Drugs / avibactam
avibactam
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Zavicefta | — | 2016-06-23 | europa.eu ↗ |
| Approved | US (FDA) | AVYCAZ | — | 2015-02-25 | fda.gov ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials · 1 met primary | ||||||
| Phase 1 | NCT04973826 | Aug → Sep 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04486625 | Aug 2020 → Sep 2021 | impaired renal function disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01920399 | Oct → Nov 2013 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01789528 | Aug 2013 → Mar 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01893346 | Jul 2013 → Oct 2014 | infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01689207 | Sep 2012 → Dec 2014 | opportunistic bacterial infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01624246 | May 2012 → Mar 2013 | — | Forest Laboratories | Completed | No outcome recorded |
| Phase 1 | NCT01534247 | Feb → Jul 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01448395 | Oct → Nov 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01395420 | Aug 2011 → Jul 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01290900 | Feb → May 2011 | — | Pfizer | Completed | Met primary |
| Phase 1 | NCT01291602 | Feb → Apr 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT06462235 | Sep 2024 → Apr 2027 expected | gram-negative bacterial infections | Pfizer | Recruiting | No outcome recorded |
| Phase 2 | NCT05639647 | Apr 2023 → Mar 2027 expected | gram-negative bacterial infections | Pfizer | Recruiting | No outcome recorded |
| Phase 2 | NCT04126031 | Jan 2020 → Dec 2022 | gram-negative bacterial infections | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02655419 | May 2016 → Oct 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT02497781 | Sep 2015 → Sep 2017 | urinary tract infection | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01281462 | Dec 2010 → Mar 2012 | urinary tract infection | Forest Laboratories | Completed | No outcome recorded |
| Phase 2 | NCT00752219 | Mar → Nov 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00690378 | Nov 2008 → Jun 2010 | bacterial urinary tract infection | Pfizer | Completed | No outcome recorded |
| Phase 39 trials · 5 met primary | ||||||
| Phase 3 | NCT04927312 | Oct 2021 → Sep 2022 | — | Pfizer | Completed | Met primary |
| Phase 3 | NCT03580044 | Dec 2020 → Jan 2023 | bacterial infectious disease | Pfizer | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03329092 | Apr 2018 → Feb 2023 | nosocomial infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01808092 | Apr 2013 → Jan 2016 | — | Pfizer | Completed | Met primary |
| Phase 3 | NCT01726023 | Jan 2013 → Mar 2015 | — | Pfizer | Completed | Met primary |
| Phase 3 | NCT01644643 | Jan 2013 → Sep 2014 | urinary tract infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01595438 | Oct 2012 → Aug 2014 | acute pyelonephritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01599806 | Oct 2012 → Aug 2014 | acute pyelonephritis | Pfizer | Completed | Met primary |
| Phase 3 | NCT01499290 | Mar 2012 → Apr 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06811727 | May 2025 → May 2027 expected | primary bacterial infectious disease | Ivan Šitum, MD | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04882085 | Aug 2021 → Aug 2023 | acute pyelonephritis, bacterial pneumonia, infectious peritonitis | Pfizer | Completed | No outcome recorded |
| Phase 4 | NCT04774094 | May 2021 → May 2023 | nosocomial infection | Pfizer | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT06672276 Comparator | Nov 2024 → May 2025 | — | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05340530 Comparator | Apr 2022 → Dec 2023 | infectious disease | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05588531 Comparator | Dec 2021 → Apr 2022 | — | Nanjing Yoko Biomedical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01430910 Comparator | Sep 2011 → Oct 2012 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT07840105 Comparator | Sep 2026 → Sep 2027 expected | acute pyelonephritis | Wockhardt | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07327619 Comparator | Jan 2026 → Jun 2028 expected | bacterial pneumonia | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07063095 Background | Aug 2025 → Dec 2026 expected | gram-negative bacterial infections, infectious disease with sepsis | Angela HUTTNER | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2025-04-25 | AbbVie | Regulatory AbbVie Reports First-Quarter 2025 Financial Results abbvie.com ↗
AbbVie announced that the FDA approved Emblaveo (aztreonam and avibactam), as the first monobactam/β-lactamase inhibitor combination antibiotic therapy to treat complicated intra-abdominal infections, including those caused by Gram-negative bacteria. |
| 2025-02-07 | AbbVie | Regulatory U.S. FDA Approves EMBLAVEO™ (aztreonam and avibactam) for the Treatment of Adults With Complicated Intra-Abdominal Infections With Limited or No Treatment Options abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EMBLAVEO™ (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. |
| 2024-04-22 | Pfizer | Regulatory European Commission Approves Pfizer’s EMBLAVEO® for Patients with Multidrug-Resistant Infections and Limited Treatment Options pfizer.com ↗
Pfizer Inc . (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for EMBLAVEO ® (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis. |
| 2023-06-01 | Pfizer | Results Phase 3 Studies of Pfizer’s Novel Antibiotic Combination Offer New Treatment Hope for Patients with Multidrug-Resistant Infections and Limited Treatment Options pfizer.com ↗
Data support that ATM-AVI is effective and well-tolerated, with no new safety findings and a similar safety profile to aztreonam alone. |
| 2019-11-11 | AbbVie | Regulatory Allergan Receives FDA Qualified Infectious Disease Product (QIDP) Designation And Fast Track Designation For ATM-AVI (Aztreonam And Avibactam) For Antibiotic-Resistant Gram-Negative Infections abbvie.com ↗
Allergan plc (NYSE: AGN) today announced the U.S. Food and Drug Administration ( FDA ) has granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track Designation for ATM-AVI (aztreonam and avibactam) |
| 2019-03-18 | AbbVie | Regulatory Allergan Announces FDA Approval of AVYCAZ® (ceftazidime and avibactam) for Pediatric Patients abbvie.com ↗
This is the first FDA approval of a pediatric indication for cUTI and cIAI in more than a decade. |
| 2018-11-20 | AbbVie | Regulatory Allergan Announces FDA Acceptance of Supplemental New Drug Application for AVYCAZ® (ceftazidime and avibactam) abbvie.com ↗ |
| 2018-02-01 | AbbVie | Regulatory FDA Approves AVYCAZ® (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia abbvie.com ↗ |
| 2017-04-24 | Pfizer | Results Pivotal Phase III Study Underscores Efficacy Of Zavicefta™ (ceftazidime-avibactam) For Treatment Of Hospital-Acquired Pneumonia, A Leading Cause Of Mortality In Hospitals pfizer.com ↗
In addition, patients treated with Zavicefta and Meropenem experienced comparable rates of tolerability consistent with the known profile of ceftazidime alone. |
All press releases naming this drug 10 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | avibactam | “Patients aged between 18 and 90 years with cUTI were enrolled and stratified by infection type (acute pyelonephritis or other cUTI) and randomized 1:1 to receive intravenous...” PMID 23145859 ↗ Nov 201233“Patients received a single 2-h intravenous infusion of ceftazidime-avibactam (cohort 1, 2,000 to 500 mg; cohort 2, 2,000 to 500 mg [≥40 kg] or 50 to 12.5 mg/kg [<40 kg];...” PMID 27503642 ↗ Sep 2016 “The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics.” NCT06462235 ↗ “Ceftazidime-Avibactam powder for concentrate for solution for infusion 2.0 g/ 0.5 g. Dosage will be adjusted based on renal function after enrollment.” NCT04927312 ↗ “investigational monobactam/β-lactamase inhibitor combination aztreonam/avibactam in patients with complicated intra-abdominal infection (cIAI)” PMID 31828337 ↗ Mar 2020 “An aztreonam/avibactam 500/137 mg 30-min loading dose and 1500/410 mg 3-h maintenance infusions q6h were selected for further evaluation.” PMID 38252170 ↗ Jan 2024 “Cohort 1: CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) by intravenous infusion given over 2 hours, every 8 hours” NCT01789528 ↗ “Ceftazidime and avibactam pharmacokinetics were well-described by two-compartment disposition models” PMID 30221827 ↗ Sep 2018 “Aztreonam-avibactam, a fixed-ratio (3:1) β-lactam/β-lactamase inhibitor combination” PMID 40530972 ↗ Jun 2025 “TQD3606 is a fixed-dose combination of meropenem and avibactam.” NCT06672276 ↗ “CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)” NCT01534247 ↗ |
| Known as | AVI | “The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics.” NCT06462235 ↗1“Avibactam (AVI)” NCT01689207 ↗ |
| Known as | Avibactam component of zavicefta | ChEMBL registry synonym — accepted as the source's own label CHEMBL1689063 ↗ |
| Known as | AVIBACTAM SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL1689063 ↗ |
| Known as | Avibactam sodium component of avycaz | ChEMBL registry synonym — accepted as the source's own label CHEMBL1689063 ↗ |
| Known as | Avibactam sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1689063 ↗ |
| Known as | Avibactam(NXL104) | “Ceftaroline fosamil and Avibactam(NXL104) (q8h)” NCT01281462 ↗ |
| Known as | Nxl-104 free acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL1689063 ↗ |
| Known as | NXL104 | “Part B investigates how much Avibactam (NXL104) and Ceftazidime enter the blood when Avibactam and Ceftazidine are given separately or together intravenously.” NCT01430910 ↗ |
| Action | Inhibit | “Ceftazidime-avibactam is a novel β-lactam/β-lactamase inhibitor combination for the treatment of serious infections caused by resistant gram-negative pathogens.” PMID 30221827 ↗ Sep 2018 |
| Modality | Small molecule | “Ceftazidime-avibactam is a novel β-lactam/β-lactamase inhibitor combination for the treatment of serious infections caused by resistant gram-negative pathogens.” PMID 30221827 ↗ Sep 2018 |
| Route | Intravenous | “receive intravenous ceftazidime 500 mg plus avibactam 125 mg every 8 hours” PMID 23145859 ↗ Nov 2012 |