<p>Lerodalcibep (lerodalcibep-liga; LEROCHOL<sup>®</sup>), a subcutaneously administered third-generation proprotein convertase subtilisin/kexin type&#xa0;9 (PCSK9) inhibitor, is being developed by LIB Therapeutics for the treatment of hypercholesterolaemia. Lerodalcibep received its first approval on 12&#xa0;December 2025 in the USA, as an adjunct to diet and exercise, to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia. Lerodalcibep is in preregistration for hypercholesterolaemia in the EU. Lerodalcibep is administered as a once-monthly subcutaneous injection. This article summarizes the milestones in the development of lerodalcibep leading to this first approval for the treatment of adults with hypercholesterolaemia.</p>

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Lerodalcibep: First Approval

  • Amy Zhuang-Yan,
  • Hannah A. Blair

摘要

Lerodalcibep (lerodalcibep-liga; LEROCHOL®), a subcutaneously administered third-generation proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, is being developed by LIB Therapeutics for the treatment of hypercholesterolaemia. Lerodalcibep received its first approval on 12 December 2025 in the USA, as an adjunct to diet and exercise, to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia. Lerodalcibep is in preregistration for hypercholesterolaemia in the EU. Lerodalcibep is administered as a once-monthly subcutaneous injection. This article summarizes the milestones in the development of lerodalcibep leading to this first approval for the treatment of adults with hypercholesterolaemia.