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elafibranor 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5824 | 923978-27-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Elafibranor and its main active metabolite GFT1007 are peroxisome proliferator-activated receptor (PPAR) agonists, both of which activate PPAR-alpha, PPAR-gamma, and PPAR-delta in vitro. However, the mechanism by which elafibranor exerts its therapeutic effects in patients with PBC is not well understood. Pharmacological activity that is potentially relevant to therapeutic effects includes inhibition of bile acid synthesis through activation of PPAR-alpha and PPAR-delta. Although the in vitro pharmacology studies detected PPAR-gamma activation by elafibranor and its metabolite GFT1007, toxicology studies in rats and monkeys (species with plasma metabolite profiles comparable to human) showed none of the adverse effects that are associated with PPAR-gamma activation.
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 |
|---|---|---|---|
| June 10, 2024 | FDA | Ipsen Biopharmaceuticals, Inc. | |
| Oct. 19, 2024 | EMA | Ipsen Pharma |
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 | A05AX06 | ALIMENTARY TRACT AND METABOLISM BILE AND LIVER THERAPY BILE THERAPY Other drugs for bile therapy |
| FDA MoA | N0000185506 | Cytochrome P450 3A4 Inducers |
| FDA EPC | N0000194128 | Peroxisome Proliferator-activated Receptor Agonist |
| FDA MoA | N0000194129 | Peroxisome Proliferator-activated Receptor Agonists |
| CHEBI has role | CHEBI:35526 | hypoglycemic agent |
| CHEBI has role | CHEBI:48705 | agonist |
| CHEBI has role | CHEBI:70781 | PPAR modulator |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | 11185519 | March 30, 2037 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN PATIENTS UNABLE TO TOLERATE UDCA |
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | 11331292 | March 30, 2037 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | 11850223 | March 30, 2037 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | 11857523 | March 30, 2037 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN ADULTS WHO HAVE HAD AN INADEQUATE RESPONSE TO UDCA, OR AS MONOTHERAPY IN PATIENTS UNABLE TO TOLERATE UDCA |
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | 12233038 | March 30, 2037 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | 12295927 | March 30, 2037 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | 12295928 | March 30, 2037 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | 12310935 | March 30, 2037 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) |
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | 12589086 | March 30, 2037 | TREATMENT OF PRIMARY BILIARY CHOLANGITIS (PBC) AS MONOTHERAPY IN PATIENTS UNABLE TO TOLERATE UDCA |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | June 10, 2029 | NEW CHEMICAL ENTITY |
| 80MG | IQIRVO | IPSEN | N218860 | June 10, 2024 | RX | TABLET | ORAL | June 10, 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 alpha | Nuclear hormone receptor | AGONIST | EC50 | 7.34 | DRUG LABEL | DRUG LABEL | |||
| Peroxisome proliferator-activated receptor gamma | Nuclear hormone receptor | AGONIST | EC50 | 6.84 | DRUG LABEL | DRUG LABEL | |||
| Peroxisome proliferator-activated receptor delta | Nuclear hormone receptor | AGONIST | EC50 | 6.75 | DRUG LABEL | DRUG LABEL | |||
| NACHT, LRR and PYD domains-containing protein 3 | Cytosolic other | IC50 | 4.40 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| MUO | PDB_CHEM_ID |
| CHEMBL3707395 | ChEMBL_ID |
| DB05187 | DRUGBANK_ID |
| 4043219 | VANDF |
| C4508936 | UMLSCUI |
| CHEBI:747793 | CHEBI |
| 9973 | INN_ID |
| 9864881 | PUBCHEM_CID |
| 386249 | MMSL |
| 42909 | MMSL |
| d10192 | MMSL |
| 019781 | NDDF |
| 11135 | IUPHAR_LIGAND_ID |
| 2J3H5C81A5 | UNII |
| 2684941 | RXNORM |
| 44008811000001104 | SNOMEDCT_US |
| C585906 | MESH_SUPPLEMENTAL_RECORD_UI |
| D11208 | KEGG_DRUG |
| 2J3H5C81A5 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| IQIRVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 15054-0080 | TABLET, FILM COATED | 80 mg | ORAL | NDA | 30 sections |