Rexulti Clinical Trials

What are Rexulti Clinical Trials?

Rexulti is the brand name of brexpiprazole, an antipsychotic drug. In 2015, it was approved by the FDA to treat schizophrenia and is an augmented therapy for major depression disorder (MDD).

Developed in a joint partnership by the pharmaceutical companies Otsuka and Lundbeck, Rexulti is a more potent version of Abilify, a non-patent generic medication made by Otsuka that uses the antipsychotic aripiprazole.

Known side effects of Rexulti include dizziness, akathisia, weight gain, upper respiratory tract infections, and cold-like symptoms. In rare cases, Rexulti, as with other antipsychotic drugs, can cause tardive dyskinesia, a condition that results in stiff, jerky uncontrollable movements of the face and body. Additionally, Rexulti is unsuitable for young children, pregnant women, and elderly patients with dementia-related psychosis.

Why Is Rexulti Being Studied In Clinical Trials?

In the United States, two of the most common mental disorders are schizophrenia and major depression. Statistics estimate that 1 in every 100 is affected by schizophrenia, while 8 in every 100 have at least one episode of major depression.

As the general population's awareness of mental health increases and diagnostics methods for such mental disorders improve, researchers believe that the number of cases of such disorders will rise and affect the quality of life for a greater percentage of the population.

This information makes clinical trials for medications such as Rexulti all the more critical. More research is necessary to understand the long-term safety and determine its effectiveness in treating other mental disorders like bipolar disorders, acute agitation, and autism.

How Does Rexulti Treatment Work?

Pharmacologically, the exact mechanism of action of Rexulti is unknown. Still, research shows that it works as a partial activator of specific serotonin and dopamine receptors, which are the target of many antipsychotic drugs.

Taken orally with or without food, the dosage for Rexulti starts at 1 mg daily. This is built up over two weeks to the required dose, which usually lies between 2 – 4 mg daily. However, for patients with liver or kidney problems, the dosage is capped at 3 mg to prevent further complications.

Rexulti is known to interact with other drugs; therefore, healthcare providers must be aware of other medications a patient may be taking.

What Are Some of the Breakthrough Clinical Trials Involving Rexulti?

2014: a clinical trial that tested the effect of Rexulti in 636 patients with acute schizophrenia. Sponsored by Otsuka Pharmaceutical, this study found that patients given dosages of 2 and 4 mg per day of brexpiprazole showed acceptable tolerability and significant effectiveness in managing the symptoms of acute schizophrenia.

2023: An ongoing clinical trial for FDA approval, sponsored by the pharmaceutical companies Ostuka and Lundbeck, is studying the short-term safety and effectiveness of Rexulti monotherapy in patients aged 13 – 17 with schizophrenia. 315 patients are enrolled and have been divided into three groups. The first is being treated with only brexpiprazole, the second is being treated with aripiprazole, and the third is a placebo. Currently in its third phase, this trial will be completed in 2023.