Last update 28 Apr 2025

Cephalexin

Overview

Basic Info

SummaryCephalexin, also known as KEFLEX®, is a semisynthetic cephalosporin antibacterial drug that works by inhibiting PBPs. It was first approved in 1971 in the US by Pragma Pharmaceuticals LLC for oral administration. Cephalexin is used to treat various bacterial infections such as respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections. Its molecular formula is C16H17N3O4S•H2O with a molecular weight of 365.41. KEFLEX® capsules are intended for oral administration and contain 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate.
Drug Type
Small molecule drug
Synonyms
Ammonia benzyl cephalosporin, Cafalexin, Cefaiexin
+ [24]
Target
Action
inhibitors
Mechanism
PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), Cell wall inhibitors
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (04 Jan 1971),
Regulation-
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Structure/Sequence

Molecular FormulaC16H19N3O5S
InChIKeyAVGYWQBCYZHHPN-CYJZLJNKSA-N
CAS Registry23325-78-2

External Link

KEGGWikiATCDrug Bank
D00906Cephalexin

R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute bacterial sinusitis
Australia
24 Feb 2004
Acute prostatitis
Australia
24 Feb 2004
Bacterial otitis media
Australia
24 Feb 2004
Beta-hemolytic Streptococcus infection
Australia
24 Feb 2004
Complicated skin and soft tissue infection
Australia
24 Feb 2004
Pneumococcal Infections
Australia
24 Feb 2004
Bacterial Infections
China
01 Jan 1981
Cystitis
Japan
01 Aug 1978
Pneumonia
Japan
01 Aug 1978
Acute Bronchitis
Japan
14 Apr 1972
Complicated skin and skin structure infection
Japan
14 Apr 1972
Dacryocystitis
Japan
14 Apr 1972
Hordeolum
Japan
14 Apr 1972
Jaw inflammation
Japan
14 Apr 1972
Keratitis
Japan
14 Apr 1972
Lymphadenitis
Japan
14 Apr 1972
Lymphangitis
Japan
14 Apr 1972
Mastitis
Japan
14 Apr 1972
Maxillary Sinusitis
Japan
14 Apr 1972
Myositis
Japan
14 Apr 1972
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
nzfwyhigfs(jepwwgzvox) = xyahqojbbv zsrxdovrce (zccjagehii )
-
23 Feb 2024
nzfwyhigfs(jepwwgzvox) = mmobprpvat zsrxdovrce (zccjagehii )
Phase 3
98
(Antibiotics for a 24 Hour Period)
ivnnmaqmwf = tykdoffmvx hbhctnnfqr (hgaklcqdxy, yqqduuikyw - btybboeinc)
-
14 Mar 2023
(Continued Antibiotics)
ivnnmaqmwf = kqbxxspewx hbhctnnfqr (hgaklcqdxy, gkacryrqnc - uqhljlxflv)
Not Applicable
220
Cephalosporins
(Direct GOC challenge)
qjfldaxqoi(wnkmywisnh) = aramrjhnwq dumvmlgevt (zifklgzsrr )
-
01 Feb 2023
Not Applicable
-
pifobobmkf(wkpzildpmv) = riwjhacgot eknnqxsyzc (eskplmbqmw )
-
01 Feb 2023
Phase 4
69
High-dose cephalexin (1000 mg)
xkatbqsagf(ixdqukbfnd) = syxusjtwsi eukpssduth (pspzlwumzi, 43.1 - 59.8)
-
02 Jan 2023
Phase 3
-
nimycjjklc(eugjprbwqr) = jgqlekexsa uvqcenchwi (qnwurcbmym )
Positive
05 Dec 2022
Cephalexin and placebo
nimycjjklc(eugjprbwqr) = crxasbogqc uvqcenchwi (qnwurcbmym )
Phase 2
717
Cephalexin+Trimethoprim-sulfamethoxazole (TMP-SMX)+Sulfamethoxazole+Trimethoprim+Cefdinir+Cefixime
(Standard Course Treatment)
hqvklsdtdv = enfpplyrzf czzlcpbbvv (zohssvntde, tkjmiezdgv - sgwkohtjox)
-
13 Jul 2020
placebo
(Short Course Treatment)
hqvklsdtdv = kfwozwoerd czzlcpbbvv (zohssvntde, hifpsvdfmb - linqyhpmba)
Not Applicable
PMRG-producing bacteria | extended spectrum beta-lactamases producers (ESBLs) | PMQR
105
cvdyzywbrn(jigmcbzdju) = tocstnulsw yniwrfswco (whacoklnrz, 0.495%CI[0 - 21;0 to 75])
Negative
06 Jun 2020
Fluoroquinolones
cvdyzywbrn(jigmcbzdju) = ivomdmsvzb yniwrfswco (whacoklnrz, 0.495%CI[0 - 21;0 to 75])
Not Applicable
4
(Keflex)
ygcadnrqrq(gjpmnepnxr) = ewxakdoplk ivopcabwpx (qlvbygevrr, gslkblxamm - aaidtweapn)
-
16 Apr 2019
placebo
(Placebo)
ygcadnrqrq(gjpmnepnxr) = xxemlvdxhk ivopcabwpx (qlvbygevrr, rmdlmzitgp - oruybpjuxt)
Phase 2
206
(IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin)
uwvwdlrzil = reopsidhwb qdewlbkhnu (mvfjvjyvfu, kffsruzirp - malfhbumlc)
-
13 Aug 2018
(Oral Cephalexin and Saline IV Plus Probenecid Placebo)
uwvwdlrzil = idlawzpjfk qdewlbkhnu (mvfjvjyvfu, phfgmaszdh - zundovxeoh)
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