FDA
FDA greenlights Icotyde for moderate-to-severe plaque psoriasis
Brand name: Icotyde
Generic name: icotrokinra
Manufacturer: Janssen Biotech, Inc.
Approval date: March 17, 2026
FDA approved Icotyde (icotrokinra), an oral interleukin-23 (IL-23) receptor antagonist, for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.
Efficacy
Icotyde (icotrokinra) was evaluated in four multi-center, randomized, double-blind, phase 3 trials (ICONIC-ADVANCE 1, ICONIC-ADVANCE 2, ICONIC-LEAD, and ICONIC-TOTAL) including a total of 2,500 participants (2,428 adults and 72 pediatric patients) with moderate-to-severe plaque psoriasis.
In ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, adult participants were randomized to receive Icotyde 200 mg orally once daily, deucravacitinib 6 mg orally once daily, or placebo. In ICONIC-LEAD, 684 participants (618 adults and 66 pediatric patients ≥12 years old weighing ≥40 kg) were randomized to receive Icotyde 200 mg orally once daily or placebo. Participants in all three studies had moderate-to-severe plaque psoriasis defined as Investigator’s Global Assessment (IGA) score ≥3, a Psoriasis Area and Severity Index (PASI) score ≥12, and body surface area (BSA) involvement ≥10%. All three trials evaluated Icotyde (icotrokinra) vs. placebo for two co-primary endpoints: IGA 0/1 and PASI 90 responses at week 16. Study results were as follows:
ICONIC-ADVANCE 1 (N=774)
- IGA 0/1 at week 16: 68% icotrokinra vs. 11% placebo (treatment difference 58%; 95% confidence interval [CI], 50-64%)
- PASI 90 at week 16: 55% vs. 4% (treatment difference 51%; 95% CI, 44-57%)
ICONIC-ADVANCE 2 (N=723 evaluated for efficacy)
- IGA 0/1 at week 16: 71% vs. 9% (treatment difference 63%, 95% CI, 53-70%)
- PASI 90 at week 16: 58% vs. 1% (treatment difference 57%; 95% CI, 49-62%)
ICONIC-LEAD (N=684)
- IGA 0/1 at week 16: 65% vs. 8% (treatment difference 56%; 95% CI, 50-62%)
- PASI 90 at week 16: 50% vs. 4% (treatment difference 45%; 95% CI, 40-50%)
The fourth study, ICONIC-TOTAL, enrolled 311 participants (305 adults and 6 pediatric patients ≥12 years old weighing ≥40 kg) with moderate-to-severe plaque psoriasis who had a minimum BSA involvement of ≥1%, an IGA score of ≥2, and failed response to at least one topical therapy. Additionally, subjects had one or more of the following at baseline: at least moderate plaque psoriasis of the scalp, genital area, and/or the hands/feet. Participants were randomized to receive Icotyde 200 mg orally once daily or placebo. The primary endpoint was IGA 0/1 response at week 16. Icotyde achieved 57% IGA 0/1 response vs. 6% with placebo, representing a treatment difference of 51% (95% CI, 42-59%).
Safety
Most common adverse reactions (≥1%): headache, nausea, cough, fungal infection, and fatigue. Other adverse reactions reported in <1% of study participants: gastritis, abdominal discomfort, and one fatal case involving upper GI bleeding in a participants with underlying risk factors. The prescribing information for Icotyde also includes warnings regarding infections, tuberculosis, and use of live vaccines.
Recommended dose
The recommended dosage of Icotyde is 200 mg orally once daily. Administer on an empty stomach with water upon waking. Wait at least 30 minutes after taking Icotyde before eating food. For patients who have trouble swallowing tablets, Icotyde may be dispersed in water according to the directions in the prescribing information.
Sources:
(2026, March 18). FDA approval of Icotyde (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. [Press release]. https://www.jnj.com/media-center/press-releases/fda-approval-of-icotyde-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide
Icotyde (icotrokinra). [Package insert]. Janssen Biotech, Inc. https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/ICOTYDE-pi.pdf Revised March 2026. Accessed March 18, 2026.