Data Visualization

Antibiotics Currently in Clinical Development

As of June 2014, there are at least 43 new antibiotics1 with the potential to treat serious bacterial infections 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.

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

ACHN-975

Phase 1

Achaogen

LpxC inhibitor

Yes

 

Bacterial infections

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

Monobactam + novel beta-lactamase inhibitor

Yes

 

Bacterial infections

BAL30072

Phase 1

Basilea Pharmaceutica

Monosulfactam

Yes

 

Multidrug-resistant Gram-negative bacterial infections6

Carbavance

Phase 1

Rempex Pharmaceuticals/the Medicines Co.

Carbapenem (biapenem) + 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.

CRS-3123

Phase 1

Crestone, Inc.

Methionyl tRNA synthetase (MetRS) inhibitor

 

 

C. difficile infection

EDP-788

Phase 1

Enanta Pharmaceuticals

Bicyclolide

 

 

Bacterial infections

GSK-2696266

Phase 1

GlaxoSmithKline (partnered product)

Cephalosporin

 

 

Bacterial infections6

LCB01-0371 

Phase 1

LegoChem Biosciences (S. 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 infection, bronchiectasis

TD-1607

Phase 1

Theravance, Inc.

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

Fluoroquinolone

Yes

Yes

Community-acquired bacterial pneumonia, acute bacterial skin and skin structure infections

Brilacidin

Phase 2

Cellceutix Corp.

Defensin-mimetic

 

 

Acute bacterial skin and skin structure infections6

Ceftaroline+Avibactam8

Phase 2

AstraZeneca/Forest Laboratories

Cephalosporin + novel beta-lactamase inhibitor

Yes

 

Complicated urinary tract infections

CG-400549

Phase 2

CrystalGenomics, Inc.

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

GSK-1322322

Phase 2

GlaxoSmithKline

Peptide deformylase inhibitor

 

 

Acute bacterial skin and skin structure infections

GSK-2140944

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

LFF571

Phase 2

Novartis

Elongation factor inhibitor

 

 

Clostridium difficile-associated diarrhea

MK-7655+ (imipenem/cilastatin)8

Phase 2

Merck & Co.

Carbapenem + novel beta-lactamase inhibitor

Yes

 

Complicated urinary tract infections, acute pyelonephritis, complicated intra-abdominal infections

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 Pharmaceuticals

Oxazolidinone

Yes

Yes

Acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia

Ramoplanin

Phase 2

Nanotherapeutics

Lipoglycopeptide

 

 

Clostridium difficile-associated diarrhea6

Taksta (Fusidic acid)10

Phase 2

Cempra Pharmaceuticals

Fusidane

 

 

Prosthetic joint infections

TD-1792

Phase 2

Theravance, Inc.

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

Phase 3

AstraZeneca/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

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 Pharmaceuticals

Fluoroquinolone

Yes

Yes

Acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, uncomplicated gonorrhea

Eravacycline8

Phase 3

Tetraphase Pharmaceuticals

Tetracycline

Yes

Yes

Complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired bacterial pneumonia6

Oritavancin

New Drug Application (NDA) submitted

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 Enterobacteriaeceae

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 – 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

 

 

Bacterial infections

WCK 2349

Phase 1

Wockhardt

Fluoroquinolone (WCK 771 pro-drug)

 

 

Bacterial infections

SMT19969

Phase 2

Summit Corporation Plc.

 

 

Yes

Clostridium difficile-associated diarrhea


* M. Hay et al. "Clinical Development Success Rates for Investigational Drugs," Nature Biotechnology 32, no. 1 (2014): 40-51.

NOTE: In previous pipeline iterations, ceftobiprole -- an antibiotic developed by Basilea Pharmaceutica -- had been included in our analysis; however, the company recently announced that they are not currently pursuing further development in the US until a partner has been acquired. In order to accurately portray the US antibiotic development pipeline, we have removed from the chart until further pursuit of development is indicated.

  1. Antibiotics 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 Clostridium 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.
  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 Disease Society of America, multidrug-resistant strains of these organisms represent today's most pressing medical needs.
  9. Marketing applications were submitted for nemonoxacin in China and Taiwan.
  10. Taksta was granted an orphan drug designation for the indication of prosthetic joint infections.
Citations:
i. Citeline's Pharmaprojects Pipeline, Informa, 2012.
ii. "Antibiotics NCE pipeline," BioCentury, accessed October 28, 2013, http://www.biocentury.com/antibioticsncepipeline.htm.
iii. ClinicalTrials.Gov, U.S. National Institutes of Health, http://www.clinicaltrials.gov/.
iv. H.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.
v. M.J. Pucci, K. Bush. "Investigational Antimicrobial Agents of 2013," Clinical Microbiology Reviews 26 (2013): 792-821.
vi. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2013, September 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