Brexpiprazole
Alzheimer Disease
Floatz Rating
BBB72/100
Confidence
Indicative
Sponsor
Otsuka Pharmaceutical Co., Ltd.
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
71High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT06875986CT.gov REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease) | — | Recruiting | — | — | — |
NCT03724942CT.gov Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type | — | Completed | — | — | — |
NCT03594123CT.gov A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type | — | Completed | — | — | — |
NCT03620981CT.gov Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type | — | Completed | — | — | — |
NCT03548584CT.gov A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type | — | Completed | — | — | — |
NCT01922258CT.gov Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type | — | Completed | — | — | — |
NCT01862640CT.gov A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Alzheimer Disease
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Brexpiprazole (this asset) | Otsuka Pharmaceutical Co., Ltd. | P3 | BBB · 72 |
| 4-((1E)-2-(6-(2-)2-(2-FLUOROETHOXY)ETHOXY)ETHOXY)PYRIDIN-3-YL)ETHENYL)-N-METHYLBENZENAMINE | Akiva Mintz | P4 | BBB |
| Memantine | Carnot Laboratories | P4 | BBB |
| Escitalopram | NYU Langone Health | P4 | BBB |
| Flortaucipir | Eli Radiopharma | P4 | BBB |
| Rivastigmine | Anhui Provincial Hospital | P4 | BBB |
| Florbetaben | National Institute of Mental Health (NIMH) | P4 | BBB |
| 6H-BENZOFURO(3A,3,2-EF)(2)BENZAZEPIN-6-OL, 4A,5,9,10,11,12-HEXAHYDRO-3-METHOXY-11-METHYL-, (4AS,6R,8AS) | Anhui Provincial Hospital | P4 | BBB |
| Sertraline | AstraZeneca | P4 | BBB |
+42 more in the Alzheimer Disease cohort
Other indications for Brexpiprazole
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Depressive Disorder | — | P4 | A · 82 |
| Major Depressive Disorder | — | P4 | BBB · 75 |
| Schizophrenia | — | P4 | BBB · 75 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Citation
Floatz Terminal. Brexpiprazole in Alzheimer Disease. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 13, 2026. https://terminal.floatz.ai/assets/brexpiprazole-alzheimer-disease
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