Guselkumab: Pediatric First Approval

Funding The preparation of this review was not supported by any external funding.DeclarationsAuthorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sheridan M. Hoy is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.Additional information about this Adis Drug Review can be found here. AbstractGuselkumab (TREMFYA®) is a fully human IgG1λ monoclonal antibody developed by Johnson & Johnson to selectively target the p19 subunit of interleukin (IL)-23, a cytokine that plays a key role in various immune-mediated inflammatory diseases. Guselkumab is approved in multiple countries worldwide, including the USA and those of the EU, for the treatment of adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderately-to-severely active ulcerative colitis and Crohn’s disease. In September 2025, guselkumab received its first pediatric approvals in the USA for the treatment of pediatric patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis who are 6 years of age and older and weigh ≥ 40 kg. Subsequently, guselkumab was approved in December 2025 in the EU for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Johnson & Johnson is currently undertaking phase III development of guselkumab in pediatric patients with Crohn's disease and ulcerative colitis in various countries. This article summarizes the milestones in the development of guselkumab leading to these first pediatric approvals for plaque psoriasis and psoriatic arthritis.© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2026