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, non-alcoholic fatty liver disease, non-alcoholic steatohepatitis, primary biliary cholangitis.

It was under development for diabetic retinopathy and diabetic macular edema.

Kowa overview

Kowa is a pharmaceutical company which is involved into the business related to the manufacturing and selling of therapeutic drugs, medical devices, energy-saving products. It imports and exports LED lighting equipment, optical equipment and renewable energy power generation systems; and trading of textile, lifestyle products, construction materials, machinery, chemicals, and commodities. 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. 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 18 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.