Aztreonam
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cystic fibrosis 5 milestones | |||||
| Refused (EMA) | EU (EMA) | — | cystic fibrosis | 2009-03-19 | “has adopted a negative opinion on the company’s Marketing Authorisation Application (MAA) for aztreonam lysine 75 mg powder and solvent for nebuliser solution” gilead.com ↗ |
| Rejected (CRL) | US (FDA) | — | cystic fibrosis | 2008-09-16 | “received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for aztreonam lysine for inhalation” gilead.com ↗ |
| Filed | Other | — | cystic fibrosis | 2008-03-21 | “Gilead submitted its application for aztreonam lysine in Australia on November 30, 2007 and in Canada on March 21, 2008.” gilead.com ↗ “in Canada on March 21, 2008.” gilead.com ↗ |
| Filed | Other | — | cystic fibrosis | 2007-11-30 | “Gilead submitted its application for aztreonam lysine in Australia on November 30, 2007” gilead.com ↗ |
| Filed | US (FDA) | — | cystic fibrosis | 2007-11-16 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of aztreonam lysine” gilead.com ↗ “Gilead submitted its U.S. New Drug Application for aztreonam lysine for inhalation to the FDA on November 16, 2007.” gilead.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Approved | EU (EMA) | Cayston | — | 2009-09-21 | europa.eu ↗ |
| Label expansion | US (FDA) | AZACTAM IN PLASTIC CONTAINER | — | 1998-12-24 | fda.gov ↗ |
| Label expansion | US (FDA) | AZACTAM | — | 1996-11-01 | fda.gov ↗ |
| Approved | US (FDA) | AZACTAM | — | 1986-12-31 | fda.gov ↗ |
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05777603 | Apr 2024 → Jun 2027 expected | non-small cell lung carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| 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 | NCT03376529 | Nov → Dec 2017 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01689207 | Sep 2012 → Dec 2014 | opportunistic bacterial infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03978091 | Jul 2019 → Nov 2020 | bacterial infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07463339 | May 2026 → Apr 2027 expected | — | University of Calgary | Not yet recruiting | No outcome recorded |
| 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 | NCT02730793 | Jan 2017 → Sep 2019 | cystic fibrosis | Virginia Commonwealth University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02655419 | May 2016 → Oct 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT01375049 | Aug 2011 → May 2013 | cystic fibrosis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00805025 | Dec 2008 → Oct 2009 | bronchiectasis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01055847 | Jun 2003 → Aug 2004 | Pseudomonas aeruginosa infectious disease, cystic fibrosis, respiratory tract infectious disorder | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT07113574 | Aug 2021 → Jul 2022 | chronic renal failure syndrome, infectious peritonitis | Karl Landsteiner Insitute for Nephrology and Haemato-Oncology | Completed | No outcome recorded |
| Phase 2/3 | NCT03867734 | Apr → Sep 2019 | gonorrhea | University of Washington | Completed | No outcome recorded |
| Phase 2/3 | NCT07113587 | Apr 2014 → Jul 2017 | infectious peritonitis | Karl Landsteiner Insitute for Nephrology and Haemato-Oncology | Completed | No outcome recorded |
| Phase 314 trials · 5 met primary · 3 missed | ||||||
| Phase 3 | NCT05905055 | Sep 2023 → Sep 2025 | acute pyelonephritis, bacterial pneumonia | Meiji Seika Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05887908 | May 2023 → Nov 2024 | acute pyelonephritis | Meiji Seika Pharma Co., Ltd. | 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 | NCT01404234 | Dec 2011 → Apr 2013 | Pseudomonas aeruginosa infectious disease, cystic fibrosis | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01314716 | Apr 2011 → Apr 2013 | bronchiectasis | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01313624 | Apr 2011 → Mar 2013 | bronchiectasis | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT01059565 | Feb 2010 → Sep 2011 | burkholderia infectious disease, cystic fibrosis | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT00757237 | Aug 2008 → May 2010 | cystic fibrosis | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT00712166 | May 2008 → Jun 2009 | Pseudomonas aeruginosa infectious disease, cystic fibrosis, respiratory tract infectious disorder | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT00128492 | Aug 2005 → Nov 2008 | cystic fibrosis | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT00112359 | May 2005 → Apr 2007 | cystic fibrosis | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT00104520 | Feb 2005 → Sep 2006 | cystic fibrosis | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT00228410 | Nov 2002 → Dec 2003 | skin infection | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 44 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07478484 | Mar 2026 → Dec 2027 expected | gram-negative bacterial infections | Jing Zhou | Recruiting | No outcome recorded |
| Phase 4 | NCT03158116 | Jul 2017 → Feb 2020 | tracheitis | UCSF Benioff Children's Hospital Oakland | Terminated | No outcome recorded |
| Phase 4 | NCT02894684 | Jan 2017 → Feb 2019 | Pseudomonas infection, cystic fibrosis | Liverpool Heart and Chest Hospital NHS Foundation Trust | Completed | Met primary |
| Phase 4 | NCT01469364 | Mar 2013 → Mar 2015 | bronchiolitis obliterans syndrome | Duke University | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT05850871 | Jan 2023 → Jan 2025 | — | Qianfoshan Hospital | Unknown | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT00499720 | — | Pseudomonas aeruginosa infectious disease, cystic fibrosis | Gilead Sciences | Approved for marketing | No outcome recorded |
| — | NCT00989807 | — | Pseudomonas aeruginosa infectious disease, cystic fibrosis | Gilead Sciences | Approved for marketing | No outcome recorded |
| Comparator or background therapy23 trials | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02168816 Comparator | Mar 2014 → Feb 2017 | osteomyelitis | Loyola University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00794586 Comparator | Nov 2008 → Feb 2010 | cystic fibrosis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT00633152 Comparator | Feb → Jul 2008 | bacterial infectious disease | Forest Laboratories | Completed | No outcome recorded |
| Phase 2 | NCT00303589 Comparator | Dec 2005 → Oct 2007 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2/3 | NCT03749226 Comparator | Mar → Sep 2019 | respiratory tract infectious disorder | Hospital Universitari Joan XXIII de Tarragona. | Terminated | No outcome recorded |
| Phase 2/3 | NCT01400867 Comparator | Dec 2011 → May 2014 | primary bacterial infectious disease | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT03138733 Comparator | Aug 2018 → Mar 2022 | staphylococcus aureus infection | Basilea Pharmaceutica | Completed | Met primary |
| Phase 3 | NCT03137173 Comparator | Feb 2018 → Apr 2019 | — | Basilea Pharmaceutica | Completed | Met primary |
| Phase 3 | NCT02795949 Comparator | Oct 2016 → Jan 2020 | bacterial infectious disease | Andalusian Public Foundation for Health Research in Seville | Completed | Met primary |
| Phase 3 | NCT02276482 Background | Mar 2015 → Sep 2018 | skin disease caused by bacterial infection, skin infection | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02202135 Comparator | Jun 2014 → Jan 2015 | — | Pfizer | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT01984684 Comparator | May 2014 → Dec 2015 | skin disease caused by bacterial infection | Melinta Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT01811732 Comparator | Apr 2013 → Jul 2014 | skin disease caused by bacterial infection | Melinta Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT01641822 Comparator | Dec 2012 → Jan 2015 | cystic fibrosis | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01499277 Comparator | May 2012 → Jun 2014 | necrotizing soft tissue infection | Pfizer | Completed | Met primary |
| Phase 3 | NCT00423657 Comparator | Mar → Dec 2007 | bacterial infectious disease | Forest Laboratories | Completed | Met primary |
| Phase 3 | NCT00424190 Comparator | Feb → Nov 2007 | bacterial infectious disease | Forest Laboratories | Completed | Met primary |
| Phase 4 | NCT07236944 Comparator | Dec 2025 → Mar 2029 expected | bacterial urinary tract infection | Uppsala University | Recruiting | No outcome recorded |
| Phase 4 | NCT07004049 Comparator | Apr 2025 → Dec 2028 expected | bacterial pneumonia, infectious disease with sepsis | National University of Singapore | Recruiting | No outcome recorded |
| Phase 4 | NCT03380793 Background | Sep 2016 → Oct 2018 | appendicitis | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 4 | NCT01951768 Comparator | Sep 2013 → Jun 2016 | ulcer of lower limbs | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 4 | NCT01659866 Comparator | Aug 2012 → Aug 2015 | infectious disease | Northwestern University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| 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) |
| 2010-10-21 | Gilead Sciences | Results Gilead's Cayston(R) Superior to Tobramycin Inhalation Solution in Six-Month Head-to-Head Cystic Fibrosis Study gilead.com ↗
Patients receiving Cayston had an adjusted mean actual increase in FEV 1 percent predicted from baseline over six months of 2.05 percent compared to a 0.66 percent decrease for patients receiving TIS. |
| 2010-06-18 | Gilead Sciences | Results Gilead's Head-to-Head Study of Cayston(R) Versus Tobramycin Inhalation Solution in Cystic Fibrosis Patients Achieves Co-Primary Efficacy Endpoint of Non-Inferiority gilead.com ↗
Patients receiving Cayston had a mean increase in FEV1 percent predicted from baseline to Day 28 of 8.35 percent compared to 0.55 percent for patients receiving TIS, which meets the statistical definition of superiority. |
| 2010-02-22 | Gilead Sciences | Regulatory U.S. Food and Drug Administration Approves Cayston(R) (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston(R)(aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa). |
| 2009-12-10 | Gilead Sciences | Regulatory FDA Advisory Committee Supports Use of Aztreonam for Inhalation Solution for Patients With Cystic Fibrosis gilead.com ↗ |
| 2009-09-23 | Gilead Sciences | Regulatory European Commission Grants Conditional Marketing Authorization to Cayston(R) (Aztreonam Lysine) for the Treatment of Chronic Pulmonary Infections Due to Pseudomonas Aeruginosa in Patients with Cystic Fibrosis gilead.com ↗ |
| 2009-06-26 | Gilead Sciences | Regulatory European CHMP Adopts Positive Opinion for Aztreonam Lysine gilead.com ↗
The opinion is for conditional approval, contingent on the successful completion of an ongoing study. |
| 2009-03-19 | Gilead Sciences | Regulatory European CHMP Adopts Negative Opinion on Aztreonam Lysine gilead.com ↗ |
| 2009-02-18 | Gilead Sciences | Regulatory Gilead Receives Response From U.S. FDA on Company's Request for Formal Dispute Resolution for Aztreonam for Inhalation Solution gilead.com ↗ |
| 2008-09-16 | Gilead Sciences | Regulatory Gilead Receives Complete Response Letter from U.S. Food and Drug Administration for Aztreonam Lysine for Inhalation, an Investigational Treatment for Cystic Fibrosis gilead.com ↗
The agency stated that they cannot approve the application in its current form and an additional clinical study will be required. |
| 2008-06-13 | Gilead Sciences | Results Gilead Announces Interim 12-Month Phase III Study Results for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis gilead.com ↗
At the time of this analysis, 64 patients had discontinued treatment. |
| 2008-03-07 | Gilead Sciences | Regulatory Gilead Sciences Submits Marketing Authorisation Application for Aztreonam Lysine 75 mg Powder for Nebuliser Solution, a Potential New Treatment for Cystic Fibrosis, to European Medicines Agency gilead.com ↗ |
| 2007-11-16 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. FDA for Aztreonam Lysine for Inhalation for Cystic Fibrosis gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of aztreonam lysine for inhalation (75 mg three times daily), an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. |
| 2007-10-04 | Gilead Sciences | Results Gilead Announces Detailed Results of Phase III Study of Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis gilead.com ↗
In this study, a 28-day treatment course of aztreonam lysine improved respiratory symptoms as assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a patient-reported outcome (PRO) tool. |
| 2007-05-29 | Gilead Sciences | Results Gilead Announces Achievement of Primary Efficacy Endpoint in Second Phase III Study of Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis gilead.com ↗ |
| 2007-04-19 | Gilead Sciences | Results Gilead Announces Presentation of Positive Phase III Data on Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis gilead.com ↗
In the study, a 28-day treatment course of aztreonam lysine significantly improved the time to need for inhaled or intravenous (IV) antibiotics versus placebo. |
| 2006-12-19 | Gilead Sciences | Results Gilead Announces Preliminary Results From Phase III Study of Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis gilead.com ↗
Study of CF Patients With Pulmonary Pseudomonas Aeruginosa Meets Primary Efficacy Endpoint |
All press releases naming this drug 23 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Aztreonam | “Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic...” NCT01404234 ↗59“This therapy is usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin,...” NCT02168816 ↗ “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 ↗ “We aimed to assess safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with non-cystic fibrosis bronchiectasis and Gram-negative bacterial colonisation.” PMID 25154045 ↗ Aug 2014 “daptomycin at a dose of 6 to 10 mg per kilogram of body weight intravenously every 24 hours plus optional aztreonam (at the discretion of the trial-site investigators).” PMID 37754204 ↗ Sep 2023 “AZLI, an investigational formulation of the antibiotic aztreonam and administered three times a day using the PARI eFlow® electronic nebulizer” NCT00712166 ↗ “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 “AZLI, an investigational formulation of the antibiotic aztreonam and administered TID using the PARI eFlow® electronic nebulizer” NCT00112359 ↗ “morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.” NCT03380793 ↗ “AZLI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with CF and PA.” NCT00128492 ↗ |
| Known as | ATM | “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 ↗ |
| Known as | AZACTAM | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03978091 ↗ |
| Known as | AZLI | “This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using...” NCT01404234 ↗14“This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P....” NCT00989807 ↗ “BACKGROUND: We assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibiotic]) in patients with cystic fibrosis...” PMID 19420195 ↗ May 2009 “We aimed to assess safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with non-cystic fibrosis bronchiectasis and Gram-negative bacterial colonisation.” PMID 25154045 ↗ Aug 2014 “The purpose of this study was to evaluate whether AZLI, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with CF and PA.” NCT00128492 ↗ “Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis” NCT01375049 ↗ “Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily combined with diluent administered using an eFlow nebulizer” NCT01641822 ↗ “Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day” NCT01059565 ↗ “Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa.” PMID 21441078 ↗ Mar 2011 “The delivery profile of Aztreonam lysine (AZLI) during mechanical ventilation (MV) is unknown.” PMID 29041861 ↗ Oct 2017 “75 mg aztreonam for inhalation solution (AZLI), administered 3 times daily” NCT00805025 ↗ |
| Known as | Aztreonam for Inhalation Solution | “We aimed to assess safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with non-cystic fibrosis bronchiectasis and Gram-negative bacterial colonisation.” PMID 25154045 ↗ Aug 20141“Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis” NCT01375049 ↗ |
| Known as | aztreonam lysine | “This program is to provide expanded access to aztreonam lysine for inhalation (AZLI) prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P....” NCT00989807 ↗2“BACKGROUND: We assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibiotic]) in patients with cystic fibrosis...” PMID 19420195 ↗ May 2009 “Aztreonam Lysine for Inhalation (AZLI)” NCT01469364 ↗ |
| Known as | Aztreonam Lysine For Inhalation | “A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease,...” NCT00712166 ↗ |
| Known as | Cayston | “Antibiotics currently on the market as inhaled antibiotics include tobramycin (TOBI), polymyxin E (Colistin), and aztreonam (Cayston).” NCT03158116 ↗ |
| Modality | Small molecule | “AZLI, marketed as Cayston, is an inhaled beta-lactam antibiotic.” NCT02894684 ↗ |
| Route | Inhaled | “inhaled aztreonam lysine” PMID 18658109 ↗ Jul 2008 |