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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[1]
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][3] It is taken by mouth.[1]

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][3][4][5] It contains the (R)- and (S)-enantiomers of amisulpride (aramisulpride and esamisulpride) in an 85:15 ratio rather than a 50:50 ratio.[3] The modification is hoped to give the compound improved effectiveness and fewer side effects.[3][6]

If approved, it would be the first form of amisulpride approved in the United States for psychiatric indications.[5] It is in phase 3 clinical trials for bipolar depression as of December 2023.[1][7] Its development was reported to have been discontinued in certain countries including the United States and Japan in November and December 2023.[1] Sources are conflicting on whether it remains in development.[1][2]

See also

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References

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  1. ^ a b c d e f g "SEP 4199". AdisInsight. 20 December 2023. Retrieved 22 October 2024.
  2. ^ a b "Delving into the Latest Updates on Aramisulpride/Esamisulpride with Synapse". Synapse. 15 October 2024. Retrieved 23 October 2024.
  3. ^ a b c d Wu J, Kwan AT, Rhee TG, Ho R, d'Andrea G, Martinotti G, Teopiz KM, Ceban F, McIntyre RS (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 Rev Clin Pharmacol. 16 (11): 1085–1092. doi:10.1080/17512433.2023.2274538. PMID 37864424.
  4. ^ Hopkins, Seth C.; Wilkinson, Scott; Corriveau, Taryn J.; Nishikawa, Hiroyuki; Nakamichi, Keiko; Loebel, Antony; Koblan, Kenneth S. (2021). "Discovery of Nonracemic Amisulpride to Maximize Benefit/Risk of 5-HT7 and D2 Receptor Antagonism for the Treatment of Mood Disorders". Clinical Pharmacology & Therapeutics. 110 (3): 808–815. doi:10.1002/cpt.2282. PMC 8453756. PMID 33961287.
  5. ^ a b Loebel, Antony; Koblan, Kenneth S.; Tsai, Joyce; Deng, Ling; Fava, Maurizio; Kent, Justine; Hopkins, Seth C. (1 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. ISSN 0165-0327. PMID 34614447. S2CID 238422271.
  6. ^ Wu, Jie; Kwan, Angela TH; Rhee, Taeho Greg; Ho, Roger; d’Andrea, Giacomo; Martinotti, Giovanni; Teopiz, Kayla M; Ceban, Felicia; McIntyre, Roger S (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. ISSN 1751-2433. PMID 37864424. S2CID 264378098.
  7. ^ "Sumitomo, Otsuka's Schizophrenia Candidate Fails Phase III Trials". BioSpace. 31 July 2023. Retrieved 9 November 2023. Ulotaront failed to meet primary endpoints in two studies. [...] Ulotaront is also in Phase II/III clinical studies as an adjunctive treatment for major depressive disorder as well as generalized anxiety disorder. Another asset from the deal, SEP-4199, is in a Phase III study for bipolar I depression.


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