Pemafibrate: First Global Approval

Drugs. 2017 Oct;77(16):1805-1810. doi: 10.1007/s40265-017-0818-x.

Abstract

Pemafibrate (Parmodia®) is a novel, highly selective peroxisome proliferator-activated receptor (PPAR)-α modulator (SPPARM). It acts by binding to PPAR-α and regulating the expression of target genes that modulate lipid metabolism, thereby decreasing plasma triglyceride levels and increasing high-density lipoprotein cholesterol levels. Developed by Kowa Company, Ltd., oral pemafibrate has been approved in Japan for the treatment of hyperlipidaemia (including familial hyperlipidaemia). This article summarizes the milestones in the development of pemafibrate leading to this first global approval for hyperlipidaemia.

Publication types

  • Review

MeSH terms

  • Benzoxazoles / administration & dosage
  • Benzoxazoles / adverse effects
  • Benzoxazoles / chemistry*
  • Benzoxazoles / pharmacology*
  • Butyrates / administration & dosage
  • Butyrates / adverse effects
  • Butyrates / chemistry*
  • Butyrates / pharmacology*
  • Cholesterol, HDL / blood
  • Drug Approval
  • Humans
  • Hyperlipidemias / drug therapy*
  • Lipid Metabolism / drug effects
  • Lipid Metabolism / genetics
  • Lipoproteins, HDL / blood
  • PPAR alpha / chemistry
  • PPAR alpha / genetics
  • PPAR alpha / metabolism*
  • Protein Binding

Substances

  • (R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid
  • Benzoxazoles
  • Butyrates
  • Cholesterol, HDL
  • Lipoproteins, HDL
  • PPAR alpha