Elafibranor is under clinical development by Ipsen and currently in Phase III for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). According to GlobalData, Phase III drugs for Primary Biliary Cholangitis (Primary Biliary Cirrhosis) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Elafibranor’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Elafibranor overview
Elafibranor (GFT-505) is under development for the treatment of colitis, non-alcoholic fatty liver disease, primary biliary cholangitis (PBC), primary sclerosing cholangitis. The drug candidate is administered orally as a coated tablet. It acts by targeting peroxisome proliferator-activated receptor (PPAR) alpha and PPAR-beta / PPAR- delta. The drug candidate was under development for dyslipidemia, abdominal obesity, type 2 diabetes, Crohn’s disease, insulin resistance and glucose intolerance, colitis and NAFLD/NASH-induced hepatocellular carcinoma (HCC). It was also underdevelopment for non-alcoholic steatohepatitis, liver fibrosis.
Ipsen overview
Ipsen is a global specialty biopharmaceutical company engaged in the manufacturing and distribution of drugs for the treatment of cancer, rare diseases and neurological diseases, including specialty pharmaceutical products. The company develops and commercializes novel medicines for cancer, neuroscience and rare diseases and also offers products to treat gastrointestinal disorders, neurodegenerative pathologies and rheumatic diseases. Ipsen sells its drugs through a network of distributors and directly to hospitals in a few countries. The company operates its research and development facilities in Paris-Saclay, France; Oxford, the UK; and Cambridge, the US. The company offers products in Europe, North America, Asia and rest of the world. Ipsen is headquartered in Paris, France.
For a complete picture of Elafibranor’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.
