This section highlights FDA-related milestones and regulatory updates for drugs developed by Inventiva (IVA).
Over the past two years, Inventiva has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Lanifibranor and NATiV3. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Lanifibranor - FDA Regulatory Timeline and Events
Lanifibranor is a drug developed by Inventiva for the following indication: Nonalcoholic steatohepatitis (NASH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lanifibranor
- Announced Date:
- July 2, 2025
- Indication:
- Nonalcoholic steatohepatitis (NASH)
Announcement
Inventiva announces the publication in Journal of Hepatology Reports, a peer-reviewed, scientific journal, of results from the Phase 2b NATIVE clinical trial and preclinical study evaluating the effects of lanifibranor on liver sinusoidal endothelial cells in Metabolic dysfunction-associated steatotic liver disease ("MASLD") and MASH.
AI Summary
Inventiva announced that results from its Phase 2b NATIVE clinical trial and an accompanying preclinical study have been published in the peer-reviewed Journal of Hepatology Reports. The studies focused on lanifibranor’s effects on liver sinusoidal endothelial cells (LSECs) in patients with Metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). Researchers observed that LSEC capillarization—a change linked to liver fibrosis and inflammation—appears early in the disease. In patients with MASH, this capillarization was even more pronounced, while those treated with lanifibranor showed improvement compared to placebo. Additionally, preclinical models revealed that lanifibranor not only reversed capillarization but also normalized portal pressure and intrahepatic vascular resistance, outperforming single PPAR agonists. These findings support lanifibranor’s promise as a comprehensive pan-PPAR agonist therapy to slow disease progression and potentially prevent cirrhosis.
Read Announcement- Drug:
- Lanifibranor
- Announced Date:
- April 24, 2025
- Indication:
- Nonalcoholic steatohepatitis (NASH)
Announcement
Inventiva announced publication in the peer-reviewed medical journal Clinical Gastroenterology and Hepatology, of its analysis on new non-invasive biomarker signatures predictive of histology response following treatment with lanifibranor in patients with MASH and fibrosis.
AI Summary
Inventiva recently published an analysis in the peer-reviewed journal Clinical Gastroenterology and Hepatology, focusing on new non-invasive biomarker signatures. The study examined blood markers in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis to predict their histological response to lanifibranor treatment. The developed signatures target improvements in fibrosis, resolution of MASH, or a combination of both and showed high predictive accuracy, with AUROC values above 0.80. These results suggest that the new scores outperform traditional diagnostic methods such as FIB4 and NFS in identifying treatment responders.
The findings highlight a promising non-invasive approach for evaluating treatment response, potentially guiding better clinical decisions. Inventiva intends to refine these composite biomarker scores further during its Phase 3 clinical trial, aiming to enhance personalized care for patients with liver disease and select those most likely to benefit from lanifibranor.
Read Announcement- Drug:
- Lanifibranor
- Announced Date:
- April 1, 2025
- Indication:
- Nonalcoholic steatohepatitis (NASH)
Announcement
Inventiva announced the completion of patient enrollment in its NATiV3 Phase 3 clinical trial with the randomization of the last patient in the main cohort.
AI Summary
Inventiva announced a major milestone in its NATiV3 Phase 3 clinical trial. The company has successfully randomized the last patient in the main cohort, completing enrollment for this part of the study. A total of 1009 patients have been enrolled in the main cohort, along with 410 patients in the exploratory cohort, exceeding the original targets. This achievement marks a significant step forward in the evaluation of lanifibranor, Inventiva’s lead candidate for treating metabolic dysfunction-associated steatohepatitis (MASH).
Topline results for the trial are expected in the second half of 2026. If the findings are positive, they could form the basis for a regulatory approval submission. The company expressed gratitude to patients, investigators, and all clinical trial staff for their contributions to reaching this important milestone.
Read Announcement- Drug:
- Lanifibranor
- Announced Date:
- November 15, 2024
- Indication:
- Nonalcoholic steatohepatitis (NASH)
Announcement
Inventiva announced the presentation of the final analysis of LEGEND, Phase 2 proof-of-concept clinical trial, evaluating lanifibranor in combination with empagliflozin in patients with MASH and Type 2 Diabetes (T2D).
AI Summary
Inventiva announced it will present the final analysis of the LEGEND Phase 2 trial at AASLD The Liver Meeting® in San Diego on November 18, 2024. The trial evaluated lanifibranor both as a single treatment and in combination with empagliflozin for patients with metabolic dysfunction-associated steatohepatitis (MASH) and type 2 diabetes (T2D). The study met its primary goal by significantly lowering HbA1c levels compared to placebo. Notably, 50% of patients achieved an HbA1c under 6.5% at week 24, with 58% of the lanifibranor-only group and 80% of the combination group experiencing at least a 1% decrease. The combination therapy also helped mitigate weight gain seen with lanifibranor alone. Inventiva’s Chief Medical Officer expressed optimism that these findings support a new treatment approach for managing both liver disease and T2D.
Read Announcement- Drug:
- Lanifibranor
- Announced Date:
- May 13, 2024
- Indication:
- Nonalcoholic steatohepatitis (NASH)
Announcement
Inventiva announced the publication in the peer-reviewed scientific journal Nature Communications of additional results from its NATIVE Phase IIb clinical trial demonstrating the improvement of markers of cardiometabolic health in patients with MASH/NASH treated with lanifibranor.
AI Summary
Inventiva announced new encouraging findings from its NATIVE Phase IIb clinical trial. The results, recently published in the peer‐reviewed journal Nature Communications, show that treatment with lanifibranor improved markers of cardiometabolic health in patients with MASH/NASH. These findings are significant because patients with metabolic-associated steatohepatitis (MASH) or nonalcoholic steatohepatitis (NASH) are at a higher risk for developing cardiovascular problems. By demonstrating that lanifibranor can contribute to better cardiometabolic profiles, the study supports its potential as a treatment option that addresses both liver and heart issues simultaneously. The publication in a respected scientific journal highlights the robustness of the trial data and the interest of the medical community in new treatments that target complex metabolic conditions.
Read Announcement
NATiV3 - FDA Regulatory Timeline and Events
NATiV3 is a drug developed by Inventiva for the following indication: In adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NATiV3
- Announced Date:
- July 5, 2024
- Indication:
- In adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis.
Announcement
Inventiva provided an update on its clinical program evaluating lanifibranor for the treatment of MASH/NASH and its financial position.
AI Summary
Inventiva provided an update on its clinical program for lanifibranor in the treatment of MASH/NASH. In its NATiV3 Phase III trial, the company is successfully recruiting patients, with about 82% of the main cohort enrolled to date. Early data show that the weight gain observed in patients appears to plateau between weeks 24 and 36, a promising finding compared to other treatments. Moreover, Inventiva has strengthened its intellectual property by securing a new patent that could protect lanifibranor until 2043.
On the financial front, the company announced that its cash, cash equivalents, and deposits are expected to fund operations through mid-July 2024. However, Inventiva is actively pursuing additional financing options, including a potential royalty-based deal, to extend its cash runway and further advance lanifibranor toward market approval.
Read Announcement- Drug:
- NATiV3
- Announced Date:
- May 16, 2024
- Indication:
- In adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis.
Announcement
Inventiva announced the positive recommendation from the fourth scheduled meeting of the Data Monitoring Committee ("DMC") to continue the NATiV3 Phase III clinical trial evaluating lanifibranor in patients with MASH/NASH without modification to the current trial protocol.
AI Summary
Inventiva announced that the Data Monitoring Committee (DMC), during its fourth scheduled meeting, gave a positive recommendation to continue the NATiV3 Phase III clinical trial. The trial, which tests lanifibranor in patients with MASH/NASH, will proceed without any modifications to the existing trial protocol. This decision indicates that the current data supports the ongoing evaluation of lanifibranor’s safety and effectiveness in treating this form of liver disease. The independent review by the DMC reassures that the trial is being conducted safely and that the treatment remains a promising option for patients battling MASH/NASH. Inventiva’s announcement emphasizes the commitment to carefully study the drug under the established robust protocol while gathering more data on its potential benefits and risks. This development marks a significant step forward in the clinical evaluation process for treating these liver conditions.
Read Announcement
