Dasotraline

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Dasotraline
Identifiers
  • (1R,4S)-4-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydro-1-naphthalenamine
JSmol)
  • C1C[C@H](C2=CC=CC=C2[C@@H]1C3=CC(=C(C=C3)Cl)Cl)N
  • InChI=1S/C16H15Cl2N/c17-14-7-5-10(9-15(14)18)11-6-8-16(19)13-4-2-1-3-12(11)13/h1-5,7,9,11,16H,6,8,19H2/t11-,16+/m0/s1
  • Key:SRPXSILJHWNFMK-MEDUHNTESA-N
 ☒NcheckY (what is this?)  (verify)

Dasotraline (

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:[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.

See also

References

  1. ^ "International Nonproprietary Names for Pharmaceutical Substances (INN)" (PDF). WHO Drug Information. 27 (4). WHO. 2013. Retrieved 4 November 2014.
  2. S2CID 20271918
    .
  3. PMID 21680689
    .
  4. S2CID 260312446
    .
  5. S2CID 54263757
    .
  6. PMID 25948101
    .
  7. ^ "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. Archived from the original on 2018-05-01. Retrieved 2018-05-01.
  8. ^ "FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of Adhd". Sumitomo Dainippon Pharma Co., Ltd. August 31, 2018. Archived from the original on October 13, 2019. Retrieved October 13, 2019.
  9. ^ "Pipeline Report: Brand Drugs" (PDF). Welldyne. February 2018. pp. 1, 4. Retrieved 1 May 2018.
  10. ^ Clinical trial number NCT02276209 for "Dasotraline Adult ADHD Study" at ClinicalTrials.gov
  11. ^ "Sunovion Announces Acceptance by the US FDA of the New Drug Application for Dasotraline for the Treatment of Adults with Moderate-to-Severe Binge Eating Disorder". Sumitomo Dainippon Pharma Co., Ltd. July 30, 2019. Archived from the original on October 13, 2019. Retrieved October 13, 2019.
  12. ^ "Sunovion Discontinues Dasotraline Program". www.businesswire.com. 13 May 2020. Retrieved 27 June 2020.

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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