Drugs / clavulanic acid
clavulanic acid
English name Clavulanic acid
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | — | “Teva currently has ANDAs pending before the FDA for amoxicillin and clavulanic acid (the generic equivalent of Augmentin®)” tevapharm.com ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 met primary | ||||||
| Phase 1 | NCT04411914 | Sep 2020 → Nov 2021 | cocaine dependence | Temple University | Completed | No outcome recorded |
| Phase 1 | NCT03986762 | Mar → Dec 2019 | cocaine abuse, cocaine dependence | Temple University | Completed | No outcome recorded |
| Phase 1 | NCT02563769 | Oct 2016 → May 2018 | cocaine abuse, cocaine dependence | Temple University | Completed | No outcome recorded |
| Phase 1 | NCT02393586 | Feb → Oct 2015 | tuberculosis | National University Hospital, Singapore | Completed | No outcome recorded |
| Phase 1 | NCT00836901 | Sep 2003 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02571959 | Jul → Oct 2015 | obesity disorder | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | Completed | No outcome recorded |
| Phase 28 trials · 1 met primary | ||||||
| Phase 2 | NCT05753735 | Jan → Mar 2024 | pancreas disorder | Case Comprehensive Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT05340257 | Oct 2023 → Jul 2024 | bacterial infectious disease | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05562349 | May 2023 → Jul 2024 overdue | cocaine dependence | Temple University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02381470 | Feb → Sep 2019 | pulmonary tuberculosis | National University Hospital, Singapore | Completed | No outcome recorded |
| Phase 2 | NCT03435900 | Feb → Jul 2018 | appendicitis | Herlev Hospital | Completed | Met primary |
| Phase 2 | NCT01273376 | Dec 2010 → Sep 2011 | major depressive disorder | Rexahn Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00839176 | Jan → Sep 2009 | major depressive disorder | Rexahn Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00693056 | Jun 2008 → Mar 2009 | erectile dysfunction | Rexahn Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07556991 | Sep 2024 → Dec 2026 expected | — | University of Rostock | Recruiting | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07587450 | Sep 2026 → Sep 2029 expected | appendicitis | University Hospital, Toulouse | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05224401 | May 2023 → Sep 2027 expected | bacterial urinary tract infection | Lund University | Recruiting | No outcome recorded |
| Phase 3 | NCT02764710 | May 2016 → May 2018 | — | Tel-Aviv Sourasky Medical Center | Unknown | 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 | NCT01524081 | Jul 2008 → Jul 2011 | appendicitis, intestinal obstruction, peptic ulcer perforation | The Faculty Hospital Na Bulovce | Completed | No outcome recorded |
| Phase 3 | NCT00161330 | Jun 2000 → Jul 2005 | urinary tract infection | University of Padova | Terminated | No outcome recorded |
| Phase 411 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT05830162 | Mar 2023 → Jan 2024 | infectious disease, obstetric disorder | Hanna Jangö | Completed | Missed primary |
| Phase 4 | NCT05394298 | Jul 2022 → Jul 2024 | Enterococcus infectious disease | Andalusian Public Foundation for Health Research in Seville | Unknown | No outcome recorded |
| Phase 4 | NCT04707092 | Jun 2021 → Jun 2022 | ear infection, poisoning | Sunnybrook Health Sciences Centre | Unknown | No outcome recorded |
| Phase 4 | NCT03574090 | Oct 2020 → May 2023 | — | Universitat Internacional de Catalunya | Completed | No outcome recorded |
| Phase 4 | NCT04400110 | Jun 2020 → Dec 2022 | urinary tract infection | IRCCS Burlo Garofolo | Completed | No outcome recorded |
| Phase 4 | NCT04082598 | Oct 2016 → Sep 2018 | — | Antonio Barone | Completed | No outcome recorded |
| Phase 4 | NCT01096927 | Jan 2010 → Jan 2011 | appendicitis | Maggiore Bellaria Hospital, Bologna | Completed | No outcome recorded |
| Phase 4 | NCT00603317 | Mar 2008 → Mar 2010 | atrial fibrillation, pulmonary embolism, venous thromboembolism | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT00917592 | Dec 2005 → May 2008 | diverticulitis | Consorci Sanitari de Terrassa | Completed | No outcome recorded |
| Phase 4 | NCT00343135 | Dec 2004 → Mar 2005 | skin infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01559753 | Jan 1998 → Sep 2002 | — | Centre Hospitalier Universitaire de Besancon | Completed | Met primary |
| Phase not applicable4 trials | ||||||
| — | NCT03033147 | Oct 2019 → Mar 2020 | periapical periodontitis | Cairo University | Completed | No outcome recorded |
| — | NCT04350502 | Jul 2019 → Dec 2025 | empyema, pneumonia | Centre Hospitalier Universitaire, Amiens | Completed | No outcome recorded |
| — | NCT01356641 | Sep 2012 → Jan 2017 | appendicitis | Ramon R. Gorter | Completed | No outcome recorded |
| — | NCT00462020 | Mar 2007 → Nov 2008 | appendicitis | Children's Mercy Hospital Kansas City | Completed | No outcome recorded |
| Comparator or background therapy27 trials | ||||||
| Phase 1 | NCT04376554 Comparator | Feb 2020 → Apr 2021 | — | Spero Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT07492134 Comparator | Jul 2026 → Apr 2028 expected | diverticulitis | Vanderbilt University Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03713424 Comparator | Mar 2019 → Aug 2027 expected | nicotine dependence | University of Missouri-Columbia | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06055257 Background | Jan 2025 → Dec 2027 expected | osteoradionecrosis of the mandible | Sunnybrook Health Sciences Centre | Recruiting | No outcome recorded |
| Phase 3 | NCT05392634 Comparator | Feb 2022 → Feb 2023 | urinary bladder cancer | N.N. Petrov National Medical Research Center of Oncology | Unknown | Met primary |
| Phase 3 | NCT04549311 Comparator | Nov 2021 → Jan 2023 | anal fistula | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| Phase 3 | NCT02281929 Comparator | Jun 2015 → Nov 2019 | alcoholic hepatitis | University Hospital, Lille | Completed | No outcome recorded |
| Phase 3 | NCT02021006 Comparator | Dec 2013 → Jan 2020 | chronic kidney disease, renal hypodysplasia/aplasia 1, vesicoureteral reflux | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Unknown | No outcome recorded |
| Phase 3 | NCT00828971 Comparator | Nov 2008 → Sep 2009 | infectious disease | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT00402727 Comparator | Sep 2006 → Jun 2008 | abscess, skin infection, ulcer disease | Bayer | Completed | Met primary |
| Phase 4 | NCT04084106 Comparator | Sep 2019 → Nov 2022 | infectious disease | Uppsala University | Completed | No outcome recorded |
| Phase 4 | NCT03809312 Comparator | Aug 2019 → Dec 2020 | chronic rhinosinusitis | CHU de Quebec-Universite Laval | Unknown | No outcome recorded |
| Phase 4 | NCT03508921 Background | Jul 2018 → Jun 2022 | overactive bladder, urinary tract infection | Vanderbilt University Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03247920 Comparator | Nov 2017 → Jun 2021 | neonatal sepsis | Franciscus Gasthuis | Completed | No outcome recorded |
| Phase 4 | NCT04110587 Comparator | Dec 2013 → Jul 2019 | temporomandibular joint dysfunction syndrome | Universidad Complutense de Madrid | Completed | No outcome recorded |
| Phase 4 | NCT02141217 Comparator | Mar → Dec 2013 | tooth disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00656747 Comparator | Mar 2008 → Dec 2010 | chronic bronchitis | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00495586 Comparator | Oct 2007 → Jul 2010 | chronic obstructive pulmonary disease | Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC) | Completed | No outcome recorded |
| Phase 4 | NCT01583062 Comparator | Jan 2006 → Nov 2012 | — | Insel Gruppe AG, University Hospital Bern | Terminated | No outcome recorded |
| Phase 4 | NCT01166932 Comparator | Apr 2005 → Apr 2007 | pneumonia | UPECLIN HC FM Botucatu Unesp | Completed | No outcome recorded |
| — | NCT05840588 Background | Nov 2023 → Mar 2025 | bacterial infectious disease | Liaquat University of Medical & Health Sciences | Completed | No outcome recorded |
| — | NCT04856319 Comparator | Sep 2022 → Sep 2023 | tooth disorder | Biruni University | Unknown | No outcome recorded |
| — | NCT05248620 Comparator | Feb 2022 → Oct 2028 expected | — | Zealand University Hospital | Recruiting | No outcome recorded |
| — | NCT04803422 Comparator | Apr 2021 → May 2024 | appendicitis | Zealand University Hospital | Completed | No outcome recorded |
| — | NCT04438655 Background | May 2019 → Nov 2021 | — | University of Turin, Italy | Completed | No outcome recorded |
| — | NCT03362697 Comparator | Dec 2017 → Dec 2018 | bacterial urinary tract infection | Innovacion y Desarrollo de Estrategias en Salud | Completed | No outcome recorded |
| — | NCT00135603 Comparator | Feb 2004 → Feb 2008 | appendicitis | Assistance Publique - Hôpitaux de Paris | 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 7 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | clavulanic acid | “The current protocols include broad spectrum antibiotics aimed at oral bacteria and main pathogens in acute bacterial sinusitis (Streptoccocus pneumoniae, Moraxella...” NCT02764710 ↗59“At week 0 patients will be randomized in a single blinded manner (participants and care providers) in a 1:1 manner to receive 500/125mg amoxicillin/clavulanic acid 30-120...” NCT05248620 ↗ “with initiation of antibiotic therapy at day 1 with Amoxicillin/clavulanic acid IntraVeinous (IV) in 2 doses daily for a minimum of 24 hours and a maximum of 48 hours with a...” NCT07587450 ↗ “Study participants were stratified by sex and block-randomised in a 1:1 ratio to treatment with either tebipenem pivoxil hydrobromide (600 mg orally every 8 h) or...” PMID 38432233 ↗ Feb 2024 “Amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) for patients with...” NCT03362697 ↗ “A computer-generated randomisation sequence was used to allocate patients randomly in a 1:1 ratio to receive amoxicillin plus clavulanic acid (3 g per day) for 8-15 days or...” PMID 21550483 ↗ May 2011 “Study treatment includes amoxicillin + clavulanic acid (875mg/125mg) two times daily or clindamycin (150mg) four times daily for 5-7 days both administered orally with meal.” NCT02141217 ↗ “Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).” NCT04110587 ↗ “switch to an oral suspension of amoxicillin 75 mg/kg plus clavulanic acid 18·75 mg/kg (in a 4:1 dosing ratio, given daily in three doses)” PMID 36088952 ↗ Sep 2022 “Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week” NCT04707092 ↗ “IV Amoxicilline/clavulanic acid 2000/200 mg TID followed by PO amoxicilline/clavulanate 875/125 mg TID for a total of 7 to 21 days” NCT00828971 ↗ |
| Known as | CLAV | “A Phase 1B Double Blind, Placebo (PBO) Controlled, Pharmaco- Magnetic Resonance Spectroscopy (MRS) Inpatient Study of Clavulanic Acid (CLAV) 500, 750, 1000 mg Daily Repeated...” NCT04411914 ↗1“A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)” NCT05562349 ↗ |
| Known as | clavulanate potassium | “Co-amoxiclav is an antibacterial combination consisting of the semisynthetic antibiotic amoxicillin and the ß-lactamase inhibitor, clavulanate potassium.” NCT01583062 ↗ |
| Known as | RX-10100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00693056 ↗ |
| Action | Inhibit | “the ß-lactamase inhibitor, clavulanate potassium” NCT01583062 ↗ |
| Modality | Small molecule | “nonantibiotic small molecule beta-lactam compound” PMID 22203317 ↗ Dec 2011 |
| Route | Oral | “oral amoxicillin + clavulanic acid” NCT00161330 ↗ |