Analysis of antibacterial agents in clinical and preclinical development: overview and analysis 2025

The World Health Organization’s (WHO) “2025 Antibacterial agents in clinical and preclinical development: an overview and analysis” report provides a comprehensive evaluation of the global antibacterial pipeline. This seventh clinical and fifth preclinical review examines both traditional (direct-acting small molecules) and non-traditional antibacterial candidates in development worldwide.   

The analysis specifically evaluates how effectively the current pipeline addresses infections caused by priority pathogens, as defined by the updated 2024 WHO bacterial priority pathogens list. For traditional agents, the report assesses innovation based on specific criteria: absence of known cross-resistance, new targets, novel modes of action, and/or new drug classes. 

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 2-18). 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 15 February 2025, the cut-off date of the 2025 analysis.