Dasotraline
Chemical compound
From Wikipedia, the free encyclopedia
Dasotraline (INN;[1] 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).[2][3][4][5] Structurally, dasotraline is a stereoisomer of desmethylsertraline (DMS), which is an active metabolite of the marketed selective serotonin reuptake inhibitor (SSRI) antidepressant sertraline (Zoloft).
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| Elimination half-life | 47-77 hours |
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| Formula | C16H15Cl2N |
| Molar mass | 292.20 g·mol−1 |
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Adverse Effects
In phase I clinical trials for attention deficit hyperactivity disorder, test subjects reported the following side effects:[6]
History
In 2017, the U.S. Food and Drug Administration accepted Sunovion's New Drug Application (NDA) for review for the treatment of ADHD;[7] however, the NDA was ultimately rejected citing the need for additional studies to determine efficacy and tolerability.[8][9][10] In July 2019, Sunovion’s NDA for the treatment of BED was accepted with an expected action date of May 2020.[11] In May 2020, Sunovion halted its drug development program for dasotraline, withdrawing both NDAs for ADHD and BED.[12]
Law
Finland
Dasotraline is completely unscheduled.