Source: FDA, National Drug Code (US) Revision Year: 2024
Elafibranor and its main active metabolite GFT1007 are peroxisome proliferator-activated receptor (PPAR) agonists. Elafibranor is practically insoluble in aqueous media at pH in the range 1.2 to 6.8. It is very slightly soluble at pH 7.5. It is soluble in dichloromethane, freely soluble in DMSO and sparingly soluble in 2-propanol and ethanol.
Its chemical formula is C22H24O4S, the molecular weight is 384.49 g/mol, the chemical name is 2-(2,6-Dimethyl4-{3-[4-(methylsulfanyl)phenyl]-3-oxoprop-1-en-1-yl}phenoxy)-2-methylpropanoic acid and it has the following structural formula:
IQIRVO (elafibranor) tablets are supplied as 80 mg film-coated tablets for oral administration. Each tablet contains 80 mg elafibranor and the following inactive ingredients: colloidal silica dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and povidone. The film coating consists of: iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
| Dosage Forms and Strengths |
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Tablets: 80 mg, round, orange, film-coated tablets, debossed with “ELA 80” on one side and plain on the other side. |
| How Supplied |
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IQIRVO (elafibranor) tablets are available as 80 mg, round, orange, film-coated tablets, debossed with ‘ELA 80’ on one side and plain on the other side. IQIRVO is supplied in a child-resistant 30 count bottle (NDC 15054-0080-1). Manufactured for: Ipsen Biopharmaceuticals, Inc., One Main Street, 7th Floor, Cambridge, MA, 02142, USA |
| Drug | Countries | |
|---|---|---|
| IQIRVO | United States |
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