The U.S. Food and Drug Administration (FDA) has approved a once-daily pill called icotrokinra (Icotyde) for moderate to severe plaque psoriasis in adults and in teens ages 12 and older. This approval adds a new oral (by mouth) option for people who need more than topical treatments to manage psoriasis.

In clinical trials, around 70 percent of people taking the drug reached “clear” or “almost clear” skin by Week 16. By Week 52, about half of people in two phase 3 trials reached complete skin clearance, defined as Psoriasis Area and Severity Index (PASI) 100.

What Is Icotyde?

Icotyde is a type of medicine that blocks the interleukin-23 (IL-23) receptor, which plays a role in the inflammation linked to plaque psoriasis. It’s approved for people with moderate to severe plaque psoriasis who are candidates for systemic (whole-body) therapy or phototherapy.

Icotyde isn’t the first oral treatment for psoriasis, but it’s the only one designed to block the IL-23 receptor.

What Did the Studies Show?

The FDA approval was supported by four phase 3 clinical trials that included about 2,500 participants overall. Among the trials’ key findings:

• In two trials that compared icotrokinra with placebo (and also included an active comparator arm), about 70 percent of people taking icotrokinra reached “clear” or “almost clear” skin on the Investigator’s Global Assessment (IGA) scale by Week 16.
• Over half (55 percent to 58 percent) reached PASI 90 (at least a 90 percent improvement) at Week 16 in those trials.
• In a study focused on psoriasis in sensitive areas, like the scalp or genitals, 57 percent reached IGA 0/1 at Week 16, compared with 6 percent on placebo.
• In long-term (52-week) trial follow-up, complete skin clearance became more common over time. In two studies, the share of people reaching PASI 100 rose from Week 24 to Week 52, from 41 percent to 49 percent in one trial, and from 33 percent to 48 percent in the other.

Side Effects and Safety Considerations

Like all treatments, icotrokinra can cause side effects. The most common side effects listed in the drug’s prescribing label are headache, nausea, cough, fungal infection, and fatigue. Rare but serious risks include infections.

What This Could Mean for People Living With Psoriasis

For some people, an effective once-daily pill could feel more doable than injections or clinic-based treatments, especially if psoriasis affects sensitive or hard-to-treat areas like the scalp or genitals.

If you’re thinking about switching from topicals to a systemic option, talk to your doctor about potential benefits and drawbacks of this new option.

Connect With Others Who Understand

On MyPsoriasisTeam, people share their experiences with psoriasis, get advice, and find support.

Have you tried an oral treatment for plaque psoriasis before? Let others know in the comments below.