YESINTEK (ustekinumab-kfce)
Yesintek helps patients manage several chronic inflammatory conditions, including moderate to severe plaque psoriasis and active psoriatic arthritis in both adults and children six years and older. It is also used for adults with moderately to severely active Crohn’s disease or ulcerative colitis. For those with plaque psoriasis, it is specifically used when patients are candidates for systemic therapy or phototherapy.
How YESINTEK Works
This drug works by binding to the p40 protein subunit shared by the IL-12 and IL-23 cytokines, which are key drivers of immune and inflammatory responses. By blocking these cytokines from interacting with their receptors, the medication disrupts the signaling cascades that lead to chronic inflammation. This process helps control the overactive immune response seen in conditions like Crohn’s disease and ulcerative colitis.
Details
- Status
- Prescription
- First Approved
- 2024-11-29
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
YESINTEK Approval History
What YESINTEK Treats
4 indicationsYESINTEK is approved for 4 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Plaque Psoriasis
- Psoriatic Arthritis
- Crohn's Disease
- Ulcerative Colitis
YESINTEK Target & Pathway
ProTarget
Pharmacists can substitute YESINTEK for Stelara without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
YESINTEK 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 YESINTEK's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications YESINTEK treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to YESINTEK
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
YESINTEK FDA Label Details
Indications & Usage
FDA Label (PDF)YESINTEK is indicated for the treatment of Plaque Psoriasis; Psoriatic Arthritis; Crohn's Disease; Ulcerative Colitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.