Dimdazenil: First Approval

Drugs. 2024 May;84(5):607-611. doi: 10.1007/s40265-024-02020-9. Epub 2024 Mar 28.

Abstract

Dimdazenil (Junoenil®) is a small-molecule, oral, partial positive allosteric modulator of the gamma-aminobutyric acid (GABA)A receptor that is being developed by Zhejiang Jingxin Pharmaceutical in collaboration with Evotec for the treatment of insomnia. Dimdazenil is designed to overcome issues associated with full GABAA receptor agonists, such as tolerance, withdrawal symptoms and associated adverse effects. On 29 November 2023, dimdazenil oral capsules received approval in China for the short-term treatment of insomnia. This article summarizes the milestones in the development of dimdazenil leading to this first approval for insomnia.

Publication types

  • Review

MeSH terms

  • Administration, Oral
  • China
  • Drug Approval*
  • Flumazenil / pharmacology
  • Flumazenil / therapeutic use
  • GABA Modulators / administration & dosage
  • GABA Modulators / adverse effects
  • GABA Modulators / pharmacology
  • GABA Modulators / therapeutic use
  • Humans
  • Receptors, GABA-A / drug effects
  • Receptors, GABA-A / metabolism
  • Sleep Initiation and Maintenance Disorders* / drug therapy

Substances

  • GABA Modulators
  • Receptors, GABA-A
  • Flumazenil