WHO Analysis Highlights Antibacterial Pipeline Challenges and Progress

As of December 2023, 97 products are currently in clinical development, aimed at tackling drug-resistant infections caused by priority pathogens identified by the WHO in 2024. This includes 57 antibiotics and 40 non-traditional antibacterials. Notably, 3 products have advanced to the pre-registration phase, marking a step towards potential market availability.¹

Dr. Yukiko Nakatani, WHO’s Assistant Director-General for Antimicrobial Resistance ad interim, emphasized, “Antimicrobial resistance is only getting worse, yet we’re not developing new trailblazing products fast enough to combat the most dangerous and deadly bacteria. Innovation is badly lacking, and even when new products are authorized, access remains a serious challenge. Antibacterial agents are simply not reaching the patients who desperately need them, in countries of all income levels.”²

Among the products under development, 57 antibiotics and 40 non-traditional antibacterials were in clinical development and three are in the pre-registration phase:

• Priority Pathogens: 32 antibiotics and 30 non-traditional antibacterials targeting WHO-designated bacterial priority pathogens.
• 19 antibiotics focus on combating M tuberculosis, a critical priority pathogen globally.
• Specific Targets: Additional efforts include 5 antibiotics and 9 non-traditional antibacterials targeting C difficile, as well as 1 antibiotic, and 1 non-traditional antibacterial targeting Helicobacter pylori.

Analysis reveals that of the 32 antibiotics targeting priority pathogens:

• 18 are anticipated to demonstrate activity against at least one critical priority pathogen.
• 12 meet one or more innovation criteria, such as a new chemical entity, novel molecular binding site, or unique mode of action.

The analysis of antibacterial products has limitations. It focuses only on products for drug-resistant infections from WHO's 2024 priority pathogens list, excluding others. Data cutoff is 31 December 2023, missing recent developments. It covers only products in phases I-III without global market approval, potentially skewing results. Vaccines, topical agents, inorganic substances, biodefense agents, and non-systemic formulations are excluded, limiting a full view of antibacterial research and development.

The current landscape of antibacterial R&D reflects progress and ongoing challenges in addressing antimicrobial resistance. With promising developments in novel antibiotics and non-traditional antibacterial, researchers and policymakers continue to emphasize the need for sustained innovation and investment in combating drug-resistant infections globally. While advancements in the antibacterial pipeline offer hope, concerted efforts are required to overcome the evolving threat posed by antimicrobial resistance worldwide.

References

1. WHO. Antibacterial products in clinical development for priority pathogens. Published June 2024. Accessed June 18, 2024. https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/antibacterial-products-in-clinical-development-for-priority-pathogens

2. WHO. WHO releases report on state of development of antibacterials. Published June 14, 2024. Accessed June 18, 2024. https://www.who.int/news/item/14-06-2024-who-releases-report-on-state-of-development-of-antibacterials