Hepion receives FDA support for planned Phase 2 trial of GV104 in gambling disorder
HEPA•Hepion Pharmaceuticals said the FDA supported the general design of subsidiary Gravitas Life Sciences’ planned Phase 2 trial of GV104 for gambling disorder. Gravitas expects to file an investigational new drug application in 2027, and the trial design remains subject to FDA review.
1. FDA feedback on trial design
The FDA supported the general design of Gravitas Life Sciences’ planned Phase 2 trial evaluating GV104 as an addition to psychosocial care for gambling disorder. The agency permitted Gravitas to cross-reference existing nonclinical and manufacturing data, potentially supporting a 12-week study without repeating earlier work. FDA guidance also outlined a potential 505(b)(2) approval pathway relying partly on prior agency findings for an approved nalmefene product.
