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SEP-363856
SEP-363856 is a trace amine-associated receptor 1 (TAAR1) agonist that modulates glutamatergic and dopaminergic neurotransmission in the brain.
SEP-363856 is a trace amine-associated receptor 1 (TAAR1) agonist that modulates glutamatergic and dopaminergic neurotransmission in the brain. Used for Schizophrenia, Bipolar disorder (exploratory).
At a glance
| Generic name | SEP-363856 |
|---|---|
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Drug class | TAAR1 agonist |
| Target | TAAR1 (trace amine-associated receptor 1) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
TAAR1 is a G-protein coupled receptor expressed on glutamatergic and dopaminergic neurons that acts as a negative feedback regulator of neurotransmitter release. By activating TAAR1, SEP-363856 reduces excessive glutamate and dopamine signaling, which is hypothesized to address core symptoms of schizophrenia and other psychiatric disorders without blocking dopamine D2 receptors like traditional antipsychotics.
Approved indications
- Schizophrenia
- Bipolar disorder (exploratory)
Common side effects
- Headache
- Nausea
- Dizziness
- Insomnia
Key clinical trials
- A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder (PHASE2)
- A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia (PHASE3)
- A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia (PHASE3)
- A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia. (PHASE3)
- A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication (PHASE3)
- An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication (PHASE3)
- A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder (PHASE2, PHASE3)
- A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |