Efinaconazole

Overview

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis	2017/09/13	NCT03280927	Phase 4	Completed	Dong-A ST Co., Ltd.
Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients	2017/05/30	NCT03168841	Phase 3	Completed	Western University of Health Sciences
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	2017/04/12	NCT03110029	Phase 4	Completed	University of Alabama at Birmingham
Study Evaluating the Effect of Jublia on Dermatophytomas	2017/04/04	NCT03098615	Phase 4	Completed	University of Alabama at Birmingham
Real-World Evaluation of the Effect of Jublia on Nail Polish	2017/01/18	NCT03022916	Not Applicable	Completed	University of Alabama at Birmingham
Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis	2016/06/24	NCT02812771	Phase 4	Completed	Bausch Health Americas, Inc.
Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis	2009/11/05	NCT01008033	Phase 3	Completed	Dow Pharmaceutical Sciences
The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis	2009/11/04	NCT01007708	Phase 3	Completed	Dow Pharmaceutical Sciences

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
JUBLIA	Bausch Health US LLC	0187-5400	TOPICAL	100 mg in 1 mL	3/31/2022

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
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
JUBLIA	bausch health, canada inc.	02413388	Solution - Topical	10 % / W/W	7/21/2014

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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