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Rezdiffra (Resmetirom) is a first-in-class prescription medication approved by the FDA in March 2024 for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH), in adults with moderate to advanced liver fibrosis (stages F2–F3). It is used in conjunction with diet and exercise. Rezdiffra is the first and only FDA-approved medication specifically for NASH/MASH, representing a major breakthrough for patients with this progressive liver disease. It is manufactured by Madrigal Pharmaceuticals.
Rezdiffra works as a selective thyroid hormone receptor-beta (THR-β) agonist. THR-β is the predominant thyroid hormone receptor in the liver. By selectively activating THR-β, Rezdiffra reduces intrahepatic triglycerides (liver fat), decreases liver inflammation, and slows the progression of fibrosis (scarring). Importantly, Rezdiffra does not significantly activate THR-α, which is the receptor responsible for thyroid hormone effects on the heart and bones, helping to minimize cardiovascular and skeletal side effects.
Rezdiffra scores a 35 out of 100 on our findability scale, meaning it is significantly harder to locate than most medications. Rezdiffra is a specialty drug distributed through a limited network of specialty pharmacies — you will not find it at your local retail pharmacy like CVS or Walgreens. Because it was only approved by the FDA in March 2024 for noncirrhotic NASH/MASH with moderate to advanced fibrosis, distribution channels are still narrow. Patients must work with their prescriber and a specialty pharmacy to obtain Rezdiffra, which can add days or weeks to the process.
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Rezdiffra is typically prescribed by hepatologists (liver specialists) and gastroenterologists who manage NASH/MASH patients. Endocrinologists and internal medicine physicians with experience in metabolic liver disease may also prescribe it. Because Rezdiffra requires a confirmed diagnosis of NASH/MASH with moderate to advanced fibrosis (often via liver biopsy or validated non-invasive testing), most prescriptions originate from specialists rather than primary care providers.
No, Rezdiffra is not a controlled substance. It is not listed under any DEA schedule. However, it is a specialty medication that requires a prescription and is dispensed only through specialty pharmacies, so access is more restricted than typical prescription drugs.
Serious but less common side effects include hepatotoxicity (liver injury with elevated liver enzymes), gallstones (cholelithiasis), acute cholecystitis, and hypersensitivity reactions. Patients should have liver function monitored regularly while taking Rezdiffra.
There is no other FDA-approved medication specifically for NASH/MASH, but several drugs are used off-label or are under investigation:
Rezdiffra is a groundbreaking medication — the first FDA-approved treatment specifically targeting NASH/MASH with liver fibrosis. However, its specialty pharmacy–only distribution, high cost (around $4,000/month without insurance), and the need for prior authorization make it challenging to access. Patients should work closely with their hepatologist or gastroenterologist and contact Madrigal Patient Support at 1-877-219-7770 for help navigating insurance coverage, prior authorization, and copay assistance. Commercially insured patients may qualify for the Madrigal Copay Savings Card to significantly reduce out-of-pocket costs.
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