Antibiotics Currently in Global Clinical Development

Note: This data visualization was originally published in February 2014.

As of June 2019, approximately 42 new antibiotics with the potential to treat serious bacterial infections are in clinical development. The success rate for clinical drug development is low; historical data show that, generally, only 1 in 5 infectious disease products that enter human testing (phase 1 clinical trials) will be approved for patients.* Below is a snapshot of the current antibiotic pipeline, based on publicly available information and informed by external experts.

Please note that this resource focuses exclusively on small molecule products that act systemically (drugs that work throughout the body), contain at least one component not previously approved, and have the potential to treat serious or life-threatening infections.¹ In September 2017, Pew’s assessment of the antibiotic pipeline was expanded to include products in development globally.

Because this resource is updated periodically, footnote numbers may not be sequential. Please contact abxpipeline@pewtrusts.org with additions or updates.

September 2019 (PDF) | March 2019 (PDF) | September 2018 (PDF) | September 2017 (PDF)  |  March 2017 (PDF)  |  September 2016 (PDF)  |  March 2016 (PDF)  | September 2015 (PDF) | March 2015 (PDF)  |  December 2014 (PDF)  | September 2014 (PDF)  |  June 2014 (PDF)  |  February 2014 (PDF)

Endnotes

1. Drugs with the potential to treat Clostridioides  difficile-associated disease are also included in this resource, even though they do not necessarily work systemically, as the Centers for Disease Control and Prevention (CDC) cited C. difficile as an urgent public health threat in a 2013 report (“Antibiotic Resistance Threats in the United States, 2013”:  http://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf). Specifically excluded are drugs to treat mycobacterial infections, such as tuberculosis and Mycobacterium avium complex, Helicobacter pylori, and biothreat pathogens. Locally acting drugs such as topical, ophthalmic, and inhaled products are also excluded. Biological products, including vaccines and antibodies, are tracked separately in Pew’s nontraditional pipeline (“Nontraditional Products for Bacterial Infections in Clinical Development,” http://www.pewtrusts.org/en/research-and-analysis/data-visualizations/2017/nontraditional-products-for-bacterial-infections-in-clinical-development).
2. Based on the most advanced development phase for any indication according to trials registered in a government clinical trial registry (United States, http://www.clinicaltrials.gov, Australian New Zealand Clinical Trials Registry, http://www.anzctr.org.au, European Union Clinical Trials Register, https://www.clinicaltrialsregister.eu, Japan Pharmaceutical Information Center, http://www.clinicaltrials.jp), unless direct communication from the company indicated differently. If no trials were included in a clinical trial registry, then the phase listed on the company website or provided directly by the company is noted by footnote 6. Antibiotics that have been approved will remain listed for one year following approval of the initial indication. The country and regulatory agency that approved the drug will be indicated in parentheses. Antibiotics that are approved in a country outside of the U.S., but are still in clinical development for the U.S. market, will remain in the pipeline and noted.
3. A “yes” in this column indicates that a drug has in vitro and/or in vivo data showing activity against bacteria that are considered ESKAPE pathogens (Gram-positive: Enterococcus faecium, Staphylococcus aureus; Gram-negative: Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, or Enterobacter species). An ESKAPE pathogen indicated as “yes,” requires activity against at least one bacterial species. A “possibly” in this column indicates a candidate with activity information reported by the company via a corporate website, news release, or direct communication, and/or with inconclusive in vitro/in vivo data. Drugs noted with an endnote 12 may be listed as “possibly” because activity is uncertain until the paired antibiotic is confirmed.  The column definition was revised in September 2019. In previous versions of this chart, the column included all drugs with Gram-negative activity (including drugs active against Neisseria gonorrhoeae or Haemophilus influenzae), and drugs with activity against resistant Gram-negative ESKAPE pathogens.
4. A “yes” in this column indicates a drug with the potential to address at least one of the pathogens identified by CDC as an urgent threat or World Health Organization (WHO) critical threat. The target pathogen is listed in parentheses. CDC urgent threats include C. difficile, carbapenem-resistant Enterobacteriaceae (CRE), and drug-resistant N. gonorrhoeae. WHO critical priority pathogens include carbapenem-resistant Acinetobacter baumannii (CRAB), carbapenem-resistant Pseudomonas aeruginosa (CRPA), carbapenem-resistant Enterobacteriaceae (CRE) extended spectrum β-lactamase (ESBL) producing Enterobacteriaceae (WHO, “Global Priority List of Antibiotic-Resistant Bacteria to Guide Research, Discovery, and Development of New Antibiotics” (2017), https://www.who.int/news-room/detail/27-02-2017-who-publishes-list-of-bacteria-for-which-new-antibiotics-are-urgently-needed). Because a drug with activity against CRE is also generally active against ESBL-producing Enterobacteriaceae, ESBL activity is not noted unless the drug is not active against CRE, but is against ESBL-producing Enterobacteriaceae. A “possibly” in this column indicates a drug with activity information reported by the company via a corporate website, news release, or direct communication, and/or with inconclusive in vitro/in vivo data. Drugs noted with an endnote 12 may be listed as “possibly” because activity is uncertain until the paired antibiotic is confirmed. This column was revised in September 2017 to include WHO’s critical threat pathogens.
5. Based on clinical trials currently registered on a government clinical trial registry, and/or reported qualified infectious disease product (QIDP) designations, unless otherwise noted. Bolded indications are reported QIDP designations. QIDP designations are given by the FDA to antibiotics intended to treat serious or life-threatening infections. QIDPs are eligible to receive benefits under the Generating Antibiotic Incentives Now Act (signed into law as part of the Food and Drug Administration Safety and Innovation Act), including expedited FDA review and extended exclusivity for approved products.
6. Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication.
7. This antibiotic has been approved in a country outside the U.S., but remains in the pipeline because it is currently in development for the U.S. market. Taigexyn (Nemonoxacin) has been approved for community-acquired bacterial pneumonia in Taiwan, Province of China and China. ARV-1801 (Taksta, fusidic acid) has been approved for acute bacterial skin and soft tissue infections in outside markets. Ceftobiprole has been approved for community-acquired pneumonia and hospital-acquired bacterial pneumonia in outside markets. SPR994 has been approved for pneumonia, otitis media, and sinusitis in Japan.
8. Products added after expanded methodology in September 2017 pipeline update to include global antibiotic development (see methodology section for further details on determining product inclusion). Currently, there is no public information available indicating that these antibiotics are in development for the U.S. market.
9. In February 2015, FDA approved an otic suspension formulation of finafloxacin to treat acute otitis externa. Because a systemic formulation of finafloxacin has not received approval in any country, this drug remains listed in our pipeline. Finafloxacin has shown the potential for improved activity under certain conditions, namely, acidic environments. Additionally, a company press release noted that Phase 2 complicated urinary tract infection study results have shown improved clinical outcomes in patients treated with finafloxacin compared to patients treated with the current standard of care.
10. A novel drug class is defined as a core chemical structure (scaffold) that has not previously been used systemically as an antibacterial in humans.
11. A target is defined as novel if the drug acts on a bacterial structure that has not previously been targeted by a systemic antibacterial in humans.
12. This drug is an antibiotic potentiator, which increases the entry and, therefore, the efficacy of antibiotics. The antibiotic this drug will be paired with has not yet been announced.
13. Delpazolid (LCB01-0371) is also in development for tuberculosis, but remains in the pipeline because it is also being developed for bacterial infections.
14. This is the prodrug form of the antibiotic, which has the same mechanism of action and core chemical structure, and is being developed for the distinct benefit of being able to be administered in other ways, e.g., oral or intravenously.
15. The drug target has not yet been fully elucidated.

Sources

1. Citeline, “Pharmaprojects,” (2012), http://www.citeline.com/products/pharmaprojects.
2. U.S. National Institutes of Health, “Search for Studies,” http://www.clinicaltrials.gov.
3. Helen W. Boucher et al., “10 x ’20 Progress—Development of New Drugs Active Against Gram-Negative Bacilli: An Update From the Infectious Diseases Society of America,” Clinical Infectious Diseases 56 (2013): 1685-94, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3707426.
4. Michael J. Pucci and Karen Bush, “Investigational Antimicrobial Agents of 2013,” Clinical Microbiology Reviews 26, no. 4 (2013): 792-821, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3811234.
5. Centers for Disease Control and Prevention, “Antibiotic Resistance Threats in the United States, 2013” (2013), http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf.
6. World Health Organization, “Global Priority List of Antibiotic-Resistant Bacteria to Guide Research, Discovery, and Development of New Antibiotics” (2017), http://www.who.int/medicines/publications/global-priority-list-antibiotic-resistant-bacteria/en.
7. World Health Organization, “Antibacterial Agents in Clinical Development: An Analysis of the Antibacterial Clinical Development Pipeline, Including Tuberculosis,” (2017), http://www.who.int/medicines/areas/rational_use/antibacterial_agents_clinical_development/en/.