A data table from Sept 2018 Antibiotics Currently in Global Clinical Development Note: This data visualization was updated in September 2018 with new data. As of June 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, the antibiotics 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 against CDC Development Drug name Company Drug class Target resistant Gram- urgent or WHO Potential indication(s)?5 phase2 negative ESKAPE critical threat pathogens?3 pathogen?4 Approved for: Complicated urinary tract Melinta infections including pyelonephritis; other Vabomere β-lactam (carbapenem) Approved Aug. 30, Therapeutics Inc. potential indications: complicated (meropenem + + β-lactamase inhibitor PBP, β-lactamase Yes Yes (CRE) 2017 (U.S. FDA) (formerly The intra-abdominal infections, hospital- vaborbactam) (cyclic boronate)11,13 Medicines Co.) acquired bacterial pneumonia/ventilator- associated bacterial pneumonia Approved for: Complicated urinary tract infections including acute pyelonephritis; Zemdri Approved June 26, 30S subunit of other potential indications: hospital- Achaogen Inc. Aminoglycoside Yes Yes (CRE) (plazomicin) 2018 (U.S. FDA) bacterial ribosome acquired bacterial pneumonia/ventilator- associated bacterial pneumonia, complicated intra-abdominal infections New drug application submitted for Acute bacterial skin and Dihydrofolate Iclaprim acute bacterial Motif Bio PLC 2,4-diaminopyrimidine No No skin structure infections and hospital- reductase skin and skin acquired bacterial pneumonia structure infections (U.S. FDA) Continued on the next page Expected Expected activity activity against against CDC Development Drug name Company Drug class Target resistant Gram- urgent or WHO Potential indication(s)?5 phase2 negative ESKAPE critical threat pathogens?3 pathogen?4 New drug application submitted for Kyorin Lascufloxacin Bacterial type II Community-acquired community- Pharmaceutical Fluoroquinolone No No (KRP-AM1977)9 topoisomerase bacterial pneumonia acquired bacterial Co. Ltd. pneumonia (Japan PMDA) New drug application submitted for Community-acquired bacterial community- Paratek pneumonia, acute bacterial skin and skin acquired bacterial 30S subunit of Omadacycline Pharmaceuticals Tetracycline Yes Possibly (CRAB) structure infections, complicated urinary pneumonia and bacterial ribosome Inc. tract infections, and uncomplicated acute bacterial skin urinary tract infections and skin structure infections (U.S. FDA) New drug application submitted for Tetraphase Xerava 30S subunit of Yes (CRE), possibly complicated Pharmaceuticals Tetracycline Yes Complicated intra-abdominal infections (eravacycline) bacterial ribosome (CRAB) intra-abdominal Inc. infections (U.S. FDA) Possibly (CRE, CRPA, AIC4999 Phase 16 AiCuris β-lactam PBP Possibly Bacterial infections CRAB) β-lactam VenatoRx Cefepime + (cephalosporin) + Yes (CRE), possibly Phase 1 Pharmaceuticals PBP, β-lactamase Yes Bacterial infections VNRX-5133 β-lactamase inhibitor (CRPA and CRAB) Inc. (cyclic boronate) β-lactam Complicated urinary tract infections6 Cefepime + (cephalosporin) + Yes (CRE), possibly and hospital-acquired bacterial zidebactam Phase 1 Wockhardt Ltd. PBP, β-lactamase Yes β-lactamase inhibitor (CRPA) pneumonia/ventilator-associated (WCK 5222) (diazabicyclooctane) bacterial pneumonia6 CrystalGenomics Acute bacterial skin and CG400549 Phase 16 Benzyl pyridinone11 FabI12 No No Inc. skin structure infections Methionyl-tRNA CRS3123 Phase 1 Crestone Inc. Diaryldiamine11 No Yes (C. difficile) C. difficile infections synthetase12 Continued on the next page Expected Expected activity activity against against CDC Development Drug name Company Drug class Target resistant Gram- urgent or WHO Potential indication(s)?5 phase2 negative ESKAPE critical threat pathogens?3 pathogen?4 Delpazolid15 LegoChem 50S subunit of Phase 1 Oxazolidinone No No Bacterial infections (LCB01-0371) Biosciences Inc. bacterial ribosome β-lactam Entasis (cephalosporin) + ETX0282CPDP Phase 1 PBP, β-lactamase Yes Yes (CRE) Bacterial infections Therapeutics Inc. β-lactamase inhibitor (diazabicyclooctane) KBP BioSciences 30S subunit of Community-acquired KBP-7072 Phase 1 Pharmaceutical Tetracycline Possibly Possibly (CRAB) bacterial ribosome bacterial pneumonia6 Technical Co. Ltd. 50S subunit Deinove SA of bacterial Oxazolidinone- MCB3837 Phase 16 (formerly ribosome, No Yes (C. difficile) C. difficile infections6 quinolone hybrid Morphochem AG) bacterial type II topoisomerase MGB Biopharma DNA minor groove MGB-BP-3 Phase 1 Distamycin11 No Yes (C. difficile) C. difficile infections Ltd. binder12 Meiji Seika Meropenem + Pharma Co. β-lactam (carbapenem) nacubactam Ltd./Fedora PBP, β-lactamase, Yes (CRE), possibly Phase 1 + β-lactamase inhibitor Yes Bacterial infections (OP0595/ Pharmaceuticals PBP2 (CRPA) (diazabicyclooctane) RG6080) Inc. (Roche licensee) Spero Possibly (CRE, CRPA, SPR74114 Phase 1 Polymyxin Cell membrane12 Possibly Bacterial infections Therapeutics CRAB) Community-acquired bacterial Spero SPR9947 Phase 16 β-lactam (carbapenem) PBP Yes No pneumonia6 and complicated Therapeutics urinary tract infections6 Tetraphase 30S subunit of Community-acquired TP-271 Phase 1 Pharmaceuticals Tetracycline No Possibly (CRAB) bacterial ribosome bacterial pneumonia Inc. Tetraphase 30S subunit of TP-6076 Phase 16 Pharmaceuticals Tetracycline Yes Yes (CRE and CRAB) Bacterial infections bacterial ribosome Inc. Afabicin (Debio Debiopharm Benzofuran Acute bacterial skin and skin structure Phase 2 FabI12 No No 1450) International SA naphthyridine11 infections (Staphylococcus-specific) Continued on the next page Expected Expected activity activity against against CDC Development Drug name Company Drug class Target resistant Gram- urgent or WHO Potential indication(s)?5 phase2 negative ESKAPE critical threat pathogens?3 pathogen?4 Innovation Acute bacterial skin and Brilacidin Phase 2 Pharmaceuticals Defensin mimetic11 Cell membrane No No skin structure infections Inc. Complicated urinary tract infection β-lactam (carbapenem) Imipenem/ including acute pyelonephritis, and Entasis + β-lactam (sulbactam) Yes (CRE and CRAB), cilastatin + Phase 2 PBP, β-lactamase Yes hospital-acquired bacterial Therapeutics Inc. + β-lactamase inhibitor possibly (CRPA) ETX2514SUL pneumonia/ventilator-associated (diazabicyclooctane) 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,6 Gepotidacin GlaxoSmithKline topoisomerase acute bacterial skin and skin structure Phase 2 Triazaacenaphthylene11 No Yes (N. gonorrhoeae) (GSK2140944) PLC (novel A subunit infections, uncomplicated urogenital site)12 gonorrhea,6 and community-acquired bacterial pneumonia6 β-lactam Complicated urinary tract infections and LYS228 Phase 2 Novartis AG PBP Yes Yes (CRE) (monobactam) complicated intra-abdominal infections Nafithromycin 50S subunit of Community-acquired Phase 2 Wockhardt Ltd. Macrolide No No (WCK 4873) bacterial ribosome bacterial pneumonia Community-acquired bacterial TaiGen Bacterial type II pneumonia, diabetic foot infection, Nemonoxacin7 Phase 2 Biotechnology Co. Quinolone No No topoisomerase and acute bacterial skin and skin Ltd. structure infections Otsuka Bacterial type II OPS-2071 Phase 2 Pharmaceutical Quinolone No Yes (C. difficile) C. difficile infections topoisomerase Co. Ltd. Ridinilazole Summit Phase 2 Bis-benzimidazole11 Unknown No Yes (C. difficile) C. difficile infections (SMT 19969) Therapeutics PLC WCK 771/WCK Bacterial type II Phase 26 Wockhardt Ltd. Fluoroquinolone No No Hospital-acquired bacterial pneumonia6 234916 topoisomerase Bacterial type II Zoliflodacin Entasis Phase 2 Spiropyrimidinetrione11 topoisomerase No Yes (N. gonorrhoeae) Uncomplicated gonorrhea (ETX0914) Therapeutics Inc. (GyrB)12 Continued on the next page Expected Expected activity activity against against CDC Development Drug name Company Drug class Target resistant Gram- urgent or WHO Potential indication(s)?5 phase2 negative ESKAPE critical threat pathogens?3 pathogen?4 Complicated urinary tract infections β-lactam including pyelonephritis, complicated Cefepime + (cephalosporin) + Phase 3 Allecra PBP, β-lactamase Yes Possibly (CRE) intra-abdominal infections, and hospital- AAI1019 β-lactamase inhibitor acquired bacterial pneumonia/ventilator- (β-lactam) associated bacterial pneumonia Complicated urinary tract infections