Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) announced that the U.S. Patent and Trademark Office issued three new patents related to resmetirom, the active ingredient in its MASH treatment Rezdiffra.

Two of the patents cover F2/F3 fibrosis indications and will be listed in the FDA's Orange Book. U.S. Patent No. 12,667,575, issued June 30, 2026, covers a weight-threshold step-down dosing method of 60mg or 80mg resmetirom for patients with F2/F3 MASH who are also using a moderate CYP2C8 inhibitor, with protection expected through 2045. U.S. Patent No. 12,661,359, issued June 23, 2026, covers the co-administration of rosuvastatin and resmetirom, limiting the daily rosuvastatin dose to a maximum of 20mg to reduce dose-related side effects, with protection expected through 2042.

The third patent, U.S. Patent No. 12,661,361, also issued June 23, 2026, is directed to a method of administering resmetirom to treat well-compensated cirrhosis, known as F4c. Protection on this patent is also expected through 2042.

Bill Sibold, Chief Executive Officer of Madrigal, said: "Building a robust patent estate is a core pillar of our long-term strategy. Last year, we secured our pivotal 2045 F2/F3 patent. Today, we're building on that foundation with three additional patents – two that reinforce our protection in F2/F3 and one supporting our potential F4c indication."

Rezdiffra is currently approved by the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis. A Phase 3 outcomes trial is ongoing to evaluate the drug for compensated MASH cirrhosis. The information is based on a press release statement from the company.