Gyre Pharmaceuticals has completed participant enrolment for its 52-week Phase III clinical trial assessing Pirfenidone capsules to treat pneumoconiosis.
This randomised, multicentre, placebo-controlled, double-blind trial, which is being conducted across 18 clinical research centres in China, has enrolled 272 participants.
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It aims to evaluate the safety and efficacy of Pirfenidone capsule treatment in subjects with the chronic occupational lung disease pneumoconiosis, marked by progressive pulmonary fibrosis.
The trial will evaluate the capsules at a daily dosage of 1,800mg (600mg administered three times daily) in comparison to a placebo over a period of 52 weeks.
The primary endpoint focuses on the change from baseline in the percentage predicted forced vital capacity at week 52.
Key secondary endpoints encompass alterations in the diffusing capacity of the lungs for carbon monoxide, St George’s Respiratory Questionnaire score, six-minute walk distance and the Modified Medical Research Council dyspnoea scale, as well as the rates of mortality, acute exacerbations and hospitalisations.
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By GlobalDataSafety monitoring is based on Gyre’s development safety update report, which covers December 2023 to December 2024.
The majority of reported adverse events are classified as mild to moderate, with no unexpected safety signals identified.
Pirfenidone is an oral antifibrotic small molecule that was approved by Gyre Pharmaceuticals in China in 2011 for the treatment of idiopathic pulmonary fibrosis. This medication works by inhibiting TGF-β signalling and fibroblast proliferation.
Pneumoconiosis continues to be the most prevalent occupational disease in the country, impacting more than 450,000 individuals, with thousands of new cases reported annually.
This condition arises from the prolonged inhalation of mineral dusts such as silica and coal, leading to progressive fibrosis and chronic inflammation of lung tissue.
