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 65 indications[4].[1]
Levaquin is one of 651 small molecule programs targeting Urinary Tract Infection. It is currently in Approved.
65
Indications
175
Total Trials
25
Active Trials
650
Competitors
5
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 64 indications
Competition
Competitive Landscape
348 competitors in Prostate Cancer
#DrugCompanyPhaseTrials
1Levaquin
WWim Janssens
Approved
Cortef
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase 3
LHRH Agonist
RochePhase 3
Aglatimagene Besadenovec
CCandel Therapeutics, Inc.
Phase 3
PSMA-1007
AABX advanced biochemical compounds GmbH
Phase 3
INR101
YYunhe Pharmaceutical (Tianjin) Co., Ltd
Phase 3
Florastamin
HHTA Co., Ltd.
Phase 3
Trexall
Jazz PharmaceuticalsPreclinical
Botox
VVitae Pharmaceuticals Inc., an Allergan affiliate
Preclinical
Duragesic
CCephalon
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Q4 2026
PreclinicalNot yet recruiting
Surgical Site Infection (SSI)
NCT07696819
Phase 3Active, not recruiting
Tuberculosis
NCT06081361
Clinical
Trials by Indication[1]
Urinary Tract Infection14 trials
Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections
Unknown status·—·Phase 4·NCT03160807·214 enrolled
Show 11 more trials
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females
Unknown status·—·Phase 4·NCT02094703·126 enrolled
Pneumonia12 trials
Show 9 more trials
Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors
Unknown status·—·Phase 4·NCT00752947·186 enrolled
Tuberculosis8 trials
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
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
Helicobacter Pylori5 trials
Show 2 more trials
Pulmonary Tuberculosis5 trials
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
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
Shortened Regimens for Drug-susceptible Pulmonary Tuberculosis
Unknown status·—·Phase 4·NCT02901288·3,900 enrolled
78 more indications
Helicobacter Pylori Infection5 trials
Show 2 more trials
Antibiotics4 trials
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome
Recruiting·—·Phase 1·NCT05302531·10 enrolled
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
Show 1 more trial
Safety and Efficacy4 trials
Chronic Bronchitis4 trials
Show 1 more trial
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.·Phase 2/3·NCT00257140·367 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2/3·NCT00257140·367 enrolledEffectiveness4 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.·Phase 2/3·NCT00257036·431 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2/3·NCT00257036·431 enrolledA 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.·Phase 3·NCT00257062·361 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00257062·361 enrolledShow 1 more trial
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.·Phase 3·NCT00249210·614 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00249210·614 enrolledProstatitis4 trials
Ischemic stroke3 trials
Antibiotic3 trials
Tics3 trials
Efficacy and Safety3 trials
Efficacy and Safety of Levofloxacin for the Treatment of MDR-TB
Completed·—·Phase 2·NCT01918397·111 enrolled
H Pylori Infection3 trials
Cataract3 trials
Helicobacter Pylori Eradication3 trials
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
Sinusitis2 trials
Neutropenia2 trials
Antibiotic Prophylaxis2 trials
Prophylaxis2 trials
Treatment2 trials
BK Treatment Study
Completed·—·Phase 4·NCT01034176·43 enrolled
First-line Treatment2 trials
Chronic Rhinosinusitis2 trials
Double-blind2 trials
Bacterial Pneumonia2 trials
Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia
Completed·—·Phase 4·NCT01524302·12 enrolled
Inflammation2 trials
Endocarditis2 trials
Liver Transplant1 trial
Acute Leukemia1 trial
RR-TB1 trial
Infection1 trial
Bacteremia1 trial
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
Pneumococcal Pneumonia1 trial
Pulmonary Sarcoidosis1 trial
Stem Cell Transplantation1 trial
Function1 trial
Lymphoid Malignancies1 trial
Kidney Transplant1 trial
Meropenem1 trial
COPD Exacerbation1 trial
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.·Phase 1·NCT00601432·24 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT00601432·24 enrolledPyelonephritis1 trial
Chronic Prostatitis1 trial
An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
Completed·Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00402688·242 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00402688·242 enrolledBronchitis1 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.·Phase 3·NCT00269932·485 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00269932·485 enrolledDyspepsia1 trial
Fluoroquinolone1 trial
Resistance1 trial
Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.
Unknown status·—·Phase 4·NCT04090021·304 enrolled
TIA1 trial
Levofloxacin Concomitant Versus Levofloxacin Sequential
Not yet recruiting·—·Phase 4·NCT06065267·150 enrolled
Hematological Malignancies1 trial
Ciprofloxacin1 trial
Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia
Completed·—·Phase 4·NCT04456712·200 enrolled
Oral Mucositis1 trial
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
Prostate1 trial
Peptic Ulcer Disease1 trial
Endophthalmitis1 trial
Study of Antibiotic Prophylaxis for Endophthalmitis Following Cataract Surgery
Completed·—·N/A·NCT00136344·35,000 enrolled
Lymphoma1 trial
Typhoid Fever1 trial
Efficacy of Levofloxacin Versus Ciprofloxacin in the Treatment of Childhood Typhoid Fever
Completed·—·Phase 2·NCT07150065·360 enrolled
Intraoperative1 trial
Allergy1 trial
Skin Infection1 trial
Brain Injury1 trial
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
Sepsis1 trial
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
Tuberculosis, Latent1 trial
Lactating Women on Select DOI1 trial
Surgical Site Infection (SSI)1 trial
Tuberculosis, Multidrug-Resistant1 trial
Myeldysplastic Syndrome (MDS)1 trial
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
Show 5 more trials
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]
- [2]MedlinePlus Drug Information — Levaquin drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Levofloxacin. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
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