What Was Approved?
On March 17, 2026, the U.S. Food and Drug Administration approved Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in:
- Adults
- Pediatric patients 12 years of age and older
- Patients who weigh at least 40 kg
- Patients who are candidates for systemic therapy or phototherapy
How Does Icotyde Work?
Icotyde is an IL-23 receptor antagonist.
It selectively binds to the interleukin-23 receptor and blocks IL-23 signaling, which is involved in inflammatory and immune pathways that contribute to plaque psoriasis.
How Is Icotyde Taken?
Icotyde is supplied as a 200 mg oral tablet and is taken once daily.
Patients should follow the exact administration instructions provided in the FDA-approved prescribing information.
What Did the Clinical Trials Show?
FDA approval was supported by four randomized, double-blind, placebo-controlled clinical trials involving approximately 2,500 patients with moderate-to-severe plaque psoriasis.
Effectiveness was evaluated at Week 16 using standard psoriasis measures.
These study results apply to the populations studied and do not guarantee the same response for every patient.
What Are Common Side Effects?
The FDA Medication Guide lists common side effects including:
- Headache
- Nausea
- Cough
- Fungal infection
- Fatigue
Other adverse effects may also occur.
Bottom Line
Icotyde (icotrokinra) is a newly FDA-approved once-daily oral treatment for moderate-to-severe plaque psoriasis in adults and eligible patients age 12 and older who weigh at least 40 kg.
It provides a new oral treatment option for patients who are candidates for systemic therapy or phototherapy.
Sources
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Icotyde.
- U.S. Food and Drug Administration (FDA) — Icotyde (icotrokinra) Prescribing Information, March 2026.