Treats noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly…. NDA 217785, held by Madrigal. Resmetirom.
As of Nov 13, 2026, NDA 217785 (Rezdiffra), held by Madrigal, was first approved by FDA on Mar 14, 2024, with 4 approved supplements and 0 published complete response letters.
REZDIFFRA is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitations of Use Avoid use of REZDIFFRA in patients with decompensated cirrhosis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Rezdiffra60MG · tablet;oral | Resmetirom | RxReference drug |
| Rezdiffra80MG · tablet;oral | Resmetirom | RxReference drug |
| Rezdiffra100MG · tablet;oral | Resmetirom | RxReference drug |
| Jul 24, 2026 | Supplement 6Labeling · Standard review | Approved | |
| Dec 19, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Dec 19, 2025 | Supplement 4Labeling · Standard review | Approved | |
| Dec 19, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Mar 14, 2024 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
