Intarsia

Intarcia Therapeutics was a clinical-stage biotechnology company that developed the Medici Drug Delivery System, a proprietary platform designed to provide continuous, long-term delivery of therapeutic proteins and peptides. The company's lead candidate, ITCA 650, was an implantable subcutaneous osmotic mini-pump for the treatment of type 2 diabetes, delivering the GLP-1 receptor agonist exenatide. Despite raising over $1.5 billion in private capital and completing Phase 3 trials, the product faced significant regulatory hurdles, receiving multiple Complete Response Letters from the FDA due to safety concerns regarding acute kidney injury and manufacturing consistency. Following a final rejection of its appeal by the FDA in 2023, the company effectively ceased operations and began the process of winding down.