# Hepion Pharmaceuticals Gains FDA Feedback for Gambling Disorder Candidate

- URL: https://stocks.freetheai.org/news/hepion-pharmaceuticals-gains-fda-feedback-for-gambling-disorder-candidate-d1dfc0
- Published: 2026-10-19T12:01:00Z
- Category: company_news; sentiment: bullish; impact: medium
- Symbols: [OTC:HEPA](https://stocks.freetheai.org/symbols/OTC-HEPA)
- Written by our AI from expert market sources across the web for FreeTheAI Stocks, built by Vibhek Soni
- How write-ups are made: https://stocks.freetheai.org/how-we-write
- Not financial advice: https://stocks.freetheai.org/disclaimer

Hepion Pharmaceuticals, Inc. (OTC:HEPA) announced that its subsidiary, Gravitas Life Sciences, LLC, received written guidance from the U.S. Food and Drug Administration regarding its drug candidate GV104. The response addresses the regulatory pathway and study design for using the drug to treat gambling disorder.

There are currently no FDA-approved medications for gambling disorder, leaving patient care reliant on therapy and psychosocial programs. The regulator confirmed that existing manufacturing and nonclinical data can be cross-referenced, supporting a planned 12-week Phase 2 trial.

Hepion plans to incorporate the feedback into its study design and expects to file an Investigational New Drug application in 2027. Following the announcement, the company's stock rose 5.50% to $0.1036.

## Key points

- The FDA issued written regulatory guidance to Hepion Pharmaceuticals for its drug candidate GV104 in gambling disorder.
- Existing nonclinical and manufacturing data can be cross-referenced for the new clinical program.
- There are currently no FDA-approved pharmaceutical treatments available for gambling disorder.
- Hepion anticipates filing an Investigational New Drug application for GV104 in 2027.

## Questions and answers

### What did the FDA state regarding Hepion's GV104 drug candidate?

The FDA confirmed that prior nonclinical and manufacturing data may be cross-referenced and supported the general design of a planned Phase 2 study for gambling disorder.

### Are there any FDA-approved medications for treating gambling disorder?

No, there are currently no FDA-approved drugs for gambling disorder. Existing care relies on counseling, peer support, and psychosocial programs.

### When does Hepion plan to file an IND for GV104 in gambling disorder?

Hepion anticipates submitting an Investigational New Drug application for GV104 in 2027 before initiating Phase 2 trials.