REZDIFFRA
NDA 217785 · New Drug Application (NDA) Prescription
RESMETIROM
- Sponsor (Drugs@FDA)
- MADRIGAL Company: MADRIGAL PHARMACEUTICALS, INC. (MDGL)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | REZDIFFRA RESMETIROM | TABLET;ORAL 60MG | Prescription | – | Reference listed drug | RXApproved |
| 002 | REZDIFFRA RESMETIROM | TABLET;ORAL 80MG | Prescription | – | Reference listed drug | RXApproved |
| 003 | REZDIFFRA RESMETIROM | TABLET;ORAL 100MG | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 6 | Approved | standard | Labeling | Letter for Supplement 6 (opens in a new tab)Label for Supplement 6 (opens in a new tab) | |
| Supplement 2 | Approved | standard | Labeling | Letter for Supplement 2 (opens in a new tab)Label for Supplement 2 (opens in a new tab) | |
| Supplement 4 | Approved | standard | Labeling | Letter for Supplement 4 (opens in a new tab)Label for Supplement 4 (opens in a new tab) | |
| Supplement 5 | Approved | standard | Labeling | Letter for Supplement 5 (opens in a new tab)Label for Supplement 5 (opens in a new tab) | |
| Original 1 | Approved | priority | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
22 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 7452882Product 001 | Drug substance, Drug product | – | ||
| 9266861Product 001 | Drug substance, Drug product | – | ||
| 10376517Product 001 | Method of use | U-3861 | ||
| 11564926Product 001 | Drug substance, Drug product | U-3861 | ||
| 11986481Product 001 | Method of use | U-3861 | ||
| 12661359Product 001 | Method of use | U-4568 | ||
| 12667575Product 001 | Method of use | U-4567 | ||
| 7452882Product 002 | Drug substance, Drug product | – | ||
| 9266861Product 002 | Drug substance, Drug product | – | ||
| 10376517Product 002 | Method of use | U-3861 | ||
| 11564926Product 002 | Drug substance, Drug product | U-3861 | ||
| 11986481Product 002 | Method of use | U-3861 | ||
| 12661359Product 002 | Method of use | U-4568 | ||
| 12667575Product 002 | Method of use | U-4567 | ||
| 12377104Product 002 | Method of use | U-3861 | ||
| 7452882Product 003 | Drug substance, Drug product | – | ||
| 9266861Product 003 | Drug substance, Drug product | – | ||
| 10376517Product 003 | Method of use | U-3861 | ||
| 11564926Product 003 | Drug substance, Drug product | U-3861 | ||
| 11986481Product 003 | Method of use | U-3861 | ||
| 12661359Product 003 | Method of use | U-4568 | ||
| 12377104Product 003 | Method of use | U-3861 |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| NCE | 001 | |
| NCE | 002 | |
| NCE | 003 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
REZDIFFRA
RESMETIROM · Madrigal Pharmaceuticals, Inc. · ORAL · Version 4 · effective
Indications and usage
1 INDICATIONS AND USAGE 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 [see Clinical Studies (14) ] . 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 [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] . REZDIFFRA ® is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic s…
NDC products
3 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 82576-060 in openFDA (opens in a new tab) | REZDIFFRA Resmetirom | Madrigal Pharmaceuticals, Inc. | TABLET, COATED ORAL | NDA | From |
| 82576-080 in openFDA (opens in a new tab) | REZDIFFRA resmetirom | Madrigal Pharmaceuticals, Inc. | TABLET, COATED ORAL | NDA | From |
| 82576-100 in openFDA (opens in a new tab) | REZDIFFRA RESMETIROM | Madrigal Pharmaceuticals, Inc. | TABLET, COATED ORAL | NDA | From |
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FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.