Pemafibrate is under clinical development by Kowa and currently in Phase II for Primary Biliary Cholangitis (Primary Biliary Cirrhosis). According to GlobalData, Phase II drugs for Primary Biliary Cholangitis (Primary Biliary Cirrhosis) have a 42% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Pemafibrate’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.

Pemafibrate overview

Pemafibrate (Parmodia) acts as dyslipidemic agent. It is formulated as film-coated tablets oral route of administration. Parmodia is indicated for the treatment of hyperlipidemia (including familial).

Pemafibrate (K-877) is under development for the treatment of dyslipidemia including hypertriglyceridemia, hypercholesterolemia, primary biliary cholangitis and acute coronary syndrome.

It was under development for diabetic retinopathy, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis  and diabetic macular edema.

Kowa overview

Kowa is a company that specializes in trading and manufacturing. The company offers trading, manufacturing, and hospitality, with a focus on textiles, machinery, construction materials, chemicals, commodities, pharmaceuticals, and medical devices. Its major products include over the counter and prescription drugs, energy-saving solutions, architecture and various textile products. It also trades various items, such as pharmaceutical ingredients, ingredients for cosmetics, monomers and specialty chemicals, oil and fats, feed additives, activated carbon and coal, industrial machinery and equipment and vessels. Kowa’s products and services cater to industries such as healthcare, construction, fashion and lifestyle. The company operates through its subsidiaries and affiliates across Japan, North America, Latin America, Europe, and Asia. Kowa is headquartered in Nagoya, Aichi, Japan.

For a complete picture of Pemafibrate’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 12 April 2024

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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 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.