MedPath

Efinaconazole

Generic Name
Efinaconazole
Brand Names
Jublia
Drug Type
Small Molecule
Chemical Formula
C18H22F2N4O
CAS Number
164650-44-6
Unique Ingredient Identifier
J82SB7FXWB
Background

Efinaconazole is a 14 alpha-demethylase inhibitor indicated in the treatment of fungal infection of the nail, known as onychomycosis. It was approved for use in Canada and the USA in 2014 and is marketed by Valeant Pharmaceuticals North America LLC under the name Jublia.

Indication

Indicated in the treatment of fungal infection of the nail, known as onychomycosis.

Associated Conditions
Onychomycosis

Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis

Phase 4
Completed
Conditions
Mild to Moderate Onychomycosis Due to Dermatophyte
Interventions
First Posted Date
2017-09-13
Last Posted Date
2021-04-27
Lead Sponsor
Dong-A ST Co., Ltd.
Target Recruit Count
97
Registration Number
NCT03280927
Locations
🇰🇷

Konkuk University Medical Center, Seoul, Korea, Republic of

Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients

Phase 3
Completed
Conditions
Onychomycosis
Interventions
First Posted Date
2017-05-30
Last Posted Date
2020-10-30
Lead Sponsor
Western University of Health Sciences
Target Recruit Count
40
Registration Number
NCT03168841
Locations
🇺🇸

Western University of Health Sciences, Pomona, California, United States

Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish

Phase 4
Completed
Conditions
Onychomycosis of Toenail
Interventions
First Posted Date
2017-04-12
Last Posted Date
2019-06-27
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
13
Registration Number
NCT03110029
Locations
🇺🇸

The Kirklin Clinic, Birmingham, Alabama, United States

Study Evaluating the Effect of Jublia on Dermatophytomas

Phase 4
Completed
Conditions
Dermatophytosis
Onychomycosis
Interventions
First Posted Date
2017-04-04
Last Posted Date
2019-12-10
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
19
Registration Number
NCT03098615
Locations
🇺🇸

The Kirklin Clinic, Birmingham, Alabama, United States

Real-World Evaluation of the Effect of Jublia on Nail Polish

Not Applicable
Completed
Conditions
Evaluation of Jublia on Nail Polish With Healthy Toenails
Interventions
First Posted Date
2017-01-18
Last Posted Date
2020-01-06
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
5
Registration Number
NCT03022916
Locations
🇺🇸

The Kirklin Clinic, Birmingham, Alabama, United States

Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

Phase 4
Completed
Conditions
Onychomycosis
Interventions
First Posted Date
2016-06-24
Last Posted Date
2021-11-01
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
62
Registration Number
NCT02812771
Locations
🇺🇸

Valeant Site 01, Birmingham, Alabama, United States

🇺🇸

Valeant Site 08, Baltimore, Maryland, United States

🇺🇸

Valeant Site 06, Philadelphia, Pennsylvania, United States

and more 7 locations

Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

Phase 3
Completed
Conditions
Onychomycosis
Interventions
Drug: Vehicle
First Posted Date
2009-11-05
Last Posted Date
2012-06-22
Lead Sponsor
Dow Pharmaceutical Sciences
Target Recruit Count
870
Registration Number
NCT01008033
Locations
🇺🇸

Temple University School of Podiatric Medicine, Philadelphia, Pennsylvania, United States

🇺🇸

Therapeutics Clinical Research, San Diego, California, United States

🇺🇸

University Clinical Trials, Inc, San Diego, California, United States

and more 61 locations

The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

Phase 3
Completed
Conditions
Onychomycosis
Interventions
Drug: Vehicle
First Posted Date
2009-11-04
Last Posted Date
2012-06-22
Lead Sponsor
Dow Pharmaceutical Sciences
Target Recruit Count
780
Registration Number
NCT01007708
Locations
🇨🇦

K. Papp Clinical Research, Waterloo, Ontario, Canada

🇨🇦

Beatrice Wang, MD, Westmount, Quebec, Canada

🇺🇸

South Bend Clinic, South Bend, Indiana, United States

and more 41 locations
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