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Lanifibranor is an orally available small molecule drug developed by Inventiva for the treatment of metabolic and fibrotic diseases, most notably non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatotic liver disease (MASLD). It is a pan-peroxisome proliferator–activated receptor (pan-PPAR) agonist, meaning it activates all three PPAR isoforms—PPAR-alpha, PPAR-delta, and PPAR-gamma. This balanced activation leads to anti-fibrotic, anti-inflammatory, vascular protective, and beneficial metabolic effects that are not achievable with single or dual PPAR agonists. Lanifibranor has received Breakthrough Therapy and Fast Track designations from the FDA for MASH/NASH. It is currently in Phase III clinical trials for NASH/fibrosis and has been investigated in other indications such as type 2 diabetes mellitus and idiopathic pulmonary fibrosis[1][4][6].
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