WHO antibacterial preclinical pipeline review

Published: April 2021

WHO’s 2020 update of the global review of antibacterial products in preclinical development captures 292 antibacterial products that are being developed in 162 institutions around the world. These products target WHO priority pathogens, Mycobacterium tuberculosis and Clostridium difficile. This is WHO’s first update that provides a comprehensive overview of the preclinical antibacterial pipeline to date that is based on publicly available data. This overview will be updated on a regular basis.

Candidate products (therapeutics and vaccines) are reported by country of development, type and size of developer, preclinical stage, infection stage being targeted, route of administration, treatment modality and mode of action. Details of pathogen-specific products and pathogens targeted are also reported. 

See also:

Antibacterial products in clinical development for priority pathogens

Health products in the pipeline from discovery to market launch for all diseases

What you see | Scope and limitations | Data sources 

What you see

The data visualization shows the numbers of antibacterial products by:
  • geographical distribution and developer's characteristics (chart A) (hover over the circles in chart A for details on the country and number of products)
  • preclinical stage (chart B)
  • infection stage targeted (chart C)
  • route of administration (chart D)
  • treatment modality (chart E)
  • mode of action (chart F)
  • whether or not the product is pathogen specific (chart G) and the pathogens targeted by the products (chart H)
  • list of products with further information on each product (chart I) (hover on the stage to open a popup window for additional information, including product developer

Select a product type at the top left of the data visualization to filter data for therapeutic or vaccines.

Points to note:

  • As of September 2020, a total of 292 products (245 therapeutics and 47 vaccines) are in preclinical development (click on each product type at the top left and view chart A.1).
  • Around 50% of the products (149) are being developed in Europe, followed by the Americas region (35%; 102) (chart A.1); with 90% (264) of the products being developed by high income countries (chart A.2).
  • Most products are developed by private institutions (73%; 212 products), followed by public institutions (16%; 47 products) (chart A.3).
  • 45% of the products (132) are developed by micro sized entities (<10 employees), followed by small and medium sized entities (28% and 15% of products, respectively) (chart A.4).
  • Almost 80% (232) of the products target the diseases at their symptomatic stage (chart C).
  • Around two-fifths of the products (39%; 115) are single agents (i.e. direct-acting small molecules) followed by 47 vaccines. 29 products are direct acting antimicrobial peptides.
  • The top mode of action is 'direct membrane effect' (62 products), followed by 'immunomodulation' and 'protein synthesis' (56 and 28 products respectively) (chart F).
  • 152 products (52%) are pathogen specific with 41 (27%) of those targeting M. tuberculosis (select 'yes' in chart G and view chart H).

To explore the data further

  • Select a stage of development, product type, spectrum, pathogen, or another element (e.g. by clicking on a bar in a chart or a cell in a table) – or a combination of elements– to display the corresponding data in the other charts.
  • Hover the cursor on a bar, a slice in a pie chart or a cell in a table to see more information in a popup window.
  • Hold the ‘Ctrl’ key on your keyboard to select more than one option.
  • Undo a selection by clicking ‘undo’ or ‘reset’ near the bottom of the page or by clicking the same element again.

Scope and limitations of the data

Scope
  • The review focuses on candidate antibacterial products that target WHO priority pathogens, Mycobacterium tuberculosis and Clostridium difficile that are in lead-optimization (post hit expansion), preclinical candidate, to formal Investigational New Drug Application (IND). IND is also termed as a Clinical Trial Application (CTA), or for regulatory authorities that do not use IND/CTA, this is indicative of the commencement of human testing.
  • The review includes both traditional and non-traditional products:
    -- direct- and indirect-acting antibacterials;
    -- small and large molecules;
    -- antivirulence agents;
    -- biofilm disruptors;
    -- potentiators;
    -- microbiome modifying agents;
    -- immunomodulators;
    -- re-purposed non-antibiotics and antibiotics from animal to human use;
    -- de-colonisation agents;
    -- combination therapies.
  • The review does not include:
    -- diagnostics;
    -- antifungals;
    -- antivirals;
    -- antiparasitics;
    -- wound care agents;
    -- unspecific supportive treatments;
    -- medical devices;
    -- products for industrial or animal use.
Limitations of the data
  • The preclinical pipeline review relies largely on data submitted by the respective developers through an open data call.
  • A thorough data cleaning was undertaken and, where available, other sources were used for additional information. Alternatively, the developer was contacted to clarify or fill gaps in the submission.
  • In the absence of clinical data as well as detailed data on the different molecules in development, no independent assessment was undertaken with respect to the bacterial targets or innovativeness of the individual projects.
  • The WHO Secretariat welcomes any additional information and/or feedback on the data presented in this document, which should be sent to: antibacterialpipeline@who.int. WHO will hold another open WHO data call for the next antibacterial preclinical pipeline review at a future date; it encourages wide participation.