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resmetirom 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antihyperlidaemics, thyromimetic derivatives | 5811 | 920509-32-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Resmetirom is a thyroid hormone receptor (THR) beta agonist. Resmetirom selectively binds to and activates THR beta, the predominant thyroid hormone receptor isoform in the liver.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 14, 2024 | FDA | Madrigal Pharmaceuticals Inc. | |
| Aug. 18, 2025 | EMA | Madrigal Pharmaceuticals EU Limited |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pruritus | 59.69 | 48.71 | 26 | 177 | 581534 | 110007562 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A05BA11 | ALIMENTARY TRACT AND METABOLISM BILE AND LIVER THERAPY LIVER THERAPY, LIPOTROPICS Liver therapy |
| FDA MoA | N0000187062 | Cytochrome P450 2C8 Inhibitors |
| FDA MoA | N0000190107 | Organic Anion Transporting Polypeptide 1B1 Inhibitors |
| FDA MoA | N0000190108 | Organic Anion Transporting Polypeptide 1B3 Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| FDA EPC | N0000194131 | Thyroid Hormone Receptor beta Agonist |
| FDA MoA | N0000194132 | Thyroid Hormone Receptor beta Agonists |
| CHEBI has role | CHEBI:35821 | anticholesteremic drug |
Related Drugs by ATC class:
A05BA Liver therapy 7 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Nonalcoholic steatohepatitis with liver fibrosis | indication | 442685003 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 100MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 10376517 | Sept. 17, 2033 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 100MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 11564926 | Sept. 17, 2033 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 100MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 11986481 | Sept. 17, 2033 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 60MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 10376517 | Sept. 17, 2033 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 60MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 11564926 | Sept. 17, 2033 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 60MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 11986481 | Sept. 17, 2033 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 80MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 10376517 | Sept. 17, 2033 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 80MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 11564926 | Sept. 17, 2033 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 80MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 11986481 | Sept. 17, 2033 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 100MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 12377104 | Feb. 4, 2045 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 60MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 12377104 | Feb. 4, 2045 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
| 80MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | 12377104 | Feb. 4, 2045 | TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | March 14, 2029 | NEW CHEMICAL ENTITY |
| 60MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | March 14, 2029 | NEW CHEMICAL ENTITY |
| 80MG | REZDIFFRA | MADRIGAL | N217785 | March 14, 2024 | RX | TABLET | ORAL | March 14, 2029 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Thyroid hormone receptor beta | Nuclear hormone receptor | PARTIAL AGONIST | EC50 | 6.68 | DRUG LABEL | DRUG LABEL | |||
| Thyroid hormone receptor alpha | Nuclear hormone receptor | PARTIAL AGONIST | EC50 | 5.43 | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL3261331 | ChEMBL_ID |
| C588408 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB12914 | DRUGBANK_ID |
| 4043025 | VANDF |
| C3850197 | UMLSCUI |
| CHEBI:755243 | CHEBI |
| 10850 | INN_ID |
| 15981237 | PUBCHEM_CID |
| 383877 | MMSL |
| 42716 | MMSL |
| d10173 | MMSL |
| 019687 | NDDF |
| 12026 | IUPHAR_LIGAND_ID |
| RE0V0T1ES0 | UNII |
| 2677894 | RXNORM |
| D11602 | KEGG_DRUG |
| RE0V0T1ES0 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| REZDIFFRA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82576-060 | TABLET, COATED | 60 mg | oral | NDA | 18 sections |
| REZDIFFRA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82576-080 | TABLET, COATED | 80 mg | ORAL | NDA | 18 sections |
| REZDIFFRA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82576-100 | TABLET, COATED | 100 mg | ORAL | NDA | 18 sections |