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Source document· March 18, 2026

FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide

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FDA approval of ICOTYDE™ (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide Johnson & Johnson introduces the first and only IL-23R targeted oral peptide that delivers complete skin clearance and favorable safety profile in a once-daily pill ICOTYDE offers…

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ICOTYDE met all primary efficacy endpoints and demonstrated a favorable safety profile across four Phase 3 studies including 2,500 patients
60% confidence
At Johnson & Johnson, we are harnessing our scientific expertise to transform cutting-edge science into meaningful solutions for patients. ICOTYDE is a fundamentally different treatment with the potential to redefine what physicians and patients can expect from psoriasis treatment
60% confidence
Finding the right treatment can take time, during which people with psoriatic disease should be considering multiple factors from efficacy to safety to how the treatment fits into their everyday life
60% confidence
ICOTYDE delivers something unique in psoriasis treatment – combining skin clearance with a favorable safety profile in a once-daily pill, making it an easy addition to a patient's routine
60% confidence
In the head-to-head superiority studies, approximately 70% of patients achieved clear or almost clear skin (IGA 0/1) and 55% of patients achieved a PASI 90 response at Week 16
60% confidence
We're proud to bring this game-changing innovation to the market, marking a transformative shift in plaque psoriasis management that empowers patients and clinicians to reach their treatment goals
60% confidence
With new guidance from the International Psoriasis Council clarifying when to move beyond cycling on topical treatments to systemic therapy, an innovative option like ICOTYDE is a potential game-changer for many adult and adolescent patients
60% confidence
With the FDA approval of ICOTYDE, Johnson & Johnson is setting a new standard for the treatment of moderate-to-severe plaque psoriasis
60% confidence
Transition to systemic therapy should occur if two cycles of topical medications applied for four weeks fail to bring meaningful improvement
60% confidence
The approval of ICOTYDE represents a pivotal moment for people with plaque psoriasis
60% confidence
Rates of adverse reactions for ICOTYDE treated patients were within 1.1% of placebo through Week 16 and no new safety signals were identified through Week 52
60% confidence
The approval of a novel systemic therapy changes the conversation about treatment options for our community
60% confidence