Antibiotics Currently in Global Clinical Development
In December 2021, Pew’s antibiotic resistance project discontinued its work tracking antibiotics and nontraditional products in global clinical development. The World Health Organization has more information on the state of the global antibiotic pipeline.
Editor's note: This data visualization was updated on March 9, 2021 based on analysis as of December 2020.
As of December 2020, approximately 43 new antibiotics with the potential to treat serious bacterial infections were in clinical development.
The below interactive resource – based on publicly available information and informed by external experts and company communication – 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. To view subsets of antibiotics in development, use filter options below.
Please contact [email protected] with additions or updates.
March 2021 (XLSX) | April 2020 (XLSX) | September 2019 (PDF) | March 2019 (PDF) | September 2018 (PDF) | September 2017 (PDF) | March 2017 (PDF) | September 2016 (PDF) | March 2016 (PDF) | September 2015 (PDF) | March 2015 (PDF) | December 2014 (PDF) | September 2014 (PDF) | June 2014 (PDF) | February 2014 (PDF)
Tracking the Global Pipeline of Antibiotics
Drug-resistant bacteria, or superbugs, present a serious and worsening threat to human health. According to a report from the Centers for Disease Control and Prevention, 2.8 million Americans acquire serious infections caused by antibiotic-resistant bacteria each year, and 35,000 of them die as a result.
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By development phase
By expected activity against CDC urgent or WHO critical threat pathogens
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Novel class or target
QIDP-designated
not QIDP
Drug name | Development phase | Company | Expected activity against ESKAPE pathogens? | Expected activity against CDC urgent or WHO critical threat pathogen? | Potential indication(s) | |||||||||||||
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Contezolid (MRX-I)/contezolid acefosamil (MRX-4) (Does not have novel class or target)Contezolid acefosamil (MRX-4) is the prodrug form of the antibiotic contezolid (MRX-I). | New drug application submitted (China NMPA) | MicuRx Pharmaceuticals Inc. |
Yes: E. faecium, S. aureus |
No |
(Is QIDP-designated)2
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Sulopenem/sulopenem etzadroxil-probenecid (Does not have novel class or target)Sulopenem etzadroxil-probenecid is the prodrug form of the antibiotic sulopenem. | New drug application submitted (U.S. FDA) | Iterum Therapeutics PLC |
Yes: K. pneumoniae, Enterobacter spp. |
Yes: ESBL, Drug-resistant N. gonorrhoeae |
(Is QIDP-designated)1
(Is QIDP-designated)8
(Is QIDP-designated)9
(Is QIDP-designated)10
(Is QIDP-designated)15
(Is QIDP-designated)20
(Is QIDP-designated)25
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Benapenem (Does not have novel class or target) | Phase 3 | Sihuan Pharmaceutical Co. Ltd. |
Yes: K. pneumoniae, Enterobacter spp. |
Yes: ESBL |
(Is not QIDP-designated)8
(Is not QIDP-designated)12
(Is not QIDP-designated)19
(Is not QIDP-designated)23
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Cefepime + taniborbactam (Does not have novel class or target) | Phase 3 | Venatorx Pharmaceuticals Inc./Global Antibiotic Research and Development Partnership (GARDP) (Everest Medicines II Ltd. Licensee) |
Yes: K. pneumoniae, P. aeruginosa, Enterobacter spp. Possibly: S. aureus |
Yes: CRE, CRPA |
(Is QIDP-designated)11
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Cefilavancin (Does not have novel class or target)Currently, there is no public information available indicating that cefilavancin is in development for the U.S. market. | Phase 3 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | R-Pharm |
Yes: S. aureus |
No |
(Is not QIDP-designated)2
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EMROK/EMROK O (Does not have novel class or target)EMROK O (alalevonadifloxacin) is the prodrug form of the antibiotic EMROK (levonadifloxacin). EMROK/EMROK O has been approved for acute bacterial skin and skin structure infections including diabetic foot infections and concurrent bacteremia in India. | Phase 3 | Wockhardt Ltd. |
Yes: S. aureus |
No |
(Is not QIDP-designated)2
(Is not QIDP-designated)14
(Is QIDP-designated)18
(Is not QIDP-designated)28
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Exblifep (cefepime + enmetazobactam) (Does not have novel class or target) | Phase 3 | Allecra Therapeutics GmbH |
Yes: K. pneumoniae, Enterobacter spp. |
Yes: ESBL |
(Is QIDP-designated)9
(Is QIDP-designated)12
(Is QIDP-designated)18
(Is QIDP-designated)27
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Gepotidacin (GSK2140944) (Has novel class or target) | Phase 3 | GlaxoSmithKline PLC |
Yes: S. aureus |
Yes: Drug-resistant N. gonorrhoeae Possibly: ESBL |
(Is QIDP-designated)25
(Is QIDP-designated)26
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Ridinilazole (Has novel class or target)The drug target for ridinilazole is currently being determined. | Phase 3 | Summit Therapeutics Inc. | No |
Yes: C. difficile |
(Is QIDP-designated)6
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Sulbactam + durlobactam (Does not have novel class or target) | Phase 3 | Entasis Therapeutics Inc. |
Yes: A. baumannii |
Yes: CRAB |
(Is not QIDP-designated)4
(Is not QIDP-designated)11
(Is QIDP-designated)18
(Is QIDP-designated)27
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T-4288 (solithromycin) (Does not have novel class or target)Currently, there is no public information available indicating that T-4288 (solithromycin) is in development for the U.S. market. | Phase 3 | Toyama Chemical Co. Ltd. |
Yes: E. faecium |
Yes: Drug-resistant N. gonorrhoeae |
(Is QIDP-designated)8
(Is QIDP-designated)26
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Tebipenem/tebipenem pivoxil hydrobromide (Does not have novel class or target)Tebipenem pivoxil hydrobromide is the prodrug form of the antibiotic tebipenem. Tebipenem (Orapenem) has been approved for pneumonia, otitis media, and sinusitis in Japan. | Phase 3 | Spero Therapeutics Inc. |
Yes: K. pneumoniae, Enterobacter spp. |
Yes: ESBL Possibly: C. difficile |
(Is not QIDP-designated)3
(Is QIDP-designated)8
(Is QIDP-designated)10
(Is QIDP-designated)14
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WCK 5222 (cefepime + zidebactam) (Does not have novel class or target) | Phase 3 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | Wockhardt Ltd. |
Yes: K. pneumoniae, Enterobacter spp. Possibly: S. aureus, P. aeruginosa |
Yes: CRE Possibly: CRPA |
(Is QIDP-designated)10
(Is QIDP-designated)18
(Is QIDP-designated)27
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Zevtera (ceftobiprole) (Does not have novel class or target)Ceftobiprole has been approved for community-acquired pneumonia and hospital-acquired bacterial pneumonia in markets outside the U.S. | Phase 3 | Basilea Pharmaceutica International Ltd. |
Yes: S. aureus, K. pneumoniae, Enterobacter spp. Possibly: P. aeruginosa |
No |
(Is QIDP-designated)2
(Is QIDP-designated)8
(Is not QIDP-designated)18
(Is QIDP-designated)22
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Zoliflodacin (ETX0914) (Has novel class or target) | Phase 3 | Entasis Therapeutics Inc./Global Antibiotic Research and Development Partnership (GARDP) |
Yes: S. aureus |
Yes: Drug-resistant N. gonorrhoeae |
(Is QIDP-designated)24
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Afabicin (Debio 1450) (Has novel class or target) | Phase 2 | Debiopharm International SA |
Yes: S. aureus |
No |
(Is QIDP-designated)2
(Is QIDP-designated)5
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ARV-1801 (sodium fusidate) (Does not have novel class or target)Fusidic acid has been approved for acute bacterial skin and soft tissue infections in markets outside the U.S. | Phase 2 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | Arrevus Inc. |
Yes: S. aureus |
No |
(Is QIDP-designated)13
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BOS-228 (Does not have novel class or target) | Phase 2 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | Boston Pharmaceuticals Inc. |
Yes: K. pneumoniae, Enterobacter spp. |
Yes: CRE |
(Is QIDP-designated)9
(Is QIDP-designated)10
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Brilacidin (Has novel class or target) | Phase 2 | Innovation Pharmaceuticals Inc. |
Yes: S. aureus |
No |
(Is QIDP-designated)2
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CRS3123 (Has novel class or target) | Phase 2 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | Crestone Inc. |
Yes: E. faecium, S. aureus |
Yes: C. difficile |
(Is not QIDP-designated)6
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Delpazolid (LCB01-0371) (Does not have novel class or target)Delpazolid (LCB01-0371) is also in development for tuberculosis but remains on the pipeline list because it is being developed for Gram-positive bacterial infections. | Phase 2 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | LegoChem Biosciences Inc./Nawei Biotechnology |
Yes: E. faecium, S. aureus |
No |
(Is not QIDP-designated)17
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DNV3837/ DNV3681 (Does not have novel class or target)DNV3837 is the prodrug form of the antibiotic DNV3681. | Phase 2 | Deinove SA | No |
Yes: C. difficile |
(Is QIDP-designated)6
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Finafloxacin (Does not have novel class or target)In February 2015, FDA approved an otic suspension formulation of finafloxacin to treat acute otitis externa. Because a systemic formulation of finafloxacin has not received approval in any country, this drug remains listed in our pipeline. | Phase 2 | MerLion Pharmaceuticals GmbH |
Yes: S. aureus, K. pneumoniae, A. baumannii Possibly: Enterobacter spp. |
Possibly: ESBL |
(Is QIDP-designated)2
(Is QIDP-designated)9
(Is QIDP-designated)12
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Ibezapolstat (Has novel class or target) | Phase 2 | Acurx Pharmaceuticals LLC | No |
Yes: C. difficile |
(Is QIDP-designated)6
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MGB-BP-3 (Has novel class or target) | Phase 2 | MGB Biopharma Ltd. |
Possibly: E. faecium, S. aureus |
Yes: C. difficile |
(Is QIDP-designated)6
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Nafithromycin (WCK 4873) (Does not have novel class or target) | Phase 2 | Wockhardt Ltd. |
Yes: S. aureus |
No |
(Is QIDP-designated)8
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Taigexyn (nemonoxacin) (Does not have novel class or target)Taigexyn (nemonoxacin) has been approved for community-acquired bacterial pneumonia in markets outside the U.S. | Phase 2 | TaiGen Biotechnology Co. |
Yes: S. aureus |
No |
(Is QIDP-designated)2
(Is QIDP-designated)8
(Is QIDP-designated)14
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TNP-2092 (Does not have novel class or target) | Phase 2 | TenNor Therapeutics Ltd. |
Yes: E. faecium, S. aureus |
Yes: C. difficile Possibly: Drug-resistant N. gonorrhoeae |
(Is QIDP-designated)2
(Is QIDP-designated)7
(Is QIDP-designated)21
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Apramycin (EBL-1003) (Does not have novel class or target) | Phase 1 | Juvabis AG |
Yes: K. pneumoniae, A. baumannii, Enterobacter spp. Possibly: S. aureus, P. aeruginosa |
Yes: CRE, CRAB |
(Is not QIDP-designated)9
(Is not QIDP-designated)10
(Is not QIDP-designated)18
(Is not QIDP-designated)27
(Is not QIDP-designated)30
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BV100 (Does not have novel class or target)Rifabutin has been previously approved in the U.S. to prevent Mycobacterium avium infections. | Phase 1 | BioVersys AG |
Yes: A. baumannii |
Yes: CRAB |
(Is QIDP-designated)18
(Is QIDP-designated)27
(Is QIDP-designated)30
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CG-549 (Has novel class or target) | Phase 1 | CrystalGenomics Inc. |
Yes: S. aureus |
No |
(Is not QIDP-designated)2
(Is not QIDP-designated)29
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ETX0282CPDP/ ETX1317 (Does not have novel class or target)ETX0282CPDP is the prodrug form of the antibiotic ETX1317. | Phase 1 | Entasis Therapeutics Inc. |
Yes: K. pneumoniae, Enterobacter spp. |
Yes: CRE |
(Is not QIDP-designated)10
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Imipenem/cilastatin + XNW4107 (Does not have novel class or target) | Phase 1 | Suzhou Sinovent Pharmaceutical Technology Co. Ltd. |
Possibly: A. baumannii, P. aeruginosa |
No |
(Is not QIDP-designated)16
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KBP-7072 (Does not have novel class or target) | Phase 1 | KBP BioSciences Pharmaceutical Technical Co. Ltd. |
Yes: A. baumannii Possibly: E. faecium, S. aureus |
Yes: CRAB |
(Is QIDP-designated)8
(Is not QIDP-designated)18
(Is not QIDP-designated)27
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MRX-8 (Does not have novel class or target) | Phase 1 | MicuRx Pharmaceuticals Inc. |
Possibly: K. pneumoniae, A. baumannii, P. aeruginosa |
Possibly: CRE, CRAB, CRPA |
(Is not QIDP-designated)16
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Nacubactam (OP0595) (Does not have novel class or target)The β-lactam with which nacubactam will be paired will be either cefepime or aztreonam. | Phase 1 | Meiji Seika Pharma Co. Ltd. |
Yes: K. pneumoniae, Enterobacter spp. Possibly: P. aeruginosa |
Possibly: CRE |
(Is not QIDP-designated)10
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OMNIvance (QPX7728) (Does not have novel class or target)The antibiotic with which QPX7728 will be paired has not been announced. | Phase 1 | Qpex Biopharma |
Possibly: A. baumannii, P. aeruginosa, Enterobacter spp. |
Possibly: CRE, CRAB, CRPA |
(Is not QIDP-designated)16
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SPR206 (Does not have novel class or target) | Phase 1 | Spero Therapeutics Inc./Everest Medicines |
Yes: K. pneumoniae, A. baumannii, P. aeruginosa, Enterobacter spp. |
Yes: CRE, CRAB, CRPA |
(Is QIDP-designated)10
(Is QIDP-designated)18
(Is QIDP-designated)27
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SPR741 (Does not have novel class or target)SPR741 is an antibiotic potentiator, which increases the entry, and therefore the efficacy, of antibiotics. The antibiotic with which SPR741 will be paired has not been announced. | Phase 1 | Northern Antibiotics |
Possibly: K. pneumoniae, A. baumannii, Enterobacter spp. |
Possibly: CRE, CRAB |
(Is not QIDP-designated)16
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TP-271 (Does not have novel class or target) | Phase 1 There are no active studies nor anticipated future studies for TP-271. The company intends to seek out-licensing opportunities; however, at this time, is unable to predict the likelihood of successfully out-licensing. | La Jolla Pharmaceutical Company |
Yes: S. aureus, A. baumannii |
Possibly: CRAB, ESBL, C. difficile |
(Is QIDP-designated)8
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TP-6076 (Does not have novel class or target) | Phase 1 There are no active studies nor anticipated future studies for TP-6076. The company intends to seek out-licensing opportunities; however, at this time, is unable to predict the likelihood of successfully out-licensing. | La Jolla Pharmaceutical Company |
Yes: K. pneumoniae, A. baumannii, Enterobacter spp. |
Yes: CRE, CRAB |
(Is not QIDP-designated)16
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TXA709/TXA707 (Has novel class or target)TXA709 is the prodrug form of the antibiotic TXA707. | Phase 1 Information not currently registered on a clinical trial registry. Information obtained from the company via a corporate website, news release, and/or direct communication. | Taxis Pharmaceuticals Inc. |
Yes: S. aureus |
No |
(Is QIDP-designated)2
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VNRX-7145 + ceftibuten (Does not have novel class or target) | Phase 1 | Venatorx Pharmaceuticals Inc. |
Yes: Enterobacter spp. Possibly: K. pneumoniae |
Yes: CRE |
(Is not QIDP-designated)16
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Key
- 1
- Acute bacterial prostatitis
- 2
- Acute bacterial skin and skin structure infections
- 3
- Acute pyelonephritis
- 4
- Bacteremia
- 5
- Bone and joint infections
- 6
- C. difficile infections
- 7
- Catheter related blood stream infections
- 8
- Community-acquired bacterial pneumonia
- 9
- Complicated intra-abdominal infections
- 10
- Complicated urinary tract infections
- 11
- Complicated urinary tract infections including acute pyelonephritis
- 12
- Complicated urinary tract infections including pyelonephritis
- 13
- Cystic fibrosis pulmonary exacerbations
- 14
- Diabetic foot infection
- 15
- Gonococcal urethritis
- 16
- Gram-negative bacterial infections
- 17
- Gram-positive bacterial infections
- 18
- Hospital-acquired bacterial pneumonia
- 19
- Intra-abdominal infections
- 20
- Pelvic inflammatory disease
- 21
- Prosthetic joint infections
- 22
- S. aureus bacteremia
- 23
- Soft tissue infections
- 24
- Uncomplicated gonorrhea
- 25
- Uncomplicated urinary tract infections
- 26
- Uncomplicated urogenital gonorrhea
- 27
- Ventilator-associated bacterial pneumonia
- 28
- Concurrent bacteremia
- 29
- Osteomyelitis
- 30
- Bloodstream infections
For definitions of drug development terms, visit https://www.pewtrusts.org/en/research-and-analysis/articles/2014/03/12/glossary-for-the-antibiotic-pipeline.
See the methodology section for further details.
For a multi-year analysis showing the evolution of the antibiotic pipeline since 2014, including candidates that have been removed, visit this interactive.
The Critical Need for New Antibiotics
In the U.S., there are not enough antibiotics in development to meet current and anticipated patient needs.
Don’t miss our latest facts, findings, and survey results in The Rundown