Sarecycline: First Global Approval

Drugs. 2019 Feb;79(3):325-329. doi: 10.1007/s40265-019-1053-4.

Abstract

Sarecycline (Seysara™) is an oral, once-daily, tetracycline-class drug for which a tablet formulation is approved in the USA for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged ≥ 9 years. The drug was developed by Paratek and Allergen and later acquired by Almirall S.A. (a Barcelona-based pharmaceutical company focused on medical dermatology). Sarceycline tablets were approved in early October 2018 and are planned to be available for patients in January 2019. Sarecycline capsules have also been studied in the USA, but no recent reports of development have been identified for this formulation. There are currently no clinical trials underway assessing sarecycline in rosacea. This article summarizes the milestones in the development of sarecycline leading to this first approval for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.

Publication types

  • Review

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Administration, Oral
  • Anti-Bacterial Agents / pharmacology*
  • Dose-Response Relationship, Drug
  • Drug Approval
  • Drug Development
  • Humans
  • Molecular Structure
  • Rosacea / drug therapy
  • Tetracyclines / pharmacology*
  • United States
  • United States Food and Drug Administration

Substances

  • Anti-Bacterial Agents
  • Tetracyclines
  • sarecycline