TheraRadar
Data updated: May 26, 2026

YESINTEK (ustekinumab-kfce)

Interleukin-12 Antagonists Genetically Validated
Immunology Approved 2024-11-29

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.

Source: FDA Label • BIOCON BIOLOGICS INC • Interleukin-12 Antagonist

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.

2
Indications
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2024-11-29
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: USTEKINUMAB-KFCE

YESINTEK Approval History

2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2024 to 2026
Jan 2026 SUPPL
Update
Apr 2025 ORIGINAL
Update
Nov 2024 ORIGINAL
New Ingredient · Type 2 - New Active Ingredient

What YESINTEK Treats

4 indications

YESINTEK 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
Source: FDA Label

YESINTEK Target & Pathway

Pro

Target

IL-12 (Interleukin 12) Cytokine

Auto-substitute OK for Stelara

Pharmacists can substitute YESINTEK for Stelara without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.

YESINTEK Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to YESINTEK

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CYLTEZO
ADALIMUMAB-ADBM
4 shared
Boehringer Ingelheim
OTULFI
USTEKINUMAB-AAUZ
4 shared
Fresenius Kabi
PYZCHIVA
USTEKINUMAB-TTWE
4 shared
SAMSUNG BIOEPIS CO LTD
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.