Conatus Pharmaceuticals' medicine, emricasan (IDN-6556), is considered investigational, meaning that it is being evaluated in clinical trials and is not yet approved for use by regulatory authorities. Approval by regulatory authorities around the world, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), is the means to make our medicines available to the patient.
How to Access Conatus' Emricasan
At Conatus, our goal is to serve patients by developing the safety and efficacy information that is needed to obtain regulatory approval for our investigational medications. In order to obtain regulatory approval for an investigational medication, the medication must be tested in clinical trials designed to prove whether the medication is safe and efficacious. It is important for patients to participate in clinical trials because that is the only way for companies to generate the essential information needed for regulatory approval, which provides all patients broader access to the medication. Clinical trials generally offer the best opportunity for patients to access an investigational medication.
Current Conatus Trials
To learn more about Conatus' current clinical programs, you can visit www.clinicaltrials.gov.
A Multicenter, Randomized, Double-Blind, Placebo-controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Non-alcoholic Steatohepatitis (NASH) Fibrosis (ENCORE-NF)
Emricasan, an Oral Caspase Inhibitor, in Subjects With Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension (ENCORE-PH)
Expanded Access Policy
In exceptional circumstances, when a patient with a serious or immediately life-threatening disease does not qualify for any clinical trials and no other medical options remain available, we may decide to allow access to Conatus’ investigational medications outside of a clinical trial when:
- It is requested by a physician
- Is allowed by law
- The conditions for Conatus’ expanded access criteria are met.
When making determinations on requests for expanded access to Conatus’ investigational medications, we review each request as comprehensively as possible and consider the criteria below.
Criteria Used for Considering Requests for Expanded Access
- The patient has a serious or immediately life threatening disease or condition and there is no comparable or satisfactory alternative therapy for the disease or condition.
- The medication is being developed in the indication for which access is sought.
- There is sufficient clinical evidence of safety and effectiveness in that indication that the expected benefits will outweigh the known or anticipated risks.
- Granting expanded access will not interfere with the development of the investigational medication.
- The patient is ineligible or unable to participate in a clinical trial.
- Conatus has an adequate supply of investigational medication.
- The laws and regulations in the country or region allow for expanded access.
A patient’s physician should request information about how to apply for access to one of Conatus’ investigational medications by contacting David Hagerty, M.D. at email@example.com. All physicians who receive Conatus’ investigational medication for expanded access must comply with all applicable laws and regulations, and contractual conditions, including those relating to safety reporting.
More information on expanded access is available from the FDA: http://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm#different-types