Trial Profile

A phase IIa proof of concept trial of F351 for the treatment of MASH-associated liver fibrosis

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 13 Jun 2025

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At a glance

10 Jun 2025 According to a Gyre Therapeutics media release, pre-IND meeting with the U.S. Food and Drug Administration is being planned for an expected Phase 2 trial in metabolic dysfunction-associated steatohepatitis (MASH) fibrosis.
29 May 2025 According to a Gyre Therapeutics media release, the company closed $ 23 million public offering proceeds from it will be used to advance this Phase 2 clinical trial of F351.
22 May 2025 According to a Gyre Therapeutics media release, the company expects to file an investigational new drug (IND) application in the third quarter of 2025 and, subject to IND clearance, plans to initiate this study in the second half of 2025.

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