Drugs / Clavulanate
Clavulanate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | AUGMENTIN '125' | — | 1984-08-06 | fda.gov ↗ |
Trials 22 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05584683 | Aug 2023 → Dec 2024 | bacterial infectious disease | Kaizen Bioscience Co. | Completed | No outcome recorded |
| Phase 1 | NCT01728363 | Jan 2013 → May 2015 | infectious disease | Phillip Brian Smith | Completed | No outcome recorded |
| Phase 1 | NCT00354965 | Jan 2006 → Apr 2007 | respiratory tract infectious disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00840840 | Aug 2002 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00840099 | Aug 2002 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05896930 | Nov 2017 → Jan 2021 | pulmonary tuberculosis | TASK Applied Science | Completed | No outcome recorded |
| Phase 2 | NCT03174184 | Aug 2017 → May 2022 | pulmonary tuberculosis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00092170 | Mar 2002 → Jan 2004 | infectious disease, pelvic inflammatory disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT01934231 | Aug → Nov 2013 | sinusitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00644553 | May 2003 → Mar 2004 | sinusitis | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00643292 | Jan 2003 → May 2004 | otitis media | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00042718 | Nov 2001 → Aug 2003 | chronic bronchitis | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07704359 | Aug 2026 → Feb 2029 expected | anal fistula | University of Illinois at Chicago | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05867654 | Jul 2024 → Nov 2025 overdue | osteomyelitis | University of Louisville | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04600752 | May → Nov 2022 | otitis media, respiratory tract infectious disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01870167 | Jan 2013 → Jun 2014 | infectious disease | Azienda Policlinico Umberto I | Unknown | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT04378231 | May 2020 → Dec 2021 | bronchitis | Second Affiliated Hospital of Wenzhou Medical University | Unknown | No outcome recorded |
| — | NCT03007342 | Jan → Dec 2017 | periapical periodontitis | Cairo University | Unknown | No outcome recorded |
| — | NCT01860300 | Mar 2013 → Apr 2017 | tic disorder | University of Roma La Sapienza | Unknown | No outcome recorded |
| — | NCT01137903 | Apr 2010 → Apr 2011 | osteomyelitis, ulcer of lower limbs | Universidad Complutense de Madrid | Unknown | No outcome recorded |
| — | NCT00132275 | Nov 2003 → Aug 2006 | sinusitis | University of Pittsburgh | Completed | No outcome recorded |
| — | NCT00002149 | — | HIV infectious disease, sinusitis | Immune Enhancement Project | Completed | No outcome recorded |
Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03755765 Background | Jul 2019 → Jan 2020 | diarrheal disease | Georgetown University | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT06733675 Comparator | Jan 2025 → Dec 2026 expected | — | Basilea Pharmaceutica | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02554383 Comparator | Feb 2016 → Mar 2022 | respiratory tract infectious disorder, sinusitis | Nader Shaikh | Completed | No outcome recorded |
| Phase 3 | NCT03142620 Comparator | Mar 2015 → Dec 2017 | Helicobacter pylori infectious disease | Chinese University of Hong Kong | Unknown | No outcome recorded |
| Phase 3 | NCT01069900 Comparator | Jul 2010 → Jan 2015 | infectious peritonitis | Bayer | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT02340000 Comparator | Nov 2014 → Feb 2017 | sinusitis | Albany Medical College | Completed | No outcome recorded |
| Phase 4 | NCT01089218 Comparator | Apr 2008 → Jan 2009 | pneumonia | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00147914 Comparator | Feb 2005 → Feb 2007 | sinusitis | University of Chicago | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07233733 Background | Jun 2024 → Mar 2025 | periodontitis | Phạm Đình Thiên Khải | Completed | No outcome recorded |
| — | NCT06250413 Background | Feb 2024 → Dec 2026 expected | poisoning | Otto Helve | Not yet recruiting | No outcome recorded |
| — | NCT01473368 Comparator | Apr 2012 → Feb 2013 | — | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| — | NCT01507974 Comparator | Jan 2012 → Jul 2014 | pregnancy disorder | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| — | NCT01166945 Comparator | Nov 2010 → Feb 2016 | sinusitis | University of Wisconsin, Madison | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2005-02-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Amoxicillin And Clavulanate Potassium Chewable Tablets tevapharm.com ↗ |
| 2004-05-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Amoxicillin And Clavulanate Potassium For Oral Suspension, 200 mg and 400 mg tevapharm.com ↗ |
| 2004-03-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Amoxicillin/Clavulanate Potassium For Oral Suspension tevapharm.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 35 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Clavulanate | “Phase 2 Trial to Evaluate the Early EBA, Safety and Tolerability of Amoxicillin/Clavulanate With or Without Meropenem, Ertapenem or Rifampicin in Adults With Newly Diagnosed,...” NCT05896930 ↗22“All participants will be given a 5-day (Day 1-5) course of Amoxicillin + Clavulanate 875/125 mg × 2.” NCT06250413 ↗ “Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)” NCT00644553 ↗ |
| Known as | Clavulanate Potassium | “Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet” NCT03007342 ↗6“dry suspension of amoxicillin clavulanate potassium” NCT04378231 ↗ “clavulanate potassium is an enzyme inhibitor” NCT01728363 ↗ |
| Known as | clavulanic acid | “Oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination every 12 hours for five days.” NCT03007342 ↗ |
| Known as | potassium clavulanate | “co-amoxiclav is a combination antibiotic consisting of amoxicillin trihydrate, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor” NCT01870167 ↗5“Augmentin ES will be administered as reconstituted oral suspension containing Amoxicillin and Potassium Clavulanate 600 mg/42.9 mg per 5 milliliters.” NCT04600752 ↗ |
| Action | Inhibit | “clavulanate potassium is an enzyme inhibitor that helps the ticarcillin work better” NCT01728363 ↗ |
| Route | Oral | “after it has been swallowed by children” NCT00354965 ↗ |