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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 | Oct 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 · 1 missed | ||||||
| — | 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 | Missed primary |
| — | 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 |
| Comparator or background therapy13 trials | ||||||
| Phase 0 | NCT03755765 Background | Jul 2019 → Jan 2020 | diarrheal disease | Georgetown University | Completed | No outcome recorded |
| Phase 1 | NCT06733675 Comparator | Jan 2025 → Dec 2026 expected | — | Basilea Pharmaceutica | Recruiting | No outcome recorded |
| 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 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2005-02-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Amoxicillin And Clavulanate Potassium Chewable Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Amoxicillin and Clavulanate Potassium Chewable Tablets USP, 200 mg/28.5 mg and 400 mg/57 mg. |
| 2004-05-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Amoxicillin And Clavulanate Potassium For Oral Suspension, 200 mg and 400 mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the company's ANDA for Amoxicillin and Clavulanate Potassium for Oral Suspension, 200 mg/28.5 mg/5 mL and 400 mg/57 mg/5 mL. |
| 2002-10-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Generic Version of Augmentin® tevapharm.com ↗ |
| 2002-10-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of 500mg/125mg Strength of Generic Version of Augmentin® tevapharm.com ↗
Further to announcements made earlier in the day, Teva announced the receipt of U.S. Food and Drug Administration approval of its ANDA for Amoxicillin and Clavulanate Potassium Tablets, the generic version of GlaxoSmithKline's Augmentin® 500mg/125mg. |
All press releases naming this drug 5 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 ↗ |
| 2002-10-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Generic Version of Augmentin® tevapharm.com ↗ |
| 2002-10-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of 500mg/125mg Strength of Generic Version of Augmentin® 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 ↗ |