TheraRadar
Data updated: May 26, 2026

STARJEMZA (ustekinumab-hmny)

Interleukin-12 Antagonists Genetically Validated
Immunology Approved 2025-05-22

STARJEMZA is indicated for the treatment of Plaque Psoriasis; Psoriatic Arthritis; Crohn’s Disease; Ulcerative Colitis.

Source: FDA Label • BIO-THERA SOLUTIONS LTD • Interleukin-12 Antagonist

How STARJEMZA Works

STARJEMZA is a monoclonal antibody that binds specifically to the p40 protein subunit shared by the IL-12 and IL-23 cytokines. By targeting this subunit, the drug prevents these cytokines from interacting with the IL-12Rβ1 cell-surface receptor. This disruption inhibits the signaling and cytokine cascades that drive inflammatory and immune responses, including natural killer cell activation and T-cell differentiation. This mechanism is designed to reduce the chronic inflammation that characterizes diseases such as Crohn’s disease and ulcerative colitis.

1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2025-05-22
Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

Active Ingredient: USTEKINUMAB-HMNY

STARJEMZA Approval History

2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2025 to 2025
May 2025 ORIGINAL
New Ingredient · Type 2 - New Active Ingredient

What STARJEMZA Treats

4 indications

STARJEMZA is approved for 4 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Plaque Psoriasis
  • Psoriatic Arthritis
  • Crohn’s Disease
  • Ulcerative Colitis
Source: FDA Label

STARJEMZA Target & Pathway

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Target

IL-12 (Interleukin 12) Cytokine

Auto-substitute OK for Stelara

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

STARJEMZA 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 STARJEMZA

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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.

STARJEMZA FDA Label Details

Indications & Usage

FDA Label (PDF)

STARJEMZA 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.