The World Health Organization (WHO) invites stakeholders from across the public health, research, clinical, industry, and civil society sectors to review and provide comments on the draft Target Product Profiles (TPPs) for new antibacterial agents. These TPPs aim to support the development of urgently needed antibiotics to address drug-resistant bacterial infections with high morbidity and mortality, particularly in low- and middle-income countries (LMICs).
The current draft includes three TPPs for:
Therapy of severe infections caused by multidrug-resistant Gram-negative bacteria, focusing on novel antibiotics for bloodstream infections and hospital-acquired or ventilator-associated bacterial pneumonia caused by third-generation cephalosporin- and carbapenem-resistant Enterobacterales, and carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa.
Therapy of antibiotic-resistant Gram-positive infections in immunosuppressed and critically ill patients, focusing on novel antibiotics for severe infections, including bloodstream infections, caused by vancomycin-resistant Enterococcus faecium and other Gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus and coagulase-negative staphylococci.
Therapy of community-acquired and healthcare-associated bacterial meningitis, focusing on novel antibiotics for community-acquired meningitis caused by penicillin- and cephalosporin-resistant bacteria, and healthcare-associated, e.g., neurosurgical meningitis, caused by multidrug-resistant Gram-negative bacteria and methicillin-resistant Staphylococcus aureus .
Each TPP outlines the preferred and minimal product characteristics for new antibacterial treatments in terms of indication for use, target population, mechanism of action, spectrum of activity, pharmacokinetics/pharmacodynamics, safety/tolerability, product stability and storage, and access and affordability considerations. Please note this is an unedited, unformatted draft which will be finalized following public consultation.
This consultation forms part of WHO’s commitment to driving innovation and access in the antibacterial pipeline and ensuring product development is aligned with global public health priorities, including the WHO Bacterial Priority Pathogens List (BPPL), 2024.
The purpose of the antibacterial TPP Development activity is to:
1. Align antibacterial TPP development with the WHO priority pathogen list and resistance surveillance data.
2. Include use cases for severe community- and hospital-acquired infections across age groups and care settings.
3. Prioritize globally relevant syndromes with high morbidity and mortality.
4. Define pharmacokinetic/pharmacodynamic targets that reflect diverse clinical populations including neonates and immunosuppressed patients.
5. Promote partnerships with public and private sector actors, to incentivize and de-risk antibacterial R&D.
Submissions are welcome from individuals or institutions. All feedback received will be carefully reviewed to inform the finalization of the TPPs. All feedback will be held in strict confidence by WHO; it will not be shared with third parties and will be used exclusively to inform the development of the three antibacterial TPPs and related outputs.
The feedback period has officially closed as of Sunday, 7 September 2025 (Central European Time, GMT/UTC +1).