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Expanded Access Policy
At Madrigal, patients are at the center of everything we do. We are driven by a sense of urgency to address the significant needs of people living with metabolic dysfunction-associated steatohepatitis (MASH).
We recognize that patients and families facing serious diseases may seek access to investigational medicines when their treatment options are limited. Madrigal believes that participation in well-controlled clinical trials is the best pathway for patients to access investigational therapies. Clinical trials generate the safety and efficacy data needed to support regulatory approval and bring new medicines to patients as quickly as possible.
At this time, Madrigal does not offer Expanded Access (also referred to as Compassionate Use) or Right to Try access to its investigational therapies. Our priority is to focus on ongoing clinical trials and development programs to advance potential new treatments for the broader MASH patient community.
Outside of the United States, Madrigal has implemented Early Access Programs (EAPs) for resmetirom in select countries where permitted by local regulations. Availability and patient eligibility are determined by country-specific requirements and program readiness.
Patients and healthcare providers interested in Madrigal’s investigational therapies are encouraged to explore participation in Madrigal-sponsored clinical trials whenever possible. Information about ongoing studies can be found at ClinicalTrials.gov.
Madrigal will continue to evaluate this policy as our research programs evolve and patient needs guide our work. Consistent with the 21st Century Cures Act, Madrigal may revise this policy at any time.
Last Updated: September 2026