Resmetirom
Also known as Rezdiffra
MADRIGAL PHARMACEUTICALS, INC. MDGL · Non-Alcoholic Fatty Liver Disease; Cirrhosis, Liver; NASH
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
3
From ClinicalTrials.gov
Latest FDA action
Approved
NDA217785,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- MADRIGAL PHARMACEUTICALS, INC. MDGL Source: Company record for MADRIGAL PHARMACEUTICALS, INC. (opens in a new tab)
- Indications
- Non-Alcoholic Fatty Liver Disease; Cirrhosis, Liver; NASH Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 217785 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 217785 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 16 Dec 20193 linked trials
- Filed Completed
- Approved Current stageFirst approval 14 Mar 2024
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Resmetirom. Editors add each one with its source.
Filed application
No filed application is on record for Resmetirom. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Resmetirom.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05500222ClinicalTrials.gov record for NCT05500222 (opens in a new tab) | A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES) | Phase 3 | Active, not recruiting | 845 (estimated) | Dec 2026 (estimated) | No |
Publications listing NCT05500222 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04951219ClinicalTrials.gov record for NCT04951219 (opens in a new tab) | A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE) | Phase 3 | Active, not recruiting | 810 (actual) | Mar 2027 (estimated) | No |
Publications listing NCT04951219 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04197479ClinicalTrials.gov record for NCT04197479 (opens in a new tab)MAESTRO-NAFLD1 | A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients | Phase 3 | Completed | 1,343 (actual) | 6 Jan 2023 (actual) | No |
Publications listing MAESTRO-NAFLD1 (4), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA217785Action letter for NDA217785 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
AuthorisedConditional
Rezdiffra (EMEA/H/C/006220)
- Authorised
- Therapeutic area
- Non-alcoholic Fatty Liver Disease;Liver Cirrhosis
- Marketing authorisation holder
- Madrigal Pharmaceuticals EU Limited
- Active substance (INN)
- resmetirom
- ATC code
- A05
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Rezdiffra (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 217785 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05500222 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04951219 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04197479 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA217785 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.