Back to discover
Drug

Levofloxacin

Approved · FDA / EMA
ClassDNA gyrase inhibitorEmerging researchLate-stage developmentRising momentum
Also known as Iquix, Levaquin, Levofloxacin Ophthalmic, Ofloxacin S-(-)-form+8 more

Iquix, Levaquin, Levofloxacin Ophthalmic, Ofloxacin S-(-)-form, Quixin, (-)-Ofloxacin, (S)-Ofloxacin, L-Ofloxacin, Levofloxacine, Levofloxacino, (S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid, Levofloxacinum.

RxNorm82122ChEMBLCHEMBL5315124ATCJ01MA12ATCS01AE05UNII6GNT3Y5LMF
3
Research papers
25
Active clinical trials
4
Protein targets
25
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

The Effect of Levofloxacin Prophylaxis on the First Occurrence of Febrile Neutropenia During Induction Chemotherapy in Pediatric Patients With Acute Lymphoblastic Leukemia at Dr. Sardjito Hospital

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

Rationale of Subcutaneous Levofloxacin Infiltration as an Adjunct for Surgical Site Infection Prevention in Emergency Laparotomy: A Clinical Trial

Clinical trial2026-07-10Results expected Q4 2026 · ClinicalTrials.gov

Prospective, Randomized, Partially Blinded, Phase 2 Study of the Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine for Treatment of Patients With MDR-TB

Clinical trial2026-07-08Results expected Q2 2027 · ClinicalTrials.gov

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Clinical trial2026-07-07Results expected Q4 2026 · ClinicalTrials.gov

Comparison of the Post-operative Infection by Using Different Type Prophylactic Antibiotics in Low Risk Patients Who Underwent Retrograde Intrarenal Surgery

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Label change: LEVOFLOXACIN (ANDA090722)

Regulatory2024-09-20FDA

Label change: LEVOFLOXACIN (ANDA200560)

Regulatory2024-09-20FDA

Label change: LEVOFLOXACIN (ANDA090722)

Regulatory2023-06-21FDA

Ciprofloxacin and levofloxacin attenuate microglia inflammatory response via TLR4/NF-kB pathway.

Research2019-07-18Journal of neuroinflammation

Label change: LEVOFLOXACIN (ANDA090722)

Regulatory2019-05-03FDA

Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors.

Research2007-06-01Journal of cataract and refractive surgery

Risk factors associated with nosocomial methicillin-resistant Staphylococcus aureus (MRSA) infection including previous use of antimicrobials.

Research2002-06-01The Journal of antimicrobial chemotherapy

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Levofloxacin
Aliases & brands
IquixLevaquinLevofloxacin OphthalmicOfloxacin S-(-)-formQuixin(-)-Ofloxacin(S)-OfloxacinL-OfloxacinLevofloxacineLevofloxacino(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acidLevofloxacinum
RxNorm CUI
82122
ChEMBL ID
CHEMBL5315124
ATC codes
J01MA12S01AE05
UNII
6GNT3Y5LMF
Primary mechanism
DNA gyrase inhibitor
Regulatory jurisdictions
fdaemamhra

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

DNA gyrase subunit B
gyrB · P0A4L9
INHIBITORDNA gyrase inhibitor
DNA gyrase subunit A
gyrA · P72524
INHIBITORDNA gyrase inhibitor
DNA topoisomerase 4 subunit A
parC · P72525
INHIBITORTopoisomerase IV inhibitor
DNA topoisomerase 4 subunit B
parE · Q59961
INHIBITORTopoisomerase IV inhibitor

Regulatory timeline

25 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2011-06-20
Latest approval
2015-03-25
Authorities
FDA · EMA · MHRA
Total events
25
fdaU.S. Food and Drug Administration· 23 events
2024-09-20Label change
Label change: LEVOFLOXACIN (ANDA200560)
Evidence ↗
2024-09-20Label change
Label change: LEVOFLOXACIN (ANDA090722)
Evidence ↗
2023-06-21Label change
Label change: LEVOFLOXACIN (ANDA090722)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2015-03-25Approval
Approval: Quinsair (EMA)
Indication: Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis. Consideration should be given to… Show full indication

Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Levofloxacin: some indications restricted
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

177 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
177
registered trials across all phases
LATEST COMPLETION 2025
25
Active studies
21
Recruiting
141
Late-stage (III+)
102
Completed
50
Discontinued
PHASE DISTRIBUTIONn = 177
Early Phase 11Phase 110Phase 1 / 27Phase 218Phase 2 / 310Phase 353Phase 460Phase N / A18

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia: a Non-inferiority, Randomized Controlled Trial.

RecruitingPH IVMedical College of Wisconsinn=2362028

Efficacy and Safety of Vonoprazan High-Dose Dual Therapy Compared to Levofloxacin Concomitant Therapy for H. Pylori Eradication: A Randomized Controlled Trial

Not yet recruitingPH IVDamascus Hospitaln=1502027

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

RecruitingPH IVFundacion Clinic per a la Recerca Biomédican=3602027

Efficacy of Two-week Therapy With Levofloxacin-based Concomitant Regimen Versus Levofloxacin-based Sequential Regimen for Helicobacter Pylori Infection in Syrian Population: a Prospective Single-center Randomized Controlled Trial

Not yet recruitingPH IVDamascus Hospitaln=1502027

The Effect of Levofloxacin Prophylaxis on the First Occurrence of Febrile Neutropenia During Induction Chemotherapy in Pediatric Patients With Acute Lymphoblastic Leukemia at Dr. Sardjito Hospital

Not yet recruitingPH IVGadjah Mada Universityn=1242026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy of Levofloxacin Versus Ciprofloxacin in the Treatment of Childhood Typhoid Fever

CompletedPH IIAvicenna Medical College Lahoren=3602025

Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy

CompletedPH IVRoswell Park Cancer Instituten=892025

Comparison Between Effect of Empirical Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy in Children With Pyuria

CompletedPH II/IIIAin Shams Universityn=1402025

Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients

CompletedPH IIICentre Henri Becquereln=602024

Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus (Relais Oral Dans le Traitement Des Endocardites à Staphylocoques Multi-sensibles)

CompletedPH IIIUniversity Hospital, Toursn=1622024

The Role of Butirprost® as an Adjuvant in Enhancing the Effect of Antibiotics in Patients Affected by Chronic Bacterial Prostatitis: A Randomized Prospective Trial

CompletedPH IIIFederico II Universityn=602024

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20022019
Major research themes3
Antibiotic Prophylaxis1Levofloxacin1Phacoemulsification1
Journals, researchers & institutions
Top journals
  • Journal of cataract and refractive surgery1
  • Journal of neuroinflammation1
  • The Journal of antimicrobial chemotherapy1
Leading researchers
  • Franceschini D1
  • Frigo AC1
  • Giusti P1
  • Graffunder EM1
  • Lo R1
  • Lunardi V1
  • Moro S1
  • Pagetta A1
Leading institutions
free-text, unnormalised
  • Albany Medical Center Hospital1
  • Montreal Neurological Institute1
  • University of Padua1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Ofloxacin

Studied across 5 of the same disease areas as Levofloxacin in the shared literature.

5 shared diseases2 shared papers
Cefuroxime

Studied across 3 of the same disease areas as Levofloxacin in the shared literature.

3 shared diseases1 shared paper
Ciprofloxacin

Studied across the same disease area as Levofloxacin in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.