At Hepion, we’re committed to discovering and developing advancements in the areas of NASH and other Chronic Liver Diseases. At times patients may wish to access investigational medicines that are not yet approved by the U.S. Food and Drug Administration (FDA) through expanded access or compassionate use programs. At this time, we are not planning to make Rencofilstat available for expanded access in the near future, as the most appropriate means for patients to gain access for investigational medications is through ongoing or planned clinical trials. Followed closely by a team of medical experts, clinical trials are designed to determine whether an investigational medicine is safe and effective for patients.
In cases where enrolling in a clinical trial is not currently possible, there may be expanded access options for some patients. The criteria for these options are based on regulations governing this type of access.
Hepion will consider each request for expanded access on a case-by-case basis when they meet the conditions below, and access is requested by a licensed practitioner in the United States who will oversee the patient’s care while using the investigational medication.
- The condition or disease being studied is serious or life-threatening and there are no available alternative treatments
- The investigational drug is under active clinical development but is not yet approved by the FDA
- The patient is ineligible for or otherwise unable to participate in ongoing or planned clinical trials in the disease area
- The potential benefit to the patient should outweigh potential risks
- All other approved treatments did not help the patient, or there is no other approved treatment option available
- The patient meets any other relevant medical criteria for expanded access to the investigational product, as determined by Hepion
- There is adequate supply of the investigational product to meet the needs of the expanded access request without impacting the company’s clinical trials
To submit a request for an investigational medicine outside of a clinical trial, the treating physician can email Hepion at the following email address, firstname.lastname@example.org. We will endeavor to respond to requests within five (5) business days.