A first-in-class, orally administered modulator engineered with a unique mechanism that represents a paradigm shift in OUD treatment. Preclinical data demonstrate a highly differentiated Target Product Profile, with no abuse potential, minimal withdrawal, and exceptional oral bioavailability.
The program is at the Nonclinical Phase 2 (IND-enabling) stage with strategic plans to complete all necessary IND-enabling activities, including GMP manufacturing and GLP toxicology, and file an Investigational New Drug (IND) application with the FDA.