Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter, Entecavir-based, Phase IIIb Clinical Trial of Hydronidone Capsule in the Treatment of Liver Fibrosis Associated With Chronic Hepatitis B

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 15 Jan 2026

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At a glance

05 Jan 2026 According to a Gyre Therapeutics media release, company plans to submit an NDA in the first half of 2026 and conduct a confirmatory clinical trial to support full approval in China.
05 Jan 2026 According to a Gyre Therapeutics media release, as part of the agreed regulatory pathway, the company plans to conduct an additional confirmatory clinical trial (referred to as a Phase 3c trial in China) designed to evaluate liver-related clinical outcomes to support potential conversion from conditional approval to regular approval.
15 Jan 2024 Status changed from not yet recruiting to recruiting.

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