Overview and analysis 2025 Analysis of antibacterialagents in clinical andpreclinical development Overview and analysis 2025 Analysis of antibacterial agents in clinical and preclinical development: overview and analysis 2025 ISBN 978-92-4-011309-1 (electronic version)ISBN 978-92-4-011310-7 (print version) © World Health Organization 2025 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0IGO licence (CC BY-NC-SA 3.0 IGO;https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, providedthe work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHOendorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adaptthe work, then you must license your work under the same or equivalent Creative Commons licence. If you create atranslation of this work, you should add the following disclaimer along with the suggested citation: “This translationwas not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of thistranslation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules ofthe World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation. Analysis of antibacterial agents in clinical and preclinical development: overview and analysis 2025.Geneva: World Health Organization; 2025. Licence:CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available athttps://iris.who.int/. Sales, rights and licensing. To purchase WHO publications, seehttps://www.who.int/publications/book-orders.To submit requests for commercial use and queries on rights and licensing, seehttps://www.who.int/copyright. Third-party materials.If you wish to reuse material from this work that is attributed to a third party, such as tables,figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtainpermission from the copyright holder. The risk of claims resulting from infringement of any third-party-ownedcomponent in the work rests solely with the user. General disclaimers.The designations employed and the presentation of the material in this publication do not implythe expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city orarea or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on mapsrepresent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsedor recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissionsexcepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, thepublished material is being distributed without warranty of any kind, either expressed or implied. The responsibility forthe interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising fromits use. Contents AcknowledgementsivAbbreviationsvi1Introduction12Clinical pipeline33Preclinical pipeline334R&D priorities to strengthen the antibacterial pipeline465Next steps496Methods517References538Annexes56Annex 1Declaration of interests of Advisory Group members57Annex 2Cell wall inhibitors – β-lactams and β-lactamase inhibitors59Annex 3Cell membrane disruptors75Annex 4Protein synthesis inhibitors83Annex 5Novel bacterial topoisomerase inhibitors (NBTIs)91Annex 6FabI inhibitors – pyrido-enamides98Annex 7FtsZ inhibitors101Annex 8ATP disruptors103Annex 9Antibiotic hybrids105Annex 10Agents in development for treating drug-resistant TB107Annex 11Non-traditionals – antibodies135Annex 12Non-traditionals – anti-virulence agents144Annex 13Non-traditionals – bacteriophages and phage-derived enzymes146Annex 14Non-traditionals – immunomodulating agents160Annex 15Non-traditionals – microbiome-modulating agents162Annex 16Non-traditionals – miscellaneous165Annex 17Traditionals – CDI andH. pylori171Annex 18Non-traditional agents against CDI andH. pylori180 Acknowledgements This publication was prepared by Valeria Gigante(Scientist, World Health Organization (WHO) AntimicrobialResistance (AMR) Division) with support from Richard Alm,Daniela Melchiorri and Tamarie Rocke (WHO consultants)under the supervision of Alexandra Cameron (Unit Head,WHO AMR Division) and Jean-Pierre Nyemazi (Director adinterim, WHO AMR Division). •Mical Paul, Directo