Gyre Therapeutics Announces First Dosing in Phase 1 Trial of F230 for Pulmonary Arterial Hypertension
Gyre Therapeutics recently announced the first volunteer has been successfully dosed in a Phase 1 clinical trial evaluating F230, a novel endothelin A (ETA) receptor antagonist, for the treatment of pulmonary arterial hypertension (PAH).
This milestone marks Gyre’s entry into the PAH field, a rare, progressive, and high-mortality cardiovascular condition with limited treatment options. PAH is recognized in China’s National Rare Disease Catalog, underscoring its significance in public health. According to Frost & Sullivan, China’s PAH market was valued at $370 million in 2023 and is projected to grow to $480 million by 2031.
F230, originally discovered by Eisai Co., Ltd. and exclusively licensed by GNI Group Ltd. to Gyre, is a fully synthetic small molecule designed to selectively block the ETA receptor. By targeting this pathway, F230 is designed to reduce pulmonary vascular remodeling and lower pulmonary pressure, key contributors to PAH progression.
The Phase 1 trial is designed to evaluate safety, tolerability, and pharmacokinetics in healthy volunteers. The trial represents the latest expansion of Gyre’s fibrosis-first strategy beyond the liver, leveraging a robust clinical development platform and commercial infrastructure in China.
F230 joins Gyre’s pipeline alongside lead candidate Hydronidone (F351), which met the primary endpoint in a pivotal Phase 3 trial for CHB-fibrosis. A New Drug Application (NDA) submission to China’s National Medical Products Administration (NMPA) is planned for the third quarter of 2025, and a pre-IND meeting with the US FDA is being planned for an expected Phase 2 trial in metabolic dysfunction-associated steatohepatitis (MASH) fibrosis.
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis, including MASH, in the US. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.
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