Akyso

Akyso Therapeutics is a clinical-stage biotechnology company developing ultra–long-acting, fully bioabsorbable subcutaneous implants for opioid use disorder (OUD) and related conditions. Our lead program, iSTEP-N®, is a 6–12-month extended-release naltrexone implant designed to overcome the adherence challenges that limit existing treatments. We recently completed our first-in-human Phase 1a trial, which demonstrated excellent tolerability and sustained therapeutic plasma levels of naltrexone, with residual drug content suggesting the potential for year-long efficacy. We are now preparing to initiate our Phase 1b patient study, which will compare iSTEP-N to Vivitrol® and further evaluate long-term pharmacokinetics, safety, and re-implantation. In parallel, we have secured major new NIH funding to expand our pipeline to include iSTEP-B®, a 6–12-month buprenorphine implant for OUD, leveraging the same patented, fully bioabsorbable iSTEP® platform. Our proprietary polymer system (PDLLA + PCL) enables tunable, predictable, and extended drug delivery without the need for removal procedures. Akyso’s mission is to bring forward discreet, long-acting, life-changing treatments that reduce relapse risk during the most vulnerable stages of recovery. With strong preclinical data, successful early clinical results, significant NIH support, and a rapidly expanding pipeline, we are positioned to deliver the first new OUD medication option in nearly two decades.