Expended Accsess Policy

Galmed is committed to developing innovative therapies for patients with NASH and central to that commitment is the conduct of clinical studies.

We are conducting a Phase 3 study evaluating the safety and effectiveness of the investigational drug Aramchol for the treatment of patients with NASH and liver fibrosis. In some cases, patients may not be eligible to participate in this or other clinical studies.

Galmed is not currently making its investigational drug available for expanded access but may consider doing so once substantial evidence of safety and effectiveness exists for the investigational drug from a positive Phase 3 study.

At that time, Galmed will post its expanded access criteria. For any Galmed expanded access program, the following will always apply:

• The patient has a serious or immediately life-threatening condition
• There is no comparable or satisfactory alternative therapy to treat the condition
• The potential patient benefit justifies the potential risks of treatment and those potential risks are not unreasonable in the context of the condition to be treated
• Providing the drug will not interfere with the initiation, conduct or completion of clinical studies that would support marketing approval or future patient access
• The request is made by the treating physician, unsolicited by Galmed or any other individual or organization, upon a determination that (1) there is sufficient data to support the use of the investigational drug, (2) there is no comparable alternative available, and (3) the drug’s potential benefits outweigh the potential risks.
• The access is compliant with all applicable federal, state, and local, laws and regulations.

Galmed will also update this website with any additional criteria and contact information for access requests once it is accepting access requests.

The above is not a guarantee of access to any Galmed investigational drug.