FDA Approves First-of-Its-Kind Psoriasis Pill, ICOTYDE

For years, the most effective psoriasis treatments have come in the form of injections. Now, there is a new option that may feel a little easier for some to commit to. The FDA has approved ICOTYDE (icotrokinra), a once-daily pill for moderate-to-severe plaque psoriasis that targets the same IL-23 pathway as today’s leading injectables. It’s the first time this level of targeted therapy has been available in an oral form, giving patients the possibility of skipping needles without giving up results.

How It Differs From Past Oral Treatments

ICOTYDE works differently than older oral medications. It is an oral peptide designed to survive the digestive system and reach its target. “This is the first oral peptide of its kind designed to enhance absorption from the gastrointestinal tract while targeting a pathway in the pathogenesis of psoriasis,” says Detroit dermatologist Linda Stein Gold, MD. It blocks the IL-23 receptor, a key driver of inflammation and the same pathway many top injectables target, just delivered in a daily pill. “This therapy offers patients an additional oral option with clinical data suggesting meaningful efficacy and a favorable safety and tolerability profile,” she adds.

Psoriasis affects more than 8 million Americans, and many patients spend years rotating through topical treatments before moving to something stronger. “Dermatologists have long faced an unmet need for oral treatment options for patients with moderate to severe plaque psoriasis,” Dr. Stein Gold says.

Who Is a Good Candidate?

ICOTYDE is approved for adults and patients 12 and older who are candidates for systemic therapy, including those who have only used topicals in the past. Like other treatments that affect the immune system, it comes with considerations such as infection risk and side effects like headache, nausea and fatigue. In trials, its safety profile was generally comparable to placebo, supporting its potential as a well-tolerated, more convenient option.

The results are what make this especially notable. In clinical trials, about 70 percent of patients achieved clear or almost clear skin, and 55 percent reached PASI 90 by week 16. Those are numbers typically associated with injectable treatments.

“Icotrokinra introduces a differentiated oral option, with clinical data suggesting efficacy approaching that of biologic therapies, along with a favorable safety and tolerability profile,” Dr. Stein Gold says. It’s not about replacing injectables, but it does give patients another option to consider if they want similar results without injections.

The approval also signals where treatment may be headed next. “The approval of ICOTYDE represents a pivotal moment for people with plaque psoriasis,” said John Reed, MD, PhD, executive vice president of R&D and Innovative Medicine at Johnson & Johnson, in a statement. “It reflects a shift toward treatments that combine targeted science with a more accessible, patient-friendly format.”