We value your privacy

We use cookies to enhance your browsing experience, serve personalized ads or content, and analyze our traffic. By clicking "Accept All", you consent to our use of cookies.

Customize Consent Preferences

We use cookies to help you navigate efficiently and perform certain functions. You will find detailed information about all cookies under each consent category below.

The cookies that are categorized as "Necessary" are stored on your browser as they are essential for enabling the basic functionalities of the site. ... 

Always Active

Necessary cookies are required to enable the basic features of this site, such as providing secure log-in or adjusting your consent preferences. These cookies do not store any personally identifiable data.

No cookies to display.

Functional cookies help perform certain functionalities like sharing the content of the website on social media platforms, collecting feedback, and other third-party features.

No cookies to display.

Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics such as the number of visitors, bounce rate, traffic source, etc.

No cookies to display.

Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.

No cookies to display.

Advertisement cookies are used to provide visitors with customized advertisements based on the pages you visited previously and to analyze the effectiveness of the ad campaigns.

No cookies to display.

18.189.28.82
dgid:
enl:
npi:0
-Advertisement-
-Advertisement-
Home Ersodetug granted breakthrough therapy designation for congenital hyperinsulinism
Endocrinology
FDA Alerts

Ersodetug granted breakthrough therapy designation for congenital hyperinsulinism

Posted on

The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to ersodetug (RZ358; Rezolute, Inc) for treating hypoglycemia associated with congenital hyperinsulinism (HI), according to a press release.

This designation highlights ersodetug’s potential to address a critical unmet need in managing this rare and life-threatening condition. It is based on promising results from the Phase 2b RIZE study, where the therapy safely reduced hypoglycemia by 75% or more without significant hyperglycemia.

Topline data from the ongoing Phase 3 sunRIZE trial is anticipated in the second half of 2025.

Read the full press release here.

Previous Article
Next Article
-Advertisement-
-Advertisement-

Contact

Grandin Library Building
Six Leigh Street
Clinton, New Jersey 08809

+908-505-8899
info@ihmholdings.com

Social Links

© 2025 Med Journal 360® is a trademark of International Healthcare Media, LLC. All rights Reserved
-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-