Antibacterial products in clinical development for priority pathogens
Published: June 2022
WHO analysed the pipeline of antibacterial products (antibiotics and biologicals) that were in phase I-III of clinical development (as of November 2021) and which had not, at that date, received market authorization for human use anywhere in the world. The analysis matched the products in development against the WHO list of antibiotic-resistant "bacterial priority pathogens", Mycobacterium tuberculosis and Clostridioides difficile.
Candidate products are reported by type, pathogen category, phase of clinical development, and expected activity against priority pathogens. There is also an assessment of their innovativeness and whether a new chemical entity is involved. The route of administration, antibiotic class and developers are also reported. See below for details on the scope, analysis and limitations.
What you see | Scope, analysis and limitations | Data sources | Previous versions
What you see
The data visualization shows the numbers of antibacterial products by:
- type (chart A.1), and category of non-traditional products (chart A.2)
- pathogen category and phase of clinical development (chart A.3)
- expected activity against priority pathogens (chart B)
- innovativeness (chart C.1)
- whether or not a new chemical entity is involved (chart C.2)
- list of products (by pathogen category and product type) with further information on each product (hover on the phase to open a popup window for additional information) (chart D).
Points to note:
- As of November 2021, a total of 80 products (46 antibiotics and 34 non-traditional antibacterial agents) were in clinical development, three of which are in the pre-registration phase. They include (click on each of the pathogen category in chart A.3 and view chart A.1, details of non-traditional antibacterials can be found in chart A.2):
-- 28 antibiotics and 21 non-traditional antibacterials targeting priority pathogens
-- 13 antibiotics and 1 non-traditional antibacterials targeting M. tuberculosis
-- 5 antibiotics and 12 non-traditional antibacterials targeting C. difficile. - Of the 28 antibiotics targeting priority pathogens (click on “Antibiotics” in chart A.1 and “Priority pathogens” in chart A.2):
-- 18 are expected to have some activity against at least one critical priority pathogen (chart B)
-- 6 fulfil at least one of the four criteria for innovation (chart C.1)
-- All 28 antibiotics contain a new chemical entity (chart C.2). - Overall, the clinical pipeline and recently approved antibiotics are insufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance.
To explore the data further
- Select a product type, pathogen category, pathogen, phase of development or other element – or a combination of elements (e.g., by clicking on a bar in a chart or a cell in a table) – to display the corresponding data in the other charts.
- Hover the cursor on a bar, a slice in a pie 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, analysis and limitations of the data
Scope
This pipeline analysis focuses on products developed to address the WHO priority pathogen list, M. tuberculosis and C. difficile. It covers information available as of November, 2021 and is limited to products in phases I-III of clinical development that do not have market authorization anywhere in the world for human use.
The analysis does not include:
-- vaccines;
-- topical decolonizing agents;
-- nonspecific inorganic substances;
-- biodefense agents;
-- agents not developed for systemic use (injectable or oral formulations) or inhalation use, but only for topical application (e.g. creams or eye drops);
-- new formulations of existing treatments; or
--antibacterials that have had their development terminated, are no longer listed on a company’s pipeline and/or have no development updated for 3 years (1 November 2018).
Analysis
- The analysis was conducted by the WHO Advisory Group on the R&D of Antibacterial Treatments comprised of clinicians, microbiologists, and leading experts in antibiotic R&D, pharmacokinetics/pharmacodynamics (PK/PD) and antibiotic resistance.
- Products under development were assessed against the available evidence of activity against the priority pathogens. Assessment for use against OPPs was done for products not active against critical priority pathogens.
- Products developed against M. tuberculosis and C. difficile were assessed in terms of these pathogens respectively. Their activity was not assessed against the priority pathogens.
- Four criteria were used to assess if a product could be considered as innovative (at least one should be present):
-- new chemical class;
-- new target;
-- new mode of action; and/or
-- no cross resistance to other antibiotic classes.
Limitations of the data
The analysis relies on data available in the public domain and input from the WHO Technical Advisory Group on R&D. Some of the products in this analysis are not listed in any clinical trial registry and many registered trials have not disclosed results within the recommended 12 months after completion.
The WHO Secretariat welcomes additional information and/or feedback on the data presented in this analysis. Feedback should be sent to antibacterialpipeline@who.int.