Related Experiment Video

Updated: Jun 12, 2026

A High-Throughput Luciferase Assay to Evaluate Proteolysis of the Single-Turnover Protease PCSK9
08:14

A High-Throughput Luciferase Assay to Evaluate Proteolysis of the Single-Turnover Protease PCSK9

Published on: August 28, 2018

Recaticimab: The First Fc-Engineered PCSK9 Monoclonal Antibody for More Long-Lasting Effect in Lipid Lowering

Sha Li1, Ying Gao1, Cheng-Gang Zhu2

  • 1Cardiometabolic Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, National Clinical Research Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, China.

Drugs
|June 11, 2026
PubMed

Insights

Recaticimab, a novel anti-PCSK9 antibody, offers potent low-density lipoprotein cholesterol reduction with infrequent dosing. Further research is needed to confirm cardiovascular benefits in diverse populations.

Area of Science:

  • Cardiovascular Medicine
  • Pharmacology
  • Immunology

Background:

  • Atherosclerotic cardiovascular disease (ASCVD) is a major global health concern.
  • Elevated low-density lipoprotein cholesterol (LDL-C) is a key modifiable risk factor for ASCVD.
  • Existing proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors effectively lower LDL-C but face challenges with patient adherence and dosing frequency.

Purpose of the Study:

  • To evaluate the efficacy, safety, and tolerability of recaticimab, an Fc-engineered anti-PCSK9 monoclonal antibody with an extended half-life.
  • To assess recaticimab's potential to overcome limitations of current PCSK9 inhibitors, such as frequent injections and suboptimal real-world persistence.

Main Methods:

  • Recaticimab incorporates a YTE mutation (M252Y/S254T/T256E) for enhanced binding to the neonatal Fc receptor (FcRn), prolonging its half-life.
  • Phase III clinical trials were conducted to assess recaticimab's efficacy in LDL-C reduction.
  • Safety and tolerability profiles were evaluated in monotherapy and combination settings with statins.

Main Results:

  • Recaticimab demonstrated potent and sustained reductions in LDL-C.
  • The antibody was effective both as monotherapy and when used in conjunction with statins.
  • Recaticimab exhibited a favorable safety and tolerability profile across the trials.

Conclusions:

  • Recaticimab's YTE mutation-derived structural innovation enables ultra-long dosing intervals (up to 12 weeks), potentially improving adherence and persistence.
  • While pharmacologically advantageous, the translation of these benefits into improved cardiovascular outcomes requires further investigation.
  • Current evidence is primarily from Chinese populations; broader population validation, real-world adherence, cardiovascular outcomes, and cost-effectiveness studies are warranted.

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