Drugs / cefuroxime axetil

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (6) US (FDA) CEFTIN 1992-01-31 – 1999-08-24 fda.gov
Approved US (FDA) CEFTIN 1987-12-28 fda.gov

Trials 3 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT00000752 ? → Feb 1993 HIV infectious disease, sinusitis National Institute of Allergy and Infectious Diseases (NIAID) Withdrawn No outcome recorded
Phase not applicable2 trials
NCT07512648 Mar 2026 → Apr 2028 expected breast disorder, granulomatous mastitis Caigang Liu Not yet recruiting No outcome recorded
NCT02147249 Jul 2013 → Dec 2020 University Medical Centre Ljubljana Unknown No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02099240 Comparator Mar 2014 → Nov 2018 osteomyelitis University of Louisville Terminated No outcome recorded
Phase 41 trial
Phase 4 NCT01518192 Comparator Jun 2006 → Nov 2007 post-treatment Lyme disease syndrome University Medical Centre Ljubljana Completed No outcome recorded
Phase not applicable1 trial
NCT03584919 Comparator Jun 2006 → Sep 2007 University Medical Centre Ljubljana Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2004-10-18 Teva Branded Pharmaceutical Products R&D, Inc. Teva Announces Approval Of Cefuroxime Axetil Tablets tevapharm.com

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as cefuroxime axetil “oral cefuroxime axetil tablets (brand name: Dalixin®), 250 mg twice daily” NCT07512648
5

cefuroxime axetil orally, 500 mg, bid, 14 days” NCT02147249

Cefuroxime axetilNCT02099240

NCT01518192

NCT03584919

NCT00000752

Known as CCI 15641 ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Ceftin ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Cefurax ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Cefuroxime (as axetil) ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Cefuroxime 1-acetoxyethyl ester ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Cepazine ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Cetoxil ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Curocef ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Dalixin “oral cefuroxime axetil tablets (brand name: Dalixin®), 250 mg twice daily” NCT07512648
Known as Elobact ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Novador ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Novocef ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as NSC-758677 ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Oraxim ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Zinat ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Known as Zinnat ChEMBL registry synonym — accepted as the source's own label CHEMBL1095930
Modality Small molecule CHEMBL1095930
Route Oral “cefuroxime axetil orally” NCT02147249