Seladelpar lysine is under clinical development by Gilead Sciences and currently in Pre-Registration for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). According to GlobalData, Pre-Registration drugs for Primary Biliary Cholangitis (Primary Biliary Cirrhosis) have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Seladelpar lysine’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.
Seladelpar lysine overview
Seladelpar lysine (MBX-8025, RWJ-800025) is under development for the treatment of primary biliary cholangitis (PBC), liver fibrosis. The drug candidate is administered through the oral route as a capsule. MBX-8025 targets human PPAR-delta receptor. It was under development for the treatment of Fredrickson types I and V hyperlipoproteinemias, non-alcoholic steatohepatitis (NASH), mixed dyslipidemia, severe hypertriglyceridemia (SHTG), primary sclerosing cholangitis (PSC) and homozygous familial hypercholesterolemia (HoFH).
Gilead Sciences overview
Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It carries out the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases such as hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, cancer, and human immunodeficiency virus (HIV) infection. It markets its products through commercial teams, third-party distributors and corporate partners. Gilead’s commercial teams promote its products through direct field contact with physicians, hospitals, clinics and other healthcare providers. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East, and Africa. Gilead is headquartered in Foster City, California, the US.
For a complete picture of Seladelpar lysine’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
