Dasotraline

Overview

Dasotraline is a serotonin, norepinephrine and dopamine reuptake inhibitor (SNDRI) that is under investigation for the treatment of Binge Eating Disorder, Adult Attention Hyperactivity Disorder, Attention Deficit Hyperactivity Disorder, and Adult Attention Deficit Hyperactivity Disorder.

Background

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.	2017/07/27	NCT03231800	Phase 3	Completed	Sumitomo Pharma America, Inc.
A Study to Evaluate a Drug (Dasotraline) on the Safety, Effectiveness and How Well the Body Tolerates it, in Adults With Moderate to Severe Binge Eating Disorder	2017/04/11	NCT03107026	Phase 3	Completed	Sumitomo Pharma America, Inc.
Study of the What the Body Does to the Drug in Subjects With Mild, Moderate, and Severe Liver Dysfunction	2016/06/10	NCT02795637	Phase 1	Completed	Sumitomo Pharma America, Inc.
A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years of Age With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.	2016/04/12	NCT02734693	Phase 3	Completed	Sumitomo Pharma America, Inc.
Dasotraline Binge Eating Disorder Extension Study	2016/02/17	NCT02684279	Phase 3	Completed	Sumitomo Pharma America, Inc.
Dasotraline Binge Eating Disorder Study	2015/09/30	NCT02564588	Phase 2	Completed	Sumitomo Pharma America, Inc.
Dasotraline Pediatric Extension Study	2015/05/29	NCT02457819	Phase 3	Completed	Sumitomo Pharma America, Inc.
Dasotraline Pediatric ADHD Study	2015/04/28	NCT02428088	Phase 2	Completed	Sumitomo Pharma America, Inc.
Dasotraline Adult ADHD Study	2014/10/28	NCT02276209	Phase 3	Completed	Sumitomo Pharma America, Inc.
Dasotraline SEP360-105 Pediatric PK/PD Study	2014/07/21	NCT02195167	Phase 1	Completed	Sumitomo Pharma America, 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.

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