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Hydronidone - Gyre Therapeutics

Drug Profile

Hydronidone - Gyre Therapeutics

Alternative Names: F-351

Latest Information Update: 16 May 2024

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At a glance

  • Originator Shanghai Genomics
  • Developer Beijing Continent Pharmaceutical; 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Hepatic fibrosis
  • No development reported Non-alcoholic steatohepatitis; Renal failure
  • Discontinued Pulmonary fibrosis

Most Recent Events

  • 09 May 2024 Gyre Therapeutics announces intention to submit IND application to US FDA for Non-alcoholic Steatohepatitis by the end of 2024
  • 11 Apr 2024 Gyre Therapeutics intends to submit the National Medical Products Administration’s (NMPA) application for Hydronidone (F 351) in the People's Republic of China (PRC) in early 2025
  • 26 Mar 2024 Adverse events data from a phase I trial in volunteers released by Gyre Therapeutics
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