Pemafibrate is under clinical development by Kowa and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Pemafibrate’s likelihood of approval (LoA) and phase transition for Hypertriglyceridemia took place on 17 Oct 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Pemafibrate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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, 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. The company 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.

Quick View Pemafibrate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Pemafibrate
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Metabolic Disorders
Key Developers
Highest Development Stage
  • Marketed

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.