Hydronidone - Gyre Therapeutics
Alternative Names: F-351Latest Information Update: 16 May 2024
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
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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