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Drug ReportsResmetirom
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
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post 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
REZDIFFRAMadrigal PharmaceuticalsN-217785 RX2024-03-14
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
rezdiffraNew Drug Application2024-03-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
fatty liverEFO_0003934D005234—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
16 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 diseaseD065626EFO_0003095K75.81113——5
Fatty liverD005234EFO_0003934—113——5
Liver diseasesD008107EFO_0001421K70-K771—2——3
Liver cirrhosisD008103EFO_0001422K74.01—1——2
FibrosisD005355————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937———1———1
Hyperlipoproteinemia type iiD006938EFO_0004911E78.00—1———1
Alcoholic fatty liverD005235—K70.0—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———8————8
Hepatic insufficiencyD048550——1————1
Renal insufficiencyD051437—N191————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameResmetirom
INNresmetirom
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—
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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-ID920509-32-6
RxCUI—
ChEMBL IDCHEMBL3261331
ChEBI ID—
PubChem CID15981237
DrugBankDB12914
UNII IDRE0V0T1ES0 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 711 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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124 adverse events reported
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