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SEP-4199

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Chemical compound Pharmaceutical compound
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

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. It is taken by mouth.

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

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

See also

References

  1. ^ "SEP 4199". AdisInsight. 20 December 2023. Retrieved 22 October 2024.
  2. ^ "Delving into the Latest Updates on Aramisulpride/Esamisulpride with Synapse". Synapse. 15 October 2024. Retrieved 23 October 2024.
  3. ^ 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. ^ 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.


Dopamine receptor modulators
D1-like
Agonists
PAMs
Antagonists
D2-like
Agonists
Antagonists
Serotonin receptor modulators
5-HT1
5-HT1A
5-HT1B
5-HT1D
5-HT1E
5-HT1F
5-HT2
5-HT2A
5-HT2B
5-HT2C
5-HT3–7
5-HT3
5-HT4
5-HT5A
5-HT6
5-HT7
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