Last reviewed · How we verify
SEP363856
SEP363856 is a trace amine-associated receptor 1 (TAAR1) agonist that modulates glutamatergic and dopaminergic neurotransmission in the brain.
SEP363856 is a trace amine-associated receptor 1 (TAAR1) agonist that modulates glutamatergic and dopaminergic neurotransmission in the brain. Used for Schizophrenia, Bipolar disorder (acute mania).
At a glance
| Generic name | SEP363856 |
|---|---|
| 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 agonism enhances inhibitory feedback on glutamate and dopamine release, which may help restore balance in neural circuits dysregulated in psychotic disorders. This mechanism differs from traditional antipsychotics by targeting a modulatory pathway rather than directly blocking dopamine D2 receptors, potentially offering improved tolerability and efficacy.
Approved indications
- Schizophrenia
- Bipolar disorder (acute mania)
Common side effects
- Akathisia
- Headache
- Nausea
- Insomnia
- Somnolence
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
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SEP363856 CI brief — competitive landscape report
- SEP363856 updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI