With the long-awaited new approval of a daily pill, Johnson & Johnson and Protagonist Therapeutics are taking on a group of bioinjectable drugs that have long dominated the lucrative psoriasis market.
The FDA has approved the interleukin-23 (IL-23) receptor antagonist icotide (icotrokinra) for use in patients 12 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
This approval represents a “potentially transformative opportunity” for many patients and is consistent with new guidance from the International Council on Psoriasis, which recommends that patients move on to systemic treatment after cycles of topical treatment, Linda Stein Gold, MD, Director of Dermatology Research at Henry Ford Health, commented in J&J’s press release.
In a release, J&J cited its extensive ICONIC clinical development program and said an “unprecedented body of evidence” supports Icotyde’s benefits. The company tested Icotyde in “high-impact” psoriasis areas, such as scalp and genital plaque psoriasis, across four Phase 3 studies that enrolled 2,500 patients and compared the drug to either a placebo or Bristol-Myers Squibb’s strong competitor Sotik.
In head-to-head studies, approximately 70% of patients treated with Icotide achieved clear or near-clear skin, and more than half (55%) achieved a Psoriasis Area and Severity Index (PASI) of 90 (referring to a disease improvement score of 90%) at 16 weeks. Compared to Sotiktu, J&J’s pill candidate showed superior skin clearance at weeks 16 and 24, and its efficacy persisted through week 52.
The approval establishes “a new standard for the treatment of moderate to severe plaque psoriasis,” Jennifer Taubert, J&J’s director of innovative medicine, said in a release. Approximately 8 million people in the United States have plaque psoriasis.
“We are proud to bring this game-changing innovation to market and demonstrate a transformative change in plaque psoriasis management that will enable patients and clinicians to achieve their treatment goals,” added Taubert.
Icotide is the first targeted oral peptide that can ‘precisely block’ the IL-23 receptor and is intended to be taken once daily with water upon waking. As it stands, the bulk of the psoriasis market is made up of more cumbersome injectable options, such as AbbVie’s Skyrizi and J&J’s own Tremfya.
Icotide’s “biological-level efficacy” and once-daily pill convenience are a combination “previously unattainable in the treatment of psoriasis,” Citi analysts wrote in a recent note to clients. Analysts expect “rapid market penetration” and peak sales of $5.5 billion.
Meanwhile, Jefferies analysts had previously expected peak U.S. sales of $7.5 billion for the drug across a variety of indications. Johnson & Johnson also expects the drug’s peak year sales to be more than $5 billion.
J&J and Protagonist are long-time immunology partners who first signed a collaboration with Icotyde in 2017 and are testing the drug across other immunology indications, including active psoriatic arthritis, ulcerative colitis, and Crohn’s disease. The partners are also comparing the pill to J&J’s Stelara in treating psoriasis.
Icotide’s entry into the market strengthens J&J’s strong immunology portfolio, which reached $15 billion in sales in 2025 thanks to blockbuster products Stelara and Tremfya, while also ensuring a “transformational year” for the protagonist, Citi analysts said. The California-based biotechnology company is awaiting a third-quarter FDA decision on lasfertide, a first-in-class drug for the blood disorder polycythemia vera, in partnership with Takeda Pharmaceuticals.
