Drugs / Cefixime
Cefixime
also known as
Anhydrous cefixime · Cefixima · Cefixime (ATC code J01DD08) · Cefixime anhydrous · Cefixime hydrate · Cefixime trihydrate · Cefspan · Cephoral · +7 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | SUPRAX | — | 1993-02-05 – 2009-03-13 | fda.gov ↗ |
| Approved | US (FDA) | SUPRAX | — | 1989-04-28 | fda.gov ↗ |
Trials 18 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT06925490 | Jun 2025 → Sep 2026 expected | pulpitis | Cairo University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06478940 | Aug 2024 → Aug 2025 | dental pulp disorder | Cairo University | Unknown | No outcome recorded |
| Phase 1 | NCT02708992 | Apr → Dec 2016 | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT01949363 | Dec 2013 → Feb 2015 | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT01734759 | Nov 2012 → Jan 2013 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03752112 | Nov 2019 → Mar 2021 | syphilis | World Health Organization | Unknown | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT06406114 | May 2025 → Jul 2028 expected | anaphylaxis, drug allergy, drug pseudoallergy | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07264842 | Jun 2024 → Apr 2026 overdue | dental pulp necrosis | Dow University of Health Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT03660488 | Sep 2018 → Jan 2021 | syphilis | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2 | NCT01595529 | May 2012 → Jun 2019 | urinary tract infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04958122 | Jun 2021 → Jan 2027 expected | HIV infectious disease, syphilis | University of Southern California | Recruiting | No outcome recorded |
| Phase 3 | NCT01072136 | Mar 2010 → Sep 2011 | bacterial vaginosis, cervicitis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT05544565 | Mar 2023 → Jan 2028 expected | acute pyelonephritis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 4 | NCT06907316 | Jul 2021 → Aug 2024 | latent early syphilis | Bulovka Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT06090565 | Apr 2021 → Jun 2022 | gonorrhea | Bulovka Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02224040 | Aug 2013 → Dec 2014 | typhoid fever | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01388413 | Aug 2011 → Jan 2016 | urinary tract infection | University Hospital, Tours | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02830230 | Jul 2016 → Dec 2017 | — | Tata Memorial Hospital | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 20 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT03840811 Background | Apr 2017 → Nov 2019 | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00786669 Background | Oct 2008 → Nov 2012 | cancer | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1 | NCT00093353 Background | May 2004 → Jul 2006 | chemotherapy-induced toxicity, diarrheal disease, neuroblastoma | New Approaches to Neuroblastoma Therapy Consortium | Completed | No outcome recorded |
| Phase 1 | NCT00186979 Background | May 2003 → Mar 2010 | cancer | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00004216 Background | Aug 1999 → Jan 2008 | cancer of unknown primary site | Vion Pharmaceuticals | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05294588 Background | Apr 2022 → Feb 2026 | gonorrhea | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT05216744 Comparator | Jul 2021 → Feb 2022 | chlamydia trachomatis infectious disease, gonorrhea | Haiphong University of Medicine and Pharmacy | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04879030 Background | Jan → Aug 2020 | chronic obstructive pulmonary disease | Haiphong University of Medicine and Pharmacy | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06847126 Comparator | Feb 2025 → Jun 2026 overdue | liver abscess (disease) | Post Graduate Institute of Medical Education and Research, Chandigarh | Recruiting | No outcome recorded |
| Phase 3 | NCT03969758 Comparator | Jul 2019 → May 2020 | liver abscess (disease) | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | 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 46 trials | ||||||
| Phase 4 | NCT06468462 Comparator | Oct 2025 → Oct 2028 expected | gonorrhea, syphilis | University of Washington | Recruiting | No outcome recorded |
| Phase 4 | NCT04349826 Comparator | May 2021 → Dec 2025 | typhoid fever | Oxford University Clinical Research Unit, Vietnam | Completed | No outcome recorded |
| Phase 4 | NCT03716804 Comparator | Jun → Dec 2018 | bacterial infectious disease, urinary tract infection | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT03084601 Comparator | Mar 2017 → Jan 2018 | dental pulp necrosis | Mahmoud M Saadoon | Completed | No outcome recorded |
| Phase 4 | NCT03877289 Background | Oct 2008 → Jul 2014 | cystitis | University of Calgary | Completed | No outcome recorded |
| Phase 4 | NCT00136656 Comparator | Jul 2005 → Jun 2008 | pyelonephritis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05677945 Comparator | Mar 2023 → Mar 2024 | dental pulp necrosis | Cairo University | Unknown | No outcome recorded |
| — | NCT05027893 Comparator | Jun 2019 → Dec 2023 | bacterial infectious disease, poisoning | University of Novi Sad | Unknown | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cefixime | “Possible prescribed antibiotics include: trimethoprim and sulfamethoxazole (Septra), Cefalotin, Cephalexin, Cefapirin, Cefdroxil, Cefazolin, Cefradine, Cefacetrile,...” NCT03877289 ↗37“The antibiotics that were chosen (efficient for urinary tract infection, well tolerated, low selection pressure) included : Amoxicillin 6000 mg, Amoxicillin/clavulanic acid...” NCT01388413 ↗ “The beta-lactam antibiotics with activity against gram-negative bacilli in this study included piperacillin-tazobactam, ticarcillin-clavulanate, imipenem-cilastin, meropenem,...” NCT04879030 ↗ “Cotrimoxazole (sulfamethoxazole/trimethoprime) 30mg/kg/day (2 divided doses) OR Cefixime 8mg/kg/day (2 divided doses) during 7 days” NCT05544565 ↗ “pulp treatment with applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin” NCT06478940 ↗ “The material is a combination of 3Mix (cefixime, metronidazole, and ciprofloxacin) and a statin (Simvastatin).” NCT06925490 ↗ “Group 1 (Control): LSTR using Triple Antibiotic Paste (Ciprofloxacin + Metronidazole + Cefixime).” NCT07264842 ↗ “3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin” NCT03084601 ↗ “400 mg po cefixime plus 1 gram azithromycin po under direct observation” NCT06468462 ↗ “* Cephalosporins: cefdinir 12.5 mg, cefixime 10 mg” NCT01734759 ↗ “They received either oral cefixime for 10 days or” PMID 22291112 ↗ Jan 2012 “200 mg Cefixime caps” NCT05677945 ↗ “Cefixime*” NCT02099240 ↗ |
| Known as | Anhydrous cefixime | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | Cefixima | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | Cefixime (ATC code J01DD08) | “Cefixime (ATC code J01DD08)” NCT06090565 ↗ |
| Known as | Cefixime anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | Cefixime hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | Cefixime trihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | Cefspan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | Cephoral | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | CFM | “a single 1 g intravenous (IV) dose of ceftriaxone (CRO) plus doxycycline (DOX) versus a single 800 mg oral dose of cefixime (CFM) plus DOX for the treatment of NG-CT co-infection” PMID 35810277 ↗ Jul 2022 |
| Known as | Citropen | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | CL 284,635 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | FK 027 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | FR 17027 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | Oroken | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Known as | Suprax | ChEMBL registry synonym — accepted as the source's own label CHEMBL1541 ↗ |
| Modality | Other / unclassified | “cephalosporine by oral route : cefixime” NCT00136656 ↗ |
| Route | Oral | “cefixime orally” NCT00004216 ↗ |