Data Visualization

Antibiotics Currently in Clinical Development

As of September 2014, an estimated 38 new antibiotics1 with 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.

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
Debio 1450 Phase 1 Debiopharm Group Fabl inhibitor (Debio 1452 pro-drug)     Bacterial infections
AZD0914 Phase 1 AstraZeneca DNA gyrase inhibitor Yes Yes Uncomplicated gonorrhea
Aztreonam+avibactam7 (ATM-AVI) Phase 1 AstraZeneca/Forest Laboratories (acquired by Actavis) Monobactam+novel beta-lactamase inhibitor Yes   Bacterial infections
BAL30072 Phase 1 Basilea Pharmaceutica Monosulfactam Yes   Multidrug-resistant Gram-negative bacterial infections6
Carbavance8 Phase 3 Rempex Pharmaceuticals (wholly owned subsidiary of The Medicines Company) Carbapenem+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)
CRS3123 Phase 1 Crestone Methionyl-tRNA synthetase (MetRS) inhibitor     Clostridium difficile infection
EDP-788 Phase 1 Enanta Pharmaceuticals Bicyclolide     Bacterial infections
LCB01-0371  Phase 111 LegoChem Biosciences (South Korea) Oxazolidinone     Bacterial infections
MRX-I Phase 1 MicuRx Pharmaceuticals Oxazolidinone     Bacterial infections including community-acquired MRSA and vancomycin-resistant enterococci infections6
POL7080 Phase 2 Polyphor (Roche licensee) Macrolide (protein epitope mimetic) LptD inhibitor Yes (Pseudomonas)   Ventilator-associated bacterial pneumonia, lower respiratory tract infection, bronchiectasis
TD-1607 Phase 1 Theravance Biopharma Glycopeptide-cephalosporin heterodimer     Serious Gram-positive bacterial infections (acute bacterial skin and skin structure infections, hospital-acquired pneumonia/ventilator-associated pneumonia, bacteremia)6
Debio 1452 Phase 2 Debiopharm Group Fabl inhibitor   Yes Acute bacterial skin and skin structure infections
Avarofloxacin Phase 2 Furiex Pharmaceuticals (subsidiary of Actavis) Fluoroquinolone Yes Yes Community-acquired bacterial pneumonia, acute bacterial skin and skin structure infections
Brilacidin Phase 2 Cellceutix Defensin-mimetic     Acute bacterial skin and skin structure infections6 pneumonia/ventilator-associated bacterial pneumonia
Ceftaroline+avibactam8 Phase 2 AstraZeneca/Forest Laboratories (acquired by Actavis) Cephalosporin+novel beta-lactamase inhibitor Yes   Complicated urinary tract infections
CG-400549 Phase 2 CrystalGenomics Fabl inhibitor     Acute bacterial skin and skin structure infections, osteomyelitis6
Finafloxacin Phase 2 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     Respiratory tract infections, acute bacterial skin and skin structure infections
Lefamulin (BC-3781) Phase 2 Nabriva Therapeutics Pleuromutilin     Acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia6
Nemonoxacin9 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     Clostridium difficile-associated diarrhea,6 Clostridium difficile-relapse prevention6
TAKSTA (fusidic acid)10 Phase 2 Cempra Pharmaceuticals Fusidane     Prosthetic joint infections
TD-1792 Phase 2 Theravance Glycopeptide-cephalosporin heterodimer     Acute bacterial skin and skin structure infections, other serious infections caused by Gram-positive bacteria including hospital-acquired pneumonia/ventilator-associated pneumonia and bacteremia6
Zabofloxacin Phase 2 Dong Wha Pharmaceutical Fluoroquinolone     Community-acquired bacterial pneumonia
Cadazolid Phase 3 Actelion Pharmaceuticals Quinolonyl-oxazolidinone   Yes Clostridium difficile-associated diarrhea
Ceftazidime+avibactam (CAZ-AVI)8 NDA submitted (for complicated urinary tract infections and complicated intra-abdominal infections) AstraZeneca/Forest Laboratories (acquired by Actavis) 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
Ceftolozane+tazobactam8 New Drug Application (NDA) submitted (for complicated urinary tract infection and complicated intra-abdominal infection indications) Cubist Pharmaceuticals Novel cephalosporin+beta-lactamase inhibitor Yes Yes Complicated urinary tract infections, complicated intra-abdominal infections, acute pyelonephritis (kidney infection), hospital-acquired bacterial pneumonia/ventilator-associated pneumonia
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
Eravacycline8 Phase 3 Tetraphase Pharmaceuticals Tetracycline Yes Yes Complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired bacterial pneumonia6
Oritavancin Approved, August 6, 2014 The Medicines Company Glycopeptide   Yes Acute bacterial skin and skin structure infections
Plazomicin8 Phase 3 Achaogen Aminoglycoside Yes   Bloodstream infections and nosocomial pneumonia caused by carbapenem-resistant Enterobacteriaceae
Solithromycin Phase 3 Cempra Pharmaceuticals Macrolide (ketolide) Yes Yes Community-acquired bacterial pneumonia, uncomplicated urogenital gonorrhea
Surotomycin Phase 3 Cubist Pharmaceuticals Lipopeptide   Yes Clostridium difficile-associated diarrhea
Dalbavancin Approved, May 23, 2014 Durata Therapeutics Lipoglycopeptide   Yes Acute bacterial skin and skin structure infections
Tedizolid Approved (for acute bacterial skin and skin structure infections), June 20, 2014 Cubist Pharmaceuticals Oxazolidinone   Yes Acute bacterial skin and skin structure infections, hospital-acquired bacterial pneumonia/ventilator-acquired bacterial pneumonia
WCK 771 Phase 1 Wockhardt Fluoroquinolone   Yes Bacterial infections
WCK 2349 Phase 1 Wockhardt Fluoroquinolone (WCK 771 pro-drug)   Yes Bacterial infections
SMT19969 Phase 2 Summit     Yes Clostridium difficile-associated diarrhea
Relebactam (MK-7655)+(imipenem/cilastatin)8 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

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

  • 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 R&D 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. This drug will be included in future updates if development resumes.

* Michael Hay et al., “Clinical Development Success Rates for Investigational Drugs,” Nature Biotechnology 32, no. 1 (2014): 40-51. 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 excluded biological products, vaccines, and locally acting drugs such as topical, ophthalmic, and inhaled products. Also excluded were drugs used to treat mycobacterial infections such as tuberculosis and Mycobacterium avium complex, H. Pylori, and biothreat pathogens. 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 4 or 5 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 CDC classified as an urgent public health threat; Gram-negative bacilli such as members of the Enterobacteriaceae family such as Klebsiella pneumoniae and Escherichia coli; Acinetobacter species and Pseudomonas species; and so-called fastidious Gram-negative bacteria that commonly cause community-acquired respiratory infections.
  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, or 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 in 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. Identified as antibiotics in advanced development (phase 2 or 3) with the potential to treat infections caused by Gram-negative bacilli (Enterobacteriaceae, Pseudomonas, Acinetobacter) resistant to currently available treatments. According to the Infectious Diseases Society of America, multidrug-resistant strains of these organisms represent today’s most pressing medical threat.
  9. Approved for community-acquired bacterial pneumonia in Taiwan, marketing application submitted in China.
  10. TAKSTA was granted an orphan drug designation for the indication of prosthetic joint infections.
  11. Registered in clinicaltrials.gov, but with no current study sites within the United States.

Citations

Citeline, “Pharmaprojects,” Pipeline (2012), http://www.citeline.com/products/pharmaprojects.

BioCentury, “Antibiotics NCE Pipeline,” accessed Oct. 28, 2013, http://www.biocentury.com/antibioticsncepipeline.htm.

U.S. National Institutes of Health, “Search for Studies,” http://www.clinicaltrials.gov.

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 Disease 56 (2013): 1685-94, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3707426.

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.

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: Arlyn Riskind 202-540-6321

Topics: Antibiotics, Health

Project: Antibiotics and Innovation Project

Media Contact

Arlyn Riskind

Manager, Communications

202.540.6321