Johnson & Johnson and Protagonist Therapeutics are countering the swarm of injectable biologics that have long dominated the lucrative psoriasis market with a new approval for a much-anticipated daily pill.
The FDA signed off on interleukin-23 (IL-23) receptor antagonist Icotyde (icotrokinra) for those with moderate-to-severe plaque psoriasis who are 12 years old and up and are candidates for systemic therapy or phototherapy.
The approval marks a “potential game-changer” for many patients and aligns with new guidance from the International Psoriasis Council, which recommends that patients move to systemic therapy after cycling through topical treatments, Henry Ford Health dermatology research director Linda Stein Gold, M.D., commented in a J&J press release.
An “unprecedented body of evidence” supports Icotyde’s benefits, J&J said in its release, referring to its sweeping ICONIC clinical development program. Across four phase 3 studies that enrolled 2,500 patients, the company tested Icotyde in “high impact” psoriasis sites such as scalp and genital plaque psoriasis, comparing the med to placebo or to Bristol Myers Squibb’s heavy-hitting competitor Sotyku.
In the head-to-head studies, some 70% of patients treated with Icotyde achieved clear or almost clear skin and more than half (55%) met a Psoriasis Area and Severity Index (PASI) 90 response at week 16, which refers to a 90% disease improvement score. Compared to Sotyktu, J&J’s pill contender showed superior skin clearance at week 16 and week 24, sustaining the benefits through week 52.
The approval stands to set a “new standard for the treatment of moderate-to-severe plaque psoriasis,” J&J’s head of innovative medicine, Jennifer Taubert, said in the release. Roughly 8 million people in the U.S. have plaque psoriasis.
"We're proud to bring this game-changing innovation to the market, marking a transformative shift in plaque psoriasis management that empowers patients and clinicians to reach their treatment goals,” Taubert added.
Icotyde is the first targeted oral peptide that can “precisely block” the IL-23 receptor and is meant to be taken once daily with water upon waking. As it stands, much of the psoriasis market is made up of more tedious injectable options such as AbbVie’s Skyrizi or J&J’s own Tremfya.
Icotyde’s “biologic-level efficacy” and once-daily pill convenience factor is a combination “previously unattainable in psoriasis therapy,” Citi analysts wrote in a recent note to clients. The analysts foresee “rapid market penetration” and $5.5 billion in peak sales.
Jefferies analysts, meanwhile, previously pegged $7.5 billion in peak U.S. sales for the drug across various indications. Johnson & Johnson also forecasts $5 billion or more in peak-year sales for the drug.
J&J and Protagonist, longtime immunology partners who first signed on to the Icotyde collaboration in 2017, 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 own Stelara in psoriasis.
While Icotyde’s market entry bolsters J&J’s stalwart immunology portfolio, which pulled in $15 billion in 2025 sales on the back of blockbusters Stelara and Tremfya, it also ensures a “transformative year” for Protagonist, the Citi analysts pointed out. The California-based biotech is awaiting a third-quarter FDA decision for Takeda-partnered rusfertide, a first-in-class prospect for blood disorder polycythemia vera.