FDA Approves Icotrokinra (ICOTYDE™), a First-in-Class Oral Peptide Therapy, for Moderate-to-Severe Plaque Psoriasis

　　【Pharmaceutical Network Industry DynamicsPlaque psoriasis is an immune-mediated disease, affecting more than 125 million people worldwide, with nearly a quarter being moderate to severe cases, significantly impacting patients' physical and mental health as well as their quality of life. Recently, there has been重磅 news in the field of psoriasis.
 

On March 18, Johnson & Johnson announced that the FDA had approved icotrokinra (brand name: ICOTYDE™) for marketing, used to treat adult and adolescent patients aged 12 years or older with moderate to severe plaque psoriasis who weigh ≥40kg and are suitable for systemic therapy or phototherapy.
 

Icotrokinra is a first-in-class oral peptide drug (IL-23R antagonist) that Johnson & Johnson acquired for nearly $1 billion from Protagonist. This drug is the first targeted oral peptide drug capable of blocking the IL-23 receptor, and it represents the first approved first-line oral systemic therapy for this indication.
 

IL-23 plays a key role in the pathogenic T-cell activation in moderate to severe plaque PsO and is fundamental to the inflammatory response in PsO and other dermatologic, rheumatologic, and IL-23-mediated gastrointestinal diseases. Icotyde binds to IL-23R with single-digit picomolar affinity and potently inhibits IL-23 signaling in human T cells with high selectivity.
 

It is reported that the FDA approval of icotrokinra was based on four Phase 3 clinical studies covering approximately 2,500 patients. The studies showed that Icotyde met all primary efficacy endpoints and demonstrated a favorable safety profile. Specifically: In the superiority head-to-head study, about 70% of patients achieved clear or almost clear skin lesions (IGA 0/1) by Week 16, and 55% of patients achieved a Psoriasis Area and Severity Index (PASI) 90 response. By Week 16, the incidence of adverse reactions in the treatment group differed from that in the placebo group by within 1.1%, and no new safety signals were identified by Week 52.
 

Psoriasis is a chronic, recurrent, inflammatory skin disease that affects approximately 125 million people worldwide. In recent years, due to the combined influence of environmental factors, lifestyle, and other elements, the number of patients with psoriasis has shown a slow-growing trend. Psoriasis not only impacts skin health but can also affect joints, the cardiovascular system, and more, leading to conditions such as psoriatic arthritis and metabolic syndrome, causing various damages and significantly affecting the quality of life for patients. Data shows that over 8 million psoriasis patients in the U.S. endure the dual burden of physical discomfort and reduced quality of life, particularly when lesions are located in exposed or sensitive areas, where the impact is even more significant.
 

In China, the number of psoriasis patients is also on the rise. According to reports, on November 19, 2025, the CDE website showed that Johnson & Johnson's Class 1 new drug, Icotrokinra Hydrochloride Tablets, was submitted for marketing approval. It is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as pediatric patients aged 12 years and older. On the same day, this indication was also included by the CDE in the proposed priority review. If approved for marketing in the future, it will bring a new treatment option to patients in China.
 

A Johnson & Johnson representative stated that the approval of Icotrokinra marks that Johnson & Johnson is reshaping the treatment standard for moderate to severe plaque psoriasis. Industry experts point out that, compared with traditional psoriasis treatments including topical ointments and injectable therapies, oral peptide psoriasis drugs are more convenient, easier for patients to accept and use continuously, thereby improving treatment adherence. Additionally, oral medications can be absorbed systemically, acting directly on the immune system to achieve systemic therapeutic effects, rather than being limited to localized skin treatment.
 

Moreover, some experts pointed out that oral peptide drugs not only have broad prospects in treating psoriasis but also may be applied to treat other autoimmune diseases as research deepens. For instance, the blockade of cytokines such as IL-23 and IL-17 is also considered to have therapeutic potential in diseases like rheumatoid arthritis and ulcerative colitis. With the continuous optimization of peptide drugs, the expansion of their indications may become a long-term research direction, further promoting the breadth and depth of their clinical applications.
 

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