Drug Update · Dermatology

FDA Approves Icotrokinra for Plaque Psoriasis: 71% IGA 0/1 in PSO-2

July 15, 2026

Approval date

2026-03-17

Indication

Moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older (≥40 kg)

Approved dose

200 mg orally once daily

Primary endpoints reported

IGA 0/1 and PASI 90 at Week 16

Key PSO-2 result

IGA 0/1 71% with icotrokinra vs 9% with placebo at Week 16 [11]

Clinical Perspective

This update affects dermatologists, pediatric dermatologists, advanced practice providers, and pharmacists treating patients with moderate-to-severe plaque psoriasis by adding an oral IL-23 receptor antagonist option supported by randomized Phase 3 data ^[2]. The source-confirmed trial data support that icotrokinra provides higher IGA 0/1 and PASI 90 response rates at Week 16 versus placebo and higher IGA 0/1 rates versus deucravacitinib in PSO-1 and PSO-2 ^[2]. What patient selection criteria (comorbidities or monitoring) and longer-term safety beyond the trial windows remain unanswered?

Dr. Divya Agarwal · Dermatology

The FDA approved icotrokinra (ICOTYDE) for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg on 2026-03-17, based on randomized placebo- and active-controlled trials showing higher rates of skin clearance versus placebo and versus an active comparator in adult trials PSO-1 and PSO-2 ^[2]. The approval is supported by co-primary efficacy outcomes including IGA 0/1 and PASI 90 at Week 16 in Trial PSO-1 and Trial PSO-2 ^[2].

Clinical Context

Icotrokinra is an oral peptide that antagonizes the interleukin-23 receptor (IL-23R); it is described in the prescribing information as an IL-23 receptor antagonist that inhibits IL-23/IL-23R–dependent release of proinflammatory cytokines ^[2]. The FDA prescribing information states icotrokinra’s indication is for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years and older (≥40 kg) who are candidates for systemic therapy or phototherapy ^[2]. The approval was supported by multiple randomized, double-blind, placebo- and active-controlled trials in adults with moderate-to-severe plaque psoriasis, and efficacy end points reported in the label include Investigator’s Global Assessment (IGA) 0/1 and Psoriasis Area and Severity Index (PASI) responses at Week 16 and Week 24 ^[2].

Key Findings

Trial PSO-2 showed icotrokinra achieved an IGA 0/1 response of 71% versus 9% with placebo at Week 16 (ICOTYDE 227/320; placebo 7/81) ^[2].
Trial PSO-1 showed icotrokinra achieved an IGA 0/1 response of 68% versus 11% with placebo at Week 16 (ICOTYDE 213/311; placebo 17/156) ^[2].
In PSO-1 and PSO-2, icotrokinra produced higher PASI 90 rates at Week 16 compared with placebo: PSO-1 PASI 90 55% versus 4% (ICOTYDE 171/311; placebo 6/156) and PSO-2 PASI 90 58% versus 1% (ICOTYDE 184/320; placebo 1/81) ^[2].
Comparisons to the active comparator deucravacitinib were reported as secondary endpoints in the adult trials; for IGA 0/1 at Week 16 PSO-2 reported 71% with icotrokinra versus 55% with deucravacitinib (ICOTYDE 227/320; deucravacitinib 177/322) ^[2].

All numeric efficacy outcomes above are reported in the FDA prescribing information for Trials PSO-1 and PSO-2 ^[2].

Safety & Tolerability

Safety information was not available in the provided source excerpts.

Study Design

The FDA approval was supported by four multi-center, randomized, double-blind, placebo- and/or active-comparator-controlled trials (Trial PSO-1 [NCT06143878], Trial PSO-2 [NCT06220604], Trial PSO-3 [NCT06095115], and Trial PSO-4 [NCT06095102]) that included approximately 2,500 subjects (2,428 adults and 72 pediatric subjects 12 years and older who weigh at least 40 kg) with moderate-to-severe plaque psoriasis ^[2]. Trials PSO-1 and PSO-2 randomized adults to icotrokinra 200 mg orally once daily, deucravacitinib 6 mg once daily, or placebo, with placebo and active-comparator crossovers at specified weeks; co-primary endpoints included IGA 0/1 and PASI 90 at Week 16 ^[2]. Clinicians should consult current prescribing information for full dosing guidance. The approved dosage per prescribing information is 200 mg orally once daily ^[2].

FAQ

Q1 What is icotrokinra (ICOTYDE) approved for?

ICOTYDE (icotrokinra) is approved for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy. The approval and indication are stated in the FDA prescribing information dated 2026-03-17.

Q2 How does icotrokinra work?

Icotrokinra is an oral peptide that selectively binds to and antagonizes the interleukin-23 receptor (IL-23R), inhibiting IL-23/IL-23R–dependent release of proinflammatory cytokines. The prescribing information describes icotrokinra as an IL-23 receptor antagonist; the mechanism is reported in the FDA label and associated FDA reviews.

Q3 What is the recommended dose of icotrokinra?

The recommended dosage of ICOTYDE is 200 mg administered orally once daily. The prescribing information provides administration instructions including taking ICOTYDE on an empty stomach with water upon waking and waiting at least 30 minutes before eating; alternative administration instructions for patients who have difficulty swallowing are included in the label. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects?

[Information] was not available in the provided source excerpts.

FDA Approves Icotrokinra for Plaque Psoriasis: 71% IGA 0/1 in PSO-2

Direct Clinical Takeaway & Evidence Summary

FDA Approves Icotrokinra for Plaque Psoriasis: 71% IGA 0/1 in PSO-2

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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