Icotrokinra & ICOTYDE: New Psoriasis Treatments Approved by FDA | News & Stock Updates

March 22, 2026 Priya Shah – Business Editor Business

The U.S. Food and Drug Administration approved ICOTYDE™ (icotrokinra) on March 18, 2026, marking a new treatment option for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older weighing at least 40 kg, according to a press release from Johnson & Johnson.

ICOTYDE is the first and only interleukin-23 (IL-23) receptor antagonist administered orally, designed as a targeted peptide to block the IL-23 receptor. The approval provides a systemic treatment option for individuals who are candidates for either systemic therapy or phototherapy. Johnson & Johnson stated the drug offers a favorable safety profile alongside complete skin clearance in a once-daily pill.

“ICOTYDE delivers something unique in psoriasis treatment – combining skin clearance with a favorable safety profile in a once–daily pill, making it an easy addition to a patient’s routine,” said Linda Stein Gold, M.D., Director of Dermatology Clinical Research at Henry Ford Health.

The approval comes as new guidance from the International Psoriasis Council clarifies when to transition from topical treatments to systemic therapy, potentially positioning ICOTYDE as a significant advancement for patients cycling through topical options. Clinical trials involving 2,500 patients across four Phase 3 studies demonstrated the drug met all primary efficacy endpoints, according to Johnson & Johnson.

Protagonist Therapeutics, in collaboration with Janssen Biotech, a Johnson & Johnson company, developed icotrokinra. Protagonist Therapeutics currently has other drug therapies in clinical studies, including rusfertide for polycythemia vera, and continues Phase 2b trials for ulcerative colitis with icotrokinra. Johnson & Johnson retains exclusive global rights for the development and commercialization of icotrokinra.

Protagonist Therapeutics’ stock rallied nearly 7% in the week following the FDA approval announcement, reflecting investor confidence in the drug’s potential. The company is as well conducting clinical trials for rusfertide, a hepcidin mimetic, as a treatment for polycythemia vera.