Analysis of the clinical pipeline of treatments for drug resistant bacterial infections: despite progress, more action is needed

  12 January 2022

There is an urgent global need for new strategies and drugs to control and treat multi-drug resistant bacterial infections. In 2017, the World Health Organization (WHO) released a list of 12 antibiotic-resistant priority pathogens and began to critically analyze the antibacterial clinical pipeline. This review analyzes ‘traditional’ and ‘non-traditional’ antibacterial agents and modulators in clinical development current on 30 June 2021 with activity against the WHO priority pathogens, mycobacteria and Clostridioides difficile. Since 2017, 12 new antibacterial drugs have been approved globally, but only vaborbactam belongs to a new antibacterial class. Also innovative is the cephalosporin derivative cefiderocol, which incorporates an iron-chelating siderophore that facilitates Gram-negative bacteria cell entry. Overall, there were 76 antibacterial agents in clinical development (45 traditional and 31 non-traditional) with 28 in Phase 1, 32 in Phase 2, 12 in Phase 3 and four under regulatory evaluation. Forty-one out of 76 (54%) targeted WHO priority pathogens, 16 (21%) against mycobacteria, 15 (20%) against C. difficile and 4 (5%) are non-traditional agents with broad spectrum effects. Nineteen of the 76 antibacterial agents have new pharmacophores and four of these have new modes of actions not previously exploited by marketed antibacterial drugs. Despite there being 76 antibacterial clinical candidates, this analysis indicated that there were still relatively few clinically differentiated antibacterial agents in late-stage clinical development, especially against critical Priority Pathogens. We believe that future antibacterial R&D should focus on the development of innovative and clinically differentiated candidates that have clear and feasible progression pathways to the market.

Author(s): Mark S. Butler, Valeria Gigante, Hatim Sati, Sarah Paulin, Laila Al-Sulaiman, John H. Rex, Prabhavathi Fernandes, Cesar A. Arias, Mical Paul, Guy E. Thwaites, Lloyd Czaplewski, Richard A. Alm, Christian Lienhardt, Melvin Spigelman, Lynn L. Silver, Norio Ohmagari, Roman Kozlov, Stephan Harbarth, Peter Beyer
Smart Innovations  


Unrestricted financial support by:


Antimicrobial Resistance Fighter Coalition

Bangalore Bioinnovation Centre



Every two weeks in your inbox

Because there should be one newsletter that brings together all One Health news related to antimicrobial resistance: AMR NEWS!


What is going on with AMR?
Stay tuned with remarkable global AMR news and developments!

Keep me informed