2023 Antibacterial agents in clinical and preclinical development: an overview and analysis

The World Health Organization’s (WHO) “2023 Antibacterial agents in clinical and preclinical development: an overview and analysis” report evaluates the pipeline of antibacterial candidates in different stages of development.  

This report presents an analysis of antibacterial agents in preclinical (fourth annual review) and clinical (sixth annual review) development. The analysis covers traditional (direct-acting small molecules) and non-traditional antibacterial agents in development worldwide. It evaluates to what extent the present pipeline addresses infections caused by priority pathogens according to the updated 2024 WHO bacterial priority pathogens list. The report also provides an assessment of the traditional agents with respect to whether they meet a set of predefined criteria for innovation, namely absence of known cross-resistance, new target, mode of action and/or class. It also includes an overview of the agents that obtained authorization since 1 July 2017.  

The potential for clinical utility and clinical differentiation for each of the Phase 1–3 traditional and non-traditional antibacterials is described in detail in their respective product profiles (Annexes 3-23). A series of targeted trend analyses have been performed for this pipeline review, examining product formulations, activity and desired clinical indications data from 1 July 2017 to 31 December 2023, the cut-off date of the 2023 analysis.  

This report is part of the WHO’s efforts to prioritize and coordinate global research and development (R&D) efforts to address the ongoing void in antibacterial drug development.