Simponi
(Golimumab)ApprovedMonoclonal antibody
Johnson & JohnsonGolimumab is used to treat autoimmune diseases like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis by reducing inflammation and suppressing the immune system's overactive response.[2] Simponi is currently approved and in use across 11 indications[4].[1]
Simponi is one of 294 small molecule programs targeting Immune System Disease. It is currently in Approved.
11
Indications
81
Total Trials
9
Active Trials
293
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 11 indications
Competition
Competitive Landscape
348 competitors in Prostate Cancer
#DrugCompanyPhaseTrials
1Simponi
Johnson & JohnsonApproved
Paraplatin
AAvyxa
Phase 3
Verzenio
Eli LillyPhase 3
Leuprorelin
TakedaPhase 3
Lutetium Lu-177 PNT2002
JJonsson Comprehensive Cancer Center
Phase 3
Radium-223
BayerPhase 3
Provenge
PProstate Oncology Specialists, Inc.
Phase 3
Aglatimagene Besadenovec
CCandel Therapeutics, Inc.
Phase 3
Piflufolastat F 18
NovartisPhase 3
Trexall
Jazz PharmaceuticalsPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Rheumatoid Arthritis19 trials
Show 16 more trials
Ulcerative Colitis15 trials
Show 12 more trials
Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization
Completed·—·Phase 2·NCT03182166·51 enrolled
Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET
Completed·GGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives·Phase 4·NCT02425865·202 enrolled
Ankylosing Spondylitis8 trials
Show 5 more trials
NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis
Completed·—·Phase 4·NCT02758782·156 enrolled
Arthritis6 trials
Psoriatic Arthritis6 trials
22 more indications
Type 1 Diabetes2 trials
Juvenile Idiopathic Arthritis2 trials
Colitis, Ulcerative2 trials
Prostate Cancer1 trial
Autoimmune Inner Ear Disease1 trial
Intratympanic Injection for Autoimmune Inner Ear Disease
Terminated·—·Phase 1/2·NCT01526174·16 enrolled
Liraglutide1 trial
Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D
Completed·—·Phase 1·NCT03632759·16 enrolled
Sarcoidosis1 trial
Age1 trial
Diabetes Mellitus1 trial
Treatment1 trial
Initial Treatment With Golimumab in Early PsA
Completed·—·Phase 3·NCT01871649·51 enrolled
Spondyloarthropathy1 trial
Crohn's Disease1 trial
Arthritis, Psoriatic1 trial
Rheumatic Disease1 trial
Type 1 Diabetes (T1D)1 trial
Adaptive Platform Trial to Delay Progression From Normoglycemia to Dysglycemia in Presymptomatic Type 1 Diabetes: Golimumab Substudy
Not yet recruiting·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT07683026·255 enrolled
Regulatory
FDA Approval Timeline[5]
Apr 24, 2009
SIMPONI
BLA BLA125289
Jul 18, 2013
SIMPONI ARIA
BLA BLA125433
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Simponi drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Golimumab. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- TNF-Alpha Inhibitor[3]
- Modality
- Monoclonal antibody[3]
- Highest Phase
- Approved[1]
- Company