Nontraditional Products for Bacterial Infections in Clinical Development

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:

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 Clostridium 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. Additionally, many of these products are not likely to be used as a stand-alone 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 beta-lactam antibiotics 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.
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/).