French research and development company Valbiotis has received approval from IntegReview, an independent review board (IRB) accredited by American health authorities, to conduct the REVERSE-IT trial in the US.

The REVERSE-IT trial is a Phase IIBl clinical study of Valedia for the treatment of Type 2 Diabetes.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The global, placebo-controlled trial seeks to determine the most efficient dose of Valedia on prediabetic subjects.

Altogether 150 prediabetic individuals will be enrolled in the trial, which will be carried out in two centres in the US in Miami, Florida and Chicago, Illinois.

Valbiotis CEO Sébastien Peltier said: “The acceleration of our development in the US marks the beginning of a key phase for Valbiotis.

"The acceleration of our development in the US marks the beginning of a key phase for Valbiotis."

“The authorisation from the American authorities for the Valedia clinical study supports our access to these markets, and in particular to the prediabetes market, which affects more than 86 million people in the US.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Valedia is capable of improving insulin sensitivity and seeks to reduce the risk of Type 2 Diabetes.

It has been developed for prediabetic individuals and will apply for a health claim issued by the authorities in the US, Canada and Europe.

In a Phase I/II clinical trial, Valedia has already showed safety and early evidence of efficacy.

In November last year, Valbiotis secured authorisation from the French National Agency for Medicines and Health Products (ANSM)to conduct the REVERSE-IT trial in France.

The company has also started discussions with the US Food and Drug Administration (FDA) for obtaining a health claim for Valedia in reducing the risk of Type 2 Diabetes.