Brexpiprazole is named as an intervention in 3 current clinical trials in our Canada and Japan registers. 3 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Douglas Mental Health University Institute (1). The most-studied condition is Bipolar Depression.
Brexpiprazole was first approved in the US on 10 Jul 2015. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)
NCT05017311 · ClinicalTrials.gov ↗ · Major Depressive Disorder
|
Phase 4 | Recruiting | Nova Scotia Health Authority | Canada |
|
Brexpiprazole Treatment for Bipolar I Depression
NCT04569448 · ClinicalTrials.gov ↗ · Bipolar Depression
|
Phase 3 | Recruiting | Douglas Mental Health University Institute | Canada |
|
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)
NCT06875986 · ClinicalTrials.gov ↗ · Alzheimer Disease
|
Observational | Recruiting | Otsuka Pharmaceutical Co., Ltd | Japan |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
6 single-substance products containing Brexpiprazole on the HPRA medicines list.
No entry for Brexpiprazole in the EMA, FDA or German BfArM shortage lists we track.
| Lead sponsor | Trials |
|---|---|
| Douglas Mental Health University Institute | 1 |
| Nova Scotia Health Authority | 1 |
| Otsuka Pharmaceutical Co., Ltd | 1 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in Canada | 2 | 2 |
| Clinical trials in Japan | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
3 current trials in our Canada and Japan registers name Brexpiprazole as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.
Yes. 3 of the 3 trials are recruiting: 2 with sites in Canada and 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Douglas Mental Health University Institute (1), Nova Scotia Health Authority (1) and Otsuka Pharmaceutical Co., Ltd (1). The number in brackets is how many trials each organisation leads.
Yes. The HPRA medicines list includes 6 single-substance products containing Brexpiprazole, for example RXULTI 0.25 mg Film-coated tablet (Otsuka Pharmaceutical Netherlands B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Not in the lists we track: Brexpiprazole has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Brexpiprazole works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Brexpiprazole works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Brexpiprazole (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 27 Sep 2026.