Drugs / CEPHALEXIN ANHYDROUS
CEPHALEXIN ANHYDROUS
also known as
Cephalexin · cefalexin · keflex · 66873 · Alsporin · Anhydrous cephalexin · Biocef · Carnosporin · +40 more
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | KEFLEX | — | 1974-10-04 – 2006-05-12 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | KEFLET | — | 1978-11-07 – 1982-09-17 | fda.gov ↗ |
| Approved | US (FDA) | KEFLEX | — | 1971-01-04 | fda.gov ↗ |
Trials 41
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials · 1 missed | ||||||
| Phase 1 | NCT07300670 | Mar → May 2026 | — | Aleksi Tornio | Completed | No outcome recorded |
| Phase 1 | NCT04916951 | Jul 2021 → Nov 2025 | — | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT03802552 | May 2019 → Apr 2021 | bacterial arthritis, osteomyelitis, pyomyositis | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 1 | NCT03187106 | Aug 2017 → Jul 2023 | — | The University of Texas Medical Branch, Galveston | Completed | Missed primary |
| Phase 1 | NCT02490670 | Jul 2015 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02123459 | May 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02123472 | May 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02100826 | Apr → May 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02123446 | Apr → May 2014 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02014558 | Oct 2013 → Aug 2017 | acute myeloid leukemia | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07202949 | Feb 2026 → Oct 2027 expected | urinary tract infection | University College, London | Recruiting | No outcome recorded |
| Phase 2 | NCT06406114 | May 2025 → Jul 2028 expected | anaphylaxis, drug allergy, drug pseudoallergy | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05664568 | Mar 2023 → Jul 2024 | pulmonary tuberculosis | Western Sydney Local Health District | Unknown | No outcome recorded |
| Phase 2 | NCT05020574 | Sep 2021 → Dec 2026 expected | female breast carcinoma | University of California, San Francisco | Recruiting | 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 2/31 trial | ||||||
| Phase 2/3 | NCT00729937 | Apr 2009 → May 2013 | staphylococcal infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Mixed |
| Phase 35 trials | ||||||
| Phase 3 | NCT07686055 | Jul 2026 → Feb 2027 expected | urinary tract infection | Megan Bradley | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06336824 | Jun 2024 → May 2025 overdue | staphylococcus aureus infection | Clinical Research Centre, Malaysia | Recruiting | No outcome recorded |
| Phase 3 | NCT04553419 | Jul 2020 → Jun 2025 | cystic fibrosis | University of British Columbia | Unknown | No outcome recorded |
| Phase 3 | NCT01002911 | Dec 2009 → Jan 2012 | cardiac rhythm disease | Population Health Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT00003824 | Apr 1999 → Jul 2001 | bladder transitional cell carcinoma | SWOG Cancer Research Network | Terminated | No outcome recorded Stop: Enrollment |
| Phase 412 trials | ||||||
| Phase 4 | NCT04876131 | May 2022 → Jan 2028 expected | urinary tract infection | Murdoch Childrens Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT05156437 | Mar 2022 → Oct 2024 | endocarditis | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT04471246 | Aug 2021 → Feb 2022 | cellulitis | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT04834310 | Apr 2021 → May 2024 | breast disorder, poisoning | University of California, Los Angeles | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04580472 | Oct 2020 → Sep 2026 overdue | — | Carilion Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03148444 | Jun 2017 → Jun 2019 | primary bacterial infectious disease | Kaplan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01899690 | Jun 2016 → Aug 2017 | prosthesis-related infectious disease | Emory University | Withdrawn | No outcome recorded |
| Phase 4 | NCT02012517 | Jan 2014 → Dec 2016 | — | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02145338 | Sep 2013 → Feb 2017 | urinary tract infection | Newcastle-upon-Tyne Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 4 | NCT01628666 | Dec 2012 → Sep 2017 | cardiac rhythm disease | Population Health Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT01912651 | Sep 2011 → Nov 2025 | craniofacial and skeletal defects | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT00234949 | Mar 2005 → ? | — | Abbott | Completed | No outcome recorded |
| Phase not applicable8 trials · 1 met primary | ||||||
| — | NCT04631185 | May 2021 → Dec 2023 | — | The Plastic Surgery Foundation | Completed | No outcome recorded |
| — | NCT04146883 | Aug 2019 → Aug 2020 | prosthesis-related infectious disease | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| — | NCT02911662 | Sep 2016 → Jan 2018 | bacteriuria | Trinity Health Michigan | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01561703 | Mar 2012 → Dec 2013 | streptococcal sore throat | University of Missouri-Columbia | Completed | No outcome recorded |
| — | NCT01229553 | Jan 2011 | cystic fibrosis | State University of New York - Upstate Medical University | Withdrawn | No outcome recorded |
| — | NCT01194115 | Sep 2010 → Sep 2012 | — | University of Cincinnati | Unknown | Met primary |
| — | NCT00957827 | Aug 2009 → Aug 2011 | lip disorder | University of Pennsylvania | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00187759 | Nov 2004 → Mar 2005 | — | University of California, San Francisco | Completed | No outcome recorded |
| Comparator or background therapy38 trials | ||||||
| Phase 1 | NCT01500382 Background | Feb 2012 → Jan 2013 | overactive bladder | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05702762 Comparator | Oct 2022 → Jun 2023 | cystitis | Mercy Health Ohio | Unknown | No outcome recorded |
| Phase 2 | NCT02569866 Comparator | Nov 2014 → May 2016 | — | Federal University of São Paulo | Completed | No outcome recorded |
| Phase 2 | NCT01631617 Comparator | Sep 2012 → Jan 2027 expected | atopic eczema | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Recruiting | No outcome recorded |
| Phase 2 | NCT01029782 Comparator | May 2010 → Oct 2014 | cellulitis | Kelowna General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00300092 Comparator | Sep 2000 → Jul 2004 | — | Children's Hospital Los Angeles | Completed | No outcome recorded |
| Phase 2/3 | NCT01400867 Background | Dec 2011 → May 2014 | primary bacterial infectious disease | Forest Laboratories | Completed | No outcome recorded |
| Phase 3 | NCT07665476 Background | Sep 2026 → Dec 2030 expected | cellulitis, skin infection | Ottawa Hospital Research Institute | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04577846 Comparator | Nov 2020 → Dec 2022 | — | Aga Khan University | Unknown | No outcome recorded |
| Phase 3 | NCT04194216 Comparator | May 2020 → Dec 2026 expected | nasal disorder | Stanford University | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT03176134 Comparator | Jan 2019 → Jul 2023 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02809131 Comparator | Apr 2016 → Mar 2021 | sick sinus syndrome, systolic heart failure, third-degree atrioventricular block | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT02276482 Comparator | Mar 2015 → Sep 2018 | skin disease caused by bacterial infection, skin infection | Merck & Co., Inc. | Completed | No outcome recorded |
| Phase 4 | NCT06127160 Comparator | Jun 2024 → Aug 2025 | acute pyelonephritis | Brett A Faine | Completed | No outcome recorded |
| Phase 4 | NCT06055712 Comparator | Sep 2023 → Sep 2033 expected | infectious disease | St. Louis University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05852262 Comparator | Aug 2023 → Dec 2025 overdue | cellulitis | Ottawa Hospital Research Institute | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05977868 Background | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT05274672 Comparator | Mar 2023 → Feb 2025 | benign prostatic hyperplasia, urinary tract infection | Baylor Research Institute | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05726318 Background | Feb 2023 → Aug 2024 | urinary tract infection | Megan Bradley | Completed | No outcome recorded |
| Phase 4 | NCT05719285 Comparator | Dec 2022 → Jun 2023 | overactive bladder | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT04538053 Comparator | Jun 2021 → Dec 2026 expected | infective arthritis, osteomyelitis | Murdoch Childrens Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT04285320 Comparator | Mar 2021 → Apr 2023 | urinary tract infection | Atlantic Health System | Unknown | 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 |
| Phase 4 | NCT03275623 Comparator | Sep 2017 → Mar 2019 | cystitis, pyelonephritis | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT01613092 Comparator | May 2011 → Nov 2013 | cardiac rhythm disease | Population Health Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT00895089 Comparator | May 2009 → Dec 2010 | liver abscess (disease) | Kaohsiung Veterans General Hospital. | Completed | No outcome recorded |
| Phase 4 | NCT03877289 Background | Oct 2008 → Jul 2014 | cystitis | University of Calgary | Completed | No outcome recorded |
| Phase 4 | NCT00352612 Comparator | Sep 2006 → May 2009 | abscess, folliculitis, staphylococcal infection | Aaron Chen | Completed | No outcome recorded |
| — | NCT07032883 Background | Jun 2025 → Feb 2026 overdue | female breast carcinoma | Cairo University | Not yet recruiting | No outcome recorded |
| — | NCT06207786 Background | Sep 2024 → May 2029 | epidermal appendage tumor, skin cancer | Mayo Clinic | Withdrawn | No outcome recorded |
| — | NCT06080698 Comparator | Feb 2024 → May 2027 expected | gram-negative bacterial infections | Johns Hopkins University | Recruiting | No outcome recorded |
| — | NCT03357419 Comparator | Mar → Nov 2021 | skin disorder | Rambam Health Care Campus | Withdrawn | No outcome recorded |
| — | NCT03736187 Background | Apr → Oct 2019 | — | Ain Shams University | Unknown | No outcome recorded |
| — | NCT01823523 Comparator | Jun 2013 → Oct 2015 | craniofacial and skeletal defects | Atlantic Center for Oral and Maxillofacial Surgery | Unknown | No outcome recorded |
| — | NCT01501747 Comparator | Feb 2012 → Feb 2013 | — | King Faisal Specialist Hospital & Research Center | Completed | No outcome recorded |
| — | NCT01507974 Comparator | Jan 2012 → Jul 2014 | pregnancy disorder | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| — | NCT01155154 Comparator | Feb 2010 → Feb 2012 | — | State University of New York - Downstate Medical Center | Terminated | No outcome recorded |
| — | NCT00676130 Background | May 2007 → May 2012 | cellulitis | Brigham and Women's Hospital | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2020-12-10 | Eurofarma Laboratorios S.A. | Eurofarma reforça presença no México com aquisição do produto Keflex eurofarma.com.br ↗ |
Evidence & citations 51 cited values
Every value below carries the sentence it was read from. 80 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CEPHALEXIN ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | 66873 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Alsporin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Anhydrous cephalexin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Biocef | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Carnosporin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cefadros | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cefaleksin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | cefalexin | “Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.” NCT01628666 ↗11“Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin” NCT01613092 ↗ “oral cefalexin 500 mg every 6 hours until removal of drains” NCT02012517 ↗ “Arm 1: cefalexin 500 mg once pre-procedure” NCT05719285 ↗ “Cefalexin (500mg four times daily)” NCT07202949 ↗ |
| Known as | Cefalexin anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cefalexin hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cefalexin monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cefalexina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cefalexine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cefanex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cepahlexin | “Cepahlexin (drug)” NCT00300092 ↗ |
| Known as | Cephalexin | “Receive an oral anti-staphylococcal antibiotic (e.g. oral cephalexin) with standard dosing only if indicated for antibiotic prophylaxis per the Mayo Clinic Dermatologic Surgery...” NCT06207786 ↗65“Possible prescribed antibiotics include: trimethoprim and sulfamethoxazole (Septra), Cefalotin, Cephalexin, Cefapirin, Cefdroxil, Cefazolin, Cefradine, Cefacetrile,...” NCT03877289 ↗ “Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral provided locally by the...” NCT03176134 ↗ “Oral dose regimen for simple urinary tract infection: Including cephalexin, cefdinir, sulfamethoxazole/trimethoprim, and nitrofurantoin at appropriate dose, frequency, and duration” NCT05702762 ↗ “Antibiotic comparator drug, IV and/or orally for 10 days. Antibiotic comparator included the following: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin.” NCT02276482 ↗ “One of seven antibiotics (amoxicillin; amoxicillin/clavulanate potassium; azithromycin; cefaclor; cephalexin; cefdinir; or clindamycin) will be given at standard dosage” NCT01561703 ↗ “A pre-procedural prophylactic antibiotic (ie, levofloxacin 250 mg, cephalexin) administered orally, 30 minutes prior to each scheduled urodynamic study intervention.” NCT01500382 ↗ “Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole.” NCT06080698 ↗ “ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days” NCT07686055 ↗ “ceftriaxone 2 gm IV q 12 h for 14 days, followed by cephalexin 1 gm PO q 6 h for 1 week” NCT00895089 ↗ “Then continue oral with keflex 1g tablets (cephalexin) twice daily for 7 days.” NCT07032883 ↗ |
| Known as | cephalexin (Keflex) | “cephalexin (Keflex)” NCT01899690 ↗ |
| Known as | Cephalexin hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | CEPHALEXIN HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cephalexin monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cephalexin monohydrochloride monohydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Cephamasten | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Ceporex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Durantel | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Efalexin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Felexin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Garasin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Iwalexin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Keflet | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | keflex | “The patients will be prescribed one week of Cephalosporin Antibiotic (Keflex/Duricef/Other) of their surgeon's choice.” NCT04631185 ↗2“Then continue oral with keflex 1g tablets (cephalexin) twice daily for 7 days.” NCT07032883 ↗ |
| Known as | Kefloridina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Keftab | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | kelfex (cephalexin) | “kelfex (cephalexin)” NCT04194216 ↗ |
| Known as | Kiflone | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Lilly-66873 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | LY-061188 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | LY-66873 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Mamalexin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Novolexin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | NSC-758162 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Oracocin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Panixine disperdose | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Pyassan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | S-6437 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Sinthecillin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Taicelexin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Tenkorex | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Known as | Uphalexin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1727 ↗ |
| Modality | Small molecule | — CHEMBL1727 ↗ |
| Route | Oral | “given by mouth” NCT00352612 ↗ |