Antibiotics Currently in Global Clinical Development Note: This Data Visualization Was Updated in March 2019 with New Data
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A data table from March 2019 Antibiotics Currently in Global Clinical Development Note: This data visualization was updated in March 2019 with new data. As of December 2018, 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 [email protected] with additions or updates. Expected Expected activity activity against Development against CDC urgent Drug name Company Drug class Target resistant Gram- Potential indication(s)?5 phase2 or WHO critical negative ESKAPE threat pathogen?4 pathogens?3 Approved for: Community-acquired bacterial pneumonia, acute bacterial skin Approved 30S subunit Nuzyra Paratek and skin structure infections; other potential Oct. 2, 2018 Tetracycline of bacterial Yes No (omadacycline) Pharmaceuticals Inc. indications: complicated urinary tract (U.S. FDA) ribosome infections and uncomplicated urinary tract infections Approved 30S subunit Xerava Tetraphase Aug. 27, 2018 Tetracycline of bacterial Yes Possibly (CRE, CRAB) Complicated intra-abdominal infections (eravacycline) Pharmaceuticals Inc. (U.S. FDA) ribosome Approved for: Complicated urinary tract infections including acute pyelonephritis; Approved 30S subunit Zemdri other potential indications: hospital-acquired June 26, 2018 Achaogen Inc. Aminoglycoside of bacterial Yes Yes (CRE) (plazomicin) bacterial pneumonia/ventilator- associated (U.S. FDA) ribosome bacterial pneumonia, complicated intra-abdominal infections Continued on the next page Expected Expected activity activity against Development against CDC urgent Drug name Company Drug class Target resistant Gram- Potential indication(s)?5 phase2 or WHO critical negative ESKAPE threat pathogen?4 pathogens?3 New drug application submitted for acute Acute bacterial skin and skin Dihydrofolate Iclaprim bacterial skin and skin Motif Bio PLC 2,4-diaminopyrimidine No No structure infections and hospital- reductase structure infections acquired bacterial pneumonia (U.S. FDA) New drug application submitted for Lascufloxacin Kyorin Pharmaceutical Bacterial type II community-acquired Fluoroquinolone No No Community-acquired bacterial pneumonia (KRP-AM1977)9 Co. Ltd. topoisomerase bacterial pneumonia (Japan PMDA) New drug application Acute bacterial skin and skin structure submitted for 50S subunit infections,6 community-acquired bacterial Lefamulin Nabriva Therapeutics community-acquired Pleuromutilin11 of bacterial No No pneumonia, and hospital-acquired bacterial (BC-3781) AG bacterial pneumonia ribosome pneumonia/ventilator- associated bacterial (U.S. FDA) pneumonia6 Acurx DNA polymerase C. difficile ACX-362E Phase 16 No Yes (C. difficile) C. difficile infections Pharmaceuticals LLC IIIC inhibitor11 Pol IIIC Possibly Complicated intra-abdominal infections6 AIC4999 Phase 16 AiCuris β-lactam PBP Possibly (CRE, CRPA, CRAB) and complicated urinary tract infections6 β-lactam (cephalosporin) Cefepime + VenatoRx PBP, Yes (CRE), possibly Complicated intra-abdominal infections6 Phase 1 + β-lactamase inhibitor Yes VNRX-5133 Pharmaceuticals Inc. β-lactamase (CRPA and CRAB) and complicated urinary tract infections6 (cyclic boronate) Cefepime + β-lactam (cephalosporin) Complicated urinary tract infections6 and PBP, Yes (CRE), zidebactam Phase 1 Wockhardt Ltd. + β-lactamase inhibitor Yes hospital-acquired bacterial pneumonia/ β-lactamase possibly (CRPA) (WCK 5222) (diazabicyclooctane) ventilator-associated bacterial pneumonia6 Methionyl- CRS3123 Phase 1 Crestone Inc. Diaryldiamine11 tRNA No Yes (C. difficile) C. difficile infections synthetase12 Continued on the next page Expected Expected activity activity against Development against CDC urgent Drug name Company Drug class Target resistant Gram- Potential indication(s)?5 phase2 or WHO critical negative ESKAPE threat pathogen?4 pathogens?3 50S subunit Delpazolid14 LegoChem Phase 1 Oxazolidinone of bacterial No No Bacterial infections (LCB01-0371) Biosciences Inc. ribosome β-lactam (cephalosporin) Entasis PBP, ETX0282CPDP Phase 1 + β-lactamase inhibitor Yes Yes (CRE) Urinary tract infections Therapeutics Inc. β-lactamase (diazabicyclooctane) KBP BioSciences 30S subunit KBP-7072 Phase 1 Pharmaceutical Tetracycline of bacterial Possibly Possibly (CRAB) Community-acquired bacterial pneumonia6 Technical Co. Ltd. ribosome 50S subunit of bacterial DNV3837 Deinove SA (formerly Oxazolidinone-quinolone Phase 16 ribosome, No Yes (C. difficile) C. difficile infections6 (MCB3837) Morphochem AG) hybrid bacterial type II topoisomerase DNA minor MGB-BP-3 Phase 1 MGB Biopharma Ltd. Distamycin11 No Yes (C. difficile) C. difficile infections groove binder12 Meiji Seika Pharma Meropenem + β-lactam (carbapenem) PBP, Co. Ltd./Fedora Yes (CRE), nacubactam Phase 1 + β-lactamase inhibitor β-lactamase, Yes Bacterial infections Pharmaceuticals Inc. possibly (CRPA) (OP0595/RG6080) (diazabicyclooctane) PBP2 (Roche licensee) Complicated urinary tract infections and SPR206 Phase 1 Spero Therapeutics Polymyxin Cell membrane Yes Yes (CRE, CRPA, CRAB) hospital-acquired bacterial pneumonia/ ventilator-associated bacterial pneumonia Possibly SPR74113 Phase 1 Spero Therapeutics Polymyxin Cell membrane Possibly Bacterial infections (CRE, CRAB, CRPA) Continued on the next page Expected Expected activity activity against Development against CDC urgent Drug name Company Drug class Target resistant Gram- Potential indication(s)?5 phase2 or WHO critical negative ESKAPE threat pathogen?4 pathogens?3 30S subunit Tetraphase TP-271 Phase 1 Tetracycline of bacterial Possibly Possibly (CRAB) Community-acquired bacterial pneumonia Pharmaceuticals Inc. ribosome 30S subunit Tetraphase TP-6076 Phase 16 Tetracycline of bacterial Yes Yes (CRE and CRAB) Bacterial infections Pharmaceuticals Inc. ribosome Acute bacterial skin and skin structure Afabicin Debiopharm Benzofuran Phase 2 FabI12 No No infections and bone and joint infections (Debio 1450) International SA naphthyridine11 (Staphylococcus-specific) Innovation Acute bacterial skin and skin Brilacidin Phase 2 Defensin mimetic11 Cell membrane No No Pharmaceuticals Inc. structure infections Acute bacterial skin and skin CG400549 Phase 26 CrystalGenomics Inc. Benzyl pyridinone11 FabI12 No No structure infections Complicated urinary tract infection β-lactam (sulbactam) Entasis PBP, Yes (CRE16 and CRAB), including acute pyelonephritis, and ETX2514SUL Phase 2 + β-lactamase inhibitor Yes Therapeutics Inc. β-lactamase possibly (CRPA16) hospital-acquired bacterial pneumonia/ (diazabicyclooctane) ventilator-associated bacterial pneumonia Acute bacterial skin and skin structure MerLion Bacterial type II infections, complicated intra-abdominal Finafloxacin10 Phase 2 Pharmaceuticals Fluoroquinolone Yes No topoisomerase infections, and complicated urinary tract Pte Ltd. infections including pyelonephritis Complicated urinary tract infections,6 Bacterial type II uncomplicated urinary tract infections, Gepotidacin topoisomerase acute bacterial skin and skin structure Phase 2 GlaxoSmithKline PLC Triazaacenaphthylene11 No Yes (N. gonorrhoeae) (GSK2140944) (novel A infections, uncomplicated urogenital subunit site)12 gonorrhea, and community-acquired bacterial pneumonia6 Continued on the next page Expected Expected activity activity against Development against CDC urgent Drug name Company Drug class Target resistant Gram- Potential indication(s)?5 phase2 or WHO critical negative ESKAPE threat pathogen?4 pathogens?3 Boston BOS-228 Pharmaceuticals Complicated urinary tract infections and Phase 2 β-lactam (monobactam) PBP Yes Yes (CRE) (LYS228) (Licensed from complicated intra-abdominal infections Novartis AG) 50S subunit Nafithromycin Phase 2 Wockhardt Ltd. Macrolide of bacterial No No Community-acquired bacterial pneumonia (WCK 4873) ribosome Community-acquired bacterial pneumonia, Nemonoxacin TaiGen Biotechnology Bacterial type II Phase 2 Quinolone No No diabetic foot infection, and acute bacterial (Taigexyn)7 Co. Ltd. topoisomerase skin and skin structure infections Otsuka Bacterial type II OPS-2071 Phase 2 Pharmaceutical Quinolone No Yes (C. difficile) C. difficile infections topoisomerase Co. Ltd. Bacterial type II Zoliflodacin Entasis Phase 2 Spiropyrimidinetrione11 topoisomerase No Yes (N. gonorrhoeae) Uncomplicated gonorrhea (ETX0914) Therapeutics Inc. (GyrB)12 Complicated urinary tract infections β-lactam (cephalosporin) including pyelonephritis, complicated PBP, Cefepime + AAI101 Phase 3 Allecra + β-lactamase inhibitor Yes Possibly (CRE) intra-abdominal infections, and hospital- β-lactamase (β-lactam) acquired bacterial pneumonia/ventilator- associated bacterial pneumonia Complicated urinary tract infections, Cefiderocol Siderophore-β-lactam Yes hospital-acquired bacterial pneumonia/