Daix, France and New York, September 2, 2026
Inventiva announced that the last patient has completed the final 72-week visit in the company’s pivotal NATiV3 Phase 3 clinical trial evaluating lanifibranor in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate-to-advanced liver fibrosis. The completion of the final patient visit marks a significant development milestone for Inventiva as it moves toward the planned NATiV3 topline results in the fourth quarter of 2026. The trial enrolled 1,009 patients in its main cohort, while an additional 410 patients were enrolled in an exploratory cohort.
NATiV3 Completion Moves Lanifibranor Toward Topline Results
The NATiV3 Phase 3 study is a randomized, double-blind and placebo-controlled trial designed to evaluate the efficacy and safety of lanifibranor following 72 weeks of treatment. With the treatment period now completed by all patients, Inventiva is preparing for the next major catalyst: the topline clinical results expected in Q4 2026. Patients in the study also had the option to enter a 48-week open-label extension, providing additional information on the longer-term safety of lanifibranor. The company said the completion of NATiV3 represents an important step in its development program for a potential treatment for patients with non-cirrhotic MASH and F2/F3 fibrosis.
Inventiva Prepares for Potential 2027 Regulatory Submission
Following the expected NATiV3 topline readout, Inventiva stated that favorable results could support regulatory submissions in the first half of 2027. The company is also preparing for a potential U.S. launch of lanifibranor in 2028, subject to successful regulatory review and approval. Lanifibranor is an oral pan-PPAR agonist designed to activate all three PPAR isoforms and is being developed to address multiple disease processes associated with MASH, including inflammation, fibrosis and metabolic dysfunction. The candidate has received FDA Breakthrough Therapy and Fast Track designations, but remains investigational and has not been approved by any regulatory authority.
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Inventiva Announces September Investor and Financial Updates
Beyond the NATiV3 Phase 3 milestone, Inventiva will provide additional corporate updates during several healthcare investor conferences in September. Company executives are scheduled to participate in the Morgan Stanley 24th Annual Global Healthcare Conference on September 15, followed by the Stifel 2026 Virtual Cardiometabolic Forum and the Jefferies Healthcare C-Suite “Back to School” Series on September 30. Inventiva also revised the timing of its first-half 2026 financial results to September 28, 2026, with management scheduled to host an English-language conference call and Q&A session the same day. With NATiV3 now fully completed, the company’s focus shifts toward the Q4 2026 topline readout, which could become the next major milestone for lanifibranor and Inventiva’s MASH development strategy.
Source:Inventiva press relese
