Cephalexin
Cephalexin, Keftab (cephalexin) is a small molecule pharmaceutical. Cephalexin was first approved as Keflet on 1982-01-01. It is used to treat bacterial infections, bacterial pneumonia, bacterial skin diseases, escherichia coli infections, and haemophilus infections amongst others in the USA.
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Cephalexin (discontinued: Cephalexin, Keflet, Keflex, Keftab, Panixine)
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Abbreviated New Drug Application (ANDA)
Cephalexin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| KEFLET | Eli Lilly | N-050440 DISCN | 1982-01-01 | 3 products |
| KEFLEX | Pragma Pharmaceuticals | N-050405 DISCN | 1982-01-01 | 4 products, RLD |
| KEFLEX | Pragma Pharmaceuticals | N-050406 DISCN | 1982-01-01 | 3 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cephalexin | ANDA | 2025-12-10 |
| keflex | ANDA | 2021-06-18 |
| orapaz | unapproved drug other | 2025-02-11 |
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113 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | 5 | 8 | 6 | 21 |
| Surgical wound infection | D013530 | — | — | 1 | 1 | 1 | 4 | 4 | 11 |
| Communicable diseases | D003141 | — | — | — | 1 | 4 | 2 | 2 | 9 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 2 | — | 5 | 2 | 9 |
| Cellulitis | D002481 | EFO_0003035 | L03.90 | — | 1 | 1 | 2 | 1 | 5 |
| Infectious skin diseases | D012874 | — | — | — | — | 2 | 1 | 1 | 4 |
| Bacterial infections | D001424 | — | A49 | — | — | 1 | 2 | — | 3 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 2 | — | — | 1 | — | 3 |
| Abscess | D000038 | EFO_0003030 | — | — | — | — | 2 | 1 | 3 |
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | 1 | 2 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 1 | — | 3 | 4 |
| Bacterial skin diseases | D017192 | — | — | — | — | 3 | — | — | 3 |
| Skin diseases | D012871 | — | L00-L99 | — | 1 | 1 | — | 1 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | 1 | — | 1 | 2 |
| Nasal obstruction | D015508 | — | — | — | — | 1 | — | — | 1 |
| Nasal surgical procedures | D059747 | — | — | — | — | 1 | — | — | 1 |
| Systolic heart failure | D054143 | EFO_1001207 | I50.20 | — | — | 1 | — | — | 1 |
| Sick sinus syndrome | D012804 | EFO_0004275 | I49.5 | — | — | 1 | — | — | 1 |
| Syncope | D013575 | — | G90.01 | — | — | 1 | — | — | 1 |
| Heart block | D006327 | — | I45.89 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Wound infection | D014946 | — | — | — | 1 | — | — | 1 | 2 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 2 | — | — | — | 2 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 2 | — | — | — | 2 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | — | — | — | 1 |
| Eczema | D004485 | — | L30.9 | — | 1 | — | — | — | 1 |
| Dermatitis | D003872 | — | L30.9 | — | 1 | — | — | — | 1 |
| Genetic skin diseases | D012873 | — | — | — | 1 | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | 1 | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | 1 | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | — | — | — | — | 9 |
| Respiratory tract infections | D012141 | — | J06.9 | 3 | — | — | — | — | 3 |
| Pyomyositis | D052880 | EFO_1001409 | M60.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 3 | 3 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | — | 1 | 1 |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | — | — | — | 1 | 1 |
| Pharyngitis | D010612 | — | R07.0 | — | — | — | — | 1 | 1 |
| Snoring | D012913 | — | R06.83 | — | — | — | — | 1 | 1 |
| Mammaplasty | D016462 | — | — | — | — | — | — | 1 | 1 |
| Dentofacial deformities | D063169 | — | — | — | — | — | — | 1 | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 1 | 1 |
| Nephrolithiasis | D053040 | — | N20.0 | — | — | — | — | 1 | 1 |
| Tympanic membrane perforation | D018058 | — | H72 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cephalexin |
| INN | cefalexin |
| Description | Cefalexin, also spelled cephalexin, is an antibiotic that can treat a number of bacterial infections. It kills gram-positive and some gram-negative bacteria by disrupting the growth of the bacterial cell wall. Cefalexin is a β-lactam antibiotic within the class of first-generation cephalosporins. It works similarly to other agents within this class, including intravenous cefazolin, but can be taken by mouth.
|
| Classification | Small molecule |
| Drug class | First-generation cephalosporin |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1=C(C(=O)O)N2C(=O)[C@@H](NC(=O)[C@H](N)c3ccccc3)[C@H]2SC1.O |
Identifiers
| PDB | — |
| CAS-ID | 23325-78-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200544 |
| ChEBI ID | 3535 |
| PubChem CID | 2666 |
| DrugBank | DB00567 |
| UNII ID | 5SFF1W6677 (ChemIDplus, GSRS) |
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Cephalexin
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Safety
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10,196 adverse events reported
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