WHO unveils new target product profiles for urgent antibiotics

The World Health Organization (WHO) published today three new Target Product Profiles (TPPs) for antibacterial agents aimed at combating key drug-resistant bacteria that cause severe bloodstream and urinary tract infections, pneumonia, and meningitis in at-risk populations around the globe. The new TPPs emphasize the development of new antibiotics to tackle severe multidrug-resistant Gram-negative infections, antibiotic-resistant Gram-positive infections in immunosuppressed and critically ill patients, as well as bacterial meningitis acquired in the community or associated with healthcare.

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-resistant bacteria, especially 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, and accessible to all those who need them."

Three global priorities for innovation.

The new TPPs outline the desired characteristics of antibacterial products for three types of infections that have a significant global impact:

Severe multidrug-resistant (MDR) Gram-negative infections, including carbapenem-resistant Enterobacterales, Acinetobacter baumannii, and Pseudomonas aeruginosa, cause bloodstream infections as well as hospital-acquired or ventilator-associated bacterial pneumonia, among others. These infections result in higher mortality rates, prolonged hospital stays, and increased demand for intensive care, which subsequently put a strain on healthcare systems.

Severe Gram-positive infections in immunosuppressed and critically ill patients, particularly focusing on vancomycin-resistant Enterococcus faecium. These at-risk populations experience an elevated likelihood of serious bacterial infections, with bloodstream infections being among the most significant complications in intensive care units, leading to extended hospital stays and an increased risk of mortality.

Bacterial meningitis, which includes community-acquired infections that are resistant to penicillin and cephalosporins, as well as multi-drug resistant pathogens associated with healthcare settings, continues to be a devastating illness. Approximately one in six individuals affected by this disease dies, while one in five survives with long-term disabilities such as 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 infections that are associated with high morbidity and mortality, encompassing both community- and hospital-acquired infections across all age groups, healthcare settings, and regions. They also establish clear targets for quality, efficacy, safety, and pharmacokinetics that address the needs of diverse patient populations, including immunosuppressed individuals, critically ill patients, as well as neonates and children. Additionally, the TPPs seek to promote collaboration between public and private sector partners to incentivize and mitigate the risks linked to 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.