echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Biochemistry News > Biotechnology News > NASH's new drug is certified as GLP-1/GCCR dual agonist by FDA fast track qualification

    NASH's new drug is certified as GLP-1/GCCR dual agonist by FDA fast track qualification

    • Last Update: 2021-06-10
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    On June 2, Boehringer Ingelheim and Zealand Pharma jointly announced that the FDA has granted GLP-1/glucagon receptor (GCCR) dual agonist BI 456906 fast track designation for adult non-alcoholic steatohepatitis ( NASH).

    BI 456906 is derived from the natural intestinal hormone oxyntomodulin, which can activate GLP-1 and glucagon receptors that are essential for controlling metabolic functions.
    It is expected to become a new once-a-week dosing that is superior to existing therapies.
    treatment.
    The drug is part of Boehringer Ingelheim's research and development product portfolio in the field of cardiometabolic diseases, and its research indications also include diabetes and obesity.

    Currently, BI 456906 is conducting a randomized, double-blind, placebo-controlled Phase II clinical study (NCT04771273) to evaluate the efficacy of the drug in adult patients with NASH and liver fibrosis (F2/F3).
    In the trial, patients received subcutaneous injections of BI 456906 or placebo at different doses once a week.
    The primary endpoint was histological improvement of steatohepatitis without deterioration of fibrosis after 48 weeks of treatment.

    In China, Boehringer Ingelheim submitted a clinical application as early as December 22, 2020, and has launched an international multi-center phase 2 clinical trial for obese patients.

    Domestic progress of BI 456906 project

    From the Insight database (http://db.
    dxy.
    cn/v5/home/)

    Non-alcoholic steatohepatitis (NASH) is one of the main causes of liver fibrosis and cirrhosis.
    Its symptoms are usually asymptomatic or non-NASH-specific, making it difficult to diagnose.
    This is an area with unmet medical needs, and there are currently no approved treatments.

    Note: The original text has been deleted

    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.
    Related Articles

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent Echemi's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.