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Ozenoxacin

Generic Name
Ozenoxacin
Brand Names
Ozanex
Drug Type
Small Molecule
Chemical Formula
C21H21N3O3
CAS Number
245765-41-7
Unique Ingredient Identifier
V0LH498RFO
Background

To date, ozenoxacin has been used in trials studying the treatment of impetigo.

As of December 11, 2017 the FDA approved Ferrer Internacional S.A.'s Xepi (ozenoxacin 1%) as a topically applied cream indicated for the treatment of impetigo caused by Staphylococccus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older.

Despite being a common and highly contagious bacerial skin infection that affects millions of children and adults in the United States each year, ozenoxacin cream is a novel, non-fluorinated quinolone that has demonstrated safe and effective therapy in both the adult and pediatric population.

Indication

Ozenoxacin cream is indicated for the topical treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes in patients aged 2 months of age and older .

Associated Conditions
Impetigo

Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

Phase 3
Completed
Conditions
Impetigo
Interventions
Drug: Placebo
First Posted Date
2014-03-18
Last Posted Date
2024-08-20
Lead Sponsor
Ferrer Internacional S.A.
Target Recruit Count
412
Registration Number
NCT02090764
Locations
🇵🇷

Caparra Internal Medicine Center, Rio Grande, Puerto Rico

Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

First Posted Date
2011-07-19
Last Posted Date
2016-07-01
Lead Sponsor
Ferrer Internacional S.A.
Target Recruit Count
465
Registration Number
NCT01397461
Locations
🇩🇪

Georg Popp, Augsburg, Germany

🇩🇪

Diamant Thaci, Frankfurt/Main, Germany

🇿🇦

Yacoob Vahed, Welkom, South Africa

and more 16 locations

Study to Assess the Efficacy and Safety of GF-001001-00 Cream in Secondarily-Infected Traumatic Lesions

Phase 2
Completed
Conditions
Secondarily Infected Traumatic Lesions
Interventions
Drug: Placebo
First Posted Date
2009-11-01
Last Posted Date
2010-06-09
Lead Sponsor
Ferrer Internacional S.A.
Target Recruit Count
200
Registration Number
NCT01005771
Locations
🇩🇪

Dermatologische Praxis, Mahlow, Germany

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