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Other names | SEP4199; Non-racemic amisulpride; Aramisulpride/esamisulpride; Esamisulpride/aramisulpride |
Routes of administration | Oral [1] |
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Chemical and physical data | |
Formula | C17H27N3O4S |
Molar mass | 369.48 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]
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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.