The latest research progress and results of mirikizumab

Milikizumab has made significant progress in the treatment of inflammatory bowel disease. As a monoclonal antibody targeting interleukin-23 (IL-23p19), militizumab blocks the IL-23 signaling pathway and inhibits the activation of T cells and related inflammatory cells, thereby reducing the inflammatory response of the intestinal mucosa and providing a new treatment strategy for patients with moderate to severe ulcerative colitis and Crohn's disease (CD). In 2023, the drug was approved in the United States for the treatment of adults with moderate to severe ulcerative colitis, and in 2025 it was further approved for Crohn's disease.

The latest research shows that the maintenance treatment regimen of militizumab can be a single subcutaneous injection, and the efficacy can be maintained once a month. Compared with the previous twice-monthly injection regimen, the efficacy is not significantly different, but it significantly simplifies the patient's treatment process and improves compliance and convenience of life. During the induction treatment phase, a regimen of 300 mg of intravenous injection is still used for 12 consecutive weeks to quickly suppress inflammation, improve mucosal damage, and promote long-term remission. Clinical studies also found that in long-term maintenance treatment, militizumab can maintain the mucosal repair effect, reduce the disease recurrence rate, and control side effects. Common adverse reactions include injection site reactions, mild upper respiratory tract infection, and occasional diarrhea, and most patients tolerate long-term use.

In vitro studies and animal experiments have shown that militizumab can effectively inhibit the release of inflammatory cytokines and block pathological immune responses in different inflammatory bowel disease models. This provides a scientific basis for its use in refractory patient populations, especially those who respond poorly to TNF-α inhibitors or conventional immunosuppressants. In addition, the drug developer plans to launch a citrate-free single-injection product in prefilled pen or syringe form in 2026 to further enhance the convenience of home self-administration.

Reference materials:https://omvoh.lilly.com/