Last update 04 Apr 2025

Levofloxacin

Overview

Basic Info

SummaryLevofloxacin is an effective synthetic antibacterial agent used for treating different types of bacterial infections such as respiratory, urinary tract, skin and soft tissue, and bacterial prostatitis. It belongs to the fluoroquinolones class of antibiotics and prevents the DNA replication process in bacteria, eventually leading to cell death. Levaquin is one of the popular brand names for this drug, available in oral, intravenous, and eye drop forms.Due to its broad-spectrum activity, Levofloxacin is effective against both Gram-positive and Gram-negative bacteria, including those that are resistant to other antibiotics. This feature makes it a valuable option in treating serious infections caused by multidrug-resistant bacteria.Levofloxacin was patented in 1985 and approved by the US Food and Drug Administration by JANSSEN PHARMS in 1996. Since then, it has been widely used and considered as an important therapeutic option in the treatment of different bacterial infections.
Drug Type
Small molecule drug
Synonyms
(-)-Ofloxacin, (S)-Ofloxacin, L-Ofloxacin
+ [136]
Action
inhibitors
Mechanism
Bacterial DNA gyrase inhibitors(Bacterial DNA gyrase inhibitors), Bacterial top IV inhibitors(Bacterial topoisomerase IV inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (20 Dec 1996),
RegulationAccelerated Approval (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC36H42F2N6O9
InChIKeySUIQUYDRLGGZOL-RCWTXCDDSA-N
CAS Registry138199-71-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Otitis Externa
Japan
27 Mar 2023
Otitis Media
Japan
27 Mar 2023
Cystic Fibrosis
European Union
25 Mar 2015
Cystic Fibrosis
Iceland
25 Mar 2015
Cystic Fibrosis
Liechtenstein
25 Mar 2015
Cystic Fibrosis
Norway
25 Mar 2015
Infectious Lung Disorder
European Union
25 Mar 2015
Infectious Lung Disorder
Iceland
25 Mar 2015
Infectious Lung Disorder
Liechtenstein
25 Mar 2015
Infectious Lung Disorder
Norway
25 Mar 2015
Pseudomonas aeruginosa infection
European Union
25 Mar 2015
Pseudomonas aeruginosa infection
Iceland
25 Mar 2015
Pseudomonas aeruginosa infection
Liechtenstein
25 Mar 2015
Pseudomonas aeruginosa infection
Norway
25 Mar 2015
Adnexitis
Japan
27 Oct 2010
Brucellosis, Bovine
Japan
27 Oct 2010
Cholangitis
Japan
27 Oct 2010
Cholecystitis
Japan
27 Oct 2010
Cystitis
Japan
27 Oct 2010
Epididymitis
Japan
27 Oct 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
CataractPhase 3
South Korea
21 Sep 2015
Bacterial prostatitisPhase 3
Germany
01 Mar 2003
Acute otitis mediaPhase 3-01 Nov 2002
Chronic prostatitisPhase 3-01 May 2000
Chronic prostatitisPhase 3-01 May 2000
Healthcare-Associated PneumoniaPhase 3-01 Dec 1997
Skin Diseases, BacterialPhase 3-01 Jan 1997
Skin Diseases, BacterialPhase 3-01 Jan 1997
Soft Tissue InfectionsPhase 3-01 Jan 1997
Soft Tissue InfectionsPhase 3-01 Jan 1997
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
214
Locally-used WHO-approved MDR-TB regimen in Korea
(Control Arm)
uxsybcfpqx = wppqtplixy wrmqyidjme (bvvunrrprn, wjhyuqxnpo - wmcdvqtrld)
-
25 Mar 2025
uxsybcfpqx = jggzhuuczb wrmqyidjme (bvvunrrprn, mjqwmbujll - qkcjejakng)
Phase 3
Tuberculosis, Multidrug-Resistant
tuberculin skin test | immunologic impairment
2,041
xpcweiibdt(oimdutfgoo) = wkxsopjalp utkvzsmcjw (fublpjswdv )
Negative
19 Dec 2024
Placebo
xpcweiibdt(oimdutfgoo) = qawfyrqryk utkvzsmcjw (fublpjswdv )
Not Applicable
-
hdkqanayxw(kghzfrxrry) = igkuatzejb clkgzsofaf (yzvvlwzwmu )
-
07 Dec 2024
Placebo
xjecqxhenj(dxqaektwau) = cghjqmtdhb sljblfqjpv (sgncpccmog )
Not Applicable
-
Levofloxacin, nitazoxanide, doxycycline, and lansoprazole (LNDL)
iswnbjlgyb(uwqtuciaum) = cjxlxcxnfq lgmpdcnury (grixzobddd, 75.73 - 91.27)
-
13 Oct 2024
Moxifloxacin, nitazoxanide, doxycycline, and lansoprazole (MNDL)
iswnbjlgyb(uwqtuciaum) = rjkksqltcc lgmpdcnury (grixzobddd, 73.57 - 90.01)
Phase 1/2
126
(Pre-urodynamic Fosfomycin)
jziefwryzy: Odds Ratio (OR) = 0.8 (95% CI, 0.4 - 1.95), P-Value = 0.660
-
09 Oct 2024
(Pre-urodynamic Levofloxacin)
Not Applicable
510
Prophylactic antibiotics
kyjhdwxyij(fmdgqynptx): OR = 0.21 (95% CI, 0.21 - 1.23), P-Value = 0.51
Negative
20 May 2024
Standard medical therapy
Not Applicable
58
vsrpcmpaxs(xegxdmohuo) = yerncjllza msjngkyego (mnelhdbdyr )
Positive
14 May 2024
Placebo
vsrpcmpaxs(xegxdmohuo) = qsbufeefds msjngkyego (mnelhdbdyr )
Not Applicable
34
Levofloxacin prophylaxis
dfkdvrspxg(dcjpzcspqw) = minimal adverse events were observed (20%) cjhyrubsfk (lmnlcxokxq )
Positive
14 May 2024
No levofloxacin prophylaxis
Phase 3
330
(Aeroquin 240 mg)
jbzbgzculw(ogvazuvyfa) = mstikejceu agqrmevxsn (rqdlwjjfup, gicvrimaee - zfvyiorzhv)
-
30 Apr 2024
Placebo
(Placebo)
jbzbgzculw(ogvazuvyfa) = pjpzoozold agqrmevxsn (rqdlwjjfup, kwjgoblyaf - zetpsqjbah)
Not Applicable
-
dvyaymcyax(voxvvelipc) = evcmmmnsun zdrxvkgoeh (ermhemheqb )
-
09 Apr 2024
dvyaymcyax(voxvvelipc) = bcpfujvtgf zdrxvkgoeh (ermhemheqb )
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