Drugs / Sulbactam
Sulbactam
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | UNASYN | — | 1986-12-31 | fda.gov ↗ |
Trials 16 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06801223 | Oct 2026 → May 2028 expected | Acinetobacter infectious disease | Innoviva Specialty Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT03310463 | Oct 2017 → May 2018 | Acinetobacter infectious disease | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03303924 | Aug → Oct 2017 | — | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02971423 | Oct 2016 → Jun 2017 | Acinetobacter infectious disease | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03445195 | Jan → May 2018 | acute pyelonephritis | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01601093 | Nov 2011 → Aug 2022 | respiratory tract infectious disorder, urinary tract infection | Xiangbei Welman Pharmaceutical Co., Ltd | Suspended | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT03894046 | Sep 2019 → Jul 2021 | Acinetobacter infectious disease, bacterial pneumonia | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT03477422 | Jan 2014 → May 2017 | acute pyelonephritis | Venus Remedies Limited | Completed | No outcome recorded |
| Phase 3 | NCT02007603 | Aug 2013 → Feb 2015 | infection-related hemolytic uremic syndrome | Medical University of Vienna | Completed | No outcome recorded |
| Phase 3 | NCT01189487 | Oct 2010 → Apr 2011 | bacterial pneumonia | Pfizer | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT04290104 | Oct → Nov 2020 | acute cholecystitis | Konya Meram State Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04202068 | Jul 2015 → May 2016 | gonorrhea | Xiangbei Welman Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 4 | NCT04066621 | Apr 2015 → Jun 2016 | bacterial urinary tract infection, respiratory tract infectious disorder | Xiangbei Welman Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 4 | NCT02688322 | Sep 2014 → Aug 2016 | Acinetobacter infectious disease | Sutep Jaruratanasirikul | Completed | No outcome recorded |
| Phase 4 | NCT01897831 | Aug 2011 → Aug 2015 | respiratory tract infectious disorder, urinary tract infection | Xiangbei Welman Pharmaceutical Co., Ltd | Unknown | No outcome recorded |
| Phase 4 | NCT00360607 | Jul 2004 → Apr 2005 | infectious disease | Pfizer | Completed | No outcome recorded |
Also used as a comparator or background therapy in 7 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02060149 Background | Mar 2014 → Mar 2015 | pneumonia | Xijing Hospital | Unknown | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07326540 Comparator | Mar 2026 → Dec 2027 expected | Acinetobacter infectious disease, bacterial pneumonia | BioVersys SAS | Recruiting | No outcome recorded |
| Phase 3 | NCT01045902 Comparator | Feb 2001 → Jan 2005 | aspiration pneumonia, lung abscess | Bayer | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| 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 | NCT06440304 Comparator | Jan 2025 → Dec 2026 expected | bacterial infectious disease with sepsis | Clinical Hospital Centre Zagreb | Recruiting | No outcome recorded |
| Phase 4 | NCT02436083 Comparator | Jul 2007 → Jun 2012 | — | Technical University of Munich | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07148622 Comparator | Oct 2024 → Aug 2025 | preterm premature rupture of the membranes | Yuzuncu Yil University | Completed | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sulbactam | “Cefoperazone/ sulbactam 3.0g（intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h).” NCT02060149 ↗22“Single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hr IV infusion” NCT03310463 ↗ “17 of 88 patients (19.3%) who received amoxicillin combined with sulbactam” PMID 26251066 ↗ Aug 2015 “Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.” NCT01601093 ↗ “Piperacillin Sodium and Sulbactam Sodium for Injection(2:1)” NCT01897831 ↗ |
| Known as | CP-45,899-2 | ChEMBL registry synonym — accepted as the source's own label CHEMBL403 ↗ |
| Known as | NSC-759886 | ChEMBL registry synonym — accepted as the source's own label CHEMBL403 ↗ |
| Known as | SUL | “ETX2514 combined with sulbactam (SUL) in vitro restores sulbactam activity against Acinetobacter baumannii” PMID 30126953 ↗ Oct 20181“Sulbactam (SUL)-durlobactam (SUL-DUR) is under development for the treatment of ABC infections.” PMID 31843995 ↗ Feb 2020 |
| Known as | Sulbactam (as sodium) | ChEMBL registry synonym — accepted as the source's own label CHEMBL403 ↗ |
| Known as | Sulbactam Sodium | “Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd.” NCT00360607 ↗1“Ceftriaxone sodium and Sulbactam Sodium for injection” NCT04202068 ↗ |
| Known as | Sulbactam sodium component of sulperazone | ChEMBL registry synonym — accepted as the source's own label CHEMBL403 ↗ |
| Known as | Sulbactam sodium component of unasyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL403 ↗ |
| Known as | Sulbactam sodium component of xacduro | ChEMBL registry synonym — accepted as the source's own label CHEMBL403 ↗ |
| Known as | Sulbactam sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL403 ↗ |
| Action | Inhibit | “Sulbactam (beta-lactamase inhibitor)” NCT03477422 ↗ |
| Modality | Small molecule | “beta-lactam/beta-lactamase inhibitor combination cefoperazone-sulbactam” PMID 18570578 ↗ Jun 2008 |
| Route | Intravenous | “Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid” NCT01045902 ↗ |
| Route | Oral | “Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid” NCT01045902 ↗ |