FDA has approved Icotyde as the first oral targeted therapy for moderate-to-severe plaque psoriasis, offering adults and adolescents a once-daily pill that blocks the IL-23 receptor.
FDA approved Icotyde (icotrokinra), a first-of-its-kind oral pill for moderate-to-severe plaque psoriasis.
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The approval gives patients and physicians a new systemic treatment option that works differently from existing therapies.
“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. “With new guidance from the International Psoriasis Council that clarifies when to move beyond cycling on topical treatments to systemic therapy, an innovative option like Icotyde is a potential game‑changer for many adult and adolescent patients.”
Icotyde is the first targeted oral peptide designed to block the interleukin-23 (IL-23) receptor, a key driver of the inflammatory response in plaque psoriasis.1 Unlike existing biologics that are administered by injection, Icotyde is taken once daily by mouth with water, 30 minutes before eating.
The treatment is approved for adults and pediatric patients aged 12 and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.1 The drug was jointly discovered by Protagonist Therapeutics and Johnson & Johnson, with J&J holding exclusive worldwide rights to develop and commercialize it.1
The approval is based on data from the Iconic clinical development program, which enrolled approximately 2,500 patients across four Phase III studies. The program simultaneously evaluated Icotyde in adults and adolescents, including patients with psoriasis affecting high-impact areas such as the scalp and genitals, and ran duplicate head-to-head trials against an active comparator.2
In superiority studies, approximately 70% of patients achieved clear or almost clear skin at week 16, and 55% achieved a PASI 90 response, a 90% reduction in disease severity.2 Adverse reaction rates were within 1.1% of placebo through week 16, with no new safety signals identified through week 52.2
Psoriasis affects more than 8 million Americans, with nearly one quarter of cases considered moderate-to-severe. For patients whose disease has not responded to two cycles of topical treatments, the International Psoriasis Council recommends transitioning to systemic therapy, a threshold that leaves many patients without a convenient oral option prior to this approval.1
Leah Howard, president and CEO of the National Psoriasis Foundation, said the approval of a novel systemic therapy changes the treatment conversation for the psoriasis community.
“Finding the right treatment can take time, during which people with psoriatic disease should be considering multiple factors from efficacy to safety to how the treatment fits into their everyday life,” said Leah M. Howard, J.D., president and CEO of the National Psoriasis Foundation. “The approval of a novel systemic therapy changes the conversation about treatment options for our community.”
Johnson & Johnson is currently studying Icotyde across several additional indications. Active trials are underway in psoriatic arthritis, moderately-to-severely active ulcerative colitis, and moderately-to-severely active Crohn's disease, suggesting the company sees broad potential for IL-23 receptor blockade beyond dermatology.1
If successful in those indications, Icotyde holds the potential to become a platform therapy across multiple immune-mediated diseases.
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