Reviewed by Michael Gill, B. Sc.
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Most Recent Xofluza Clinical Trials

What Are Xofluza Clinical Trials?

Xofluza (baloxavir marboxil) is an antiviral drug tested to treat influenza (flu). Xofluza clinical trials are research studies in which Xofluza is given to people to determine if it is a safe and effective treatment.

The U.S. Food and Drug Administration (FDA) approved Xofluza for the treatment of influenza in 2018. Previous influenza treatments were only able to lessen symptoms and shorten the duration of the flu by a day or two. Still, Xofluza is effective in just one day.

More clinical trials may be needed to evaluate Xofluza's long-term safety and effectiveness. Xofluza clinical trials are necessary because they help researchers learn more about Xofluza and how well it works in different populations.

Why Is Xofluza Being Studied in Clinical Trials?

Xofluza is being studied in clinical trials because it is a new medication. Its long-term safety and effectiveness are not yet known. Xofluza may have different side effects than other influenza treatments.

The drug may also work differently with different people. Researchers must study Xofluza in a clinical trial to understand these possible differences. This includes healthy and unhealthy populations. The drug is studied for different populations, including adults, adolescents, and children.

In addition, Xofluza is being studied in people with different types of influenza, including those with the flu and pneumonia. Xofluza may also be effective in treating other respiratory viruses, such as the common cold. It has also recently been tested for use on COVID-19 patients but was proven to be noneffective.

How Does Xofluza Work?

Xofluza works by inhibiting the polymerase acidic (PA) protein. This protein is necessary for influenza viruses to replicate. Xofluza prevents the replication of the virus and stops the infection from spreading.

In addition, Xofluza has been shown to reduce the amount of virus in the respiratory tract. This helps to reduce the severity of symptoms and shorten the duration of the flu.

The drug is more effective when taken within 48 hours of the onset of symptoms. Xofluza may be less effective if it is started later than 48 hours after symptom onset.

What Are Some of The Breakthrough Clinical Trials Involving Xofluza?

Some of the breakthrough clinical trials involving Xofluza include:

2018: This study was one of the first significant studies testing the use of Xofluza in adult and adolescent populations. Its results showed that with just one dose, patients had a shorter duration of the flu, and their symptoms were less severe than with a placebo. However, there was evidence for decreased susceptibility to Baloxavir after treatment.

2019: A study showed that Xofluza is effective at shortening and alleviating symptoms of influenza virus compared to a placebo. The study also concluded that Xofluza was effective against virus types, subtypes, and pharmacokinetic and pharmacodynamic analysis.

2020: Another study showed that a single-dose treatment of Xofluza was effective at treating acute influenza in children under 12 years of age. This proved that Balozavir could be used to help alleviate symptoms of acute influenza in healthy children populations.

Who Are The Key Opinion Leaders On Xofluza Clinical Trial Research?

Dr. Frederick G. Hayden - Professor of Medicine at the University of Virginia School of Medicine. His specialties include infectious diseases and international health. His research is testing antiviral agents to prevent and treat respiratory viral infections.

Dr. Arnold S. Monto - Professor of Epidemiology at the University of Michigan School of Public Health. He is a Professor of Epidemiology and Global Public Health. He is also the Acting Chair of the FDA's Vaccines and Related Biological Products Advisory Committee. His research interests are the prevention and treatment of influenza, epidemiology of respiratory infections, and infectious disease epidemiology.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

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