Hepion Pharmaceuticals Gains FDA Clarity on GV104 Pathway for Gambling Disorder

Cross-referencing existing IND data across a new indication is rarely straightforward, but Hepion Pharmaceuticals has received written confirmation from FDA's Division of Psychiatry that its nonclinical and CMC data already on file may be applied directly to a new gambling disorder program for GV104, a transmucosal buccal film. The response, issued following a Type B pre-IND meeting request, also confirmed that the planned Phase 2 proof-of-concept design is, in general, appropriate.

For regulatory affairs leads managing multi-program development portfolios, the efficiency signal here is concrete. Under a 505(b)(2) pathway, Gravitas Life Sciences, Hepion's wholly-owned subsidiary advancing GV104, intends to rely in part on FDA's prior findings for an approved nalmefene product, while cross-referencing the existing IND for nonclinical and CMC sections. FDA further indicated that nonclinical studies already submitted appear potentially sufficient to support 12-week clinical dosing in a Phase 2 study, reducing the need for a full standalone nonclinical package.

The indication itself carries regulatory weight. Gambling disorder is a recognized psychiatric diagnosis with no approved pharmacotherapy; current standard of care relies on psychosocial interventions, counseling, and peer support. GV104 is intended as an adjunct to those approaches, not a replacement. The absence of an approved comparator shapes both the endpoint strategy and the NDA evidentiary bar, and FDA's written feedback addressed both: the proposed disease severity assessment tool was accepted as appropriate for the primary endpoint in the planned trial.

On longer-term development, FDA outlined the additional nonclinical data it will expect at the time of a New Drug Application and indicated that proposed plans to support clinical studies beyond 12 weeks appear reasonable. That alignment on Phase 3 requirements at the pre-IND stage gives the program a clearer forward architecture than most early-stage psychiatric programs carry at this point in development.

Hepion anticipates filing an IND for GV104 in this indication and commencing the path toward a Phase 2 study in 2027, with dose-ranging and endpoint validation incorporated per FDA recommendations.

Source: Hepion Pharmaceuticals via ACCESS Newswire, October 19, 2026.