ITCA 650

**ITCA 650** is an investigational long-acting, implantable drug-device combination that provides continuous subcutaneous delivery of the GLP-1 receptor agonist **exenatide** for treatment of type 2 diabetes mellitus. The product uses a matchstick-sized DUROS osmotic mini-pump implanted beneath the abdominal skin to release exenatide at a controlled rate for months, with the aim of avoiding frequent self-injections and improving adherence. It was developed by Intarcia Therapeutics and licensed outside the United States and Japan to Servier; Intarcia's cardiometabolic assets, including ITCA 650, were acquired by i2o Therapeutics in 2023. Although the FREEDOM Phase 3 program reported glycemic and weight-loss efficacy, the FDA issued a final order refusing approval of NDA 209053 on August 23, 2024, concluding that safety for the intended use had not been demonstrated. ([fda.gov](https://www.fda.gov/media/175444/download))

Other names

exenatide in DUROS deviceITCA 650 exenatide implantITCA650 exenatide implantITCA-650 exenatide implant