Johnson & Johnson’s Icotyde earns FDA approval as first oral peptide for plaque psoriasis

USA—The US Food and Drug Administration has approved Johnson & Johnson’s Icotyde (icotrokinra), introducing the first oral peptide option for patients with plaque psoriasis in the American market.

This landmark approval extends to both adults and adolescents aged 12 and older who suffer from moderate-to-severe disease, provided they qualify for systemic therapy or phototherapy.

Psoriasis is a chronic autoimmune disorder in which skin cells multiply excessively, creating thick, itchy, scaly patches that affect more than 8 million Americans.

Icotyde works by blocking interleukin-23 (IL-23), a protein that drives inflammatory responses in the body.

The once-daily pill delivers what experts describe as biologic-strength effectiveness through a macrocyclic design—a structural feature that distinguishes it from existing oral treatments currently on the market.

Clinical evidence and competitive advantage

Four Phase III trials involving 2,500 patients provided the foundation for approval. Icotyde achieved all primary efficacy goals, enabling patients to achieve clearer skin and measurably reducing disease severity.

Notably, the drug demonstrated superiority over Bristol Myers Squibb’s Sotyktu (deucravacitinib) in direct comparison studies, positioning it as a compelling alternative to competitors.

The plaque psoriasis market currently features two dominant players: Sotyktu, an oral small-molecule inhibitor targeting tyrosine kinase 2, and AbbVie’s blockbuster injectable monoclonal antibody, Skyrizi (risankizumab), both of which target IL-23 through different mechanisms.

Icotyde becomes the only oral peptide available in the US that targets IL-23 for this indication.

GlobalData analyst Stephanie Ngan observed that Icotyde’s strongest appeal lies in combining biologic-level efficacy with once-daily oral convenience—a significant departure from the commitment demands of injectables.

However, Skyrizi requires only four annual doses, presenting a lower treatment burden than daily pills.

Broader applications on the horizon

Johnson & Johnson ultimately positioned Icotyde as a successor to its patent-expired Stelara (ustekinumab), while maintaining its other psoriasis therapy, Tremfya (guselkumab), in the portfolio.

The company is actively pursuing additional inflammatory indications, including active psoriatic arthritis, moderately-to-severely active ulcerative colitis, and moderately-to-severely active Crohn’s disease.

Industry analysts at GlobalData, the parent company of Pharmaceutical Technology, project blockbuster status for the drug, forecasting global sales of USD4.4 billion in 2032.

The simultaneous approval for both adults and adolescents, rather than the traditional step-wise regulatory pathway, positions the drug to capture a wider patient base early in its commercial lifecycle.

Leah Howard, CEO of the National Psoriasis Foundation, emphasized the significance of this approval, noting that it fundamentally expands the treatment conversation for the community.

Johnson & Johnson obtained global rights to Icotyde from Protagonist Therapeutics through a deal valued at up to USD990 million in 2017.