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moxifloxacin

Trade name: avelox

Small moleculeapproved

Approved

Dec 10, 1999

Moxifloxacin is a synthetic antibacterial agent developed by Bayer AG (initially called BAY 12-8039) for oral and intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. Moxifloxacin is marketed worldwide (as the hydrochloride) under the brand names Avelox, Avalox, and Avalon for oral treatment. In most countries, the drug is also available in the parenteral form for intravenous infusion. Moxifloxacin is also sold in an ophthalmic solution (eye drops) under the brand names Vigamox, and Moxeza for the treatment of conjunctivitis (pink eye). Its antibacterial spectrum includes enteric Gram-(−) rods (Escherichia coli, Proteus species, Klebsiella species), Haemophilus influenzae, atypical bacteria (Mycoplasma, Chlamydia, Legionella), and Streptococcus pneumoniae, and anaerobic bacteria. It differs from earlier antibacterials of the fluoroquinolone class such as levofloxacin and ciprofloxacin in having greater activity against Gram-positive bacteria and anaerobes. — NCATS

Clinical trial activity

545 trials · 511 clinical orgs · 29 marketing orgs

Phase 1
322
Phase 2
118
Phase 3
77
Phase 4
67

Earliest trial started Feb 1, 2001 (NCT01045902)

Timeline

1990s

  1. Dec 10, 1999

    Bayer — Earliest FDA Approval

  2. Dec 10, 1999

    Bayer — NDA Organization

2000s

  1. Jan 1, 2001

    Bayer — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  4. Apr 15, 2003

    Novartis — NDA Secondary Org

  5. Apr 15, 2003

    Novartis — Marketing Organization

  6. May 14, 2009

    Teva — Marketing Organization

2010s

  1. Nov 19, 2010

    Harrow Health — Marketing Organization

  2. Nov 19, 2010

    Harrow Health — NDA Secondary Org

  3. Mar 4, 2014

    Aurobindo Pharma — Marketing Organization

  4. Mar 4, 2014

    Dr. Reddy's Laboratories — Marketing Organization

  5. Apr 3, 2014

    Torrent Pharmaceuticals Limited — Marketing Organization

  6. Sep 4, 2014

    Lupin — Marketing Organization

  7. Mar 6, 2015

    Watson Pharmaceuticals — Marketing Organization

  8. Mar 6, 2015

    Indoco Remedies — Marketing Organization

  9. Mar 6, 2015

    Adaptis Pharma — Marketing Organization

  10. Apr 3, 2015

    Fresenius — NDA Secondary Org

  11. Aug 31, 2015

    Natco Pharma — Marketing Organization

  12. Jan 14, 2016

    Crossmedika Sa — Marketing Organization

  13. Feb 13, 2017

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  14. Feb 13, 2017

    Chartwell Pharmaceuticals — Marketing Organization

  15. May 5, 2017

    Mylan — Marketing Organization

  16. Jun 30, 2017

    Apotex — Marketing Organization

  17. Sep 22, 2017

    MSN Laboratories — Marketing Organization

  18. Oct 4, 2017

    Eugia Pharma — Marketing Organization

  19. Nov 9, 2017

    Akorn, Inc. — Marketing Organization

  20. Nov 9, 2017

    Epic Pharma Llc — Marketing Organization

  21. Sep 28, 2018

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  22. Feb 13, 2019

    Alembic — Marketing Organization

  23. Dec 3, 2019

    Gland Pharma Ltd — Marketing Organization

2020s

  1. Mar 30, 2020

    Fosun — Marketing Organization

  2. Feb 10, 2021

    Upsher-Smith Laboratories — Marketing Organization

  3. Mar 2, 2023

    Hetero Labs Ltd — Marketing Organization

  4. Nov 14, 2024

    Somerset Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 10, 1999

Chemistry & pharmacology

Loading structure…

SMILES

COc1c(N2C[C@@H]3CCCN[C@@H]3C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12
Mol. weight
401.44 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Black box warning

Sources

Also known as

  • 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
  • 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
  • 1-cyclopropyl--7-(2,8-diazabicyclo(4.3.0)non-8-yl)-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid
  • actira
  • al-15469a
  • avalox
  • avelox
  • avelox
  • avelox
  • avelox
  • avelox
  • avelox
  • avelox
  • avelox
  • avelox i.v.
  • avelox i.v.
  • avolex
  • bay 128039
  • bay 12-8039
  • bay-128039
  • bay-128039
  • bay-128039
  • bay-12-8039
  • bay-12-8039
  • bay-12-8039
  • izilox
  • moxeza
  • moxeza
  • moxeza
  • moxiflocacin
  • moxifloxacin
  • moxifloxacin
  • moxifloxacin
  • moxifloxacin
  • moxifloxacin
  • moxifloxacin
  • moxifloxacin
  • moxifloxacin
  • moxifloxacin
  • moxifloxacine
  • moxifloxacine
  • moxifloxacine
  • moxifloxacin hcl
  • moxifloxacin hcl
  • moxifloxacin hcl
  • moxifloxacin hydrochloride
  • moxifloxacin hydrochloride
  • moxifloxacin hydrochloride
  • moxifloxacin hydrochloride
  • moxifloxacin hydrochloride
  • moxifloxacin hydrochloride
  • moxifloxaxin
  • octegra
  • proflox
  • vigamox
  • vigamox
  • vigamox

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07227779Phase 2Feb 15, 2026Makerere University, University of Minnesota
NCT07305831Phase 1Jan 13, 2026Merck
NCT07272629Phase 1Dec 3, 2025Sanofi
NCT07274020Phase 3Dec 1, 2025Assiut University
NCT07212803Phase 4Nov 1, 2025University of the Pacific
NCT07305987Phase 3Oct 27, 2025Laboratorios Sophia S.A de C.V.
NCT07229157Phase 1Oct 22, 2025Amgen
NCT07126639N/ASep 1, 2025Huazhong University of Science and Technology
NCT06798675Phase 2Aug 31, 2025nephCentric
NCT07129629Phase 2Aug 20, 2025Fudan University, Huazhong University of Science and Technology
NCT07063238Phase 1Aug 12, 2025Merck
NCT07162116Phase 1Jul 6, 2025Yiling Pharmaceutical Inc.
NCT07010744N/AJun 30, 2025Dhaka Medical College
NCT07023029Phase 1Jun 9, 2025Novo Nordisk
NCT06855264Phase 1May 31, 2025Immunome, Inc.
NCT06905522Phase 3Apr 15, 2025Shenyang Tenth People's Hospital, Shenzhen Third People's Hospital, Zhejiang University
NCT06917495Phase 2Apr 5, 2025Shandong University
NCT06837155Phase 1Mar 3, 2025Taisho Pharmaceutical
NCT06846866Phase 1Feb 27, 2025Bristol-Myers Squibb
NCT06746402Phase 1Jan 31, 2025Bristol-Myers Squibb
Showing 20 of 545 trials
Page 1 / 28

Organizations

Research & Development (511)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit312342001
PfizerFor profit212122005
GlaxoSmithKlineFor profit201522009
AlconFor profit181632005
AstraZenecaFor profit171622007
Boehringer IngelheimFor profit151512004
University of California, San FranciscoAcademic/Hospital13632006
Johns Hopkins UniversityAcademic/Hospital11542003
Johnson and JohnsonFor profit111112008
Eli LillyFor profit10822008
Seoul National UniversityAcademic/Hospital10942003
University of LondonAcademic/Hospital10232008
Global Alliance for TB Drug DevelopmentAcademic/Hospital9622006
National Institute of Allergy and Infectious Diseases (NIAID)Government9832003
ParexelFor profit9012007
MerckFor profit8722007
Radboud UniversityAcademic/Hospital8112006
Bristol-Myers SquibbFor profit7612007
Centers for Disease Control and Prevention (CDC)Government7732003
IQVIAFor profit7012009
511 organizations
Page 1 / 26

Marketing (40)

OrganizationOrg typeRelationshipDate
Adaptis PharmaFor profitMKTGMar 6, 2015
Akorn, Inc.For profitMKTGNov 9, 2017
AlembicFor profitMKTGFeb 13, 2019
AlembicFor profitSYNFeb 13, 2019
ApotexFor profitMKTGJun 30, 2017
ApotexFor profitSYNJun 30, 2017
Aurobindo PharmaFor profitMKTGMar 4, 2014
BayerFor profitSYNApr 27, 2001
BayerFor profitNDADec 10, 1999
Chartwell PharmaceuticalsFor profitMKTGFeb 13, 2017
Crossmedika SaFor profitMKTGJan 14, 2016
Dr. Reddy's LaboratoriesFor profitMKTGMar 4, 2014
Dr. Reddy's LaboratoriesFor profitSYNMar 4, 2014
Epic Pharma LlcFor profitMKTGNov 9, 2017
Eugia PharmaFor profitMKTGOct 4, 2017
FosunFor profitMKTGMar 30, 2020
FreseniusFor profitNDA2Apr 3, 2015
Gland Pharma LtdFor profitMKTGDec 3, 2019
Harrow HealthFor profitMKTGNov 19, 2010
Harrow HealthFor profitNDA2Nov 19, 2010
Hetero Labs LtdFor profitMKTGMar 2, 2023
Indoco RemediesFor profitMKTGMar 6, 2015
LupinFor profitMKTGSep 4, 2014
MSN LaboratoriesFor profitSYNSep 22, 2017
MSN LaboratoriesFor profitMKTGSep 22, 2017
MylanFor profitMKTGMay 5, 2017
MylanFor profitSYNAug 31, 2015
MylanFor profitSYNAug 31, 2015
Natco PharmaFor profitMKTGAug 31, 2015
NovartisFor profitNDA2Apr 15, 2003
NovartisFor profitMKTGApr 15, 2003
Novel Anti-Infective Technologies, LLCFor profitMKTGFeb 13, 2017
Somerset PharmaceuticalsFor profitMKTGNov 14, 2024
Sunshine Lake Pharma Co., Ltd.For profitSYNSep 28, 2018
Sunshine Lake Pharma Co., Ltd.For profitMKTGSep 28, 2018
TevaFor profitMKTGMay 14, 2009
TevaFor profitSYNFeb 18, 2014
Torrent Pharmaceuticals LimitedFor profitMKTGApr 3, 2014
Upsher-Smith LaboratoriesFor profitMKTGFeb 10, 2021
Watson PharmaceuticalsFor profitMKTGMar 6, 2015