Expanded Access Policy
Madrigal Pharmaceuticals, Inc. is applying breakthrough science to develop novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. The Company has advanced its lead candidate, resmetirom, also known as MGL-3196, a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR) β-selective agonist, through Phase 2 clinical trials in non-alcoholic steatohepatitis (NASH) and is currently enrolling two Phase 3 clinical trials: MAESTRO-NASH in NASH patients with advanced liver disease, and MAESTRO-NAFLD-1 (NAFLD: non-alcoholic f atty liver disease) in a broader segment of NASH/NAFLD patients.
Madrigal Pharmaceuticals, Inc.’s goal is to provide access to our investigational therapies through ongoing clinical trials.
- 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.
Madrigal Pharmaceuticals, Inc. must ensure adequate supply of MGL-3196 (resmetirom) is available for the ongoing clinical trial(s) and development programs, and therefore; encourages participation in a clinical trial as the best way to access MGL-3196 (resmetirom).
At this time, Madrigal Pharmaceuticals, Inc. is not making its unapproved therapies available through expanded access or right to try basis. You can learn more about our ongoing clinical trial(s) by accessing information on the Clinicaltrials.gov web site or by accessing trial and investigational site information on our web site at www.madrigalclinicaltrials.com.
Consistent with the 21st Century Cures Act, Madrigal Pharmaceuticals, Inc. may revise this policy at any time.