Inventiva Presents Five Lanifibranor Abstracts At Paris MASH 2026

With NATiV3 Phase 3 topline data expected in Q4 2026, Inventiva's presentation of five lanifibranor abstracts at the 12th Paris MASH Meeting on September 10–11 adds a substantive clinical and preclinical evidence base that formulators, CMC leads, and regulatory teams will need to track as the program approaches a potential submission inflection point.

The five poster presentations, delivered at the Institut Pasteur in Paris, draw on Phase 1 and Phase 2 clinical data alongside preclinical studies to characterize lanifibranor's balanced pan-PPAR pharmacology. Clinical findings demonstrated direct PPAR target engagement, evidenced by increases in adiponectin, alongside improvements in insulin sensitivity, glycemic control, lipid parameters, and selected cardiovascular risk factors. Effects were observed in patients with and without Type 2 diabetes, broadening the potential label population under evaluation.

A separate preclinical dataset addressed a class-level concern that will be relevant to any regulatory reviewer familiar with thiazolidinedione (TZD) and dual PPARα/γ agonist history: fluid retention and cardiac safety signals. Inventiva's data characterize lanifibranor's partial PPARγ activation as the mechanism underlying a differentiated fluid and cardiovascular profile relative to full and dual PPAR agonists. For QA and regulatory leads, this mechanistic distinction carries weight in benefit-risk documentation and will likely surface in any 21 CFR Part 314 or EMA submission narrative.

Lanifibranor is an orally available small molecule targeting all three PPAR isoforms with moderate and balanced activation of PPARα and PPARδ, and partial activation of PPARγ. It remains the only pan-PPAR agonist in clinical development for MASH, a disease area where no oral small molecule has yet achieved broad regulatory approval. The NATiV3 trial is enrolling patients with moderate to advanced fibrosis, the histological severity threshold that has defined approvable endpoints in recent MASH guidance from both FDA and EMA.

The Q4 2026 topline readout from NATiV3 will determine whether the mechanistic and early-phase clinical signals presented in Paris translate into the histological endpoints required for registration.

Source: Inventiva via GlobeNewswire, September 8, 2026.