Nontraditional Products for Bacterial Infections in Clinical Development

Note: This data visualization was originally published in March 2017.

As of June 2019, an estimated 29 new nontraditional products1 with the potential to treat or prevent serious bacterial infections were in clinical development. Below is a snapshot of the current nontraditional products pipeline, based on publicly available information and informed by external experts. It is updated periodically, as products advance or are known to drop out of development. Because of periodic updates, endnote numbers may not be sequential. Please contact abxpipeline@pewtrusts.org with additions or updates.

Please contact abxpipeline@pewtrusts.org with additions or updates.

September 2019 (PDF) | March 2019 (PDF) | September 2018 (PDF)  | September 2017 (PDF)  |  March 2017 (PDF)

A data visualization from
A data visualization from The Pew Charitable Trusts
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For definitions of drug development terms and nontraditional product types, visit https://www.pewtrusts.org/en/research-and-analysis/articles/2014/03/12/glossary-for-the-antibiotic-pipeline.

Note: The following drugs have been removed from the pipeline. Removed candidates will be included in future updates if development resumes:

  • June 2019: S. pneumoniae next generation vaccine (GSK-2189241A) was discontinued, according to a press release from the company.
  • December 2018: SA4Ag was removed because development was discontinued, according to a press release from the company.
  • June 2018: ASN100, GEN 004, Group B Streptococcus vaccine, and VLA84 (IC84) were removed because they were no longer included in the research and development pipeline on the company’s website.
  • September 2017: Shigamab and Cdiffense were removed because they were no longer included in the research and development pipeline on the company’s website.

Endnotes

  1. Products listed here contain at least one component not previously approved in the United States. This pipeline is limited to products with the potential to treat or prevent infections caused by bacterial pathogens considered by the Centers for Disease Control and Prevention to be urgent, serious, or concerning threats (CDC, “Antibiotic Resistance Threats in the United States, 2013,” https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf). All analyses were limited to systemic products (drugs that work throughout the body) and therapies to treat Clostridioides difficile-associated disease. Additionally, we excluded drugs to treat mycobacterial infections, such as tuberculosis and Mycobacterium avium complex, Helicobacter pylori, and biothreat pathogens. Lastly, locally acting therapies such as topical, ophthalmic, and inhaled products were also excluded. Many of the listed products are not likely to be used as a standalone treatment, but as an adjunct to standard-of-care antibiotics.
  2. Based on the most advanced development phase for any indication according to trials registered at clinicaltrials.gov, unless direct communication from the company indicated differently. If no trials were included at clinicaltrials.gov, the phase listed on the company website or provided directly by the company is noted.
  3. Based on clinical trials currently registered at clinicaltrials.gov, unless otherwise noted.
  4. Registered at clinicaltrials.gov, but with no current study sites within the U.S.
  5. Ribaxamase is a β-lactamase, which is given orally and prophylactically with an IV antibiotic. Ribaxamase degrades penicillins and cephalosporins (without ß-lactamase inhibitor) in the gastrointestinal tract to minimize collateral damage to the gut microbiome and prevent occurrence of C. difficile. DAV132 is an activated charcoal approach, which is given prophylactically and acts to absorb antibiotic residues in the GI tract to minimize damage to the gut microbiome and prevent the occurrence of C. difficile. DAV132 is being regulated as a drug by the U.S. Food and Drug Administration, but as a medical device in Europe.
  6. Information obtained from the company via a corporate website, news release, and/or direct company communication.
  7. Vaccines for S. pneumoniae have been approved and widely used. The products in development listed in this table have the potential for expanded serotype coverage.
  8. Clinical trial information for PolyCAb is currently registered in the WHO International Clinical Trials Registry Platform (http://apps.who.int/trialsearch/).
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