Nontraditional Products for Bacterial Infections in Clinical Development
In December 2021, Pew’s antibiotic resistance project discontinued its work tracking antibiotics and nontraditional products in global clinical development. The World Health Organization has more information on the state of the global antibiotic pipeline.
Editor's note: On April 5, 2021, this piece was updated to change the drug type of KB109 from “live biotherapeutic product” to “synthetic polymer.”
As of December 2020, an estimated 36 new nontraditional products with the potential to treat or prevent serious bacterial infections were in clinical development.
The below interactive resource—based on publicly available information and informed by external experts and company communication—focuses on the nontraditional products currently in the clinical development pipeline. To view subsets of products, use filter options below or click on corresponding sections of the pie charts.
Please contact [email protected] with additions or updates.
March 2021 (XLSX) | March 2020 (XLSX) | September 2019 (PDF) | March 2019 (PDF) | September 2018 (PDF) | September 2017 (PDF) | March 2017 (PDF)
Assessment of Products to Combat Bacterial Infections
Because the conventional antibiotics pipeline remains so thin, finding new approaches is critical
While antibiotic innovation—finding and designing new types of antibiotics and improving existing drugs—remains essential to combating antibiotic resistance, “outside-the-box” approaches to preventing and treating bacterial infections are also needed. Such nontraditional approaches encompass a variety of products.
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filtered results
Drug name | Development phase | Company | Type | Potential indication(s) | |||||||||
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20vPnC Vaccines for S. pneumoniae have been approved and widely used. 20vPnC has the potential for expanded serotype coverage. | Biologics license application submitted (U.S. FDA) | Pfizer Inc. | Vaccine |
14
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Reltecimod | New drug application submitted (U.S. FDA) | Atox Bio Ltd. | Peptide immunomodulator |
6
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V114 Vaccines for S. pneumoniae have been approved and widely used. V114 has the potential for expanded serotype coverage. | Biologics license application (U.S. FDA) and marketing authorization application (EMA) submitted | Merck & Co. Inc. | Vaccine |
14
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DAV132 | Phase 3 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | Da Volterra | Antibiotic inactivator |
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11
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Exebacase | Phase 3 | ContraFect Corp. | Lysin |
2
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PF-06425090 | Phase 3 | Pfizer Inc. | Vaccine |
8
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RBX2660/ RBX7455 RBX7455 is a lyophilized, oral formulation of the microbiota-based therapy, and RBX2660 is an enema formulation. | Phase 3 | Rebiotix Inc. (wholly owned subsidiary of Ferring Pharmaceuticals Inc.) | Live biotherapeutic product |
17
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20
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SER-109 | Phase 3 | Seres Therapeutics Inc. (Nestlé Health Science licensee) | Live biotherapeutic product |
17
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Salvecin (AR-301) | Phase 3 | Aridis Pharmaceuticals Inc. | Monoclonal antibody |
5
21
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514G3 | Phase 2 | XBiotech Inc. | Monoclonal antibody |
1
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Aerucin (AR-105) | Phase 2 | Aridis Pharmaceuticals Inc. (Serum Institute of India Ltd. licensee) | Monoclonal antibody |
5
21
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Aerumab (AR-101) | Phase 2 | Aridis Pharmaceuticals Inc. (Serum Institute of India Ltd. licensee) | Monoclonal antibody |
5
21
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CAL02 | Phase 2 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | Combioxin SA | Virulence inhibitor |
4
5
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CP101 | Phase 2 | Finch Therapeutics Group Inc. | Live biotherapeutic product |
17
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ExPEC10V (JNJ-69968054) | Phase 2 | Janssen Research & Development LLC | Vaccine |
26
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ExPEC4V (JNJ-63871860) | Phase 2 | Janssen Research & Development LLC | Vaccine |
9
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GBS6 (PF-06760805) | Phase 2 | Pfizer Inc. | Vaccine |
10
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IMM-529 | Phase 2 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | Immuron Ltd. | Polyclonal antibody |
17
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LBP-EC01 | Phase 2 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | Locus Biosciences, Inc. | Bacteriophage |
30
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N-Rephasin (SAL200) (Tonabacase) | Phase 2 | Roivant Sciences/iNtRON Biotechnology Inc. | Lysin |
1
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NTCD-M3 | Phase 2 | Destiny Pharma PLC | Live biotherapeutic product |
17
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PhageBank | Phase 2 | Adaptive Phage Therapeutics Inc. | Bacteriophage |
22
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28
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Ribaxamase (SYN-004) | Phase 2 | Synthetic Biologics Inc. | Antibiotic inactivator |
8
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Shigella4V (GSK4069327A) | Phase 2 | GlaxoSmithKline PLC/LimmaTech Biologics AG | Vaccine |
15
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Suvratoxumab | Phase 2 | AstraZeneca PLC | Monoclonal antibody |
16
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VE303 | Phase 2 | Vedanta Biosciences Inc. | Live biotherapeutic product |
17
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GSK2904545A | Phase 1 | GlaxoSmithKline PLC | Vaccine |
3
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GSK3878858A | Phase 1 | GlaxoSmithKline PLC | Vaccine |
27
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GSK3882347 | Phase 1 | GlaxoSmithKline PLC/Fimbrion Therapeutics Inc. | Virulence inhibitor |
25
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KB109 | Phase 1 | Kaleido Biosciences | Live biotherapeutic product |
30
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MET-2 | Phase 1 | NuBiyota LLC/Takeda Pharmaceutical Company Ltd. | Live biotherapeutic product |
17
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PLG0206 | Phase 1 | Peptilogics Inc. | Synthetic antimicrobial peptide |
28
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PolyCAb | Phase 1 Clinical trial information for PolyCAb is currently registered in the WHO International Clinical Trials Registry Platform (http://apps.who.int/trialsearch). | MicroPharm Ltd. | Polyclonal antibody |
3
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RECCE-327 | Phase 1 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | Recce Pharmaceuticals Ltd. | Synthetic polymer |
29
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SER-262 | Phase 1 The company continues to evaluate microbiome pharmacokinetic and pharmacodynamic data from its SER-262 Phase 1b study and other completed clinical trials to inform the design of drug candidates in the pipeline and clinical trial design, and to determine next steps in the development of SER-262 to treat an initial recurrence of C. difficile infection. | Seres Therapeutics Inc. (Nestlé Health Science licensee) | Live biotherapeutic product |
8
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STEBVax | Phase 1 | Integrated BioTherapeutics Inc. | Vaccine |
13
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Key
- 1
- Bacteremia
- 2
- Bacteremia including right-sided endocarditis
- 3
- C. difficile infections
- 4
- Community-acquired bacterial pneumonia
- 5
- Hospital-acquired bacterial pneumonia
- 6
- Necrotizing soft tissue infections
- 7
- Prevention and treatment of C. difficile infections
- 8
- Prevention of C. difficile infections
- 9
- Prevention of extra-intestinal pathogenic E. coli infections
- 10
- Prevention of group B Streptococcus infections
- 11
- Prevention of gut colonization by multi-drug resistant organisms
- 12
- Prevention of S. aureus skin and soft tissue infections
- 13
- Prevention of S. aureus toxic shock syndrome
- 14
- Prevention of S. pneumoniae infections
- 15
- Prevention of shigellosis
- 16
- Prevention of ventilator-associated bacterial pneumonia
- 17
- Recurrent C. difficile infections
- 18
- Recurrent urinary tract infections
- 19
- Sepsis-associated acute kidney injury
- 20
- Vancomycin-resistant enterococci elimination
- 21
- Ventilator-associated bacterial pneumonia
- 22
- Bacterial co-infections with COVID-19
- 23
- Complicated urinary tract infections
- 24
- Diabetic foot osteomyelitis
- 25
- Prevention and treatment of uncomplicated urinary tract infections
- 26
- Prevention of invasive extra-intestinal pathogenic E. coli disease
- 27
- Prevention of recurrent S. aureus skin and soft tissue infections
- 28
- Prosthetic joint infections
- 29
- Sepsis
- 30
- Urinary tract infections
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 .
See the methodology section for further details.
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.
Tracking the Pipeline of Antibiotics in Development
This collection page was updated in December 2017 with new content. Drug-resistant bacteria, or superbugs, present a serious and worsening threat to human health. A majority of doctors have encountered patients with infections that do not respond to available treatments, and when new drugs come to market bacteria can quickly develop resistance. According to a report from the Centers for Disease Control and Prevention, 2 million Americans acquire serious infections caused by antibiotic-resistant bacteria each year, and at least 23,000 die as a result. A sustained and robust pipeline of new antibacterial drugs and novel therapies is critical to ensure that new interventions keep pace with these evolving pathogens.
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