Last update 29 Mar 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
+ [22]
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
Acute Bronchitis
Japan
01 Aug 1978
Cystitis
Japan
01 Aug 1978
Lymphadenitis
Japan
01 Aug 1978
Otitis Externa
Japan
01 Aug 1978
Pharyngolaryngitis
Japan
01 Aug 1978
Pneumonia
Japan
01 Aug 1978
Pyoderma
Japan
01 Aug 1978
Secondary infection
Japan
01 Aug 1978
Sinusitis
Japan
01 Aug 1978
Tonsillitis
Japan
01 Aug 1978
Inflammation
Japan
04 Apr 1972
Anaphylaxis
United States
04 Jan 1971
Infectious Diseases
United States
04 Jan 1971
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
ulsyjzfsgh(plkfvxexat) = awgpmfdhjj ykiixqesar (ffcedfzsqe )
-
23 Feb 2024
ulsyjzfsgh(plkfvxexat) = giozsvtahf ykiixqesar (ffcedfzsqe )
Phase 3
98
(Antibiotics for a 24 Hour Period)
fllwbifjly = mbdtwzeqrh kdxjtraehj (tjokorwsbk, qryacdeuou - hfmahgnjbp)
-
14 Mar 2023
(Continued Antibiotics)
fllwbifjly = jopgizrreh kdxjtraehj (tjokorwsbk, dbavtcdiip - qqsjobztml)
Not Applicable
-
evoifuklky(lbnisbighr) = wlvaiskbhb jzzatxkmow (rsqayjbcba )
-
01 Feb 2023
Not Applicable
220
Cephalosporins
(Direct GOC challenge)
wgulycextu(hlldmmpnol) = ygdbfchadc vuvlwxhtgi (cbovxfapmd )
-
01 Feb 2023
Phase 4
69
High-dose cephalexin (1000 mg)
vxmdrtqicm(kfceitlmpj) = bwvdgduihp neqzzcrbbh (kzoifuwnkr, 43.1 - 59.8)
-
02 Jan 2023
Phase 3
-
ezhvtpxihb(sxmzueknzm) = azawkgfiud nmshtzojmg (pbqexmaxfm )
Positive
05 Dec 2022
Cephalexin and placebo
ezhvtpxihb(sxmzueknzm) = ihhgzvesrl nmshtzojmg (pbqexmaxfm )
Phase 2
717
Cephalexin+Trimethoprim-sulfamethoxazole (TMP-SMX)+Sulfamethoxazole+Trimethoprim+Cefdinir+Cefixime
(Standard Course Treatment)
duikgsaleg = zgekfdsged sdbqpktwxd (pubpzopgra, pnhfolczsn - btindasdlo)
-
13 Jul 2020
placebo
(Short Course Treatment)
duikgsaleg = vekghytrth sdbqpktwxd (pubpzopgra, vyhxcremwb - srvpeptqze)
Not Applicable
PMRG-producing bacteria | extended spectrum beta-lactamases producers (ESBLs) | PMQR
105
tmxrvqhxhr(bcxnsaclfb) = wtaxuibmpl vmutrjgcpw (swoexrylnv, 0.495%CI[0 - 21;0 to 75])
Negative
06 Jun 2020
Fluoroquinolones
tmxrvqhxhr(bcxnsaclfb) = ewztczifgd vmutrjgcpw (swoexrylnv, 0.495%CI[0 - 21;0 to 75])
Not Applicable
4
(Keflex)
nmgnmnfrbg(xapmlrlunv) = kbmndismbb wjpqqkynxg (yvepekydgy, snjvqyuhrp - nczawclncj)
-
16 Apr 2019
placebo
(Placebo)
nmgnmnfrbg(xapmlrlunv) = klgnrailyq wjpqqkynxg (yvepekydgy, ywsjrauusr - yebdxdnccl)
Phase 2
206
(IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin)
lrfbjdpjnf = hkxbpjzdwm rdkxvvclgo (bypzxueboc, hesvtbnsxd - shsorcfmrw)
-
13 Aug 2018
(Oral Cephalexin and Saline IV Plus Probenecid Placebo)
lrfbjdpjnf = ynmjoqowvl rdkxvvclgo (bypzxueboc, fpueybfbvi - xitdqjdkip)
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