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acoramidis 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5842 | 1446711-81-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Acoramidis is a selective stabilizer of transthyretin (TTR)..Acoramidis binds TTR at thyroxine binding sites and slows dissociation of the TTR tetramer into its constituent monomers, the rate-limiting step in amyloidogenesis.
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 |
|---|---|---|---|
| Nov. 22, 2024 | FDA | BridgeBio Pharma | |
| Feb. 10, 2025 | EMA | Bayer AG | |
| March 27, 2025 | PMDA | Alexion Pharma GK |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C01EB25 | CARDIOVASCULAR SYSTEM CARDIAC THERAPY OTHER CARDIAC PREPARATIONS Other cardiac preparations |
| FDA MoA | N0000185504 | Cytochrome P450 2C9 Inhibitors |
| FDA EPC | N0000194134 | Transthyretin Stabilizer |
| FDA MoA | N0000194135 | Transthyretin Stabilizers |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
Related Drugs by ATC class:
C01EB Other cardiac preparations 15 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Transthyretin-mediated amyloidosis | indication | 442012008 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 356MG BASE | ATTRUBY | BRIDGEBIO PHARMA | N216540 | Nov. 22, 2024 | RX | TABLET | ORAL | 10842777 | May 5, 2031 | TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
| EQ 356MG BASE | ATTRUBY | BRIDGEBIO PHARMA | N216540 | Nov. 22, 2024 | RX | TABLET | ORAL | 9169214 | May 5, 2031 | TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
| EQ 356MG BASE | ATTRUBY | BRIDGEBIO PHARMA | N216540 | Nov. 22, 2024 | RX | TABLET | ORAL | 9913826 | May 5, 2031 | TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
| EQ 356MG BASE | ATTRUBY | BRIDGEBIO PHARMA | N216540 | Nov. 22, 2024 | RX | TABLET | ORAL | 11919865 | Feb. 16, 2038 | TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
| EQ 356MG BASE | ATTRUBY | BRIDGEBIO PHARMA | N216540 | Nov. 22, 2024 | RX | TABLET | ORAL | 11058668 | March 22, 2039 | TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
| EQ 356MG BASE | ATTRUBY | BRIDGEBIO PHARMA | N216540 | Nov. 22, 2024 | RX | TABLET | ORAL | 12070449 | March 22, 2039 | TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
| EQ 356MG BASE | ATTRUBY | BRIDGEBIO PHARMA | N216540 | Nov. 22, 2024 | RX | TABLET | ORAL | 12005043 | Aug. 16, 2039 | TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 356MG BASE | ATTRUBY | BRIDGEBIO PHARMA | N216540 | Nov. 22, 2024 | RX | TABLET | ORAL | Nov. 22, 2029 | NEW CHEMICAL ENTITY |
| EQ 356MG BASE | ATTRUBY | BRIDGEBIO PHARMA | N216540 | Nov. 22, 2024 | RX | TABLET | ORAL | Nov. 22, 2031 | TREATMENT OF THE CARDIOMYOPATHY OF WILD-TYPE OR VARIANT TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR DEATH AND CARDIOVASCULAR-RELATED HOSPITALIZATION |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Transthyretin | Secreted | OTHER | Kapp | 7.79 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL3940890 | ChEMBL_ID |
| C000731204 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4043590 | VANDF |
| C5418800 | UMLSCUI |
| CHEBI:756000 | CHEBI |
| 16V | PDB_CHEM_ID |
| CHEMBL4650226 | ChEMBL_ID |
| 11205 | INN_ID |
| 2242751-53-5 | SECONDARY_CAS_RN |
| 71464713 | PUBCHEM_CID |
| 13628 | IUPHAR_LIGAND_ID |
| T12B44A1OE | UNII |
| 2698312 | RXNORM |
| D11972 | KEGG_DRUG |
| 391104 | MMSL |
| 43539 | MMSL |
| d10236 | MMSL |
| 019930 | NDDF |
| 019931 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Attruby | HUMAN PRESCRIPTION DRUG LABEL | 1 | 82228-712 | TABLET, FILM COATED | 356 mg | ORAL | NDA | 26 sections |