All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Molfile Inchi Smiles Synonyms: elafibranor iqirvo GFT505

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. Molecular weight: 384.49 Formula: C22H24O4S CLOGP: 5.16 LIPINSKI: 1 HAC: 4 HDO: 1 TPSA: 63.60 ALOGS: ROTB: 7 Status: ONP 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

cyclobutyrolhymecromonemaralixibat hydrochlorideodevixibatpiprozolinseladelpar

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	Q07869	PPARA_HUMAN	AGONIST	EC50	7.34		DRUG LABEL	DRUG LABEL
Peroxisome proliferator-activated receptor gamma	Nuclear hormone receptor	P37231	PPARG_HUMAN	AGONIST	EC50	6.84		DRUG LABEL	DRUG LABEL
Peroxisome proliferator-activated receptor delta	Nuclear hormone receptor	Q03181	PPARD_HUMAN	AGONIST	EC50	6.75		DRUG LABEL	DRUG LABEL
NACHT, LRR and PYD domains-containing protein 3	Cytosolic other		NLRP3_MOUSE		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