Business Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Speciality Dialogues
    • Education Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Business Medical Dialogues
    • News
        • Financial Results
        • Hospitals & Diagnostics
        • IT / Health Venture
        • Implants / Devices
        • Insurance
        • Key Movement
        • Pharmaceuticals
        • Policy
        • Technology
        • pharma-news
    • blog
    LoginRegister
    Business Medical Dialogues
    LoginRegister
    • Home
    • News
      • Financial Results
      • Hospitals & Diagnostics
      • IT / Health Venture
      • Implants / Devices
      • Insurance
      • Key Movement
      • Pharmaceuticals
      • Policy
      • Technology
      • pharma-news
    • blog
    • Home
    • Latest News
    • Zydus gets FDA nod for...

    Zydus gets FDA nod for phase II clinical trial of Saroglitazar

    Written by savita thakur thakur Published On 2016-06-09T11:48:04+05:30  |  Updated On 9 Jun 2016 11:48 AM IST
    Zydus gets FDA nod for phase II clinical trial of Saroglitazar

    NEW DELHI: Drug firm Zydus Cadila said it has received approval from the US health regulator to initiate a phase II clinical trial of Saroglitazar in patients with non-alcoholic steatohepatitis (NASH) of the liver.


    The company has received nod from the US Food and Drug Administration (USFDA) to conduct randomised, double-blind phase II trial to evaluate Saroglitazar in strengths of 1mg, 2mg and 4mg versus placebo, Zydus Cadila said in a statement.


    "NASH is an area of unmet healthcare need as there are no drugs approved for the treatment of NASH. Saroglitazar has significant and differentiated effect on hepatic steatosis, while it shows all other beneficial effects on reducing inflammation and fibrosis in the liver in NASH models," Zydus Cadila CMD Pankaj Patel said.


    With a phase III trial in biopsy proven NASH patients ongoing in India and a phase II trial in NASH patients planned in USA, the company is committed towards developing this drug for millions of patients suffering from NASH, he added.


    NASH is the area of significant unmet medical need in the US with an estimated 6.5 million adults in the country and five major European countries having advanced NASH.


    NASH is a liver disease in which fat accumulates in the liver. The diagnosis of NASH is most commonly carried out using liver biopsy and this condition can progress to cirrhosis and liver failure. Liver transplantation is the only treatment for advanced cirrhosis with liver failure.


    Biotech Analysts estimate the worldwide market for NASH medicines to reach USD 35-40 billion by 2025.

    NASHnon-alcoholic steatohepatitisphase II clinical trialphase III trialSaroglitazarUS Food and Drug AdministrationUSFDA
    Source : PTI

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    savita thakur thakur
    savita thakur thakur
      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      Popular Stories

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 13 Oct 2022 5:14 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok