPONI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SIMPONI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
43 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05242471 DUET-CD | CR109178 78934804CRD2001, 2021-003314-39 | Ph 2 | active not recruiting | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease |
| NCT05960578 | RG1123487 NCI-2023-04887, FHIRB0020135 | Ph 2 | active not recruiting | Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study |
| NCT05242484 DUET-UC | CR109179 78934804UCO2001, 2021-005528-39 | Ph 2 | active not recruiting | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis |
| 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 |
| NCT05071664 AFFINITY | CR109054 CNTO1959PSA2003, 2021-002012-31 | Ph 2 | completed | A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis |
| NCT04108468 GOLMePsA results posted | RR13/10782 14/EM/0124 | Ph 3 | completed | GOLimumab and Methotrexate Versus Methotrexate in Very Early PsA |
| NCT02277444 GO-VIVA results posted | CR105178 CNTO148JIA3003, 2015-004804-47 | Ph 3 | 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 |
| NCT02186873 results posted | CR103795 CNTO148AKS3001, 2014-000241-74 | Ph 3 | completed | A Study of Golimumab in Participants With Active Ankylosing Spondylitis |
| NCT05669833 EVOLUTION | CNTO1959PSA3006 | Ph 3 | recruiting | Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT05632211 results posted | AVT05-GL-P01 | Ph 1 | completed | A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants |
| NCT03270501 GO-GUT results posted | GO-GUT trial | Ph 3 | completed | Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation |
| NCT02846545 T1GER results posted | CR108187 CNTO148DML2001, 2021-000189-13 | Ph 2 | completed | A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Diabetes |
| 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) |
| NCT03733925 results posted | CR108559 CNTO148SPD4001 | Ph 4 | completed | A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis |
| NCT03298542 | CR108354 2017-000225-12, CNTO148DML1001 | Ph 1 | completed | A Study to Evaluate SIMPONI (Golimumab) Therapy in Children, Adolescents and Young Adults With Pre-Symptomatic Type 1 Diabetes |
| NCT03253796 results posted | 8259-038 MK-8259-038, 2015-004020-65 | Ph 4 | completed | Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038) |
| NCT02425865 In-TARGET | GETAID 2015-05 | Ph 4 | completed | Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET |
| NCT01900574 | CR101676 CNTO148UCO1001, 2012-004366-18 | Ph 1 | 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 |
| NCT03100253 RAFTING | IRFMN-RA-6453 | Ph 4 | terminated | Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation |
| NCT04729296 | TN30 Anti-TNFα 2U01DK106993-02, 1UC4DK117009-01 | Ph 2 | withdrawn | Anti-TNFα to Delay or Prevent Progression to Stage 3 T1D |
| NCT03124121 GO-LEVEL results posted | 2017-001374-42 | Ph 4 | completed | Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels |
| NCT02758782 CONSUL | CONSUL2016 | Ph 4 | completed | NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis |
| NCT02318667 EVOLUTION results posted | 8259-022 2014-003262-25, MK-8259-022 | Ph 4 | completed | Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). |
| NCT02065713 GO-DACT results posted | IMM-50307 | Ph 3 | completed | Efficacy of Golimumab in Combination With Methotrexate (MTX) Versus MTX Monotherapy, in Improving Dactylitis, in MTX naïve Psoriatic Arthritis Patients |
| NCT01426815 CRESPA | 2011/529 | Ph 3 | 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 |
| NCT02092285 GO-COLITIS results posted | 8259-032 2013-004583-56 | Ph 4 | completed | Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) |
| NCT01453725 GO-AHEAD results posted | P07642 MK-8259-006, 2011-000311-34 | Ph 3 | completed | Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006) |
| NCT01668004 GO-EASY results posted | 8259-012 2012-002458-21 | Ph 4 | completed | The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) |
| NCT01871649 | AMC_ 42670_PsA_Golimumab | Ph 3 | completed | Initial Treatment With Golimumab in Early PsA |
| NCT02181673 results posted | CR103796 2014-000242-30, CNTO148PSA3001 | Ph 3 | completed | A Study of Golimumab in Participants With Active Psoriatic Arthritis |
| NCT01217814 results posted | ACT11575 2010-021020-94, U1111-1115-3763 | Ph 2 | terminated | Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-α Blockers |
| NCT01863771 results posted | CR100937 CNTO148UCO3001 | Ph 3 | completed | A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis. |
| NCT01988961 | CR102851 CNTO148UCO2001, 2013-002042-36 | Ph 2 | 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 |
| NCT01295151 SWITCH | RR10/9589 2010-023880-17 | Ph 4 | completed | SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug. |
| NCT01718951 | CREC/769/09 | Ph 4 | completed | Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial |
| NCT01212653 AS | AS_2010 | Ph 4 | completed | Effect of Anti-TNF (Alpha) Treatment on Vascular Stiffness in Ankylosing Spondylitis (AS) |
| NCT00955279 results posted | CR016405 1275148SCD2001, 2009-010714-30 | Ph 2 | completed | A Study to Evaluate the Safety and Effectiveness of Ustekinumab or Golimumab Administered Subcutaneously (SC) in Patients With Sarcoidosis |
| NCT01288157 | CR016273 C0524T30 | Ph 1 | completed | A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects |
| NCT00973479 results posted | CR015784 CNTO148ART3001, 2008-006064-11 | Ph 3 | completed | An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy |
| NCT01526174 AIED | HRI-002 TNFalpha | Ph 1, Ph 2 | terminated | Intratympanic Injection for Autoimmune Inner Ear Disease |
| NCT01248780 results posted | CR015913 C0524T28 | Ph 3 | completed | Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy |
| NCT01248793 results posted | CR015916 C0524T29 | Ph 3 | completed | Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis |
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.
SIMPONI FDA Label Details
Indications & Usage
FDA Label (PDF)SIMPONI is indicated for the treatment of Rheumatoid arthritis; Psoriatic arthritis; Ankylosing spondylitis; Ulcerative colitis.
WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other...
Pro Intelligence Preview
Deep insights for SIMPONI
Revenue Insights
- • Q4-2024: $171M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2024
- • Generic/biosimilar risk
Trial Analysis
- • 44 total trials
- • Stage: Declining
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