BLAINJECTIONINJECTABLE
Approved
Apr 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
SIMPONI (golimumab) by Johnson & Johnson is tumor necrosis factor receptor blocking activity [moa]. First approved in 2009.
Drug data last refreshed 11h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SIMPONI (golimumab) is a fully human monoclonal antibody that blocks tumor necrosis factor (TNF), a key inflammatory mediator implicated in autoimmune diseases. It is administered via subcutaneous injection and is indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. The drug reduces inflammation by neutralizing TNF, allowing immune function to normalize in patients with dysregulated inflammatory responses.
$177MPart D
LOE ApproachingSIMPONI is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling transition planning and potential resource reallocation within the immunology franchise.
Mechanism of Action
Tumor Necrosis Factor Receptor Blocking Activity
Pharmacologic Class:
Tumor Necrosis Factor Blocker
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study
Started May 2024
8 enrolled
Metastatic Castration-Resistant Prostate CarcinomaProstate AdenocarcinomaStage IV Prostate Cancer AJCC v8
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Started Jul 2023
63 enrolled
Psoriatic Arthritis
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Started Dec 2022
336 enrolled
Healthy Adult Subjects
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Started Sep 2022
577 enrolled
Colitis, Ulcerative
A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi®
Started Aug 2022
375 enrolled
Psoriatic Arthritis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.