> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/moxifloxacin-hydrochloride-4ece6ff8-05f0-4c28-bc77-7234f29c553b
> Record changed: 2026-10-13

# Moxifloxacin hydrochloride

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

First approval year

1999

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

## Development status

**First approval year**

1999

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

**Drug name**

Moxifloxacin hydrochloride

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

**Molecular weight**

437.9

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

**Structure (SMILES)**

COc1c(N2C\[C@@H\]3CCCN\[C@@H\]3C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12.Cl

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

### Brand names (12)

- avelox
- Avelox
- minims
- Minims
- moxeza
- Moxeza
- moxifloxacin hydrochloride
- Moxifloxacin hydrochloride
- moxivig
- Moxivig
- vigamox
- Vigamox

### Other names (44)

- (4AS-CIS)-1-CYCLOPROPYL-6-FLUORO-1,4-DIHYDRO-8-METHOXY-7-(OCTAHYDRO-6H-PYRROLOL(3,4-B)PYRIDIN-6-YL)-4-OXO-3-QUINOLINECARBOXYLIC ACID, MONOHYDROCHLORIDE
- 1 cyclopropyl 6 fluoro 1 4 dihydro 8 methoxy 7 4as 7as octahydro 6h pyrrolo 3 4 b pyridin 6 yl 4 oxo 3 quinolinecarboxylic acid monohydrochloride
- 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-\[(4aS,7aS)-octahydro-6H-pyrrolo\[3,4-b\]pyridin-6-yl\]-4-oxo-3-quinolinecarboxylic acid, monohydrochloride
- 4as cis 1 cyclopropyl 6 fluoro 1 4 dihydro 8 methoxy 7 octahydro 6h pyrrolol 3 4 b pyridin 6 yl 4 oxo 3 quinolinecarboxylic acid monohydrochloride
- al 15469a
- AL-15469A
- bay 12 8039
- BAY 12-8039
- BAY-12-8039
- minims
- Moxifloxacin (as hydrochloride)
- moxifloxacin 0 5 ophthalmic solution vigamox
- Moxifloxacin 0.5% ophthalmic solution (Vigamox)
- moxifloxacin as hydrochloride
- moxifloxacin hcl
- Moxifloxacin hcl
- MOXIFLOXACIN HCL \[VANDF\]
- moxifloxacin hcl vandf
- moxifloxacin hydrochloride
- Moxifloxacin hydrochloride
- MOXIFLOXACIN HYDROCHLORIDE \[EP MONOGRAPH\]
- MOXIFLOXACIN HYDROCHLORIDE \[JAN\]
- MOXIFLOXACIN HYDROCHLORIDE \[MART.\]
- MOXIFLOXACIN HYDROCHLORIDE \[MI\]
- MOXIFLOXACIN HYDROCHLORIDE \[ORANGE BOOK\]

And 19 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 186826-86-8

**ChEMBL ID**

CHEMBL1200735

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

**InChIKey**

IDIIJJHBXUESQI-DFIJPDEKSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200735)

**FDA ingredient codes (UNII)**

- C53598599T

### ATC classification codes (2)

- J01MA14
- S01AE07

Sources for recorded values

Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=139462)

### PubChem compound IDs (3)

- 101526
- 66696561
- 138753053

### RxNorm IDs (RxCUI) (2)

- 139462
- 228750

## Regulatory information

### United States

**Applicant**

HARROW EYE

**Approval date**

15 Apr 2003

**Application number**

NDA021598

### Other regulatory facts

**Patents**

2

**Designations**

1

**Earliest recorded loss of exclusivity**

29 May 2029

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

**Boxed warning**

Yes

## Pharmacology

### Drug classification

**Drug name stem**

\-oxacin

#### Administration routes

- Oral
- Parenteral
- topical

### Mechanisms of action (4)

- **Mechanism**  
Bacterial DNA gyrase inhibitor

**Action type**  
Inhibitor

**Target**  
Bacterial DNA gyrase

**Protein identifier**  
P0AES4
- **Mechanism**  
Bacterial DNA gyrase inhibitor

**Action type**  
Inhibitor

**Target**  
Bacterial DNA gyrase

**Protein identifier**  
P0AES6
- **Mechanism**  
Topoisomerase IV inhibitor

**Action type**  
Inhibitor

**Target**  
Topoisomerase IV

**Protein identifier**  
P0AFI2
- **Mechanism**  
Topoisomerase IV inhibitor

**Action type**  
Inhibitor

**Target**  
Topoisomerase IV

**Protein identifier**  
P20083

### Open Targets mechanisms (2)

- **Mechanism**  
Bacterial DNA gyrase inhibitor

**Action type**  
Inhibitor

**Target**  
Bacterial DNA gyrase
- **Mechanism**  
Topoisomerase IV inhibitor

**Action type**  
Inhibitor

**Target**  
Topoisomerase IV

### Investigated indications (14)

- **Condition**  
Infections

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000544

**Subject identifier**  
D007239
- **Condition**  
Osteomyelitis

**Highest recorded phase**

0.5

**Condition identifier**  
EFO:0003102

**Subject identifier**  
D010019
- **Condition**  
Pneumonia

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0003106

**Subject identifier**  
D011014
- **Condition**  
Lung Diseases

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003818

**Subject identifier**  
D008171
- **Condition**  
Communicable Diseases

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0005741

**Subject identifier**  
D003141
- **Condition**  
Bronchitis, Chronic

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0006505

**Subject identifier**  
D029481
- **Condition**  
Sinusitis

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0007486

**Subject identifier**  
D012852
- **Condition**  
Conjunctivitis, Bacterial

**Highest recorded phase**  
4

**Condition identifier**  
EFO:1000829

**Subject identifier**  
D003234
- **Condition**  
Pelvic Inflammatory Disease

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1001388

**Subject identifier**  
D000292
- **Condition**  
Corneal Ulcer

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0004577

**Subject identifier**  
D003320
- **Condition**  
Cataract

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0005129

**Subject identifier**  
D002386
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Cystic Fibrosis

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0009061

**Subject identifier**  
D003550
- **Condition**  
Graft vs Host Disease

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0013730

**Subject identifier**  
D006086

### Open Targets indications (29)

- **Condition identifier**  
EFO\_0000544
- **Condition identifier**  
EFO\_0000544

**Highest recorded phase**  
4
- **Condition identifier**  
EFO\_0003102
- **Condition identifier**  
EFO\_0003106
- **Condition identifier**  
EFO\_0003818

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0005741

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0006505
- **Condition identifier**  
EFO\_0007315
- **Condition identifier**  
EFO\_0007486
- **Condition identifier**  
EFO\_0009449
- **Condition identifier**  
EFO\_0009450
- **Condition identifier**  
EFO\_0009536
- **Condition identifier**  
EFO\_1000829
- **Condition identifier**  
EFO\_1001388

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0003085

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0003799

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0004577
- **Condition identifier**  
MONDO\_0004577

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0004785

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005129
- **Condition identifier**  
MONDO\_0005249

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005607

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005800

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005961

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0006668

**Highest recorded phase**  
4

And 4 more, listed on the interactive page.

### Warnings (3)

- **Warning**  
Black Box Warning

**Effect**  
cardiotoxicity
- **Warning**  
Black Box Warning

**Effect**  
musculoskeletal toxicity
- **Warning**  
Black Box Warning

**Effect**  
neurotoxicity

### Open Targets warnings (3)

- **Warning**  
Black Box Warning

**Effect**  
cardiotoxicity

**Country**  
United States
- **Warning**  
Black Box Warning

**Effect**  
musculoskeletal toxicity

**Country**  
United States
- **Warning**  
Black Box Warning

**Effect**  
neurotoxicity

**Country**  
United States

### Reported adverse events (28)

- **Event**  
anaphylactic reaction

**Reports**  
997

**Reporting signal score**  
1,151.3
- **Event**  
anaphylactic shock

**Reports**  
239

**Reporting signal score**

369.642
- **Event**  
choroiditis

**Reports**  
42

**Reporting signal score**

149.233
- **Event**  
contrast media allergy

**Reports**  
94

**Reporting signal score**

315.413
- **Event**  
corneal oedema

**Reports**  
68

**Reporting signal score**

160.148
- **Event**  
delirium

**Reports**  
165

**Reporting signal score**

143.948
- **Event**  
dizziness

**Reports**  
686

**Reporting signal score**

207.486
- **Event**  
drug hypersensitivity

**Reports**  
3,106

**Reporting signal score**  
3,255.72
- **Event**  
dyspnoea

**Reports**  
862

**Reporting signal score**

296.949
- **Event**  
electrocardiogram qt prolonged

**Reports**  
489

**Reporting signal score**

408.414
- **Event**  
endophthalmitis

**Reports**  
99

**Reporting signal score**

188.903
- **Event**  
hypersensitivity

**Reports**  
1,019

**Reporting signal score**

577.732
- **Event**  
iris transillumination defect

**Reports**  
48

**Reporting signal score**

237.793
- **Event**  
mental disorder

**Reports**  
143

**Reporting signal score**

167.608
- **Event**  
musculoskeletal injury

**Reports**  
35

**Reporting signal score**

149.253
- **Event**  
myalgia

**Reports**  
873

**Reporting signal score**

381.569
- **Event**  
paraesthesia

**Reports**  
778

**Reporting signal score**

381.596
- **Event**  
pruritus

**Reports**  
1,171

**Reporting signal score**

415.147
- **Event**  
rash

**Reports**  
1,801

**Reporting signal score**

560.643
- **Event**  
swelling face

**Reports**  
199

**Reporting signal score**

155.634
- **Event**  
tendon disorder

**Reports**  
316

**Reporting signal score**

761.135
- **Event**  
tendon pain

**Reports**  
580

**Reporting signal score**  
1,807.94
- **Event**  
tendon rupture

**Reports**  
556

**Reporting signal score**  
1,259.57
- **Event**  
tendonitis

**Reports**  
847

**Reporting signal score**  
2,156.3
- **Event**  
torsade de pointes

**Reports**  
111

**Reporting signal score**

166.826

And 3 more, listed on the interactive page.

### Trial references (20)

- NCT00312338  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00312338)
- NCT00332293  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00332293)
- NCT00798577  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00798577)
- NCT01238783  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01238783)
- NCT02980523  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02980523)
- NCT00324324  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00324324)
- NCT00769171  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00769171)
- NCT00431678  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00431678)
- NCT00665327  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00665327)
- NCT00717561  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00717561)
- NCT00473460  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00473460)
- NCT00656747  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00656747)
- NCT00683865  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00683865)
- NCT00824070  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00824070)
- NCT00828971  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00828971)
- NCT01910415  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01910415)
- NCT01928693  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01928693)
- NCT02099240  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02099240)
- NCT03405168  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03405168)
- NCT04204122  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04204122)

## Dosing

**Dose**

400 mg

**Route**

Oral

**How often**

Once daily

### Conditions of use (2)

- Drink fluids liberally
- Take with or without food

## Chemical properties

**Hydrogen bond acceptors**

6

**Hydrogen bond donors**

2

**Polar surface area**

83.8

**Calculated partition coefficient (ALogP)**

2.37

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

4

**Heavy atoms**

30

**Molecular formula**

C21H25ClFN3O4

**Monoisotopic mass**

437.1517621

**Natural product**

No

## National Drug Codes

- 0781-7135
- 0832-1410
- 0904-7407
- 16714-643
- 31722-845
- 33342-322
- 46708-505
- 50268-576
- 55111-112
- 57237-156
- 62135-014
- 62332-505
- 63323-850
- 65862-603
- 65862-840
- 67457-323
- 68083-210
- 68084-722
- 68180-421
- 70069-081
- 70756-638
- 72189-334
- 72266-158
- 72789-037
- 72789-038

And 21 more, listed on the interactive page.

## Evidence counts

**Recorded assays**

1,024

**Active assays**

50

### Active assay types (3)

- Confirmatory
- Screening
- Summary

## Pharmacologic actions

- Anti-Bacterial Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000900.html)
- Topoisomerase II Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D059005.html)

## Related records

### Trials (54)

- 2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
- A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms
- A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers.
- [A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation and Inhalation Suspension Administered in Healthy Subjects and Multiple Doses in Patients With COPD.](https://trialight.com/data/trial/a-phase-i-study-of-the-safety-tolerability-pharmacokinetics-f1b5b676-9e44-4184-b82d-87236a5c1b46.md)
- A Phase II Study of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates
- A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects
- A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
- A Two Chemoprophylaxis Approaches After Phacoemulsification Surgery
- AL-15469A for the Treatment of Bacterial Conjunctivitis
- Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
- Bioequivalence of Eye Drops and Spray Administration of Vigamox
- Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
- Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas
- Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
- Determining the Effect of Antibiotic Drop Prophylaxis on the Conjunctival Flora
- Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections
- Dropless Pars Plana Vitrectomy Study
- Dropless vs. Standard Drops Contralateral Eye Study
- Effect of Moxifloxacin Versus Gatifloxacin on Corneal Epithelium Following Pterygium Excision

### Approved for (4)

- Bacterial conjunctivitis
- [Chronic bronchitis](https://trialight.com/data/condition/chronic-bronchitis-1182c6a7-3657-5c56-89e7-6c969a2220da.md)
- [Pneumonia](https://trialight.com/data/condition/pneumonia-d2f12d4d-57c5-5c54-881e-1efe392849eb.md)
- Sinusitis

### In development for (9)

- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2
- Cataract Phase 1
- Corneal ulcer Phase 2
- [Cystic fibrosis](https://trialight.com/data/condition/cystic-fibrosis-6f9870eb-6ebc-5bec-a50b-34b0b323a7c3.md) Phase 1
- Graft versus host disease Phase 2
- [Infectious disease](https://trialight.com/data/condition/infectious-disease-dadc2591-65fc-5842-b510-cfbc295d8093.md) Phase 3
- [Lung disorder](https://trialight.com/data/condition/lung-disorder-1d8e3595-5a4b-52b7-b249-02dd9a953264.md) Phase 3
- Osteomyelitis Early phase 1
- Pelvic inflammatory disease Phase 3

### Other linked conditions (4)

- Blepharitis
- Conjunctivitis
- Keratitis
- Skin disease caused by bacterial infection

---

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