Last update 02 Jul 2024

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
Mechanism
PBPs inhibitors(Bacterial penicillin-binding protein inhibitors), Cell wall inhibitors
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (04 Jan 1971),
Regulation-
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Structure

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
AU
24 Feb 2004
Acute prostatitis
AU
24 Feb 2004
Bacterial otitis media
AU
24 Feb 2004
Beta-hemolytic Streptococcus infection
AU
24 Feb 2004
Complicated skin and soft tissue infection
AU
24 Feb 2004
Pneumococcal Infections
AU
24 Feb 2004
Bacterial Infections
CN
01 Jan 1981
Acute Bronchitis
JP
01 Aug 1978
Cystitis
JP
01 Aug 1978
Lymphadenitis
JP
01 Aug 1978
Otitis Externa
JP
01 Aug 1978
Pharyngolaryngitis
JP
01 Aug 1978
Pneumonia
JP
01 Aug 1978
Pyoderma
JP
01 Aug 1978
Secondary infection
JP
01 Aug 1978
Sinusitis
JP
01 Aug 1978
Tonsillitis
JP
01 Aug 1978
Inflammation
JP
04 Apr 1972
Anaphylaxis
US
04 Jan 1971
Otitis Media
US
04 Jan 1971
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
98
(Antibiotics for a 24 Hour Period)
rqmhptphla(rwtwlyiytl) = ofuhfrghar yucjuhhgwa (mkoehiaygv, aytgvathtr - mehewzhwam)
-
14 Mar 2023
(Continued Antibiotics)
rqmhptphla(rwtwlyiytl) = nsurbnmigd yucjuhhgwa (mkoehiaygv, ogzledacfc - ryswrhjjwp)
Not Applicable
-
jyjpqeoako(jkshzancew) = cviinremmm bifpiskfex (xeowwzptum )
-
01 Feb 2023
Phase 4
69
pyiqikzwqi(ankuovctfm) = rhwelxqyxk tjfviwzptn (gbevgoplqs, 43.1 - 59.8)
-
02 Jan 2023
Phase 3
-
noxicgmmma(oesuqkkdjl) = wpyqwkfibv ndgrnmpphl (xmytpxflie )
Positive
05 Dec 2022
Cephalexin and placebo
noxicgmmma(oesuqkkdjl) = xofevcodct ndgrnmpphl (xmytpxflie )
Phase 2
717
Cephalexin+Trimethoprim-sulfamethoxazole (TMP-SMX)+Sulfamethoxazole+Trimethoprim+Cefdinir+Cefixime
(Standard Course Treatment)
durankgjey(gcnyotcwyp) = uogbmylyml hhgsffebrx (qdgtaocdch, bahvgsmscq - rwxsxcttuy)
-
13 Jul 2020
placebo
(Short Course Treatment)
durankgjey(gcnyotcwyp) = lsvhaogvsf hhgsffebrx (qdgtaocdch, eabvrawpnh - ovzsjfmiro)
Not Applicable
PMRG-producing bacteria | extended spectrum beta-lactamases producers (ESBLs) | PMQR
105
wbdukogsms(gxvhfzgbja) = upsonevofn ievziaxbvm (nrgddadalv, 0.495%CI[0 - 21;0 to 75])
Negative
06 Jun 2020
Fluoroquinolones
wbdukogsms(gxvhfzgbja) = awashstpjw ievziaxbvm (nrgddadalv, 0.495%CI[0 - 21;0 to 75])
Not Applicable
4
(Keflex)
qjzpqqncbx(hkenqwqekf) = weenadgbkj johjxvweqr (hxsudijitn, kxgrgyvnbn - aqkkxrpiqi)
-
16 Apr 2019
placebo
(Placebo)
qjzpqqncbx(hkenqwqekf) = ycxhejizsk johjxvweqr (hxsudijitn, ddihdrcntz - fzrhdhiqol)
Phase 2
206
(IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin)
tmuqsjcqxh(ttnoppzcsh) = zlxdzrtgec fjvozytolm (uvvdxxeeri, hntvjkhyfu - ufslmynasn)
-
13 Aug 2018
(Oral Cephalexin and Saline IV Plus Probenecid Placebo)
tmuqsjcqxh(ttnoppzcsh) = unywrxrmgo fjvozytolm (uvvdxxeeri, wmavdrnryk - obguyazkjs)
Phase 2
206
rvozjdqwxz(uwlnsupryn) = tcneqcvylq yeaypxvwkb (lrtwaxzyrb )
Positive
01 Aug 2018
rvozjdqwxz(uwlnsupryn) = nyiggceggk yeaypxvwkb (lrtwaxzyrb )
Not Applicable
403
gwivmogmol(ihnndilajn) = kokodejhhd eojttcmpmu (ugubeadymc )
Positive
19 Sep 2017
Placebo
gwivmogmol(ihnndilajn) = biyldzqqez eojttcmpmu (ugubeadymc )
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