MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE is indicated for the treatment of Community Acquired Pneumonia; Skin and Skin Structure Infections; Complicated Intra-Abdominal Infections; Plague; Acute Bacterial Sinusitis; Acute Bacterial Exacerbation of Chronic Bronchitis.
How MOXIFLOXACIN HYDROCHLORIDE Works
Moxifloxacin is a synthetic broad-spectrum antibacterial agent of the fluoroquinolone class. It exerts its bactericidal activity by inhibiting the type II topoisomerases, DNA gyrase and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination. This dual mechanism of action interferes with the separation of bacterial DNA strands, leading to DNA fragmentation and cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-02-18
- Routes
- OPHTHALMIC, ORAL, INTRAVENOUS
- Dosage Forms
- SOLUTION/DROPS, TABLET, SOLUTION
Companies
MOXIFLOXACIN HYDROCHLORIDE Approval History
What MOXIFLOXACIN HYDROCHLORIDE Treats
6 indicationsMOXIFLOXACIN HYDROCHLORIDE is approved for 6 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Community Acquired Pneumonia
- Skin and Skin Structure Infections
- Complicated Intra-Abdominal Infections
- Plague
- Acute Bacterial Sinusitis
- Acute Bacterial Exacerbation of Chronic Bronchitis
MOXIFLOXACIN HYDROCHLORIDE Boxed Warning
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1) ] , including: Tendinitis and tendon rupture [see Warnings and Precautions (5.2) ] Peripheral neuropathy [see Warnings and Precaution...
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1) ] , including: Tendinitis and tendon rupture [see Warnings and Precautions (5.2) ] Peripheral neuropathy [see Warnings and Precautions (5.3) ] Central nervous system effects [see Warnings and Precautions (5.4) ] Discontinue moxifloxacin hydrochloride immediately and avoid the use of fluoroquinolones, including moxifloxacin hydrochloride, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1) ]. Fluoroquinolones, including moxifloxacin hydrochloride, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin hydrochloride in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5) ]. Because fluoroquinolones, including moxifloxacin hydrochloride, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.14) ] , reserve moxifloxacin hydrochloride for use in patients who have no alternative treatment options for the following indications: Acute bacterial sinusitis [see Indications and Usage (1.6) ] Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.7) ] WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (5.1) including: Tendinitis and tendon rupture (5.2) Peripheral Neuropathy (5.3) Central nerv
MOXIFLOXACIN HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
260 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07513207 | 1378-0027 2025-524106-14-00, U1111-1318-1618 | Ph 1 | recruiting | A Study in Healthy People to Test How Vicadrostat Affects the Heart |
| NCT04310930 FORMaT | U1111-1209-0672 | Ph 2, Ph 3 | recruiting | Finding the Optimal Regimen for Mycobacterium Abscessus Treatment |
| NCT05893862 TQT results posted | 8189-019 MK-8189-019 | Ph 1 | completed | A Study To Evaluate The Effect Of A Supratherapeutic Dose Of Elpipodect (MK-8189) On The QTc Interval In Participants With Schizophrenia (MK-8189-019) |
| NCT07305831 | 8507-012 MK-8507-012 | Ph 1 | completed | A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012) |
| NCT06253715 SMILE-TB | IRB00388853 | Ph 3 | recruiting | Shortened Regimen for Drug-susceptible TB in Children |
| NCT07485010 FORMaT-EVOLVE | FORMaT002 | Ph 2 | not yet recruiting | Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial |
| NCT07422298 | IM027-1055 | Ph 1 | recruiting | A Study to Evaluate the Effect of BMS-986278 on Cardiac Repolarization in Healthy Participants |
| NCT06200467 | 1404-0011 2023-506375-10-00, U1111-1295-4369 | Ph 1 | completed | A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity |
| NCT07063238 | 8527-014 MK-8527-014 | Ph 1 | completed | A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014) |
| NCT07229157 | 20250003 | Ph 1 | active not recruiting | Effect of Maridebart Cafraglutide on the Heart's Electrical Activity |
| NCT06441006 PRISM-TB | 7200AA22CA00005 7200AA22CA00005 | Ph 2, Ph 3 | recruiting | Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis |
| NCT06795204 results posted | HSK3486-112 | Ph 1 | completed | Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT) |
| NCT07272629 | TES18591 U1111-1316-0289 | Ph 1 | active not recruiting | A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants. |
| NCT07023029 | NN7535-7975 U1111-1314-5780 | Ph 1 | completed | A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants |
| NCT06107036 results posted | 1305-0026 U1111-1295-4664 | Ph 1 | completed | A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities |
| NCT01298336 CAMOMY | PHRCN10-DR-ANDREJAK-MELLE | Ph 3 | completed | Treatment of Mycobacterium Xenopi Pulmonary Infection |
| NCT06846866 | CN007-1005 | Ph 1 | completed | A Study to Investigate the Safety, Tolerability, and Drug Levels of BMS-986419 (Part 1) and the Effects Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy Participants |
| NCT07214935 results posted | MS200527_0070 2022-002664-78 | Ph 1 | completed | A TQT Study of Effect of M2951 on Cardiac Repolarization |
| NCT06411860 | 20220016 | Ph 1 | completed | A Study to Assess the Effect of Olpasiran on QT/QTc Intervals in Healthy Participants |
| NCT05807399 | PanACEA - STEP2C -01 | Ph 2 | recruiting | PanACEA - STEP2C -01 |
| NCT06746402 | IM027-1012 | Ph 1 | completed | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants |
| NCT03244072 | PIND 134134 | Ph 2, Ph 3 | not yet recruiting | Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery |
| NCT02563327 S31PK/PD | CDC-NCHHSTP-6719 | Ph 3 | completed | Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis |
| NCT05766267 CRUSH-TB | 7406 | Ph 2, Ph 3 | active not recruiting | Short-course Regimens for the Treatment of Pulmonary Tuberculosis |
| NCT05630274 results posted | 17486 J2G-OX-JZJG, LOXO-RET-18032 | Ph 1 | completed | A Study of Effect of Selpercatinib (LY3527723) on Corrected QT (QTc) Interval in Healthy Participants |
| NCT07129629 Beams | Beams Study | Ph 2 | not yet recruiting | Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis |
| NCT06601192 | EDP 938-008 | Ph 1 | completed | A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults |
| NCT06837155 | TS172-03-07 | Ph 1 | completed | A QT/QTc Evaluation Study of TS-172 in Healthy Adult Subjects |
| NCT05927649 | 408-C-2201 | Ph 1 | completed | A TQTc Study for Omaveloxolone |
| NCT05387759 | CR109186 2021-002618-15, 67953964MDD1001 | Ph 1 | completed | A Thorough QT Study of Aticaprant (JNJ-67953964) in Healthy Adult Participants |
| NCT06194032 | D6970C00004 2023-506108-23-00 | Ph 1 | completed | A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants |
| NCT04779242 results posted | PTK0796-CABP-19302 | Ph 3 | completed | Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia |
| NCT06917495 | SDU-2024-RPT-003 | Ph 2 | not yet recruiting | Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis |
| NCT06081361 INSPIRE-CODA | BJCH-202301 | Ph 3 | active not recruiting | Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort |
| NCT04225078 | CR108643 2019-003776-39, R018553NAP1001 | Ph 1 | completed | A Study to Evaluate the Effects of Loperamide (JNJ-289679) on Electrocardiogram Intervals in Healthy Adult Participants |
| NCT04175808 results posted | 20090231 2018-003157-19 | Ph 1 | completed | Study to Assess the Effect of Omecamtiv Mecarbil (OM) on QT/QTc Intervals in Healthy Adults |
| NCT06574828 | 257HV109 | Ph 1 | completed | A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants |
| NCT06030219 | G0505124 | Ph 1 | completed | Microbiome Effect of Omadacycline on Healthy Volunteers |
| NCT04873323 | TS142-209 | Ph 1 | completed | A QT/QTc Evaluation Study of TS-142 in Healthy Adult Subjects |
| NCT06215521 results posted | LOXO-BTK-20011 J2N-OX-JZNI | Ph 1 | completed | A Study to Evaluate the Effect of Pirtobrutinib (LOXO-305) on QTc Interval in Healthy Participants |
| NCT02754765 endTB | MSF ERB-1555 | Ph 3 | completed | Evaluating Newly Approved Drugs for Multidrug-resistant TB |
| NCT02658825 | CR108108 63623872FLZ1005, 2015-004365-82 | Ph 1 | completed | A Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Participants |
| NCT02816853 | CR108170 R033812DYP1002 | Ph 1 | completed | Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Chinese Healthy Participants |
| NCT02833831 | CR108169 64041575RSV1003 | Ph 1 | completed | Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Participants |
| NCT04179500 PaSEM results posted | Pa-824-CL-012 | Ph 2 | completed | A Trial to Evaluate the Male Reproductive Safety of Pretomanid in Adult Male Participants With Drug Resistant Pulmonary Tuberculosis |
| NCT05400369 | DSCN-GRV AECOPD-CSIS-001 | Ph 4 | completed | A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease |
| NCT06589726 | MS200569_0065 2024-512841-17-00 | Ph 1 | completed | A TQT Study to Investigate the Effect of Enpatoran on Cardiac Repolarization in Healthy Participants |
| NCT05878522 results posted | C5241015 | Ph 1 | completed | A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants. |
| NCT05580003 results posted | C5091001 2022-002871-12, 2022-002871-12 | Ph 1 | completed | A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People |
| NCT05804162 | NN9838-4672 U1111-1249-3834, 2022-002357-25 | Ph 1 | completed | A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants |
Showing 50 of 260 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MOXIFLOXACIN HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)MOXIFLOXACIN HYDROCHLORIDE is indicated for the treatment of Community Acquired Pneumonia; Skin and Skin Structure Infections; Complicated Intra-Abdominal Infections; Plague; Acute Bacterial Sinusitis; Acute Bacterial Exacerbation of Chronic Bronchitis.
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious advers...
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MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Full clinical data, patents, trials, and competitive landscape for moxifloxacin hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment