WHO Report: Antibacterial Agents in Clinical and Preclinical Development Show Increase, But Innovation Still Lacking

The WHO has released its latest report on antibacterial agents, including antibiotics, in clinical and preclinical development worldwide.

The number of antibacterial agents in the clinical pipeline has gone up from 80 in 2021 to 97 in 2023, but there remains a “pressing need for new, innovative agents for serious infections and to replace those becoming ineffective due to widespread use.” The annual report evaluates how the R&D pipeline for antibacterial agents is addressing drug-resistant bacteria characterized as the most threatening to human health, according to the 2024 WHO bacterial priority pathogen list.

Anti-microbial resistance (AMR) is “driven largely by the misuse and overuse of antimicrobials, yet, at the same time, many people around the world do not have access to essential antimicrobial medicines.” According to the WHO, there are “too few antibacterials in the pipeline, given how long is needed for R&D and the likelihood of failure,” and “there is also not enough innovation.”

13 new antibiotics have obtained marketing authorization since July 1, 2017, “but only 2 represent a new chemical class and can be termed innovative.” Three non-traditional agents have also been authorized in that timespan. The preclinical pipeline remains focused on Gram-negative pathogens, which are “resistant to last-resort antibiotics.”

Increasingly, “non-traditional biological agents, such as bacteriophages, antibodies, anti-virulence agents, immune-modulating agents and microbiome-modulating agents, are increasingly being explored as complements and alternatives to antibiotics.”