tazobactam
Trade name: Zosyn
Approved
Oct 22, 1993
Tazobactam is a beta-lactamase inhibitor, which was approved by FDA for the treatment of wide range of bacterial infections either in combination with piperacillin (Zosyn) or with ceftolozane (Zerbaxa). — NCATS
Clinical trial activity
120 trials · 171 clinical orgs · 27 marketing orgs
Earliest trial started Nov 1, 1997 (NCT00003805)
Timeline
1990s
- Oct 22, 1993
Earliest FDA Approval
- Oct 22, 1993
Wyeth — NDA Secondary Org
- Oct 22, 1993
American Home Products — NDA Secondary Org
- Jan 1, 1997
Earliest Phase 3 Sponsor(trial)
- Feb 24, 1998
Baxalta — NDA Secondary Org
2000s
2010s
- Oct 21, 2010
Sandoz — Marketing Organization
- Oct 21, 2010
Novartis — Marketing Organization
- May 23, 2011
Aurobindo Pharma — Marketing Organization
- May 23, 2011
Eugia Pharma — Marketing Organization
- May 31, 2011
Istituto Bio Ita Spa — Marketing Organization
- Aug 15, 2014
Mylan — Marketing Organization
- Aug 15, 2014
STERISCIENCE — Marketing Organization
- Aug 15, 2014
ONESOURCE SPECIALTY — Marketing Organization
- Dec 19, 2014
Cubist — NDA Secondary Org
- Dec 19, 2014
Merck — NDA Secondary Org
- Jan 13, 2017
Apollo Hospitals, Chennai, India — Marketing Organization
- Jan 13, 2017
Provepharm Sas — Marketing Organization
- Jan 13, 2017
Apollo Pharmacy — Marketing Organization
- Jan 13, 2017
Milla Pharms — Marketing Organization
- Mar 17, 2017
Wockhardt — Marketing Organization
- Mar 17, 2017
Apotex — Marketing Organization
- May 11, 2018
Fresenius — Marketing Organization
- Aug 10, 2018
Qilu Pharmaceutical Co., Ltd. — Marketing Organization
- Aug 10, 2018
Shandong Lanjin Pharmaceuticals Co.,Ltd — Marketing Organization
- Jul 29, 2019
Astral — Marketing Organization
2020s
- Feb 16, 2021
Sagent Pharmaceuticals, Inc. — Marketing Organization
- Feb 16, 2021
Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization
- Apr 3, 2025
B. Braun — NDA Secondary Org
Indications
Approved for
Studied for
- Abdominal Abscess · Phase 3
- Abscess · Phase 3
- Acute Kidney Injury · Phase 4
- Anti-Bacterial Agents · Phase 3
- Appendicitis · Phase 4
- Asthma · Phase 4
- Bacteremia · Phase 4
- Bacterial Infections · Phase 4
- Bone Marrow Diseases · Phase 3
- Bronchiectasis · Phase 4
- Bronchitis · Phase 2/Phase 3
- Burkholderia Infections · Phase 4
- Burns · Phase 4
- Carbapenems · Phase 4
- Cerebrospinal Fluid Otorrhea · Phase 1/Phase 2
- Cholecystitis, Acute · Phase 3
- Clinical Trial · Phase 4
- Critical Illness · Phase 4
- Cross Infection · Phase 2
- Cystic Fibrosis · Phase 4
- Diabetes Mellitus · Phase 4
- Diabetic Foot · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 1
- Drug Resistance, Bacterial · Phase 4
- Drugs, Investigational · Phase 4
- Enterobacteriaceae Infections · Phase 4
- Escherichia coli Infections · Phase 4
- Febrile Neutropenia · Phase 4
- Fever · Phase 4
- Fractures, Open · Phase 4
- General Surgery · Phase 1
- Graft vs Host Disease · Phase 2
- Gram-Negative Bacteria · Phase 4
- Gram-Positive Bacterial Infections · Phase 4
- Healthcare-Associated Pneumonia · Phase 3
- Healthy Volunteers · Phase 1
- Hematologic Neoplasms · Phase 3
- Infections · Phase 4
- Intraabdominal Infections · Phase 3
- Kidney Failure, Chronic · Phase 1
- Klebsiella Infections · Phase 4
- Klebsiella pneumoniae · Phase 4
- Leukemia · Phase 3
- Liver Transplantation · Phase 3
- Lung Diseases · Phase 3
- Lymphoma · Phase 3
- Multiple Myeloma · Phase 3
- Myelodysplastic Syndromes · Phase 3
- Neonatal Sepsis · Phase 4
- Neoplasms · Phase 4
- Osteomyelitis · Phase 2
- Otitis Media · Phase 1/Phase 2
- Pancreatic Diseases · Phase 3
- Pancreatic Fistula · Phase 2
- Pancreatic Neoplasms · Phase 3
- Pancreaticoduodenectomy · Phase 3
- Pharmacokinetics · Phase 4
- Pneumonia · Phase 4
- Pneumonia, Bacterial · Phase 3
- Pneumonia, Ventilator-Associated · Phase 3
- Pseudomonas aeruginosa · Phase 4
- Pseudomonas Infections · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 4
- Pyelonephritis · Phase 3
- Respiratory Tract Infections · Phase 4
- Sepsis · Phase 4
- Shock, Septic · Phase 4
- Stem Cell Transplantation · Phase 4
- Surgical Wound Infection · Phase 3
- Systemic Inflammatory Response Syndrome · Phase 2
- Ulcer · Phase 3
- Urinary Tract Infections · Phase 4
- Urination Disorders · Phase 4
- Wound Infection · Phase 4
Mechanism of action
- Bacterial beta-lactamase TEMINHIBITOR
Bacterial beta-lactamase TEM inhibitor
Broad spectrum
Combination products
zerbaxa
with ceftolozane
Also known as ceftolozane and tazobactam
zosyn
with piperacillin
Also known as piperacillin and tazobactam
Approval history
- approvedOct 22, 1993
Chemistry & pharmacology
SMILES
C[C@]1(Cn2ccnn2)[C@H](C(=O)O)N2C(=O)C[C@H]2S1(=O)=O- Mol. weight
- 300.3 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL404 ↗
- WikipediaTazobactam ↗
- NCATSSE10G96M8W ↗
- ChEMBLCHEMBL1439 ↗
Also known as
- ceftolozane sulfate / tazobactam sodium
- cl-298741
- cl-298741
- cl-298741
- taszobactam sodium
- tazobactam
- tazobactam
- tazobactam
- tazobactam
- tazobactam
- tazobactam
- tazobactam
- tazobactam
- tazobactam
- tazobactam
- tazobactam sodium
- tazobactam sodium
- tazobactam sodium
- tazocel
- ytr 830
- ytr 830
- ytr-830
- ytr-830
- ytr 830h
- ytr-830h
- ytr-830h
- ytr-830h
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06954129 | Phase 4 | Oct 31, 2025 | University of Pennsylvania |
| NCT06712641 | Phase 4 | Jun 30, 2025 | Oslo Metropolitan University, University of Oslo |
| NCT06342115 | Phase 4 | Oct 31, 2024 | Beneficência Portuguesa de Sao Paulo, Merck |
| NCT06123169 | Phase 3 | Mar 31, 2024 | Rouen Normandy University |
| NCT06293677 | Phase 4 | Mar 1, 2024 | University of Lausanne |
| NCT06184659 | Phase 4 | Mar 1, 2024 | Scandinavian Critical Care Trials Group |
| NCT05943223 | Phase 2 | Jan 31, 2024 | McMaster University |
| NCT07096310 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2024 | Ain Shams University |
| NCT05753735 | Phase 2 | Dec 20, 2023 | Case Western Reserve University |
| NCT06422533 | N/A | Nov 7, 2023 | Government of Mexico |
| NCT06035055 | Phase 4 | Oct 31, 2023 | Sunshine Coast Hospital and Health Service, Sunshine Coast University, Australia, University of Queensland |
| NCT05981079 | Phase 4 | Jul 31, 2023 | Hebei University, Liaocheng People's Hospital, Nanjing Medical University, Qingdao University, Shandong Province Qianfoshan Hospital, Shandong Provincial Hospital, Shandong University, Shengli Oilfield Central Hospital, Tai'an Central Hospital |
| NCT05565222 | Phase 3 | Jan 31, 2023 | Assistance Publique - Hôpitaux de Paris |
| NCT05355350 | Phase 4 | Jul 1, 2022 | Hebrew University, Technion University, Tel Aviv University |
| NCT05061654 | Phase 4 | Feb 28, 2022 | Hamad Medical Corporation, Merck |
| NCT05102162 | Phase 4 | Dec 31, 2021 | Food and Drug Administration, University of Florida |
| NCT05060419 | Phase 2 | Oct 8, 2021 | Fudan University, Qilu Pharmaceutical Co., Ltd. |
| NCT04816968 | Phase 1 | Sep 30, 2021 | Revert ONLUS, University of Milan |
| NCT04983901 | Phase 2 | Sep 14, 2021 | University of Texas at Houston |
| NCT04948463 | Phase 4 | Jul 31, 2021 | Murdoch University |
Organizations
Research & Development (171)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Merck | For profit | 22 | 12 | 4 | 2001 |
| Cubist | For profit | 7 | 6 | 4 | 2010 |
| Pfizer | For profit | 6 | 5 | 2 | 2000 |
| Wyeth | For profit | 5 | 0 | 2 | 2000 |
| Tel Aviv University | Academic/Hospital | 4 | 2 | 2 | 2009 |
| University of Queensland | Academic/Hospital | 4 | 3 | 2 | 2014 |
| Medpace, Inc. | For profit | 3 | 0 | 1 | 2016 |
| University of Texas at Houston | Academic/Hospital | 3 | 3 | 1 | 2018 |
| Wockhardt | For profit | 3 | 3 | 2 | 2016 |
| Ain Shams University | Academic/Hospital | 2 | 2 | 2 | 2018 |
| Bayer | For profit | 2 | 1 | 1 | 2005 |
| Clinartis | For profit | 2 | 0 | 1 | 2016 |
| Duke University | Academic/Hospital | 2 | 2 | 2 | 2009 |
| Fundación Pública Andaluza | Academic/Hospital | 2 | 2 | 1 | 2011 |
| Ghent University | Academic/Hospital | 2 | 2 | 1 | 2016 |
| Government of Mexico | Government | 2 | 2 | 1 | 2017 |
| Indiana University | Academic/Hospital | 2 | 0 | 2 | 2015 |
| Nanjing Medical University | Academic/Hospital | 2 | 1 | 2 | 2012 |
| Ohio State University | Academic/Hospital | 2 | 1 | 2 | 2014 |
| People's Liberation Army of China | Government | 2 | 2 | 1 | 2012 |
Marketing (33)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| American Home Products | For profit | NDA2 | Oct 22, 1993 |
| Apollo Hospitals, Chennai, India | Academic/Hospital | MKTG | Jan 13, 2017 |
| Apollo Pharmacy | Academic/Hospital | MKTG | Jan 13, 2017 |
| Apotex | For profit | MKTG | Mar 17, 2017 |
| Astral | For profit | MKTG | Jul 29, 2019 |
| Aurobindo Pharma | For profit | MKTG | May 23, 2011 |
| B. Braun | For profit | NDA2 | Apr 3, 2025 |
| Baxalta | For profit | NDA2 | Feb 24, 1998 |
| Cubist | For profit | NDA2 | Dec 19, 2014 |
| Eugia Pharma | For profit | MKTG | May 23, 2011 |
| Eugia Pharma | For profit | SYN | Oct 12, 2023 |
| Fresenius | For profit | MKTG | May 11, 2018 |
| Fresenius | For profit | SYN | May 11, 2018 |
| Hospira | For profit | MKTG | Sep 15, 2009 |
| Istituto Bio Ita Spa | For profit | MKTG | May 31, 2011 |
| Merck | For profit | NDA2 | Dec 19, 2014 |
| Milla Pharms | For profit | MKTG | Jan 13, 2017 |
| Mylan | For profit | MKTG | Aug 15, 2014 |
| Nichi-Iko Pharmaceutical Co., Ltd. | For profit | MKTG | Feb 16, 2021 |
| Novartis | For profit | MKTG | Oct 21, 2010 |
| ONESOURCE SPECIALTY | For profit | MKTG | Aug 15, 2014 |
| Provepharm Sas | For profit | MKTG | Jan 13, 2017 |
| Qilu Pharmaceutical Co., Ltd. | For profit | MKTG | Aug 10, 2018 |
| Qilu Pharmaceutical Co., Ltd. | For profit | SYN | Aug 10, 2018 |
| STERISCIENCE | For profit | MKTG | Aug 15, 2014 |
| STERISCIENCE | For profit | SYN | Aug 15, 2014 |
| Sagent Pharmaceuticals, Inc. | For profit | MKTG | Feb 16, 2021 |
| Sandoz | For profit | MKTG | Oct 21, 2010 |
| Sandoz | For profit | SYN | Oct 29, 2014 |
| Shandong Lanjin Pharmaceuticals Co.,Ltd | For profit | MKTG | Aug 10, 2018 |
| Wockhardt | For profit | MKTG | Mar 17, 2017 |
| Wyeth | For profit | NDA | — |
| Wyeth | For profit | NDA2 | Oct 22, 1993 |