Levaquin

(Levofloxacin)

ApprovedSmall molecule

Levofloxacin is an antibiotic used to treat bacterial infections such as pneumonia, urinary tract infections, and skin infections. It works by killing bacteria that cause these infections.[2] Levaquin is currently approved and in use across 72 indications[4].[1]

Levaquin is one of 973 small molecule programs targeting Cellulitis. It is currently in Approved.

Indications

175

Total Trials

Active Trials

972

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

CellulitisApproved

Corneal UlcerActive, not recruiting

HIV InfectionActive, not recruiting

Bacterial DiseaseActive, not recruiting

DyspepsiaActive, not recruiting

AllergyActive, not recruiting

Respiratory System DiseaseActive, not recruiting

Respiratory Tract InfectionActive, not recruiting

Paratyphoid FeverActive, not recruiting

Pelvic Inflammatory DiseaseApproved

CellulitisApproved

Approved

Corneal UlcerApproved

Active, not recruiting

HIV InfectionPhase 1

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

DyspepsiaPreclinical

Active, not recruiting

AllergyApproved

Active, not recruiting

Respiratory System DiseaseApproved

Active, not recruiting

Respiratory Tract InfectionApproved

Active, not recruiting

Paratyphoid FeverApproved

Active, not recruiting

Pelvic Inflammatory DiseaseApproved

Approved

Showing 10 of 71 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Levaquin

WWim Janssens

Approved

1 2

Velban

EEastern Cooperative Oncology Group

Preclinical

15 3

Oncaspar

SServier

Preclinical

15 4

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—5

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—6

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

1 8

PEG-Intron

Merck & Co.

Preclinical

1 9

CAR-T

HHebei Senlang Biotechnology Inc., Ltd.

Preclinical

3 10

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalNot yet recruiting

Neutropenia

NCT07320534

Q4 2026

PreclinicalNot yet recruiting

Surgical Site Infection (SSI)

NCT07696819

Phase 3Active, not recruiting

Tuberculosis

NCT06081361

Q2 2027

Phase 2Active, not recruiting

Tuberculosis, Multidrug-Resistant

NCT03828201

Post-ApprovalNot yet recruiting

TIA

NCT06065267

Phase 3Active, not recruiting

Tuberculosis

NCT06649721

Clinical

Trials by Indication[1]

Urinary Tract Infection14 trials

Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections

Completed·TTetraphase Pharmaceuticals, Inc·Phase 3·NCT01978938·908 enrolled

Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

Completed·RRoswell Park Cancer Institute·Phase 4·NCT04502095·89 enrolled

Clinical Study of Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection

Unknown status·CChina Academy of Chinese Medical Sciences·Phase 4·NCT03658291·252 enrolled

Show 11 more trials

A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)

Completed·AAchaogen, Inc.·Phase 2·NCT01096849·145 enrolled

Urinary Tract Infection Study With the Antibiotic Levofloxacin Given at a Higher Dose Over a Shorter Period of Time

Terminated·UUniversity of Manitoba·Phase 4·NCT00245791·30 enrolled

Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections

Unknown status·—·Phase 4·NCT03160807·214 enrolled

A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00258089·578 enrolled

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Participants With Complicated Urinary Tract Infections

Completed·TTetraphase Pharmaceuticals, Inc·Phase 3·NCT03032510·1,205 enrolled

A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00210886·1,109 enrolled

A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)

Completed·AAchaogen, Inc.·Phase 3·NCT02486627·609 enrolled

A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Uncomplicated Lower Urinary Tract Infection With Levofloxacin Hydrochloride Tablet as Active Control

Completed·LLee's Pharmaceutical Limited·Phase 3·NCT02439632·216 enrolled

The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females

Unknown status·—·Phase 4·NCT02094703·126 enrolled

Study Comparing the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01345929·558 enrolled

A Study of the Safety and Effectiveness of Levofloxacin Compared With Lomefloxacin in the Treatment of Complicated Urinary Tract Infections

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00258102·603 enrolled

Pneumonia12 trials

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients

Completed· Pfizer logo

Pfizer·Phase 3·NCT00643734·468 enrolled

Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia

Completed· Pfizer logo

Pfizer·Phase 3·NCT00081575·434 enrolled

Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors

Unknown status·—·Phase 4·NCT00752947·186 enrolled

Show 9 more trials

Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia

Terminated·IIASO Pharma Inc.·Phase 2·NCT01081964·48 enrolled

A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00034736·691 enrolled

Study to Demonstrate the Clinical Efficacy of Levofloxacin in the Treatment of Pneumonia

Completed· Sanofi logo

Sanofi·Phase 3·NCT00253955·460 enrolled

A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236821·530 enrolled

Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia

Completed· Pfizer logo

Pfizer·Phase 4·NCT00035347·219 enrolled

A Study of the Safety and Effectiveness of Levofloxacin Compared With Ceftriaxone Sodium or Cefuroxime Axetil in the Treatment of Adults With Pneumonia

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2/3·NCT00257049·604 enrolled

Clinical Pathway Based on Procalcitonin Levels for the Management of Community-acquired Pneumonia in Outpatients

Unknown status·FFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana·Phase 4·NCT02600806·500 enrolled

Local Antibiotic Delivery for Community Acquired Pneumonia

Not yet recruiting·CCopenhagen Respiratory Research·Phase 2/3·NCT06859450·36 enrolled

Avelox for Treatment of Elderly Patients With Community Acquired Pneumonia

Completed· Bayer logo

Bayer·Phase 4·NCT00665327·401 enrolled

Tuberculosis8 trials

Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis

Completed·UUniversity College, London·Phase 2/3·NCT03474198·675 enrolled

An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis

Completed·UUniversity of Cape Town·Phase 2/3·NCT02454205·154 enrolled

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

Active, not recruiting·HHuashan Hospital·Phase 3·NCT06649721·120 enrolled

Show 5 more trials

The Treatment of Tuberculosis in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001033·650 enrolled

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort

Active, not recruiting·—·Phase 3·NCT06081361·186 enrolled

Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis

Active, not recruiting·UUniversity of Cape Town·Phase 3·NCT04951986·732 enrolled

Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care

Completed·WWits Health Consortium (Pty) Ltd·Phase 3·NCT04062201·402 enrolled

The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

Completed·IIUATLD, Inc·Phase 3·NCT02409290·588 enrolled

Helicobacter Pylori5 trials

Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02935010·382 enrolled

Tailored Therapy for Helicobacter Pylori Rescue Treatment

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03413020·200 enrolled

Comparing Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinadizole on Treatment Helicobacter Pylori

Completed·—·Phase 4·NCT04348786·78 enrolled

Show 2 more trials

Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Unknown status·YYanqing Li·Phase 4·NCT03139253·120 enrolled

Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori

Unknown status·SSherief Abd-Elsalam·Phase 3·NCT02422706·120 enrolled

Pulmonary Tuberculosis5 trials

Early Bactericidal Activity of Linezolid, Gatifloxacin, Levofloxacin, Isoniazid (INH) and Moxifloxacin in HIV Negative Adults With Initial Episodes of Sputum Smear-Positive Pulmonary Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00396084·70 enrolled

MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis

Completed· Sanofi logo

Sanofi·Phase 4·NCT00495339·100 enrolled

A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRTB) in HIV-Infected Patients.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000796·525 enrolled

Show 2 more trials

A Pilot Study of Methodology to Rapidly Evaluate Drugs for Bactericidal Activity, Tolerance, and Pharmacokinetics in the Treatment of Pulmonary Tuberculosis Using Isoniazid and Levofloxacin

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000778·44 enrolled

Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis

Unknown status·—·Phase 4·NCT02901288·3,900 enrolled

78 more indications

Helicobacter Pylori Infection5 trials

Levoﬂoxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01742429·200 enrolled

Comparison of Two Treatment Regimens of Helicobacter Pylori Infection

Not yet recruiting·RRehman Medical Institute - RMI·Phase 4·NCT07021729·156 enrolled

Intraluminal Mono-antibiotic Therapy for Helicobacter Pylori Infection - A Comparison of Levofloxacin Powder and Levofloxacin Solution

Completed·MMackay Memorial Hospital·Phase 4·NCT03832465·20 enrolled

Show 2 more trials

Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

Unknown status·UUniversity of Bari·Phase 3·NCT04107194·362 enrolled

Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT05250050·388 enrolled

Chronic Bronchitis4 trials

A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Exacerbations of Chronic Bronchitis With Levofloxacin Hydrochloride Tablet as Active Control

Unknown status·LLee's Pharmaceutical Limited·Phase 3·NCT02157571·360 enrolled

A Study of the Safety and Effectiveness of Levofloxacin Compared With Cefaclor in the Treatment of Adults With Chronic Bronchitis Experiencing Rapid Onset of Worsening of Symptoms Caused by Bacteria

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2/3·NCT00257140·367 enrolled

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis

Completed· Pfizer logo

Pfizer·Phase 3·NCT00644449·551 enrolled

Show 1 more trial

Ceftidoren Versus Levofloxacin in the Treatment of Patients With Acute Exacerbations of Chronic Bronchitis (AECB)

Completed·UUniversity of Milan·Phase 4·NCT01467297·40 enrolled

Antibiotics4 trials

Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome

Recruiting·—·Phase 1·NCT05302531·10 enrolled

Healthy Patients & Effect of Antibiotics

Completed·WWashington University School of Medicine·N/A·NCT03098485·20 enrolled

Early Antibiotics After Aspiration in ICU Patients

Terminated·UUConn Health·Phase 4·NCT05079620·5 enrolled

Show 1 more trial

The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy

Unknown status·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 1·NCT02789579·150 enrolled

Effectiveness4 trials

A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Mild to Moderate Infections of the Skin and the Supportive Layers Beneath the Skin

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2/3·NCT00257036·431 enrolled

A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Uncomplicated Infections of the Skin and the Supportive Layers Beneath the Skin

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00257062·361 enrolled

A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00249210·614 enrolled

Show 1 more trial

Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention

Completed·IIndonesia University·Phase 1/2·NCT06017479·126 enrolled

Safety and Efficacy4 trials

Safety and Efficacy Study of the Treatment of Kidney Infections With Short Course Levofloxacin

Terminated·UUniversity of Manitoba·Phase 4·NCT00239161·30 enrolled

Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer

Completed·IInnocoll·Phase 2·NCT00593567·70 enrolled

A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236652·18 enrolled

Show 1 more trial

Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS)

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT03697993·62 enrolled

Prostatitis4 trials

The Role of Butirprost® in Combination With Antibiotics in Chronic Bacterial Prostatitis (CBP) Treatment

Completed·FFederico II University·Phase 3·NCT06684626·60 enrolled

Prulifloxacin in Chronic Bacterial Prostatitis (CBP)

Completed·AAziende Chimiche Riunite Angelini Francesco S.p.A·Phase 2·NCT03201796·168 enrolled

A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236808·383 enrolled

Show 1 more trial

Levofloxacin, Chronic Bacterial Prostatitis

Completed· Sanofi logo

Sanofi·Phase 3·NCT00277511·120 enrolled

Ischemic stroke3 trials

Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

Recruiting·YYi Yang·N/A·NCT05799326·100 enrolled

Safety and Efficacy Study of Levofloxacin Combined With Endovascular Thrombectomy for Acute Ischemic Stroke

Not yet recruiting·YYi Yang·N/A·NCT05743101·80 enrolled

Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

Recruiting·YYi Yang·N/A·NCT05741905·100 enrolled

H Pylori Infection3 trials

Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection

Unknown status·NNational Institute of Public Health, Slovenia··NCT06216639·2,000 enrolled

Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03555526·320 enrolled

Comparison of Omeprazole vs Vonoprazon in Treatment of H Pylori Infection

Not yet recruiting·RRehman Medical Institute - RMI·Phase 4·NCT07040839·128 enrolled

Efficacy and Safety3 trials

Study to Evaluate the Efficacy and Safety of Oral Administration With Nemonoxacin and Levofloxacin in Patients With CAP

Completed·TTaiGen Biotechnology Co., Ltd.·Phase 3·NCT01529476·540 enrolled

A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP

Completed·TTaiGen Biotechnology Co., Ltd.·Phase 3·NCT02205112·598 enrolled

Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB

Completed·—·Phase 2·NCT01918397·111 enrolled

Helicobacter Pylori Eradication3 trials

Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia

Completed·KKing Faisal Specialist Hospital & Research Center·N/A·NCT02884713·55 enrolled

Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication

Completed·DDeva Holding A.S.·Phase 3·NCT01131026·60 enrolled

Helicobacter Pylori Eradication and Follow-up

Recruiting·SShanghai Zhongshan Hospital·Phase 4·NCT05061732·4,447 enrolled

Cataract3 trials

Safety Profile Comparison of Undiluted Intracameral Moxifloxacin vs. Levofloxacin in Cataract Surgery

Completed·IIndonesia University·Phase 1·NCT05741632·68 enrolled

A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms

Completed· AbbVie logo

AbbVie·Phase 4·NCT02028754·180 enrolled

Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery

Completed·NNTC srl·Phase 2·NCT03740659·125 enrolled

Efficacy3 trials

Efficacy and Tolerability of Delamanid, Linezolid, Pyrazinamide and Levofloxacin

Withdrawn·—·Phase 3·NCT02975570

Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori

Withdrawn·—·Phase 4·NCT03021590

Comparison Efficacy of 14-day Triple Therapy: Clarithromycin vs. Levofloxacin on Eradication of H. Pylori

Unknown status·—·Phase 4·NCT02693574·74 enrolled

Antibiotic3 trials

Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT05023577·504 enrolled

Short Compared With Standard Duration of Antibiotic Treatment for AECOPD

Completed·UUniversity of Monastir·Phase 2·NCT03698682·310 enrolled

Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP

Recruiting·MMedical College of Wisconsin·Phase 4·NCT06494072·236 enrolled

Tics3 trials

Population Pharmacokinetics and Pharmacodynamics Modeling to Optimize Dosage Regimen of Levofloxacin

Completed·PPrince of Songkla University·Phase 2·NCT02699658·45 enrolled

Evaluation of Pharmacokinetics Profiles and Bactericidal Activity of Zabofloxacin

Completed·DDong Wha Pharmaceutical Co. Ltd.·Phase 1·NCT02212795·18 enrolled

The Pharmacokinetics of Topical Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%

Unknown status·NNational University of Malaysia·Phase 1/2·NCT04214821·128 enrolled

Sinusitis2 trials

A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236522·784 enrolled

Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis

Completed·AAbbott·Phase 4·NCT00645073·271 enrolled

Neutropenia2 trials

Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia

Unknown status·JJonsson Comprehensive Cancer Center·Phase 3·NCT00020865

Levofloxacin Prophylaxis to Prevent First Febrile Neutropenia in Pediatric ALL During Induction Phase

Not yet recruiting·GGadjah Mada University·Phase 4·NCT07320534·124 enrolled

Bacterial Pneumonia2 trials

Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia

Completed·—·Phase 4·NCT01524302·12 enrolled

Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

Completed·MMelinta Therapeutics, Inc.·Phase 2·NCT01168713·132 enrolled

Inflammation2 trials

A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00044473·206 enrolled

Short Antibiotic Treatment Versus Duration Guided by Markers of Inflammation in the Treatment of AECOPD

Completed·UUniversity of Monastir·Phase 3·NCT02067780·310 enrolled

Prophylaxis2 trials

Phase 3 Multicenter Randomized Double Blind Placebo Controlled Study With Antibacterial Prophylaxis in Azacitidine Treated MDS Patients

Completed·SSheba Medical Center·Phase 3·NCT02981615·67 enrolled

Efficiency of Antibacterial Prophylaxis in Azacitidine Treated Patients

Completed·CCentre Henri Becquerel·Phase 3·NCT03594149·60 enrolled

Antibiotic Prophylaxis2 trials

Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy

Unknown status·MMansoura University·N/A·NCT03178292·300 enrolled

Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)

Completed·JJessa Hospital·N/A·NCT04212403·1,350 enrolled

Double-blind2 trials

TNF-alpha Antagonists for AECOPD: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

Completed·OOttawa Hospital Research Institute·Phase 2/3·NCT00789997·81 enrolled

A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults

Completed· Pfizer logo

Pfizer·Phase 3·NCT00643409·541 enrolled

Treatment2 trials

BK Treatment Study

Completed·—·Phase 4·NCT01034176·43 enrolled

Treatment Shortening of MDR-TB Using Existing and New Drugs

Completed·SSeoul National University Hospital·Phase 2·NCT02619994·214 enrolled

Chronic Rhinosinusitis2 trials

Topical Antibiotics in Chronic Rhinosinusitis

Completed·MMayo Clinic·Phase 1/2·NCT03673956·19 enrolled

Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations

Completed·UUniversity of Rochester·Phase 3·NCT01988779·33 enrolled

Endocarditis2 trials

Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus

Completed·UUniversity Hospital, Tours·Phase 3·NCT02701608·162 enrolled

Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis

Recruiting·FFundacion Clinic per a la Recerca Biomédica·Approved·NCT05398679·360 enrolled

First-line Treatment2 trials

Helicobacter Pylori First-line Treatment in Patients Allergic to Penicillin

Unknown status·SShandong University·Phase 4·NCT04122287·250 enrolled

Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin

Unknown status·SShandong University·Phase 4·NCT05129176·106 enrolled

Liver Transplant1 trial

"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients".

Terminated·FFundación Pública Andaluza para la gestión de la Investigación en Sevilla·Phase 3·NCT01761201·68 enrolled

Allogeneic Stem Cell Transplantation1 trial

Trial of Levofloxacin as Prophylaxis After Allogeneic Stem Cell Transplantation (SCT)

Unknown status·—·Phase 2/3·NCT00215007

Drug-Resistant Tuberculosis1 trial

A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis

Not yet recruiting·WWuhan Pulmonary Hospital·N/A·NCT07126639·200 enrolled

Acute Leukemia1 trial

Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation

Completed·CChildren's Oncology Group·Phase 3·NCT01371656·624 enrolled

RR-TB1 trial

6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province

Not yet recruiting·WWuhan Pulmonary Hospital·N/A·NCT07198685·52 enrolled

Drug1 trial

Evaluating Newly Approved Drugs for Multidrug-resistant TB

Completed·MMédecins Sans Frontières, France·Phase 3·NCT02754765·754 enrolled

Pulmonary Sarcoidosis1 trial

Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis

Completed·VVanderbilt University·Phase 2·NCT02024555·97 enrolled

Stem Cell Transplantation1 trial

Corneal Epithelium Repair and Therapy Using Autologous Limbal Stem Cell Transplantation

Unknown status·SSun Yat-sen University·Phase 1/2·NCT02148016·30 enrolled

Meropenem1 trial

Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP

Completed·MMelinta Therapeutics, Inc.·Phase 3·NCT02166476·550 enrolled

COPD Exacerbation1 trial

A Study Comparing Doxycycline and Levofloxacin for Treating COPD Exacerbations

Not yet recruiting·AAmina Aslam·N/A·NCT06915688·188 enrolled

Chronic Prostatitis1 trial

An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00402688·242 enrolled

Pneumococcal Pneumonia1 trial

Ceftriaxone Vs Levofloxacin on Cytokine Expression in Pneumococcal Pneumonia

Terminated·HHospital Mutua de Terrassa·Phase 4·NCT00429975·45 enrolled

TIA1 trial

Levofloxacin Concomitant Versus Levofloxacin Sequential

Not yet recruiting·—·Phase 4·NCT06065267·150 enrolled

Function1 trial

A Study to Evaluate the Pharmacokinetics and Safety of Levofloxacin in Patients With Varying Degrees of Renal Function.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT00645437·59 enrolled

Kidney Transplant1 trial

Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study

Completed·OOttawa Hospital Research Institute·Phase 4·NCT01353339·154 enrolled

Skin Infection1 trial

A Study of the Safety and Effectiveness of Levofloxacin Compared to Ticarcillin/Clavulanate Alone or Followed by Amoxicillin/Clavulanate in the Treatment of Complicated Skin Infections

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00249197·413 enrolled

Stenotrophomonas Maltophilia Infection1 trial

Trimethoprim-Sulfamethoxazole vs Levofloxacin as Targeted Therapy for Stenotrophomonas Maltophilia Infections: a Retrospective Cohort Study

Completed·NNational Institutes of Health Clinical Center (CC)··NCT04639817·1,621 enrolled

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 enrolled

Retrograde Intrarenal Surgery1 trial

Retrograde Intrarenal Surgery Low Risk Trial

Enrolling by invitation·NNational Taiwan University Hospital·Phase 4·NCT06741917·200 enrolled

Ciprofloxacin1 trial

Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia

Completed·—·Phase 4·NCT04456712·200 enrolled

Prostate1 trial

Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA)

Completed· GSK logo

GSK·Phase 3·NCT00169585·240 enrolled

Dyspepsia1 trial

Melatonin Supplementation in Postmenopausal Women With H. Pylori-associated Dyspepsia

Completed·MMedical University of Lodz·N/A·NCT04352062·152 enrolled

Oral Mucositis1 trial

Effects of CKI for Oral Mucositis Caused by Radiotherapy for Head and Neck Cancer

Unknown status·SShanxi Zhendong Pharmacy Co., Ltd·Phase 4·NCT04204382·144 enrolled

Laparoscopic1 trial

D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy

Not yet recruiting·GGeneral Committee of Teaching Hospitals and Institutes, Egypt·N/A·NCT06049758·80 enrolled

Intraoperative1 trial

Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin

Completed·PPeregrine Eye and Laser Institute·Phase 4·NCT04403334·114 enrolled

Oral1 trial

A Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT00601432·24 enrolled

Fluoroquinolone1 trial

Penetrance of Third Generation Fluoroquinolones in Eyes With Functioning Filtering Blebs

Completed·IIndiana University School of Medicine·Phase 4·NCT00392275·48 enrolled

Hematological Malignancies1 trial

Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies

Completed·AAzienda Ospedaliero, Universitaria Pisana·Phase 2·NCT03159845·20 enrolled

Resistance1 trial

Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.

Unknown status·—·Phase 4·NCT04090021·304 enrolled

Sepsis1 trial

Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy

Unknown status·DDiaa Eldin Taha Ramadan Mohamed·N/A·NCT04374188·200 enrolled

Lymphoid Malignancies1 trial

Study: Treatment of Relapsed Lymphoid Malignancies With an Anti-Angiogenic Approach

Terminated·NNew Mexico Cancer Research Alliance·Phase 2·NCT00250718·17 enrolled

Infection1 trial

Fast-track Blood Test for Suspected Fever by Deficiency of a Kind of White Blood Cells As Main Defense Against Infection

Unknown status·TThe University of Hong Kong·Phase 4·NCT05393505·344 enrolled

Peptic Ulcer Disease1 trial

Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT04432233·60 enrolled

Bacteremia1 trial

Efficacy of a Short-term Sequential Therapy in Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.

Terminated·FFundación Pública Andaluza Progreso y Salud·Phase 3·NCT01875263·1 enrolled

Completed·—·N/A·NCT00136344·35,000 enrolled

Typhoid Fever1 trial

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

Completed·—·Phase 2·NCT07150065·360 enrolled

Mycoplasma pneumoniae pneumonia1 trial

Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

Unknown status·SSeoul National University Hospital·Phase 4·NCT02618057·80 enrolled

Multidrug-Resistant Tuberculosis1 trial

A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China

Unknown status·—·Phase 4·NCT05306223·212 enrolled

Pyelonephritis1 trial

IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

Completed·PParatek Pharmaceuticals Inc·Phase 2·NCT03757234·201 enrolled

Bronchitis1 trial

A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Cefuroxime Axetil in the Treatment of Adults With Persistent Bronchitis Experiencing Rapid Onset of Severe Worsening of Symptoms Caused by Bacteria

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00269932·485 enrolled

Cholangitis1 trial

Antibiotics to Decrease Post ERCP Cholangitis

Unknown status·UUniversity of Southern California·Phase 4·NCT03087656·200 enrolled

HIV1 trial

Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB

Not yet recruiting·JJohns Hopkins University·Phase 2/3·NCT06568484·2,530 enrolled

Prostate Cancer1 trial

Efficiency Study of Aspirin to Prevent the Occurrence of Prostate Cancer

Unknown status·WWest China Hospital·Phase 4·NCT02757365·100 enrolled

Brain Injury1 trial

Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy

Terminated·ZZeng Changhao·N/A·NCT06199778·104 enrolled

Stem Cell Transplant1 trial

Ciprofloxacin Versus Levofloxacin in Stem Cell Transplant

Completed·HHenry Ford Health System·Phase 2·NCT03850379·308 enrolled

HIV infection1 trial

A Double-Blind Study to Evaluate the Safety and Pharmacokinetics of L-Ofloxacin (RWJ 25213) in Subjects With HIV Infection

Completed·—·Phase 1·NCT00002249

Intensive Care Unit1 trial

Pharmacokinetics of Levofloxacin in Intensive Care Unit

Completed·UUniversity Hospital, Toulouse·Phase 4·NCT02018081·52 enrolled

Surgical Site Infection (SSI)1 trial

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

Not yet recruiting·SSylhet M.A.G.Osmani Medical College·Preclinical·NCT07696819·90 enrolled

Tuberculosis, Multidrug-Resistant1 trial

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

Active, not recruiting·BBoston University·Phase 2·NCT03828201·271 enrolled

Myeldysplastic Syndrome (MDS)1 trial

Evaluation of Antibiotic Prophylaxis Among Outpatients With Myelodysplastic Syndrome and Acute Myeloid Leukemia: a Multicenter Pilot Trial

Not yet recruiting·UUniversity of Manitoba·Phase 2·NCT07528417·75 enrolled

Unspecified8 trials

Enteroaggregative E.Coli (EAEC)

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00362869·5 enrolled

LOAD VS Levofloxacine Concomitant

Unknown status·—·Phase 4·NCT04626193·80 enrolled

The Clinical Safety of Levofloxacin 1.5% vs Topical Moxifloxacin 0.5%

Unknown status·NNational University of Malaysia·Phase 1/2·NCT04212429·128 enrolled

Show 5 more trials

Intracameral Levofloxacin (0.5%) vs Intracameral Cefuroxime

Unknown status·NNational University of Malaysia·Phase 1/2·NCT04212078·138 enrolled

Bioequivalence Study of Levomerc 500 mg Tablets

Completed·UUniversity of Karachi·Phase 1·NCT05339295·24 enrolled

Study of Levofloxacin-based Concomitant Therapy for H. Pylori Eradication in Diabetic Patients

Completed·CChung-Tai Wu·Phase 4·NCT02466919·114 enrolled

A Two Week Nitazoxanidebased Quadruple Regimen

Unknown status·TTanta University·Phase 3·NCT02621359·100 enrolled

Levofloxacin in Bacterial Rhinosinussitis

Completed·—··NCT02712502·100 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 20, 1996

LEVAQUIN

NDA NDA020635

Dec 20, 1996

LEVAQUIN

NDA NDA020634

Aug 18, 2000

QUIXIN

NDA NDA021199

Mar 1, 2004

IQUIX

NDA NDA021571

Oct 21, 2004

LEVAQUIN

NDA NDA021721

Sources

References

[1]
ClinicalTrials.gov — 175 trial records for Levofloxacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Levaquin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Levofloxacin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Levofloxacin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021721). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA Gyrase Inhibitor; Topoisomerase IV Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWim Janssens

Levaquin

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Trials by Indication[1]

Urinary Tract Infection14 trials

Pneumonia12 trials

Tuberculosis8 trials

Helicobacter Pylori5 trials

Pulmonary Tuberculosis5 trials

Helicobacter Pylori Infection5 trials

Chronic Bronchitis4 trials

Antibiotics4 trials

Effectiveness4 trials

Safety and Efficacy4 trials

Prostatitis4 trials

Ischemic stroke3 trials

H Pylori Infection3 trials

Efficacy and Safety3 trials

Helicobacter Pylori Eradication3 trials

Cataract3 trials

Efficacy3 trials

Antibiotic3 trials

Tics3 trials

Sinusitis2 trials

Neutropenia2 trials

Bacterial Pneumonia2 trials

Inflammation2 trials

Prophylaxis2 trials

Antibiotic Prophylaxis2 trials

Double-blind2 trials

Treatment2 trials

Chronic Rhinosinusitis2 trials

Endocarditis2 trials

First-line Treatment2 trials

Liver Transplant1 trial

Allogeneic Stem Cell Transplantation1 trial

Drug-Resistant Tuberculosis1 trial

Acute Leukemia1 trial

RR-TB1 trial

Drug1 trial

Pulmonary Sarcoidosis1 trial

Stem Cell Transplantation1 trial

Meropenem1 trial

COPD Exacerbation1 trial

Chronic Prostatitis1 trial

Pneumococcal Pneumonia1 trial

TIA1 trial

Function1 trial

Kidney Transplant1 trial

Skin Infection1 trial

Stenotrophomonas Maltophilia Infection1 trial

Infants1 trial

Retrograde Intrarenal Surgery1 trial

Ciprofloxacin1 trial

Prostate1 trial

Dyspepsia1 trial

Oral Mucositis1 trial

Laparoscopic1 trial

Intraoperative1 trial

Oral1 trial

Fluoroquinolone1 trial

Hematological Malignancies1 trial

Resistance1 trial

Sepsis1 trial

Lymphoid Malignancies1 trial

Infection1 trial

Peptic Ulcer Disease1 trial

Bacteremia1 trial

Lymphoma1 trial

Allergy1 trial

Endophthalmitis1 trial

Typhoid Fever1 trial

Mycoplasma pneumoniae pneumonia1 trial

Multidrug-Resistant Tuberculosis1 trial

Pyelonephritis1 trial

Bronchitis1 trial