The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s (J&J) Icotyde (icotrokinra) for the treatment of plaque psoriasis, marking the first US entry of an oral peptide in the indication.
J&J’s treatment is approved for adults and paediatric patients aged 12 and older with moderate-to-severe forms of the disease. Patients who are candidates for systemic therapy or phototherapy will be eligible for Icotyde.
Psoriasis is a chronic autoimmune condition causing skin cells to multiply rapidly, resulting in thick, itchy, scaly patches. Icotyde works by inhibiting interleukin-23 (IL-23), a protein that plays a key role in inflammation. Psoriasis affects more than 8 million people in the US.
J&J’s pill was approved based on four Phase III studies that included 2,500 patients. Icotyde met all primary efficacy endpoints, helping patients achieve clearer skin and reducing psoriasis severity. The drug also performed well in head-to-head superiority studies against Bristol Myers Squibb’s (BMS) Sotyktu (deucravacitinib).
Sotyktu and AbbVie’s Skyrizi (risankizumab) currently dominate the plaque psoriasis market in the US. Sotyktu is an oral small molecule inhibitor that targets tyrosine kinase 2 (TYK2), while Skyrizi is AbbVie’s blockbuster injected monoclonal antibody that inhibits IL-23. The FDA’s approval for Icotyde means it is the only oral peptide that targets IL-23 in the plaque psoriasis US market.
GlobalData analyst, Stephanie Ngan, commented: "Its strongest selling point is its biologic-like efficacy delivered in a once-daily oral pill, likely enabled by its macrocyclic design, and contrasts existing oral options. The competitive threat against Sotyktu is especially acute, given that Icotyde has demonstrated superiority over it in head-to-head trials."
"That being said, Icotyde does entail a higher treatment burden and daily commitment than biologics such as Skyrizi, which requires only 4 doses per year," Ngan added.
Icotyde will succeed J&J’s Stelara (ustekinumab), an IL-23 inhibitor approved for plaque psoriasis treatment that lost patent exclusivity in early 2025. J&J also has Tremfya (guselkumab) on the market in this indication, though like Skyrizi, the drug is injected.
Leah Howard, CEO of the National Psoriasis Foundation, said: “The approval of a novel systemic therapy changes the conversation about treatment options for our community.”
J&J is eying further inflammatory indications for its IL-23 inhibitor. These include active psoriatic arthritis studies ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424); ICONIC-UC (NCT071196748) in moderately-to-severely active ulcerative colitis; and ICONIC-CD (NCT7196722) in moderately-to-severely active Crohn’s disease.
Analysis by GlobalData, Pharmaceutical Technology’s parent company, forecasts a blockbuster for J&J’s drug, with 2032 sales expected to reach $4.4bn globally.
Ngan stated: "Simultaneous approval of Icotyde for both adults and adolescents, rather than the traditional step-wise path from adults into paediatrics immediately casts a wider net for early uptake across a broader patient population."
J&J acquired global rights to Icotyde from Protagonist Therapeutics via a deal worth up to $990m in 2017. In late 2025, the Wall Street Journal (WSJ) reported the companies were in talks regarding a potential acquisition, though no update has been made public since.
It will take some effort to displace Skyrizi’s dominance, however. Armed with a range of immunology indications, along with a strong adoption in inflammatory bowel disease (IBD), the drug has become a major revenue driver for AbbVie. In 2025, the injectable’s global sales reached $17.6bn, exceeding growth forecasts. Skyrizi’s performance has eased AbbVie’s dependency on Humira (adalimumab), which lost exclusivity in 2023 – the product was the world’s best-selling drug between 2012 and 2020.
