Drugs / Cefadroxil

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) DURICEF — 1991-08-30 fda.gov ↗
Approved US (FDA) DURICEF — 1978-02-17 fda.gov ↗

Trials 10

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials · 2 met primary
Phase 1 NCT03802552 May 2019 → Apr 2021 bacterial arthritis, osteomyelitis, pyomyositis University of Colorado, Denver Completed No outcome recorded
Phase 1 NCT02140281 May → Aug 2014 — Ardelyx Completed No outcome recorded
Phase 1 NCT00834275 Sep → Oct 2004 — Teva Pharmaceuticals USA Completed Met primary
Phase 1 NCT00835081 Sep → Oct 2004 — Teva Pharmaceuticals USA Completed Met primary
Phase 23 trials
Phase 2 NCT06406114 May 2025 → Jul 2028 expected anaphylaxis, drug allergy, drug pseudoallergy Massachusetts General Hospital Recruiting No outcome recorded
Phase 2 NCT02381470 Feb → Sep 2019 pulmonary tuberculosis National University Hospital, Singapore Completed No outcome recorded
Phase 2 NCT00332163 Apr 2006 → Jan 2008 colorectal cancer, exanthem, toxic dermatosis Amgen Completed No outcome recorded
Phase 42 trials · 1 met primary
Phase 4 NCT07561541 Apr 2026 → Dec 2027 expected diabetes mellitus Texas Tech University Health Sciences Center, El Paso Recruiting No outcome recorded
Phase 4 NCT01244698 Nov 2010 → May 2014 bacterial infectious disease Stony Brook University Completed Met primary
Phase not applicable1 trial
— NCT04631185 May 2021 → Dec 2023 — The Plastic Surgery Foundation Completed No outcome recorded
Comparator or background therapy5 trials
Phase 3 NCT04723940 Comparator Jan 2021 → Jan 2028 expected periprosthetic joint infection Rothman Institute Orthopaedics Enrolling by invitation No outcome recorded
Phase 3 NCT02814916 Comparator Mar 2017 → Jan 2024 methicillin-resistant staphylococcus aureus infectious disease AbbVie Completed No outcome recorded
Phase 4 NCT05977868 Background Aug 2023 → Feb 2025 digestive system infectious disorder West Virginia University Terminated No outcome recorded
Phase 4 NCT04297592 Comparator Jun 2020 → Jan 2027 expected autoimmune disease, chronic kidney disease, diabetes mellitus, methicillin-resistant staphylococcus aureus infectious disease +3 Mayo Clinic Enrolling by invitation No outcome recorded
— NCT00405158 Background Jan 2002 → Mar 2004 mastitis Karlstad University Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2013-02-13 Sobi, Inc. Sobi gains distribution rights for Megace®, Monopril®, Cefzil® and Duricef® from PharmaSwiss sobi.com ↗

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as Cefadroxil “oral antibiotic (eg, doxycycline, ciprofloxacin, cefadroxil, amoxicillin/clavulanic acid), topical steroid (hydrocortisone cream), topical antibiotic (clindamycin), oral...” NCT00332163 ↗
13

NCT04723940 ↗

NCT06406114 ↗

NCT03802552 ↗

NCT00835081 ↗

NCT02814916 ↗

NCT00405158 ↗

NCT01244698 ↗

NCT07561541 ↗

NCT04297592 ↗

NCT05977868 ↗

Show 3 more sources

Known as Anhydrous cefadroxil ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Baxan ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as BL-S578 ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Cefadrops ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Cefadroxil (as monohydrate) ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Cefadroxil anhydrous ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Cefadroxil hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Cefadroxil monohydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Cefadroxil/cefadroxil hemihydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Cefadroxilo ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Cefatabs ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Duracef ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Duricef “The patients will be prescribed one week of Cephalosporin Antibiotic (Keflex/Duricef/Other) of their surgeon's choice.” NCT04631185 ↗
Known as MJF 11567-3 ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as NSC-756664 ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Known as Ultracef ChEMBL registry synonym — accepted as the source's own label CHEMBL1644 ↗
Modality Small molecule “cefadroxil (a first generation cephalosporin)” NCT02381470 ↗
Route Oral “The control group will receive oral outpatient Cefadroxil (500mg 2 times a day) until the final drain is removed.” NCT01244698 ↗