Johnson & Johnson has received approval from the US Food and Drug Administration for Icotyde (icotrokinra), a novel oral therapy for the treatment of moderate-to-severe plaque psoriasis in adults and paediatric patients aged 12 years and above weighing at least 40 kg.

Icotyde is the first and only targeted oral peptide designed to block the interleukin-23 (IL-23) receptor, a key driver of inflammation in psoriasis. The once-daily pill offers a new alternative to injectable biologics and traditional systemic therapies, aiming to improve convenience and patient adherence.

The approval is supported by data from the Phase III ICONIC clinical development programme, which included multiple randomised controlled trials involving over 2,500 patients. Across these studies, Icotyde met all primary efficacy endpoints and demonstrated a favourable safety profile.

In head-to-head trials, approximately 70 percent of patients achieved clear or almost clear skin, while 55 percent reached a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) at Week 16. Adverse event rates were comparable to placebo, with no new safety signals identified up to Week 52.

The therapy was evaluated across diverse patient populations, including those with high-impact disease areas such as the scalp, hands, feet and genital regions, reinforcing its broad applicability in clinical practice.

Psoriasis affects more than 125 million people worldwide, including over 8 million in the United States, with nearly one-quarter experiencing moderate-to-severe disease requiring systemic treatment. The condition significantly impacts quality of life, particularly when visible or sensitive areas are affected.

Icotyde’s approval aligns with evolving clinical guidelines that recommend transitioning to systemic therapies when topical treatments fail to deliver adequate improvement. As an oral therapy, it offers a simpler administration route while maintaining efficacy and safety.

Beyond psoriasis, Icotyde is also being investigated in other immune-mediated conditions, including psoriatic arthritis, ulcerative colitis and Crohn’s disease, highlighting its potential across a broader spectrum of inflammatory disorders.

The drug was discovered in collaboration with Protagonist Therapeutics, with Johnson & Johnson holding exclusive global rights for its development and commercialisation.

The approval marks a significant advancement in psoriasis treatment, introducing a new class of targeted oral therapies that could reshape disease management and expand options for patients and clinicians.