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Drug intelligence / Profile preview
SEP-4199 (Sumitomo Pharma America)
- Development stage
- Unknown
- Lead developer
- Sumitomo Pharma America
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
SEP-4199 is an investigational, orally administered, controlled-release formulation of a non-racemic ratio of amisulpride enantiomers, specifically 85% R-amisulpride and 15% S-amisulpride. Developed by Sumitomo Pharma America (formerly Sunovion), it is currently in Phase 3 clinical development for the treatment of major depressive episodes associated with Bipolar I disorder (bipolar depression). The drug's pharmacological profile is characterized by potent antagonism at serotonin 5-HT7 receptors and dopamine D2 and D3 receptors. By utilizing a specific ratio of enantiomers, SEP-4199 aims to provide robust antidepressant efficacy while minimizing the side effects typically associated with racemic amisulpride, such as extrapyramidal symptoms and elevated prolactin levels.
- Other names
- R-amisulpride/S-amisulpride (85:15 ratio)
02
Targets
HTR7 (5-hydroxytryptamine receptor 7)DRD2 (Dopamine D2 Receptor)DRD3 (Dopamine receptor D3)
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