IMULDOSA (ustekinumab-srlf) · ACCORD BIOPHARMA INC.
IMULDOSA (ustekinumab-srlf) is a human interleukin-12 and -23 antagonist indicated for the treatment of several chronic inflammatory conditions. It is approved for use in adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn’s disease or ulcerative colitis. Additionally, the medication is indicated for pediatric patients aged six years and older with moderate to severe plaque psoriasis or active psoriatic arthritis. For patients with plaque psoriasis, the drug is intended for those who are candidates for phototherapy or systemic therapy.
How IMULDOSA Works
IMULDOSA is a monoclonal antibody that binds specifically to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. By targeting this subunit, the drug prevents these cytokines from interacting with the IL-12Rβ1 receptor chain found on the surface of immune cells. This disruption inhibits the signaling and cytokine cascades that lead to natural killer cell activation and T-cell differentiation. This mechanism addresses the chronic inflammation that characterizes immune-mediated diseases like Crohn’s disease and ulcerative colitis.
Details
- Status
- Prescription
- First Approved
- 2024-10-10
- Routes
- INTRAVENOUS
- Dosage Forms
- INJECTABLE
IMULDOSA Approval History
What IMULDOSA Treats
4 indicationsIMULDOSA is approved for 4 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
IMULDOSA Target & Pathway
ProTarget
IMULDOSA is a lower-cost alternative to Stelara with no clinically meaningful differences. Requires prescriber approval to substitute.
IMULDOSA 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 IMULDOSA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IMULDOSA treats. First-in-class if their pivotal trials read out positive.
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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.
IMULDOSA FDA Label Details
Indications & Usage
FDA Label (PDF)IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: • moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. • active psoriatic arthritis (PsA). • moderately to severely active Crohn’s disease (CD). • moderately to severely active ulcerative colitis. Pediatric patients 6 years and older with: • moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. • active psoriatic arthritis (PsA). 1.1 Plaque Psoriasis (PsO) IMULDOSA is indicated for the treatment of...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.