Inventiva Completes Last Patient Visit in NATiV3 Phase 3 Trial

With all 1,009 patients in the main cohort having completed their 72-week treatment period, Inventiva is now on a direct path toward a potential NDA submission in H1 2027, a timeline that puts CMC teams and contract manufacturing partners on notice for commercial-scale GMP readiness well ahead of a targeted 2028 U.S. launch.

The NATiV3 trial, a randomized, double-blind, placebo-controlled Phase 3 study, evaluated lanifibranor at 800 mg and 1,200 mg daily doses in adults with biopsy-proven, non-cirrhotic MASH and F2/F3 liver fibrosis. Histological endpoints include MASH resolution and at least one-stage fibrosis improvement at 72 weeks. An exploratory cohort of 410 patients spanning F1 through F4 fibrosis stages ran in parallel, broadening the dataset beyond the primary registration population.

Topline results are expected in Q4 2026. If the data support regulatory submission, Inventiva has indicated it will file with the FDA in the first half of 2027. For QA directors and regulatory affairs leads, the interval between a Q4 readout and an H1 2027 submission is narrow, process validation packages, stability data, and CMC documentation will need to be substantially complete before topline data are in hand.

Lanifibranor is a pan-PPAR agonist, a mechanism that addresses MASH through both intrahepatic and extrahepatic pathways. The compound's Phase 2b NATIVE trial previously demonstrated improvements in both MASH resolution and fibrosis endpoints, providing the clinical rationale for the Phase 3 design. No approved oral small-molecule therapy for MASH currently exists in the U.S. market, which shapes the regulatory context: FDA review under a novel indication will carry heightened scrutiny of the benefit-risk profile and the robustness of histological endpoint data.

Plant heads at potential contract manufacturing organizations should note that a 2028 commercial launch, contingent on FDA approval, implies process performance qualification and commercial batch manufacturing timelines beginning no later than mid-2027, assuming a standard review cycle and no requests for additional data.

The NATiV3 topline readout in Q4 2026 will be the first measurable checkpoint determining whether Inventiva's regulatory and manufacturing preparation moves from contingency planning to active execution.

Source: Inventiva via GlobeNewswire, 2 September 2026.