drugset
Drugs / Dasotraline
last change Jun 2019 re-read 9 days ago

Dasotraline

also known as SEP-225289 · (1r,4s)-trans-norsertraline · Dasotralina · DASOTRALINE HYDROCHLORIDE · Norsertraline, (1r,4s)-trans- · SEP-225289 HCI · SEP-225289 HYDROCHLORIDE

Small molecule

Developed for
attention deficit-hyperactivity disorder · binge eating disorder · major depressive disorder
Investigated by
Sumitomo Pharma America, Inc.

Trials 13

today NCT03231800 · Ph 3 NCT03107026 · Ph 3 NCT02795637 · Ph 1 NCT02734693 · Ph 3 NCT02684279 · Ph 3 NCT02564588 · Ph 2/3 NCT02457819 · Ph 3 NCT02428088 · Ph 2/3 NCT02276209 · Ph 3 NCT02195167 · Ph 1 NCT02160262 · Ph 3 NCT01692782 · Ph 2 NCT00584974 · Ph 2
20082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT02795637 May → Nov 2016 attention deficit-hyperactivity disorder, binge eating disorder Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 1 NCT02195167 Jul 2014 → Mar 2015 attention deficit-hyperactivity disorder Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 22 trials · 1 met primary
Phase 2 NCT01692782 Dec 2012 → Nov 2013 attention deficit-hyperactivity disorder Sumitomo Pharma America, Inc. Completed Met primary
Phase 2 NCT00584974 Dec 2007 → May 2009 major depressive disorder Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 2/32 trials · 2 met primary
Phase 2/3 NCT02564588 Oct 2015 → Oct 2016 binge eating disorder Sumitomo Pharma America, Inc. Completed Met primary
Phase 2/3 NCT02428088 Apr 2015 → Jul 2016 attention deficit-hyperactivity disorder Sumitomo Pharma America, Inc. Completed Met primary
Phase 37 trials · 3 met primary · 1 missed
Phase 3 NCT03231800 Jul 2017 → Mar 2019 attention deficit-hyperactivity disorder Sumitomo Pharma America, Inc. Completed Met primary
Phase 3 NCT03107026 Mar 2017 → May 2018 binge eating disorder Sumitomo Pharma America, Inc. Completed Met primary
Phase 3 NCT02734693 Apr 2016 → Feb 2017 attention deficit-hyperactivity disorder Sumitomo Pharma America, Inc. Completed Met primary
Phase 3 NCT02684279 Feb 2016 → Jun 2019 binge eating disorder Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 3 NCT02457819 Jun 2015 → Feb 2017 attention deficit-hyperactivity disorder Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 3 NCT02276209 Dec 2014 → Sep 2016 attention deficit-hyperactivity disorder Sumitomo Pharma America, Inc. Completed Missed primary
Phase 3 NCT02160262 Jun 2014 → May 2016 attention deficit-hyperactivity disorder Sumitomo Pharma America, Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2017-04-12 Sumitomo Pharma America, Inc. Results Sumitomo Dainippon Pharma Announces Positive Topline Results from a Phase 3 Study of Novel Drug Candidate Dasotraline Being Evaluated in the Treatment of Children with Attention Deficit Hyperactivity Disorder (ADHD) sumitomo-pharma.com ↗
In this Phase 3 study, dasotraline 4 mg/day demonstrated sustained efficacy over the 12-24 hour time period post-dose and was associated with an acceptable safety profile over the 2 week study duration.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

FieldValueCited text
Known as Dasotraline ClinicalTrials.gov intervention name — accepted as the source's own label NCT02428088 ↗
10

NCT02684279 ↗

NCT02734693 ↗

NCT02457819 ↗

NCT02160262 ↗

NCT03231800 ↗

NCT02276209 ↗

NCT03107026 ↗

NCT02195167 ↗

NCT02564588 ↗

NCT02795637 ↗
Known as (1r,4s)-trans-norsertraline ChEMBL registry synonym — accepted as the source's own label CHEMBL3301595 ↗
Known as Dasotralina ChEMBL registry synonym — accepted as the source's own label CHEMBL3301595 ↗
Known as DASOTRALINE HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL3301595 ↗
Known as Norsertraline, (1r,4s)-trans- ChEMBL registry synonym — accepted as the source's own label CHEMBL3301595 ↗
Known as SEP-225289 “Pediatric PK study of SEP-225289 (Dasotraline)” NCT02195167 ↗
2

NCT00584974 ↗

NCT01692782 ↗
Known as SEP-225289 HCI ChEMBL registry synonym — accepted as the source's own label CHEMBL3301595 ↗
Known as SEP-225289 HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL3301595 ↗
Action Inhibit “Dasotraline is a potent inhibitor of presynaptic dopamine and norepinephrine reuptake with a pharmacokinetic profile characterized by slow absorption and a long elimination half-life.” PMID 30694697 ↗ Jan 2019
Modality Small molecule — CHEMBL3301595 ↗
Route Oral “2 oral dosages (4 or 8 mg SEP 225289 once daily)” NCT01692782 ↗