Update of Antibacterial Agents in Clinical Development. World Health Organization, 2018
(2018; 4 pages)

Abrégé

As of 1 July 2018, a total of 48 antibiotics (including combinations) and 10 biologicals that target the WHO priority pathogens, Mycobacterium tuberculosis and Clostridium difficile were in the pipeline. The biggest gap and need is for innovative antibacterials to treat the priority pathogens, in particular critical Gram-negative bacteria.

The antibacterial agents in the pipeline are the following:

  • 38 new therapeutic entities (30 antibiotics and 8 biologicals) and 4 combinations targeting priority pathogens.
  • 10 agents targeting Mycobacterium tuberculosis.
  • 6 agents (4 antibiotics and 2 biologicals) targeting Clostridium difficile.
  • Of the 30 antibiotics targeting priority pathogens:
    • 15 are oral formulations;
    • 11 are expected to have some activity against at least one critical Gram-negative priority pathogen; and
    • 5 fulfill at least one of the four criteria for innovation, 1 agent against Gram-negative bacteria.
  • 3 antibiotics and combinations containing a new chemical entity have gained market authorization between 2 May 2017 and 1 July 2018.

The World Health Organization’s 2018 update of antibacterial agents in clinical development is based on the outcome of the second advisory group meeting that was held on 12 July 2018. The update follows the methodology described in the WHO 2017 publication Antibacterial agents in clinical development – an analysis of the antibacterial clinical development pipeline, including tuberculosis. The update period is from 2 May 2017 to 1 July 2018 and includes a targeted search of products in development in China. Funding for this report was kindly provided by the Governments of Austria and Germany.

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