Drug intelligence / Profile preview

SEP-4199 (Sumitomo Pharma)

Development stage
Discontinued
Lead developer
Sunovion
Modality
Small Molecules
Administration
Oral
01

Overview

**SEP-4199** is an investigational oral, controlled-release non-racemic amisulpride product comprising **aramisulpride** and **esamisulpride** in an 85:15 ratio. It was developed for major depressive episodes associated with bipolar I disorder. The enantiomeric ratio was selected to emphasize serotonin 5-HT7 receptor antagonism while limiting dopamine D2 receptor antagonism and D2 receptor occupancy relative to racemic amisulpride, with the aim of improving antidepressant activity and tolerability. Sumitomo Pharma-sponsored Phase 3 studies in bipolar I depression were terminated, and SEP-4199 was absent from Sumitomo Pharma's July 31, 2026 development pipeline. ([pmc.ncbi.nlm.nih.gov](https://pmc.ncbi.nlm.nih.gov/articles/PMC8453756/))

Other names
non-racemic amisulpride
02

Targets

HTR7 (5-hydroxytryptamine receptor 7)DRD2 (Dopamine D2 Receptor)DRD3 (Dopamine receptor D3)

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