▲FilingUS21 Jul 20251 min read
Icotrokinra filed in the US as the first oral peptide aimed at the IL 23 receptor
Johnson & Johnson asks the FDA to approve its daily peptide pill for moderate-to-severe plaque psoriasis in adults and children 12 and older.
Phase 3 → Filed The molecule is closer to patients than before.
The readPsoriasis already has excellent injectables. The bet is that a pill with near-biologic results will reach people who never start an injection. That is a market question as much as a medical one.
The filing
Johnson & Johnson submitted a new drug application for icotrokinra in moderate-to-severe plaque psoriasis. The molecule came out of a long collaboration with Protagonist Therapeutics, which designed it.
The phase 3 picture
In ICONIC-LEAD, a large placebo-controlled trial, a clear majority of people on icotrokinra reached clear or almost clear skin at week 16, against a small minority on placebo; around half reached a 90 percent improvement in their psoriasis score. Side effects were similar to placebo in the reported data. A separate trial compared it with deucravacitinib, an existing oral psoriasis drug, and reported better skin clearance. Check exact rates in the trial publications.
Why the peptide is unusual
IL-23 is a signal that drives psoriasis. Today it is blocked with antibodies given by injection every few weeks or months. Icotrokinra is a short peptide that binds the IL-23 receptor instead, and it has been modified so enough of it survives the stomach and gut to act.
- Stage moves from phase 3 to filed.
- If approved, it would be one of very few oral peptides outside diabetes and obesity.
The FDA decision, data from head-to-head trials against existing pills, and the ulcerative colitis programme.
Primary sourceJohnson & Johnson press release, July 2025; ICONIC phase 3 programme
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