Akyso Therapeutics

Akyso Therapeutics is a clinical-stage biotech advancing the iSTEP platform, a tunable, bioabsorbable polymeric implant for ultra-long-acting drug delivery. Its lead program, iSTEP-N (naltrexone), has completed a Phase 1a trial, with a Phase 1b PK study slated for Q1 2026, targeting the significant compliance challenges in opioid use disorder treatment. The pipeline also includes a buprenorphine implant for OUD and exploratory work on a GLP-1 agonist implant for weight loss, positioning the company at the intersection of advanced drug delivery and high-need therapeutic areas. As a private, pre-revenue company, Akyso is seeking to translate its versatile technology into novel treatments that improve patient adherence and outcomes.

iSTEP (Implantable, Subcutaneous, Tunable, Extended-release, Polymeric implant): A proprietary, bioabsorbable, subcutaneous implant platform designed to provide sustained drug release for 6-12 months. It is tunable for different APIs, stable at room temperature, and designed for simple office-based implantation without removal.

In OUD, Akyso competes with existing long-acting injectables (e.g., Sublocade) and a non-bioabsorbable implant (Probuphine). In the broader drug delivery space, numerous companies are developing sustained-release technologies. For GLP-1s, the competition is fierce, dominated by large pharma with weekly injectables and oral formulations, though a 6-12 month implant would be a differentiated offering.