WXFL10203614 / Wuxi Fuxin - LARVOL DELTA

Wuxi Fuxin WXFL10203614 tablets started Phase I clinical trial for moderate to severe active rheumatoid arthritis [Google translation] (Sina Corp) - "Data from the Drug Clinical Trial Registration and Information Disclosure Platform show that Wuxi Fuxin Pharmaceutical Research and Development Co., Ltd. has initiated a Phase I clinical trial of [14C] WXFL10203614 in healthy adult male subjects in China. The clinical trial registration number is CTR20252506, and the first public information date is July 2, 2025...The primary endpoints of this trial include the total radioactivity recovery rate and cumulative total radioactivity recovery rate at each time interval in excreta (urine and feces); total radioactivity pharmacokinetic parameters in plasma; percentage of parent drug and its metabolites in plasma to total radioactivity exposure in plasma, etc. Secondary endpoints include pharmacokinetic parameters of WXFL10203614 and its metabolites in plasma; safety endpoints (adverse events, physical examination, etc.)....Currently, the experiment is in progress (not yet recruited), with a target enrollment of 8 people."

Trial status • Rheumatoid Arthritis

The first drug clinical trial project of Henan Provincial Third People's Hospital - Phase II clinical trial of atopic dermatitis in dermatology was officially launched (Dingxiangyuan (DXY)) - "...The Third People's Hospital of Henan Province The first drug clinical trial project: the Phase II randomized, double-blind, multicenter, placebo-controlled clinical trial project of WXFL10203614 tablets for the treatment of moderate to severe atopic dermatitis (AD) was launched in the conference room on the fifth floor of the East Campus."

New P2 trial • Atopic Dermatitis

The effect of food on the pharmacokinetics of WXFL10203614, a potential selective JAK1 inhibitor, in healthy Chinese subjects. (PubMed, Front Pharmacol) - "It was well tolerated under fasted and fed conditions in healthy Chinese subjects, so WXFL10203614 could be administered orally with or without food. Clinical Trial Registration: http://www.chinadrugtrials.org.cn/index.html, identifier CTR20191636."

Journal • PK/PD data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Safety, tolerability and pharmacokinetics of WXFL10203614 in healthy Chinese subjects: A randomized, double-blind, placebo-controlled phase Ⅰ study. (PubMed, Front Pharmacol) - " WXFL10203614 exhibited good safety, tolerability and favorable PK profiles in healthy Chinese subjects, supporting further clinical development in patients with rheumatoid arthritis. Clinical Trials Registration Number: http://www.chinadrugtrials.org.cn/index.html, #CTR20190069 and CTR20200143."

Clinical • Journal • PK/PD data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology