Overview
This World Health Organization (WHO) report presents target product profiles (TPPs) for new antibacterial agents for therapy of severe infections caused by multidrug-resistant Gram-negative bacteria, antibiotic-resistant Gram-positive infections in immunosuppressed and critically ill patients, and community-acquired and health care-associated bacterial meningitis. The TPPs outline desired characteristics for novel antibiotics, including intended use, target populations, pharmacokinetics, safety, efficacy, route of administration, stability, and access and affordability considerations, to support research and development (R&D) of products that address the greatest and most urgent public health needs posed by antimicrobial resistance (AMR).
Building on earlier WHO antibacterial TPPs, the report aligns product development with the WHO bacterial priority pathogens list, 2024 (BPPL), and with evidence from WHO antibacterial pipeline analyses, prioritizing syndromes with high morbidity and mortality and emphasizing needs in low- and middle-income countries. It highlights the importance of early integration of equity, stewardship and regulatory expectations, and underlines the need for partnerships between public and private sector actors to incentivize and de-risk antibacterial R&D and facilitate timely, equitable access to effective new antibiotics.