Product Description
For schizophrenia and parkinson's disease psychosis (Sourced from: https://www.sumitomo-pharma.com/rd/clinical/pipeline.html)
Mechanisms of Action: 5-HT1A Agonist,TAAR1 Agonist
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Otsuka
Company Location: NEW YORK NY 10271
Company CEO:
Additional Commercial Interests: Sunovion
Clinical Description
Countries in Clinic: Bulgaria, China, Colombia, Croatia, Czech Republic, Estonia, Finland, Germany, Hungary, Japan, Latvia, Malaysia, Philippines, Poland, Romania, Russia, Serbia, Slovakia, Spain, Sweden, Taiwan, Ukraine, United Kingdom, United States
Active Clinical Trial Count: 22
Highest Development Phases
Phase 3: Depressive Disorder, Major|Generalized anxiety disorder|Schizophrenia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2019-000696-16 | P3 |
Active, not recruiting |
Schizophrenia |
2022-05-28 |
17% |
| 2019-000697-37 | P3 |
Completed |
Schizophrenia |
2023-06-14 |
49% |
| 2019-002259-40 | P3 |
Active, not recruiting |
Schizophrenia |
2022-08-18 |
34% |
| 382-201-00001 | P3 |
Active, not recruiting |
Depressive Disorder, Major |
2025-03-24 |
|
| SEP361-226 | P3 |
Active, not recruiting |
Generalized anxiety disorder |
2025-08-26 |
18% |
| DA801201 | P3 |
Completed |
Schizophrenia |
2023-10-02 |
|
| JapicCTI-205195 | P1 |
Active |
Schizophrenia |
2021-05-31 |
|
| jRCT2031220039 | P3 |
Recruiting |
Schizophrenia |
2025-03-31 |
|
| jRCT2031230152 | P3 |
Recruiting |
Generalized anxiety disorder |
1970-01-01 |
18% |
| jRCT2071210003 | P3 |
Recruiting |
Schizophrenia |
2025-09-30 |
32% |
| SEP361-118 | P1 |
Completed |
Schizophrenia |
2023-06-06 |
61% |
| SEP361-301 | P3 |
Completed |
Schizophrenia |
2023-05-12 |
35% |
| NCT04092686 | P3 |
Completed |
Schizophrenia |
2023-06-14 |
49% |
| SEP361-124 | P1 |
Completed |
Schizophrenia |
2023-09-27 |
71% |
| SEP361-123 | P1 |
Completed |
Schizophrenia |
2023-08-22 |
63% |
| SEP361-122 | P1 |
Completed |
Schizophrenia |
2024-02-12 |
76% |
| NCT05593029 | P3 |
Recruiting |
Depressive Disorder, Major |
2026-02-01 |
32% |
| SEP361-308 | P3 |
Completed |
Schizophrenia |
2024-04-01 |
9% |
| SEP361-226 | P3 |
Recruiting |
Generalized anxiety disorder |
2026-02-08 |
18% |
| SEP361-309 | P3 |
Enrolling by invitation |
Schizophrenia |
2025-01-10 |
9% |
| SEP361-121 | P1 |
Completed |
Schizophrenia |
2024-03-15 |
75% |
| NCT06894212 | P3 |
Recruiting |
Schizophrenia |
2028-04-06 |
30% |