Data Visualization

Antibiotics Currently in Clinical Development

As of December 2014, an estimated 37 new antibiotics1 that have the potential to treat serious bacterial infections are in clinical development for the U.S. market. The success rate for drug development is low; at best, only 1 in 5 candidates that enter human testing will be approved for patients.* This snapshot of the antibiotic pipeline will be updated periodically as products advance or are known to drop out of development.

Please contact Rachel Zetts at rzetts@pewtrusts.org or 202-540-6557 with additions or updates.

December 2014 (PDF) | September 2014 (PDF) | June 2014 (PDF) | February 2014 (PDF)

Drug name Development phase2 Company Drug class Cited for potential activity against Gram-negative pathogens?3 Known QIDP4 designation? Potential indication(s)?5
Drug name Development phase2 Company Drug class Cited for potential activity against Gram-negative pathogens?3 Known QIDP4 designation? Potential indication(s)?5
Tedizolid (Sivextro) Approved June 20, 2014 Cubist Pharmaceuticals Oxazolidinone   Yes Approved for: acute bacterial skin and skin structure infections; other potential indications: hospital- acquired bacterial pneumonia/ventilator- acquired bacterial pneumonia
Dalbavancin (Dalvance) Approved May 23, 2014 Actavis (formerly Durata Therapeutics) Lipoglycopeptide   Yes Approved for: acute bacterial skin and skin structure infections; other potential indications: community-acquired bacterial pneumonia
Oritavancin (Orbactiv) Approved Aug. 6, 2014 The Medicines Company Glycopeptide   Yes Approved for: acute bacterial skin and skin structure infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA)
Ceftolozane+Tazobactam (Zerbaxa) Approved Dec. 19, 2014 Cubist Pharmaceuticals Novel cephalosporin+beta-lactamase inhibitor Yes Yes Approved for: complicated urinary tract infections, complicated intra-abdominal infections, acute pyelonephritis (kidney infection); other potential indications: hospital-acquired bacterial pneumonia/ventilator-associated pneumonia
Ceftazidime+Avibactam (CAZ-AVI) New Drug Application (NDA) submitted
(for complicated urinary tract infections and complicated intra-abdominal infections)
AstraZeneca/Actavis (formerly Forest Laboratories) Cephalosporin + novel beta-lactamase inhibitor Yes Yes Complicated urinary tract infections, complicated intra-abdominal infections, acute pyelonephritis (kidney infection), hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia
OP0595 (RG6080) Phase 110 Meiji Seika Pharma Co. Ltd./Fedora Pharmaceuticals Inc. (Roche licensee)12 Beta-lactamase inhibitor Yes   Bacterial infections
Debio 1450 Phase 1 Debiopharm Group Fabl inhibitor (Debio 1452 pro-drug)   Yes Acute bacterial skin and skin structure infections (staphylococcal-specific)
AZD0914 Phase 2 AstraZeneca DNA gyrase inhibitor Yes Yes Uncomplicated gonorrhea
Aztreonam+Avibactam7 (ATM-AVI) Phase 110 AstraZeneca/Actavis (formerly Forest Laboratories) Monobactam + novel beta-lactamase inhibitor Yes   Bacterial infections
BAL30072 Phase 1 Basilea Pharmaceutica Monosulfactam Yes   Multidrug-resistant Gram-negative bacterial infections6
CRS3123 Phase 1 Crestone Methionyl tRNA synthetase (MetRS) inhibitor     Clostridium difficile infection
LCB01-0371 Phase 110 LegoChem Biosciences (South Korea) Oxazolidanone     Bacterial infections
MRX-I Phase 1 MicuRx Pharmaceuticals Oxazolidinone     Acute bacterial skin and skin structure infections
TD-1607 Phase 1 Theravance Biopharma Glycopeptide-cephalosporin heterodimer   Yes Acute bacterial skin and skin structure infections,6 hospital-acquired pneumonia/ventilator-associated pneumonia,6 bacteremia6
WCK 2349 Phase 1 Wockhardt Fluoroquinolone (WCK 771 pro-drug)   Yes Bacterial infections
WCK 771 Phase 1 Wockhardt Fluoroquinolone   Yes Bacterial infections
S-649266 Phase 2 Shionogi Cephalosporin Yes   Complicated urinary tract infections
POL7080 (RG7929) Phase 210 Polyphor (Roche licensee) Macrocycle (protein epitope mimetic) LptD inhibitor Yes (Pseudomonas) Yes Ventilator-associated bacterial pneumonia (caused by Pseudomonas aeruginosa), lower respiratory tract infection, bronchiectasis
Debio 1452 Phase 2 Debiopharm Group Fabl inhibitor   Yes Acute bacterial skin and skin structure infections (staphylococcal-specific)
Avarofloxacin Phase 2 Actavis (formerly Furiex Pharmaceuticals) Fluoroquinolone Yes Yes Community-acquired bacterial pneumonia, acute bacterial skin and skin structure infections
Brilacidin Phase 2 Cellceutix Defensin-mimetic   Yes Acute bacterial skin and skin structure infections
Ceftaroline+Avibactam Phase 2 AstraZeneca/Actavis (formerly Forest Laboratories) Cephalosporin + novel beta-lactamase inhibitor Yes   Bacterial infections6
CG-400549 Phase 2 CrystalGenomics Fabl inhibitor     Acute bacterial skin and skin structure infections, osteomyelitis6
Finafloxacin Phase 213 MerLion Pharmaceuticals Fluoroquinolone Yes Yes Complicated urinary tract infections, acute pyelonephritis (kidney infection), acute intra-abdominal infections, acute bacterial skin and skin structure infections
GSK2140944 Phase 2 GlaxoSmithKline Type 2 topoisomerase inhibitor Yes   Respiratory tract infections, acute bacterial skin and skin structure infections, uncomplicated urogenital gonorrhea
Lefamulin (BC-3781) Phase 2 Nabriva Therapeutics Pleuromutilin Yes Yes Acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia6
Imipenem/cilastatin+relebactam (MK-7655) Phase 2 Merck Carbapenem + novel beta-lactamase inhibitor Yes Yes Complicated urinary tract infections, acute pyelonephritis, complicated intra-abdominal infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia
Nemonoxacin8 Phase 2 TaiGen Biotechnology Quinolone Yes Yes Community-acquired bacterial pneumonia, diabetic foot infection, acute bacterial skin and skin structure infections
Omadacycline Phase 2 Paratek Pharmaceuticals Tetracycline Yes Yes Community-acquired bacterial pneumonia, acute bacterial skin and skin structure infections, complicated urinary tract infections
Radezolid Phase 2 Melinta Therapeutics Oxazolidinone Yes Yes Acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia
Ramoplanin Phase 2 Nanotherapeutics Lipoglycopeptide     C. difficile-associated diarrhea,6 C. difficile relapse prevention6
Taksta (Fusidic acid)9 Phase 3 Cempra Inc. Fusidane     Prosthetic joint infections, acute bacterial skin and skin structure infections6
Zabofloxacin Phase 2 Dong Wha Pharmaceutical Fluoroquinolone Yes   Community-acquired bacterial pneumonia
SMT 19969 Phase 2 Summit     Yes C. difficile-associated diarrhea
Cadazolid Phase 3 Actelion Pharmaceuticals Quinolonyl-oxazolidinone   Yes C. difficile-associated diarrhea
Carbavance (RPX709+meropenem) Phase 3 Rempex Pharmaceuticals (wholly owned subsidiary of The Medicines Co.) Meropenem + novel boronic beta-lactamase inhibitor Yes Yes Complicated urinary tract infections, complicated intra-abdominal infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, febrile neutropenia, bacteremia, acute pyelonephritis (some indications specifically target infections caused by carbapenem-resistant Enterobacteriaceae)
Delafloxacin Phase 3 Melinta Therapeutics Fluoroquinolone Yes Yes Acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, uncomplicated gonorrhea, hospital-acquired bacterial pneumonia,6 complicated urinary tract infections,6 complicated intra-abdominal infections6
Eravacycline Phase 3 Tetraphase Pharmaceuticals Tetracycline Yes Yes Complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired bacterial pneumonia6
Plazomicin Phase 3 Achaogen Aminoglycoside Yes Yes11 Catheter-related bloodstream infections, hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia, complicated intra-abdominal infections, complicated urinary tract infections (some indications specifically target infections caused by carbapenem-resistant Enterobacteriaceae
Solithromycin Phase 3 Cempra Inc. Macrolide (fluroketolide) Yes Yes Community-acquired bacterial pneumonia, uncomplicated urogenital gonorrhea, urethritis6
Surotomycin Phase 3 Cubist Pharmaceuticals Lipopeptide   Yes C. difficile-associated diarrhea

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

December 2014 review: EDP-788 (Enanta Pharmaceuticals) and TD-1792 (Theravance Biopharma) were removed during the December 2014 review. These drugs were either no longer included in the research and development pipelines on the company website, or there was direct communication from the company regarding the status of the drugs. Additionally, GSK-2696266, which had been removed during the September review, is included in this pipeline again as S-649266, which is being developed by Shionogi.

September 2014 review: GSK-2696266 and GSK-1322322 (GlaxoSmithKline), ACHN-975 (Achaogen), and LFF571 (Novartis) were removed during the September 2014 review. These drugs were either no longer included in the research and development pipelines on the company website, or there was direct communication from the company regarding the status of the drugs.

June 2014 review: Ceftobiprole, an antibiotic developed by Basilea Pharmaceutica, had been included in our analysis; however, the company announced in June 2014 that it is not pursuing further development in the United States until a partner has been acquired.

* Michael Hay et al., “Clinical Development Success Rates for Investigational Drugs,” Nature Biotechnology 32, no. 1 (2014): 40–51, doi:10.1038/nbt.2786. See more at http://www.pewtrusts.org/en/multimedia/data-visualizations/2014/antibiotics-currently-in-clinical-development.

Notes

  1. Antibiotics listed here include products containing at least one component not approved in the United States previously. All analyses were strictly limited to systemic antibiotics (drugs that work throughout the body) and drugs to treat Clostridium difficile-associated disease. The Centers for Disease Control and Prevention cited C. difficile as an urgent public health threat in a 2013 report (Antibiotic Resistance Threats in the United States, 2013, Sept. 16, 2013, http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf). We also limited this pipeline to drugs with the potential to treat serious or life-threatening infections. Specifically excluded were drugs to treat mycobacterial infections, such as tuberculosis and Mycobacterium avium complex, H. pylori, and biothreat pathogens. Additionally, we excluded biological products, vaccines, and locally acting drugs such as topical, ophthalmic, and inhaled products. Avibactam, a novel beta-lactamase inhibitor, is being studied in combination with three approved antibiotics, and all three were counted for this report as each combination targets a distinct set of pathogens.
  2. Based on the most advanced development phase for any indication according to trials registered in clinicaltrials.gov. If no trials were included in clinicaltrials.gov, then the phase listed on the company website or provided directly by the company is noted. Antibiotics that have been approved will remain listed for one year following approval of the initial indication.
  3. Based on information provided on the company website or press releases or based on inclusion in citations iv or v below. “Yes” in this category means that the antibiotic has potential activity against at least one Gram-negative organism. Examples include the pathogen that causes gonorrhea, Neisseria gonorrhoeae, which the Centers for Disease Control and Prevention classified as an urgent public health threat; Gram-negative bacilli such as members of the Enterobacteriaceae family, including Klebsiella pneumonia and Escherichia coli; Acinetobacter species and Pseudomonas species; and so-called fastidious Gram-negative bacteria that commonly cause community-acquired respiratory infections. In the next update of this pipeline, this column will be split into two in order to specifically highlight those drugs that meet an unmet medical need—specifically those that target Gram-negative bacilli resistant to currently available antibiotics.
  4. Certain antibiotics intended to treat serious or life-threatening infections can be designated by the Food and Drug Administration as qualified infectious disease products (QIDPs). 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.
  5. Based on clinical trials currently registered in clinicaltrials.gov and/or reported QIDP designations unless otherwise noted. Bolded indications are reported QIDP designations.
  6. Not currently registered on clinicaltrials.gov. Information obtained from the company via a corporate website, press release, and/or direct communication.
  7. Avibactam is a new beta-lactamase inhibitor being tested in conjunction with three individual antibiotics. We list all three combinations here.
  8. Approved for community-acquired bacterial pneumonia in Taiwan; new drug application submitted in China.
  9. Taksta was granted an orphan drug designation for the indication of prosthetic joint infections.
  10. Registered in clinicaltrials.gov, but with no current study sites within the United States.
  11. Plazomicin received the QIDP designations after the December review, but before this update was published.
  12. This licensing deal was announced after the December review, but before this update was published.
  13. Phase 2 trials do not currently include any U.S. study sites; however, the company indicated in a December 2012 press release that the trial was based on updated guidance from the U.S. Food and Drug Administration.

Citations

  1. Citeline, “Pharmaprojects,” (2012), http://www.citeline.com/products/pharmaprojects.
  2. BioCentury, “Antibiotics NCE Pipeline,” accessed Oct. 28, 2013, http://www.biocentury.com/antibioticsncepipeline.htm.
  3. U.S. National Institutes of Health, “Search for Studies,” http://www.clinicaltrials.gov.
  4. Helen W. Boucher et al., “10 x ’20 Progress-Development of New Drugs 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.
  5. Michael J. Pucci and Karen Bush, “Investigational Antimicrobial Agents of 2013,” Clinical Microbiology Reviews 26 (2013): 792–821, http://cmr.asm.org/content/26/4/792.
  6. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2013 (Sept. 16, 2013), http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf.

Media Contact: Linda Paris 202.540.6354

Topics: Antibiotics, Health

Project: Antibiotic Resistance Project

Media Contact

Linda Paris

Officer, Communications

202.540.6354