Difamilast

Overview

Difamilast is under investigation in clinical trial NCT01702181 (A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis).

Background

Difamilast is under investigation in clinical trial NCT01702181 (A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)	2022/11/08	NCT05608343	Phase 3	Completed	Acrotech Biopharma Inc.
A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis	2022/10/07	NCT05571943	Phase 3	Completed	Acrotech Biopharma Inc.
A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis	2022/05/13	NCT05372653	Phase 3	Completed	Otsuka Pharmaceutical Co., Ltd.
Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis	2017/01/12	NCT03018691	Phase 2	Completed	Otsuka Pharmaceutical Co., Ltd.
Study of OPA-15406 Ointment in Patients With Atopic Dermatitis	2016/09/26	NCT02914548	Phase 2	Completed	Otsuka Pharmaceutical Co., Ltd.
A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis	2014/02/21	NCT02068352	Phase 2	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.
A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis	2012/10/05	NCT01702181	Phase 1	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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.

AI-Powered Research

Premium Access