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: *
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, Canada, 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, Unknown Location
Active Clinical Trial Count: 23
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Depressive Disorder, Major|Generalized anxiety disorder|Schizophrenia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| NCT05593029 | P2 |
Active, not recruiting |
Depressive Disorder, Major |
2025-11-14 |
2% |
2025-09-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| jRCT2071210003 | P3 |
Recruiting |
Schizophrenia |
2025-09-30 |
32% |
||
| SEP361-226 | P3 |
Completed |
Generalized anxiety disorder |
2025-09-26 |
18% |
2025-10-11 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| jRCT2031250398 | P3 |
Not yet recruiting |
Schizophrenia |
2028-01-31 |
|||
| NCT06894212 | P3 |
Recruiting |
Schizophrenia |
2026-10-20 |
37% |
2025-10-23 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
| SEP361-226 | P3 |
Active, not recruiting |
Generalized anxiety disorder |
2025-08-26 |
18% |
2025-05-02 |
Treatments |
| jRCT2031220039 | P3 |
Recruiting |
Schizophrenia |
2025-03-31 |
|||
| 382-201-00001 | P3 |
Active, not recruiting |
Depressive Disorder, Major |
2025-03-24 |
2025-05-02 |
Treatments |
|
| SEP361-309 | P3 |
Completed |
Schizophrenia |
2024-09-23 |
9% |
2025-10-01 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| SEP361-308 | P3 |
Completed |
Schizophrenia |
2024-04-01 |
9% |
2024-05-31 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| SEP361-121 | P1 |
Completed |
Schizophrenia |
2024-03-15 |
75% |
2024-06-28 |
Primary Endpoints|Treatments |
| SEP361-122 | P1 |
Completed |
Schizophrenia |
2024-02-12 |
76% |
2024-10-16 |
Primary Endpoints|Treatments |
| DA801201 | P3 |
Completed |
Schizophrenia |
2023-10-02 |
2025-05-02 |
Treatments |
|
| SEP361-124 | P1 |
Completed |
Schizophrenia |
2023-09-27 |
71% |
2024-10-16 |
Primary Endpoints|Treatments |
| SEP361-123 | P1 |
Completed |
Schizophrenia |
2023-08-22 |
63% |
2023-12-21 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| 2019-000697-37 | P3 |
Completed |
Schizophrenia |
2023-06-14 |
49% |
2025-07-09 |
|
| NCT04092686 | P3 |
Completed |
Schizophrenia |
2023-06-14 |
49% |
2024-06-28 |
Primary Endpoints |
| SEP361-118 | P1 |
Completed |
Schizophrenia |
2023-06-06 |
61% |
2023-08-10 |
Primary Endpoints|Treatments |
| SEP361-301 | P3 |
Completed |
Schizophrenia |
2023-05-12 |
35% |
2024-06-28 |
Primary Endpoints|Treatments |
| 2019-002259-40 | P3 |
Active, not recruiting |
Schizophrenia |
2022-08-18 |
34% |
2022-03-13 |
Treatments |
| 2019-000696-16 | P3 |
Active, not recruiting |
Schizophrenia |
2022-05-28 |
17% |
2022-03-13 |
Treatments |
| JapicCTI-205195 | P1 |
Active |
Schizophrenia |
2021-05-31 |
|||
| jRCT2031230152 | P3 |
Recruiting |
Generalized anxiety disorder |
1970-01-01 |
18% |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
05/06/2024 |
PubMed |
Advancements in Non-Dopaminergic Treatments for Schizophrenia: A Systematic Review of Pipeline Developments. |
|
04/23/2024 |
PubMed |
The trace amine-associated receptor 1 agonists - non-dopaminergic antipsychotics or covert modulators of D2 receptors? |
|
04/23/2024 |
PubMed |
Beyond dopamine: Novel strategies for schizophrenia treatment. |
|
09/25/2023 |
News Article |
Generalized Anxiety Disorder Pipeline, Clinical Trials Assessment, and FDA Approvals 2023 (Updated) |
|
07/10/2023 |
News Article |
Sumitomo Pharma America Launches as New Combined Organization with Expanded Scale, Resources & Capabilities |
|
04/26/2023 |
News Article |
Sunovion and Otsuka Initiate Clinical Development of Ulotaront for the Treatment of Generalized Anxiety Disorder |
|
04/06/2023 |
News Article |
PsychoGenics Launches eCube, a New AI-Enabled Platform for Drug Discovery |