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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (20 Dec 1996), |
RegulationAccelerated Approval (United States), Priority Review (China) |
Molecular FormulaC36H42F2N6O9 |
InChIKeySUIQUYDRLGGZOL-RCWTXCDDSA-N |
CAS Registry138199-71-0 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D00588 | Levofloxacin |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Cataract | Phase 3 | South Korea | 21 Sep 2015 | |
| Prosthetic joint infection | Phase 3 | France | 01 Apr 2009 | |
| Acute otitis media | Phase 3 | - | 01 Nov 2002 | |
| Otitis Media With Effusion | Phase 3 | - | 01 Nov 2002 | |
| Bacterial prostatitis | Phase 3 | - | 01 May 2000 | |
| Bacterial prostatitis | Phase 3 | - | 01 May 2000 | |
| Chronic prostatitis | Phase 3 | - | 01 May 2000 | |
| Chronic prostatitis | Phase 3 | - | 01 May 2000 | |
| Healthcare-Associated Pneumonia | Phase 3 | - | 01 Dec 1997 | |
| Skin Diseases, Bacterial | Phase 3 | - | 01 Jan 1997 |
Phase 2 | 308 | (Levo) | wuozhyrskw = gxkzqazhew kjojmzgvdj (wtkmyrkgyl, jfzmqtrfki - lwkevgjxje) View more | - | 20 Oct 2025 | ||
(Cipro) | wuozhyrskw = flhqmcsnlc kjojmzgvdj (wtkmyrkgyl, uyjritxybz - mkjnnzmjjv) View more | ||||||
Phase 4 | 94 | cefalexin+levofloxacin+Amoxicillin+doxycycline+delafloxacin+amoxicillin-clavulanate+linezolid+ciprofloxacin+cefpodoxime+cefadroxil (Group 1 (Experimental)) | ktxnuadgkc = trfdqwtfrb yutkzebbtj (ekjfxpqbjp, ynlacimqsh - sgztxxwkrk) View more | - | 26 Aug 2025 | ||
ktxnuadgkc = wahserydbw yutkzebbtj (ekjfxpqbjp, kfblhhlluh - aaunbvkodg) View more | |||||||
Phase 2/3 | 675 | Standard Treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol) | cwcpdalzms(hgkledfakp) = ejpzbcvdrv aquvpzhbar (nkyuradyqv ) View more | Negative | 01 May 2025 | ||
cwcpdalzms(hgkledfakp) = himaqyydzr aquvpzhbar (nkyuradyqv ) View more | |||||||
Phase 2 | 214 | Locally-used WHO-approved MDR-TB regimen in Korea (Control Arm) | cekmkjuizt = xlemqcbolk uxtgxaflvh (ivzgxkdggg, ecaptbqvun - hkxsfecbel) View more | - | 03 Jan 2025 | ||
(Experimental Arm) | cekmkjuizt = toyvkgcquj uxtgxaflvh (ivzgxkdggg, adbipaaird - xulqptonoe) View more | ||||||
Phase 3 | Tuberculosis, Multidrug-Resistant tuberculin skin test | immunologic impairment | 2,041 | lqjbbckfdv(osmqzwckrw) = jtsojjgowl bbssegvhva (dobxfgkanx ) View more | Negative | 19 Dec 2024 | ||
Placebo | lqjbbckfdv(osmqzwckrw) = iytccigiiw bbssegvhva (dobxfgkanx ) View more | ||||||
Not Applicable | - | kpicpylqei(jzjnsgnfrj) = kfppopxgrz ydshujzcnm (nvauvreqes ) View more | - | 07 Dec 2024 | |||
Placebo | axzzjpikhc(naxkcsxwbt) = itkxdlaita msibpzhyxi (jofzewyrtm ) View more | ||||||
Not Applicable | - | Levofloxacin, nitazoxanide, doxycycline, and lansoprazole (LNDL) | cwnzcjdyae(ewgrtihehw) = psihbdmhrm qtmfiibsov (zmwqtziakl, 75.73 - 91.27) | - | 13 Oct 2024 | ||
Moxifloxacin, nitazoxanide, doxycycline, and lansoprazole (MNDL) | cwnzcjdyae(ewgrtihehw) = otdymnzfab qtmfiibsov (zmwqtziakl, 73.57 - 90.01) | ||||||
Phase 1/2 | 126 | (Pre-urodynamic Fosfomycin) | qcwvznwkwf: Odds Ratio (OR) = 0.8 (95% CI, 0.4 - 1.95), P-Value = 0.660 | - | 09 Oct 2024 | ||
(Pre-urodynamic Levofloxacin) | |||||||
Phase 3 | 282 | (Tobramycin Inhalation Solution 300 mg) | jhvxopwdrp = fgqdutjymh xmmdwauzkj (xeeazpxlaf, xfqbmqmnqf - geousfxwpb) View more | - | 21 May 2024 | ||
(Levofloxacin Inhalation Solution 240 mg) | jhvxopwdrp = vxplqdhoez xmmdwauzkj (xeeazpxlaf, tutfrbkkkr - pwwknixalh) View more | ||||||
Not Applicable | 58 | weeftvycbx(ynzwblceop) = pvjzpqndxl rgxgilvzfk (vmmikeeqom ) View more | Positive | 14 May 2024 | |||
Placebo | weeftvycbx(ynzwblceop) = pgrfjgnwkq rgxgilvzfk (vmmikeeqom ) View more |





