Dasotraline (INN; former developmental code name SEP-225,289) is a serotonin-norepinephrine-dopamine reuptake inhibitor (SNDRI) that was under development by Sunovion for the treatment of attention-deficit hyperactivity disorder (ADHD) and binge eating disorder (BED). Structurally, dasotraline is a stereoisomer of desmethylsertraline (DMS), which is an active metabolite of the marketed selective serotonin reuptake inhibitor (SSRI) antidepressant sertraline (Zoloft).

Adverse Effects

In phase I clinical trials for attention deficit hyperactivity disorder, test subjects reported the following side effects:

History

In 2017, the U.S. Food and Drug Administration accepted Sunovion's New Drug Application (NDA) for review for the treatment of ADHD; however, the NDA was ultimately rejected citing the need for additional studies to determine efficacy and tolerability. In July 2019, Sunovion’s NDA for the treatment of BED was accepted with an expected action date of May 2020. In May 2020, Sunovion halted its drug development program for dasotraline, withdrawing both NDAs for ADHD and BED.

Law

Finland

Dasotraline is completely unscheduled.