Guselkumab, sold under the brand name Tremfya, is a monoclonal antibody against interleukin-23 used for the treatment of plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
[5] Guselkumab lowers the release of immune system signalling molecules, increasing the risk of infections from bacteria, viruses, and fungi.
[14] In November 2016, Janssen submitted a Biologics License Application (BLA) to the FDA seeking approval of guselkumab.
[20][21] In September 2024, the FDA approved guselkumab for the treatment of moderately to severely active ulcerative colitis in adults.
[23] The phase III clinical trial "NAVIGATE" (ClinicalTrials.gov ID: NCT02203032) included only patients who had poor responses to treatment with ustekinumab.