AI-401

AI-401 is a discontinued oral insulin formulation originally developed by **Autoimmune Inc.** in collaboration with **Eli Lilly**. Unlike standard insulin therapy used for glycemic control, AI-401 was designed as an antigen-specific immunotherapy to induce "oral tolerance." The therapeutic rationale was that delivering recombinant human insulin to the gut-associated lymphoid tissue (GALT) would stimulate regulatory T cells to suppress the autoimmune destruction of pancreatic beta cells. It was primarily investigated for the prevention or delay of Type 1 diabetes in individuals at high risk for the disease. AI-401 was a central component of the large-scale, NIH-sponsored **Diabetes Prevention Trial-Type 1 (DPT-1)**. However, the program was discontinued in the late 1990s after Phase 3 clinical trial results failed to demonstrate a significant clinical benefit in preventing the onset of diabetes.

Other names

Oral insulinOral insulin (Autoimmune Inc.)