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seladelpar 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| PPAR delta agonists | 5830 | 851528-79-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Seladelpar is a peroxisome proliferator-activated receptor (PPAR) delta agonist. Activation of PPAR delta by seladelpar regulates genes involved in bile acid synthesis, lipid metabolism, and inflammation. However, the mechanism by which seladelpar exerts its therapeutic effects in patients with PBC is not well understood.
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 |
|---|---|---|---|
| Aug. 14, 2024 | FDA | Gilead Sciences Inc |
FDA Adverse Event Reporting System (Female)
| 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 |
|---|---|---|---|---|---|---|
| Blood alkaline phosphatase increased | 60.91 | 53.79 | 15 | 173 | 48064 | 90580195 |
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 | A05AX07 | ALIMENTARY TRACT AND METABOLISM BILE AND LIVER THERAPY BILE THERAPY Other drugs for bile therapy |
| MeSH PA | D000960 | Hypolipidemic Agents |
| MeSH PA | D000963 | Antimetabolites |
| MeSH PA | D057847 | Lipid Regulating Agents |
| CHEBI has role | CHEBI:35821 | anticholesteremic drug |
Related Drugs by ATC class:
A05AX Other drugs for bile therapy 6 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Primary biliary cholangitis | indication | 31712002 | DOID:12236 |
🐶 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 10MG BASE | LIVDELZI | GILEAD SCIENCES INC | N217899 | Aug. 14, 2024 | RX | CAPSULE | ORAL | 10272058 | March 19, 2035 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| EQ 10MG BASE | LIVDELZI | GILEAD SCIENCES INC | N217899 | Aug. 14, 2024 | RX | CAPSULE | ORAL | 11406611 | March 19, 2035 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| EQ 10MG BASE | LIVDELZI | GILEAD SCIENCES INC | N217899 | Aug. 14, 2024 | RX | CAPSULE | ORAL | 11596614 | March 19, 2035 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| EQ 10MG BASE | LIVDELZI | GILEAD SCIENCES INC | N217899 | Aug. 14, 2024 | RX | CAPSULE | ORAL | 9486428 | March 19, 2035 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 10MG BASE | LIVDELZI | GILEAD SCIENCES INC | N217899 | Aug. 14, 2024 | RX | CAPSULE | ORAL | Aug. 14, 2029 | NEW CHEMICAL ENTITY |
| EQ 10MG BASE | LIVDELZI | GILEAD SCIENCES INC | N217899 | Aug. 14, 2024 | RX | CAPSULE | ORAL | Aug. 14, 2031 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO URSODEOXYCHOLIC ACID (UDCA), OR IN PATIENTS UNABLE TO TOLERATE UDCA |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Peroxisome proliferator-activated receptor delta | Nuclear hormone receptor | AGONIST | EC50 | 8.64 | DRUG LABEL | DRUG LABEL | |||
| Peroxisome proliferator-activated receptor alpha | Nuclear hormone receptor | AGONIST | EC50 | 5.84 | DRUG LABEL | ||||
| Peroxisome proliferator-activated receptor gamma | Nuclear hormone receptor | AGONIST | EC50 | 5.77 | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| KKB | PDB_CHEM_ID |
| CHEMBL230158 | ChEMBL_ID |
| C000713688 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB12390 | DRUGBANK_ID |
| 4043335 | VANDF |
| C5238203 | UMLSCUI |
| CHEBI:748784 | CHEBI |
| CHEMBL3989960 | ChEMBL_ID |
| CHEMBL3545019 | ChEMBL_ID |
| 10340 | INN_ID |
| 928821-40-3 | SECONDARY_CAS_RN |
| 11236126 | PUBCHEM_CID |
| 388472 | MMSL |
| 43059 | MMSL |
| d10212 | MMSL |
| 11137 | IUPHAR_LIGAND_ID |
| 7C00L34NB9 | UNII |
| 2690868 | RXNORM |
| 1371803007 | SNOMEDCT_US |
| 1373067000 | SNOMEDCT_US |
| C572244 | MESH_SUPPLEMENTAL_RECORD_UI |
| D11256 | KEGG_DRUG |
| 019836 | NDDF |
| 019837 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Livdelzi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61958-3301 | CAPSULE | 10 mg | ORAL | NDA | 32 sections |
| Livdelzi | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61958-3301 | CAPSULE | 10 mg | ORAL | NDA | 32 sections |