Icotyde Approved for Moderate-to-Severe Plaque Psoriasis

On March 18, 2026, the US Food and Drug Administration (FDA) approved Johnson & Johnson and Protagonist Therapeutics’ Icotyde^™ (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis (PsO) in adults and pediatric patients aged 12 years and older weighing at least 40kg who are candidates for systemic therapy or phototherapy. Icotyde is a first-in-class, targeted oral peptide interleukin‑23 (IL‑23) receptor antagonist designed to precisely block the IL‑23 receptor, a key driver of inflammatory pathways in psoriasis. Icotyde is administered as a once‑daily 200mg oral pill. A specific launch date and pricing have not yet been announced. Full prescribing information can be found here.

u  At a Glance

• Brand Drug: Icotyde^™ (icotrokinra)
• Manufacturer: Protagonist Therapeutics & Johnson and Johnson Innovation Medicine
• Date Approved: March 18, 2026
• Indication: Moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40kg who are candidates for systemic therapy or phototherapy
• Dosage Forms Available: 200mg tablets
• Launch Date: Unknown.
• Estimated Annual Cost: Not yet announced. 
• FDA Designation: N/A
• Plaque psoriasis is a chronic, immune‑mediated skin disease that causes the rapid buildup of skin cells, leading to inflamed, scaly plaques that can be itchy or painful and commonly affect the scalp, elbows, knees and trunk.
• More than 8 million people in the US live with PsO, and roughly one in four patients – or 2 million Americans – have moderate to severe disease.
• Approval was supported by four phase III ICONIC studies that enrolled approximately 2,500 patients, which met all primary efficacy endpoints.
• In phase III head‑to‑head superiority studies, approximately 70% of patients achieved clear or almost clear skin and 55% achieved Psoriasis Area and Severity Index (PASI) 90 at week 16 with Icotyde, demonstrating superiority to Sotyktu^® (deucravacitinib – Bristol Myers Squibb).
• There is an ongoing study comparing Icotyde to Stelara^® (ustekinumab – Johnson and Johnson Innovative Medicine) in PsO.
• Safety analyses showed similar rates of adverse events between Icotyde and placebo. The most frequently reported events were infections, including COVID‑19, nasopharyngitis and upper respiratory tract infection.
• Multiple injectable, oral and topical therapies are FDA-approved for the treatment of PsO, including biologics such as TNF-alpha inhibitors like adalimumab (Humira^® and biosimilars) and injectable IL‑23 and IL‑17 inhibitors, including Skyrizi^® (risankizumab-rzaa – AbbVie) and Tremfya^® (Johnson & Johnson).
• Oral treatment options for moderate to severe plaque psoriasis include Sotyktu (deucravacitinib – Bristol Myers Squibb), a tyrosine kinase 2 (TYK2) inhibitor, and Otezla^® (apremilast – Amgen), a phosphodiesterase 4 (PDE4) inhibitor.
• Oral agents in the moderate to severe plaque psoriasis pipeline include zasocitinib (Takeda), an oral TYK2 inhibitor projected for approval in 2027, envudeucitinib (Alumis), another oral TYK2 inhibitor in the second half of 2027 and orismilast (UNION Therapeutics), an oral next‑generation PDE4 inhibitor with potential approval in 2028 or later.
• Icotyde is also in clinical development for psoriatic arthritis, ulcerative colitis and Crohn’s disease.