Dasotraline (INN;[1] former developmental code name SEP-225,289) is a serotonin-norepinephrine-dopamine reuptake inhibitor (SNDRI) that is under development by Sunovion for clinical use.[2][3][4][5] In 2017, the U.S. Food and Drug Administration accepted Sunovion's New Drug Application (NDA) for review for the treatment of attention-deficit hyperactivity disorder (ADHD);[6] however, the NDA was ultimately rejected citing the need for additional studies to determine efficacy and tolerability.[7][8][9] In July 2019, Sunovion’s NDA for the treatment of binge eating disorder (BED) was accepted with an expected action date of May 2020. [10] The drug is no longer being developed for major depressive disorder (MDD).[11] Structurally, dasotraline is a stereoisomer of desmethylsertraline, which is an active metabolite of the marketed selective serotonin reuptake inhibitor (SSRI) antidepressant sertraline (Zoloft) and an SNDRI similarly.

CAS Number
PubChem CID
CompTox Dashboard (EPA)
Chemical and physical data
Molar mass292.20 g·mol−1
3D model (JSmol)
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Side Effects

In phase I trials for ADHD, test subjects reported the following side effects:[12][13]

See also


  1. "International Nonproprietary Names for Pharmaceutical Substances (INN)" (PDF). WHO Drug Information. WHO. 27 (4). 2013. Retrieved 4 November 2014.
  2. Chen, Zhengming; Skolnick, Phil (2007). "Triple uptake inhibitors: therapeutic potential in depression and beyond". Expert Opinion on Investigational Drugs. 16 (9): 1365–77. doi:10.1517/13543784.16.9.1365. PMID 17714023.
  3. DeLorenzo, C.; Lichenstein, S.; Schaefer, K.; Dunn, J.; Marshall, R.; Organisak, L.; Kharidia, J.; Robertson, B.; Mann, J. J.; Parsey, R. V. (2011). "SEP-225289 Serotonin and Dopamine Transporter Occupancy: A PET Study". Journal of Nuclear Medicine. 52 (7): 1150–5. doi:10.2967/jnumed.110.084525. PMC 3856248. PMID 21680689.
  4. Ziegler, L.; Küffer, G.; Euler, E.; Wilhelm, K. (1990). "Arthrographische Darstellung von Ganglien im Handbereich" [Arthrographic imaging of ganglions of the hand]. RöFo (in German). 153 (2): 143–6. doi:10.1055/s-2008-1033352. PMID 2168068.
  5. Guiard, B.; Chenu, F.; El Mansari, M.; Blier, P. (2009). "P.1.c.059 Electrophysiological properties of the triple reuptake inhibitor SEP 225289 on monoaminergic neurons". European Neuropsychopharmacology. 19: S285. doi:10.1016/S0924-977X(09)70419-5.
  6. "Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD" (Press release). Marlborough, Massachusetts: Sunovion. Business Wire. November 10, 2017. Retrieved 2018-05-01.
  7. https://news.sunovion.com/press-release/fda-issues-complete-response-letter-new-drug-application-dasotraline-treatment-adhd
  8. "Pipeline Report: Brand Drugs" (PDF). Welldyne. February 2018. pp. 1, 4. Retrieved 1 May 2018.
  9. Clinical trial number NCT02276209 for "Dasotraline Adult ADHD Study" at ClinicalTrials.gov
  10. https://news.sunovion.com/press-release/sunovion-announces-acceptance-us-fda-new-drug-application-dasotraline-treatment
  11. http://adisinsight.springer.com/drugs/800023450%5B%5D
  12. Koblan, Kenneth S; Hopkins, Seth C; Sarma, Kaushik; Jin, Fengbin; Goldman, Robert; Kollins, Scott H; Loebel, Antony (2015). "Dasotraline for the Treatment of Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial in Adults". Neuropsychopharmacology. 40 (12): 2745–52. doi:10.1038/npp.2015.124. PMC 4864650. PMID 25948101.
  13. http://www.additudemag.com/adhdblogs/19/11101.html%5B%5D

Further reading

Liming Shao Patent
  • US application 2007203111, Shao L, Wang F, Malcolm SC, Hewitt MC, Bush LR, Ma J, Varney MA, Campbell U, Engel SR, Hardy LW, Koch P, Campbell JE, "Cycloalkylamines as monoamine reuptake inhibitors", published 2007-08-30, assigned to Sepracor Inc.
Asymmetry Patent
  • US patent 7129378, Han X, Krishnamurthy D, Senanayake CH, Lu Z-H, "Method of preparing amine stereoisomers", published 2005-07-28, assigned to Apsinterm LLC
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