We need a reliable pipeline with new antibacterial agents that are innovative, affordable, accessible to all those who need them.
The World Health Organization (WHO) published today three new Target Product Profiles (TPPs) for antibacterial agents designed to address key drug-resistant bacteria causing severe bloodstream and urinary tract infections, pneumonia and meningitis in at-risk populations worldwide. The new TPPs focus on developing new antibiotics for severe multidrug-resistant Gram-negative infections, antibiotic-resistant Gram-positive infections in immunosuppressed and critically ill patients, and community-acquired and health care-associated bacterial meningitis.
Developed through extensive global consultation, the TPPs define the minimum and preferred characteristics of future antibacterials, supporting researchers, product developers, regulators and funders to align innovation with unmet clinical needs and bacterial priority pathogens.
Despite 90 new antibacterial agents being in preclinical or clinical development, as highlighted in WHO's 2025 antibacterial pipeline analysis , few clinical candidates target bacterial priority pathogens and even fewer are considered innovative.
"The scientific community has developed and approved new antibiotics in recent years. This is good, but unfortunately not sufficient to catch up with evolving drug-resistance bacteria, especially against those of greatest concern," said Dr Yvan Hutin, Director of Antimicrobial Resistance at WHO. "We need a reliable pipeline with new antibacterial agents that are innovative, affordable, accessible to all those who need them."
Three global priorities for innovation
The new TPPs outline the desired antibacterial product characteristics for three types of infections with profound global impact:
Severe multidrug-resistant (MDR) Gram-negative infections, including carbapenem-resistant Enterobacterales, Acinetobacter baumannii and Pseudomonas aeruginosa, which cause bloodstream infections and hospital-acquired or ventilator-associated bacterial pneumonia, among others. These infections lead to more deaths, prolonged hospital stays and increased demand for intensive care that in turn strain health care systems.
Severe Gram-positive infections in immunosuppressed and critically ill patients, with a focus on vancomycin-resistant Enterococcus faecium. These vulnerable populations face increased risk of severe bacterial infections, with bloodstream infections being one of the leading complications in intensive care units, causing prolonged stays and higher risk of death.
Bacterial meningitis, including penicillin- and cephalosporin-resistant community-acquired infections and multi drug resistant pathogens in health care-associated meningitis. Bacterial meningitis remains a devastating disease. Of those affected, approximately one person in six dies and one in five survives with long-term disabilities, including hearing loss, epilepsy or cognitive impairment.
Each TPP includes specific guidance on the development of new treatments in line with the WHO bacterial priority pathogen list and the most urgent research and development needs for novel antibacterials .
The TPPs aim to prioritize globally those infections associated with high morbidity and mortality, including both community- and hospital-acquired infections across all age groups, health care settings, and regions. They also define clear targets for quality, efficacy, safety, and pharmacokinetics that reflect the needs of diverse patient populations, including immunosuppressed and critically ill patients, as well as neonates and children. The TPPs also seek to foster collaboration between public and private sector partners to incentivize and reduce the risks associated with antibacterial research and development.
The TPPs contribute to a unified framework designed to steer future research and development, as well as investment decisions. They also emphasize the importance of strengthening the antibiotic pipeline, integrating stewardship and access principles from early in the product development process. This initiative is part of the WHO and European Commission's Health Emergency Preparedness Authority (HERA) partnership to combat antimicrobial resistance under the EU4Health programme.
