Resmetirom
Rezdiffra (resmetirom) is a small molecule pharmaceutical. Resmetirom was first approved as Rezdiffra on 2024-03-14. It is used to treat fatty liver in the USA.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Rezdiffra
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Resmetirom
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| REZDIFFRA | Madrigal Pharmaceuticals | N-217785 RX | 2024-03-14 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rezdiffra | New Drug Application | 2025-02-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| fatty liver | EFO_0003934 | D005234 | — |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 1 | 1 | 3 | — | — | 5 |
| Fatty liver | D005234 | EFO_0003934 | — | 1 | 1 | 3 | — | — | 5 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | 2 | — | — | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | — | 1 | — | — | 2 |
| Fibrosis | D005355 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | — | — | — | 1 | — | — | — | 1 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | 1 | — | — | — | 1 |
| Alcoholic fatty liver | D005235 | — | K70.0 | — | 1 | — | — | — | 1 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 1 | — | — | — | 1 |
| Hiv-2 | D015498 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | — | 9 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Resmetirom |
| INN | resmetirom |
| Description | Resmetirom, sold under the brand name Rezdiffra, is a medication used for the treatment of noncirrhotic nonalcoholic steatohepatitis. It is thyroid hormone receptor beta (NR1A2) agonist.
|
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)c1cc(Oc2c(Cl)cc(-n3nc(C#N)c(=O)[nH]c3=O)cc2Cl)n[nH]c1=O |
Identifiers
| PDB | — |
| CAS-ID | 920509-32-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3261331 |
| ChEBI ID | — |
| PubChem CID | 15981237 |
| DrugBank | DB12914 |
| UNII ID | RE0V0T1ES0 (ChemIDplus, GSRS) |
Target
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Trends
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Safety
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Adverse Events
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565 adverse events reported
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