SELARSDI (ustekinumab-aekn) · ALVOTECH USA INC
SELARSDI (ustekinumab-aekn) is a human interleukin-12 and -23 antagonist indicated for the treatment of several chronic inflammatory conditions. It is approved for use in adult and pediatric patients aged six years and older with moderate to severe plaque psoriasis or active psoriatic arthritis. Additionally, the drug is indicated for adult patients with moderately to severely active Crohn’s disease or ulcerative colitis. Its therapeutic role focuses on managing systemic inflammation in patients who are candidates for phototherapy or systemic therapy.
How SELARSDI Works
SELARSDI is a monoclonal antibody that binds 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 receptor found on the surface of immune cells. This disruption inhibits signaling pathways and cytokine cascades responsible for natural killer cell activation and T-cell differentiation. This mechanism helps control the chronic inflammation and immune responses that characterize psoriasis and inflammatory bowel diseases.
Details
- Status
- Prescription
- First Approved
- 2024-04-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SELARSDI Approval History
What SELARSDI Treats
4 indicationsSELARSDI is approved for 4 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
SELARSDI Target & Pathway
ProTarget
Pharmacists can substitute SELARSDI for Stelara without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
SELARSDI 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 SELARSDI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SELARSDI 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.
SELARSDI FDA Label Details
Indications & Usage
FDA Label (PDF)SELARSDI 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) SELARSDI™ is indicated for the treatment of adults a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.