Product Description
Brexpiprazole is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). It is also used with an antidepressant to treat depression when symptoms cannot be controlled by the antidepressant alone. Brexpiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain. (Sourced from: https://medlineplus.gov/druginfo/meds/a615046.html)
Mechanisms of Action: D2 Agonist, 5-HT1A Agonist, 5-HT2A Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Croatia | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Malaysia | Mexico | Netherlands | Norway | Peru | Philippines | Poland | Portugal | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United States | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Otsuka
Company Location: NEW YORK NY 10271
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, France, India, Italy, Japan, Mexico, Poland, Romania, Russia, Serbia, Spain, Ukraine, United States
Active Clinical Trial Count: 22
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Alzheimer Disease|Autism Spectrum Disorder|Borderline Personality Disorder|Depressive Disorder, Major|Psychomotor Agitation|Schizophrenia|Stress Disorders, Post-Traumatic
Phase 1: Depressive Disorder
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04258839 |
NCT04258839 | P3 |
Completed |
Autism Spectrum Disorder |
2023-03-16 |
37% |
2024-05-31 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
JapicCTI-184045 |
JapicCTI-184045 | P3 |
Active |
Depressive Disorder, Major |
2022-07-01 |
|||
2019-002897-30 |
2019-002897-30 | P3 |
Active, not recruiting |
Borderline Personality Disorder |
2021-05-17 |
44% |
2025-07-09 |
Treatments |
NCT05325645 |
NCT05325645 | P3 |
Recruiting |
Schizophrenia |
2026-02-01 |
33% |
2025-01-24 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04174170 |
NCT04174170 | P3 |
Completed |
Stress Disorders, Post-Traumatic |
2023-07-25 |
62% |
2025-05-31 |
Primary Endpoints |
NCT03620981 |
NCT03620981 | P3 |
Completed |
Alzheimer Disease|Psychomotor Agitation |
2023-04-21 |
48% |
2023-05-26 |
Primary Endpoints |
CTR20240882 |
CTR20240882 | P1 |
Recruiting |
Schizophrenia |
None |
2025-04-29 |
Start Date |
|
2022-500583-36-00 |
331-102-00062 | P3 |
Recruiting |
Schizophrenia |
2026-03-31 |
2025-05-02 |
Treatments |
|
NCT05326347 |
NCT05326347 | P3 |
Active, not recruiting |
Schizophrenia |
2025-08-01 |
27% |
2024-11-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT03238326 |
NCT03238326 | P3 |
Active, not recruiting |
Schizophrenia |
2025-06-06 |
77% |
2025-05-16 |
|
2017-001459-30 |
2017-001459-30 | P3 |
Completed |
Schizophrenia |
2024-08-27 |
2025-06-25 |
Treatments |
|
NCT04124614 |
NCT04124614 | P3 |
Completed |
Stress Disorders, Post-Traumatic |
2023-07-19 |
62% |
2025-06-14 |
Primary Endpoints |
2017-001447-12 |
2017-001447-12 | P3 |
Completed |
Schizophrenia |
2023-04-03 |
71% |
2025-06-29 |
Treatments |
NCT03198078 |
NCT03198078 | P3 |
Completed |
Schizophrenia |
2023-04-03 |
71% |
2024-10-16 |
Primary Endpoints|Treatments |
JapicCTI-184044 |
JapicCTI-184044 | P3 |
Active |
Depressive Disorder, Major |
2022-07-01 |
|||
NCT07266792 |
Brexpiprazole | P1 |
Completed |
Schizophrenia |
2025-08-04 |
2025-12-06 |
Primary Endpoints|Treatments |
|
CTR20190492 |
CTR20190492 | P3 |
Recruiting |
Schizophrenia |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
NCT06036108 |
NCT06036108 | P1 |
Completed |
Schizophrenia |
2025-03-18 |
50% |
2025-04-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
CTR20243729 |
CTR20243729 | P1 |
Completed |
Schizophrenia |
2025-01-21 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20240966 |
CTR20240966 | P1 |
Completed |
Schizophrenia |
2024-07-18 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
JapicCTI-194984 |
JapicCTI-194984 | P1 |
Active |
Schizophrenia |
2021-03-31 |
|||
CTR20181688 |
CTR20181688 | P1 |
Active, not recruiting |
Depressive Disorder |
None |
2025-04-29 |
Patient Enrollment|Treatments |