TREMFYA
Tremfya (guselkumab) is an interleukin-23 antagonist indicated for the treatment of several chronic inflammatory and autoimmune conditions. It is approved for adults and pediatric patients aged 6 years and older weighing at least 40 kg with moderate-to-severe plaque psoriasis or active psoriatic arthritis. The medication is also indicated for adult patients with moderately to severely active ulcerative colitis and Crohn's disease. It serves as a systemic therapeutic option for patients requiring advanced management of these conditions.
How TREMFYA Works
Guselkumab is a human monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23). By binding to this subunit, the drug inhibits the interaction between IL-23 and its receptor. IL-23 is a naturally occurring cytokine that plays a key role in normal inflammatory and immune responses. By blocking this pathway, guselkumab prevents the release of proinflammatory cytokines and chemokines that contribute to disease pathology.
Details
- Status
- Prescription
- First Approved
- 2017-07-13
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TREMFYA Approval History
What TREMFYA Treats
4 indicationsTREMFYA is approved for 4 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Moderate-to-severe plaque psoriasis
- Active psoriatic arthritis
- Moderately to severely active ulcerative colitis
- Moderately to severely active Crohn's disease
TREMFYA Target & Pathway
ProTarget
A cytokine that promotes Th17 cell development and maintenance. IL-23 is upstream of IL-17 in the inflammatory cascade driving psoriasis and inflammatory bowel disease. Blocking IL-23 provides sustained control of these conditions.
TREMFYA Competitors
Pro10 other drugs also target IL-23. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (IL-23). Earlier expiry dates signal biosimilar/generic opportunities.
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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.
TREMFYA FDA Label Details
ProIndications & Usage
FDA Label (PDF)TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease. 1.1 Plaque Psoriasis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years o...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.