Madrigal’s goal is to provide access to our investigational therapies through ongoing clinical trials.
Expanded access to investigational therapies may be considered when:
- Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- Patient enrollment in a clinical trial is not possible.
- Potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
At this time, Madrigal is not making its unapproved therapies available through expanded access or on a right to try basis. Madrigal must ensure adequate supply of resmetirom is available for the ongoing clinical trials and development programs, and therefore encourages participation in a clinical trial as the best way to access resmetirom. You can learn more about our ongoing clinical trials by accessing information on the Clinicaltrials.gov web site. Consistent with the 21st Century Cures Act, Madrigal may revise this policy at any time.