France-based Inventiva S.A. and China’s Chia Tai Tianqing have successfully filed a clinical trial application with the Center for Drug Evaluation (CDE) for the Category 1 drug lanifibranor. The submission has been accepted for review, marking a significant step forward in the development of this promising treatment.
Licensing and Regulatory Milestones
Lanifibranor, an oral peroxisome proliferator-activated receptor (PPAR) agonist, is designed to treat non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The drug was the centerpiece of a licensing agreement between Inventiva and Chia Tai Tianqing in September of the previous year. Chia Tai Tianqing holds the development, manufacturing, and commercialization rights for Greater China. Lanifibranor has already achieved breakthrough therapy designation (BTD) and fast-track statuses in the United States, highlighting its potential in the global market.
Clinical Trial Results and Future Studies
Lanifibranor has demonstrated excellent safety and tolerability across multiple ongoing clinical trials. In the Phase IIb NATIVE trial, a dosage of 1200 mg/day of lanifibranor for 24 weeks significantly reduced the SAF-A (activity of steatosis, activity, and fibrosis) score in obese patients with biopsy-confirmed NASH. The trial also met several secondary endpoints, further validating the drug’s efficacy. According to ClinicalTrials.gov, lanifibranor is currently undergoing multiple late-stage clinical trials, including Phase III trials for NASH and stage II or III hepatic fibrosis, as well as a Phase II study for NASH or NAFLD with type 2 diabetes.-Fineline Info & Tech
