FDA approves icotrokinra for patients aged ≥12 years with moderate-to-severe plaque psoriasis

On March 18, 2026, the U.S. Food and Drug Administration (FDA) approved icotrokinra, an oral interleukin-23 (IL-23) inhibitor, for the treatment of adults and pediatric patients (aged ≥12 years who weigh ≥40 kg and are candidates for systemic therapy or phototherapy) with moderate-to-severe plaque psoriasis.¹ This approval is based on results from the phase III ICONIC trials, which evaluated icotrokinra in adults and adolescents with plaque psoriasis.¹  

As previously reported by the PsOPsA Hub, in the ICONIC-LEAD study (NCT06095115), icotrokinra vs placebo demonstrated greater rates of Investigator’s Global Assessment (IGA) scores of 0/1 (65% vs 8%; p < 0.001) and of ≥90% improvement in Psoriasis Area and Severity Index (PASI90; 50% vs 4%; p < 0.001) at Week 16.² Safety profiles were similar between groups, with nasopharyngitis (7%), upper respiratory tract infection (URTI; 7%), and gastrointestinal (GI) events (6%) being the most common adverse events (AEs) in the icotrokinra group.² 

In the ongoing ICONIC-TOTAL trial (NCT06095102), icotrokinra is being evaluated in adult and adolescent patients with moderate plaque psoriasis affecting special areas, such as scalp, genital, and palmoplantar.¹ At Week 16, 57% of patients receiving icotrokinra demonstrated an IGA score of 0/1 vs 6% of patients receiving placebo (p < 0.001).³ Rates of AEs were similar between groups (50% vs 42%) and most commonly included nasopharyngitis and GI events.³  

Results from Week 16 of the ongoing ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) studies, comparing icotrokinra with deucravacitinib and placebo in adults with moderate-to-severe plaque psoriasis, have previously been reported by the PsOPsA Hub. Higher proportions of patients receiving icotrokinra vs placebo demonstrated an IGA score of 0/1 (ADVANCE 1, 68% vs 11%; ADVANCE 2, 70% vs 9%) and PASI90 (ADVANCE 1, 55% vs 4%; ADVANCE 2, 57% vs 1%) at Week 16.⁴ The most common AEs were nasopharyngitis (icotrokinra, 6%; placebo, 5%) and URTI (icotrokinra, 4%; placebo, 3%).⁴ 

The ICONIC-ASCEND (NCT06934226) study is currently underway, investigating icotrokinra vs placebo and ustekinumab in patients with moderate-to-severe plaque psoriasis.¹ Additional studies, including ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424), are in progress to evaluate icotrokinra in active psoriatic arthritis.¹