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SEP-4199

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SEP-4199
Aramisulpride
(R)-amisulpride
Esamisulpride
(S)-amisulpride
Clinical data
Other namesSEP4199; Non-racemic amisulpride; Aramisulpride/esamisulpride; Esamisulpride/aramisulpride
Routes of
administration		Oral
Legal status
Legal status
  • Investigational
Identifiers
CAS Number
PubChem CID
UNII
Chemical and physical data
FormulaC17H27N3O4S
Molar mass369.48 g·mol−1

SEP-4199, also known as non-racemic amisulpride, is a non-racemic form of amisulpride which is under development for the treatment of bipolar depression.[1][2]

It was developed to have higher binding affinity for the serotonin 5-HT7 receptor and lower affinity for the dopamine D2 receptor compared to conventional racemic amisulpride.[1][2][3][4] It contains the (R)- and (S)-enantiomers of amisulpride (aramisulpride and esamisulpride) in an 85:15 ratio rather than a 50:50 ratio.[2] The modification is hoped to give the compound improved effectiveness and fewer side effects.[2][5]

If approved, it would be the first form of amisulpride approved in the United States for psychiatric indications.[4] It is in phase 3 clinical trials as of 2023.[1][6]

See also

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References

[edit]
  1. ^ a b c "SEP 4199". AdisInsight. Springer Nature Switzerland AG. 20 December 2023. Retrieved 22 October 2024.
  2. ^ a b c d Wu J, Kwan AT, Rhee TG, Ho R, d'Andrea G, Martinotti G, et al. (2023). "A narrative review of non-racemic amisulpride (SEP-4199) for treatment of depressive symptoms in bipolar disorder and LB-102 for treatment of schizophrenia". Expert Review of Clinical Pharmacology. 16 (11): 1085–1092. doi:10.1080/17512433.2023.2274538. PMID 37864424.
  3. ^ Hopkins SC, Wilkinson S, Corriveau TJ, Nishikawa H, Nakamichi K, Loebel A, et al. (September 2021). "Discovery of Nonracemic Amisulpride to Maximize Benefit/Risk of 5-HT7 and D2 Receptor Antagonism for the Treatment of Mood Disorders". Clinical Pharmacology and Therapeutics. 110 (3): 808–815. doi:10.1002/cpt.2282. PMC 8453756. PMID 33961287.
  4. ^ a b Loebel A, Koblan KS, Tsai J, Deng L, Fava M, Kent J, et al. (January 2022). "A Randomized, Double-blind, Placebo-controlled Proof-of-Concept Trial to Evaluate the Efficacy and Safety of Non-racemic Amisulpride (SEP-4199) for the Treatment of Bipolar I Depression". Journal of Affective Disorders. 296: 549–558. doi:10.1016/j.jad.2021.09.109. PMID 34614447. S2CID 238422271.
  5. ^ Wu J, Kwan AT, Rhee TG, Ho R, d'Andrea G, Martinotti G, et al. (21 October 2023). "A narrative review of non-racemic amisulpride (SEP-4199) for treatment of depressive symptoms in bipolar disorder and LB-102 for treatment of schizophrenia". Expert Review of Clinical Pharmacology. 16 (11): 1085–1092. doi:10.1080/17512433.2023.2274538. PMID 37864424. S2CID 264378098.
  6. ^ "Sumitomo, Otsuka's Schizophrenia Candidate Fails Phase III Trials". BioSpace. Retrieved 9 November 2023.
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