Resmetirom clinical trials
Resmetirom is named as an intervention in 7 current clinical trials in our USA, Canada, UK, Germany, France, Spain, Italy, Belgium, Israel, Poland, Switzerland, Austria, Mexico and Australia registers. 4 are recruiting patients now. The most common phase is Phase 3. The lead sponsor is Madrigal Pharmaceuticals, Inc. The most-studied condition is MASH - Metabolic Dysfunction-Associated Steatohepatitis.
Where Resmetirom is approved
All regulators →Of the three regulators tracked here, the first to approve Resmetirom was the US, on 14 Mar 2024. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Resmetirom patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Resmetirom, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 8 listed patents; the last listed expires 4 Feb 2045 (US 12377104).
- Latest patent on the drug substance itself: 17 Sep 2033 (US 11564926).
- Exclusivity NCE: New chemical entity, until 14 Mar 2029.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Resmetirom
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Resmetirom works
All drug targets →- Thyroid hormone receptor beta-1 agonist AgonistTarget: THRB thyroid hormone receptor beta✓ In ChEMBL and the Guide to Pharmacology
- FibrosisPhase 3
- Metabolic dysfunction-associated steatohepatitisPhase 3
- Familial hypercholesterolemiaPhase 2
- Familial hyperlipidemiaPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL3261331, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 12026, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Resmetirom
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: RezdiffraEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Resmetirom
- ChEMBL
- CHEMBL3261331
- DrugBank
- DB12914
- PubChem CID
- 15981237
- CAS number
- 920509-32-6
- FDA UNII
- RE0V0T1ES0
- Wikidata
- Q27288071
- Wikipedia
- Resmetirom
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Resmetirom
7 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Resmetirom across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Resmetirom on the HPRA medicines list.
- Rezdiffra 100 mg film-coated tabletsMadrigal Pharmaceuticals EU Limited · EU/1/25/1962/003
- Rezdiffra 60 mg film-coated tabletsMadrigal Pharmaceuticals EU Limited · EU/1/25/1962/001
- Rezdiffra 80 mg film-coated tabletsMadrigal Pharmaceuticals EU Limited · EU/1/25/1962/002
Supply shortages
No entry for Resmetirom in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Resmetirom
7 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Madrigal Pharmaceuticals, Inc | 7 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Resmetirom trials
How many clinical trials are testing Resmetirom?
7 current trials in our USA, Canada, UK, Germany, France, Spain, Italy, Belgium, Israel, Poland, Switzerland, Austria, Mexico and Australia registers name Resmetirom (also registered as MGL-3196) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Resmetirom trials recruiting patients?
Yes. 4 of the 7 trials are recruiting: 4 with sites in USA and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Resmetirom clinical trials?
The lead sponsor is Madrigal Pharmaceuticals, Inc. The number in brackets is how many trials each organisation leads.
Is Resmetirom licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Resmetirom, for example Rezdiffra 100 mg film-coated tablets (Madrigal Pharmaceuticals EU Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Resmetirom shortage?
Not in the lists we track: Resmetirom has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Resmetirom works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Resmetirom works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Resmetirom (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.