Resmetirom
As of the edition of 20 October 2026, Resmetirom is a small molecule: marketed, first approved in 2024 (US); acts on THRB; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Rezdiffra
- First approved
- 14 March 2024 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Madrigal Pharmaceuticals; 2 holders in all
- Registered trials
- 20, 0 stopped early
- Disease areas
- Digestive system; Hormones; Nutrition and metabolism; Urinary and reproductive; Immune system; Infections
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Madrigal Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product12 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Resmetirom.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| THRB | Thyroid hormone receptor beta | P10828 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 11 | 10 | 1 | 0 |
| Phase 2 | 4 | 2 | 2 | 0 |
| Phase 3 | 2 | 1 | 1 | 0 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Madrigal Pharmaceuticals | Originator, Applicant and Lead sponsor of trials | 2011 to now |