Hydronidone

Drug Profile

Hydronidone

Alternative Names: F-351

Latest Information Update: 10 Oct 2017

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At a glance

  • Originator Shanghai Genomics
  • Class Antifibrotics; Nonsteroidal anti-inflammatories; Small molecules
  • Mechanism of Action Collagen inhibitors; Fibroblast growth factor inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Hepatic fibrosis
  • Preclinical Renal failure
  • Discontinued Pulmonary fibrosis

Most Recent Events

  • 09 Oct 2017 GNI USA plans an open-label phase I trial to determine safety, tolerability and pharmacokinetics of single and repeated doses of hydronidone in USA in early 2018
  • 29 Sep 2017 GNI USA receives the US FDA clearance for the Investigational New Drug application for clinical trials in Hepatic fibrosis in USA
  • 11 Mar 2016 Preclinical trials in Hepatic fibrosis in USA (PO) before March 2016
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