Overview
Moxifloxacin is a synthetic fluoroquinolone antibiotic agent. Bayer AG developed the drug (initially called BAY 12-8039) and it is marketed worldwide (as the hydrochloride) under the brand name Avelox (in some countries also Avalox) for oral treatment.
Indication
For the treatment of sinus and lung infections such as sinusitis, pneumonia, and secondary infections in chronic bronchitis. Also for the treatment of bacterial conjunctivitis (pinkeye).
Associated Conditions
- Acute Exacerbation of Chronic Bronchitis (AECB)
- Bacterial Conjunctivitis
- Community Acquired Pneumonia (CAP)
- Plague
- Postoperative Infections
- Postoperative Inflammatory Response
- Sinusitis
- Skin Infections
- Ocular bacterial infections
Research Report
A Comprehensive Monograph on Moxifloxacin: Pharmacology, Clinical Utility, and Safety Profile
Executive Summary and Introduction to Moxifloxacin
Overview
Moxifloxacin is a potent, fourth-generation synthetic fluoroquinolone antibiotic characterized by a broad spectrum of bactericidal activity against a wide range of Gram-positive, Gram-negative, atypical, and anaerobic pathogens.[1] Developed by Bayer AG under the initial research designation BAY 12-8039, it is a small molecule drug (DrugBank ID: DB00218; CAS Number: 151096-09-2) that has become a significant tool in the management of various bacterial infections.[1] It is marketed globally under several trade names, most notably Avelox® for systemic (oral and intravenous) formulations and Vigamox® or Moxeza® for ophthalmic use.[2]
Key Characteristics and Clinical Position
The clinical identity of moxifloxacin is defined by a profound duality. On one hand, it possesses several highly desirable attributes: enhanced potency against critical pathogens like multi-drug resistant Streptococcus pneumoniae (MDRSP), excellent activity against atypical respiratory pathogens, and a favorable pharmacokinetic profile that includes high oral bioavailability and a long half-life permitting once-daily dosing.[2] These characteristics led to its classification as a "respiratory quinolone" and secured its place in treating serious infections such as community-acquired pneumonia and drug-resistant tuberculosis.[4]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/14 | Not Applicable | Not yet recruiting | |||
2025/06/15 | Phase 1 | Not yet recruiting | |||
2025/06/11 | Not Applicable | Recruiting | |||
2025/04/08 | Phase 2 | Not yet recruiting | Shandong University | ||
2025/04/01 | Phase 3 | Not yet recruiting | Shenzhen Third People's Hospital | ||
2025/03/03 | Phase 1 | Active, not recruiting | |||
2025/02/26 | Phase 1 | Recruiting | |||
2025/02/20 | Phase 1 | Completed | |||
2025/01/27 | Phase 1 | Completed | |||
2025/01/20 | Phase 4 | Completed | Inas Abd |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Major Pharmaceuticals | 0904-7407 | ORAL | 400 mg in 1 1 | 3/14/2024 | |
AvPAK | 50268-576 | ORAL | 400 mg in 1 1 | 5/16/2022 | |
A-S Medication Solutions | 50090-6248 | OPHTHALMIC | 5 mg in 1 mL | 8/18/2020 | |
Teva Pharmaceuticals USA, Inc. | 0093-7387 | ORAL | 400 mg in 1 1 | 1/1/2022 | |
RedPharm Drug, Inc. | 67296-1679 | ORAL | 400 mg in 1 1 | 1/14/2021 | |
Bryant Ranch Prepack | 71335-2329 | ORAL | 400 mg in 1 1 | 6/25/2020 | |
Novel Laboratories, Inc. | 40032-034 | ORAL | 400 mg in 1 1 | 12/21/2019 | |
Akorn | 17478-519 | OPHTHALMIC | 5 mg in 1 mL | 7/6/2017 | |
Direct Rx | 72189-334 | OPHTHALMIC | 5 mg in 1 mL | 3/8/2022 | |
DIRECT RX | 72189-076 | OPHTHALMIC | 5 mg in 1 mL | 3/3/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
FLONOXIN FILM-COATED TABLET 400MG | SIN16347P | TABLET, FILM COATED | 400MG | 10/12/2021 | |
MOLOXIN FILM-COATED TABLETS 400MG | SIN15579P | TABLET, FILM COATED | 400.00mg | 11/12/2018 | |
AVELOX SOLUTION FOR INFUSION 400 mg/250 ml | SIN11971P | INJECTION | 400 mg/250 ml | 5/31/2002 | |
MO-FLOREN OPHTHALMIC SOLUTION 0.5% USP | SIN14899P | SOLUTION, STERILE | 5mg/ml | 12/1/2015 | |
AVELOX TABLET 400 mg | SIN11351P | TABLET, FILM COATED | 400 mg | 7/13/2000 | |
MOXIFLOXACIN-TEVA F.C. TABLET 400 MG | SIN14900P | TABLET, FILM COATED | 400 mg | 12/1/2015 | |
JOYLOXIN INJECTION 400MG/250ML | SIN15654P | INJECTION, SOLUTION | 400MG | 3/29/2019 | |
FLOXSAFE 400 FILM COATED TABLET 400MG | SIN15361P | TABLET, FILM COATED | 400 mg | 11/14/2017 | |
MOXETERO MOXIFLOXACIN FILM-COATED TABLETS 400 MG | SIN15769P | TABLET, FILM COATED | 400.00 mg | 8/6/2019 | |
MOXIFLOXACIN KABI SOLUTION FOR INFUSION 400MG/250ML | SIN15310P | INFUSION, SOLUTION | 400mg/250ml | 7/31/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
ZANAFLOX EYE DROPS 0.5% W/V | N/A | N/A | N/A | 9/4/2024 | |
MOXICIN EYE DROPS 0.5% | N/A | N/A | N/A | 11/14/2011 | |
VIGAMOX OPHTHALMIC SOLUTION 0.5% | N/A | N/A | N/A | 4/1/2005 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
AVELOX IV 400 moxifloxacin 400 mg/250 mL (as hydrochloride) intravenous infusion solution bag | 78977 | Medicine | A | 1/31/2002 | |
AVELOX IV 400 moxifloxacin 400 mg/250 mL (as hydrochloride) intravenous infusion solution bottle | 81598 | Medicine | A | 1/31/2002 | |
AVELOX moxifloxacin 400 mg (as hydrochloride) tablet blister pack | 75766 | Medicine | A | 12/21/2000 | |
MOXIFLOXACIN KABI moxifloxacin (as hydrochloride) 400mg/250mL intravenous infusion injection bag | 241252 | Medicine | A | 5/9/2016 | |
MOXIFLOXACIN KABI moxifloxacin (as hydrochloride) 400mg/250mL intravenous infusion injection bottle | 241253 | Medicine | A | 5/9/2016 | |
MOXIFLOXACIN-BAXTER moxifloxacin (as hydrochloride) 400 mg/250 mL solution for intravenous infusion bottle | 260842 | Medicine | A | 8/30/2016 | |
MOXIFLOXACIN-AFT moxifloxacin (as hydrochloride) 400 mg / 250 mL intravenous infusion injection bottle | 405619 | Medicine | A | 4/16/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
MOXIFLOXACINO RATIOPHARM 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 77514 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
ABIMOX 5 MG/ML COLIRIO EN SOLUCION | Tiedra Farmaceutica S.L. | 78338 | COLIRIO EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
MOXIFLOXACINO TEVAGEN 400 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Teva Pharma S.L.U. | 76633 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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