Drug intelligence / Profile preview

lanifibranor + empagliflozin

Development stage
Phase 2
Lead developer
Inventiva
Modality
Small Molecules
Administration
Oral
01

Overview

**lanifibranor + empagliflozin** is a fixed-dose combination of two orally administered small molecules under clinical evaluation for the treatment of metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) in patients with type 2 diabetes. - **Lanifibranor** is a moderate, balanced pan-PPAR agonist that activates all three peroxisome proliferator-activated receptor isoforms (PPARα, PPARδ, and PPARγ), inducing anti-inflammatory, antifibrotic, and vascular-metabolic effects. - **Empagliflozin** is a selective sodium-glucose cotransporter-2 (SGLT2) inhibitor that lowers blood glucose by promoting urinary glucose excretion and has proven cardiometabolic benefits in type 2 diabetes and heart failure. In the LEGEND Phase II trial, the combination showed significant improvements in glycemic control (HbA1c), hepatic steatosis, markers of liver injury, and cardiometabolic parameters, and maintained stable weight, with favorable tolerability over 24 weeks in patients with non-cirrhotic MASH and type 2 diabetes[1][3][4][5][6]. The combination leverages complementary mechanisms: lanifibranor's pan-PPAR activity targets fibrosis, inflammation, and metabolism, while empagliflozin enhances glucose control and reduces weight-related risks[1][3][5].

02

Targets

NHE1 (Sodium/hydrogen exchanger 1)NHE3 (Sodium/hydrogen exchanger 3)PPARA (Peroxisome proliferator-activated receptor alpha)PPARG (Peroxisome proliferator-activated receptor gamma)PPARD (Peroxisome proliferator–activated receptor delta)SGLT2 (Sodium-glucose cotransporter protein subunit 2)

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