IVA-337 Market Summary

Key Factors Driving IVA-337 Growth

• Strong Phase IIb Efficacy With Both FDA Histology Endpoints Achieved

Lanifibranor became one of the first MASH candidates to demonstrate statistically significant improvement in both key FDA-relevant histologic endpoints in a Phase IIb trial.

In the NATIVE Phase IIb study:

1. 49% of patients receiving 1200 mg/day achieved the primary endpoint versus 27% on placebo

2. The drug demonstrated both:

o NASH resolution without worsening fibrosis

o Fibrosis improvement without worsening NASH

The results were subsequently published in the New England Journal of Medicine, significantly increasing scientific credibility and investor confidence.

• Large and Rapidly Expanding MASH Market Opportunity

MASH/NASH represents one of the largest unmet needs in hepatology, with millions of patients globally progressing toward cirrhosis, liver failure, and transplantation.

Lanifibranor is being positioned for patients with:

1. Non-cirrhotic MASH

2. Fibrosis stages F2/F3

3. Metabolic comorbidities such as type 2 diabetes

The approval of Rezdiffra validated the commercial potential of the MASH market and increased attention on next-generation oral therapies with stronger fibrosis benefits.

• Fully Enrolled Phase III NATiV3 Trial De-Risks Development Pathway

Inventiva announced in April 2025 that the pivotal Phase III NATiV3 trial completed enrollment with:

1. 1,009 patients in the main cohort

2. 410 patients in the exploratory cohort

3. Enrollment exceeding the original target numbers

Topline Phase III results are expected in the second half of 2026, and positive data could support:

• U.S. accelerated approval
• EU conditional approval

Completion of enrollment substantially reduces operational uncertainty and improves investor visibility into the regulatory timeline.

• Differentiated Pan-PPAR Mechanism May Provide Broader Metabolic Benefits

Unlike therapies targeting a single metabolic pathway, lanifibranor activates:

1. PPAR-α

2. PPAR-δ

3. PPAR-γ

This broad mechanism may provide:

• Anti-inflammatory activity
• Anti-fibrotic effects
• Improved insulin sensitivity
• Lipid metabolism benefits

In diabetic MASH patients, lanifibranor demonstrated improvements in glycemic parameters in addition to liver histology, which may become commercially important because a large proportion of MASH patients also have obesity and type 2 diabetes.

• Favorable Safety and Long-Term Tolerability Profile

Multiple independent Data Monitoring Committee (DMC) reviews recommended continuation of the Phase III NATiV3 study without protocol modification.

The fifth DMC review in 2024 evaluated safety data from more than:

1. 1,000 randomized patients

2. Including over 800 patients treated >24 weeks

Inventiva stated that these reviews continue confirming the “good safety profile” of lanifibranor, an important factor in chronic metabolic disease therapy adoption.

IVA-337 Recent Developments

Inventiva, an emerging biopharmaceutical company developing innovative therapies notably to treat especially fibrosis, announced the beginning of patient enrollment for its Phase IIb clinical trial (NATIVE - NASH Trial to Validate IVA337 Efficacy) evaluating the Company’s lead compound, IVA337, for the treatment of Non-Alcoholic Steatohepatitis (NASH).

“IVA-337 Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of IVA-337 for potential indication like Fibrosis, Non-alcoholic steatohepatitis, Non-alcoholic fatty liver disease, and Type 2 diabetes mellitus in the 7MM. A detailed picture of IVA-337’s existing usage in anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the IVA-337 for potential indications. The IVA-337 market report provides insights about IVA-337’s sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current IVA-337 performance, future market assessments inclusive of the IVA-337 market forecast analysis for potential indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of IVA-337 sales forecasts, along with factors driving its market.

IVA-337 Drug Summary

IVA-337 is an investigational oral pan-peroxisome proliferator-activated receptor (PPAR) agonist developed by Inventiva Pharma for the treatment of metabolic and fibrotic diseases, particularly metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH). The drug activates all three PPAR isoforms—PPAR-α, PPAR-δ, and PPAR-γ—helping regulate lipid metabolism, glucose homeostasis, inflammation, and fibrosis, thereby addressing multiple underlying mechanisms involved in progressive liver disease. Administered orally once daily, IVA-337 has demonstrated promising efficacy in reducing liver inflammation and fibrosis progression while improving metabolic parameters in patients with MASH/NASH. In the Phase IIb NATIVE trial, lanifibranor achieved significant improvements in steatohepatitis resolution and fibrosis markers compared with placebo, supporting its advancement into the pivotal Phase III NATiV3 study. The therapy has received Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration for MASH/NASH with fibrosis, and ongoing studies continue to evaluate its long-term efficacy, cardiovascular benefits, and safety profile, which has generally included gastrointestinal adverse events, weight gain, and peripheral edema. The report provides IVA-337’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the IVA-337 Market Report

The report provides insights into:

• A comprehensive product overview including the IVA-337 MoA, description, dosage and administration, research and development activities in potential indication like Fibrosis, Non-alcoholic steatohepatitis, Non-alcoholic fatty liver disease, and Type 2 diabetes mellitus.
• Elaborated details on IVA-337 regulatory milestones and other development activities have been provided in IVA-337 market report.
• The report also highlights IVA-337‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in potential indications across the United States, Europe, and Japan.
• The IVA-337 market report also covers the patents information, generic entry and impact on cost cut.
• The IVA-337 market report contains current and forecasted IVA-337 sales for potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The IVA-337 market report also features the SWOT analysis with analyst views for IVA-337 in potential indications.

Methodology

The IVA-337 market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

IVA-337 Analytical Perspective by DelveInsight

• In-depth IVA-337 Market Assessment

This IVA-337 sales market forecast report provides a detailed market assessment of IVA-337 for potential indication like Fibrosis, Non-alcoholic steatohepatitis, Non-alcoholic fatty liver disease, and Type 2 diabetes mellitus in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted IVA-337 sales data uptil 2034.

• IVA-337 Clinical Assessment

The IVA-337 market report provides the clinical trials information of IVA-337 for potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

IVA-337 Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

IVA-337 Market Potential & Revenue Forecast

• Projected market size for the IVA-337 and its key indications
• Estimated IVA-337 sales potential (IVA-337 peak sales forecasts)
• IVA-337 Pricing strategies and reimbursement landscape

IVA-337 Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• IVA-337 Market positioning compared to existing treatments
• IVA-337 Strengths & weaknesses relative to competitors

IVA-337 Regulatory & Commercial Milestones

• IVA-337 Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

IVA-337 Clinical Differentiation

• IVA-337 Efficacy & safety advantages over existing drugs
• IVA-337 Unique selling points

IVA-337 Market Report Highlights

• In the coming years, the IVA-337 market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The IVA-337 companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence IVA-337’s dominance.
• Other emerging products for Fibrosis, Non-alcoholic steatohepatitis, Non-alcoholic fatty liver disease, and Type 2 diabetes mellitus are expected to give tough market competition to IVA-337 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of IVA-337 in potential indications.
• Analyse IVA-337 cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted IVA-337 sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of IVA-337 in potential indications.

Key Questions

• What is the class of therapy, route of administration and mechanism of action of IVA-337? How strong is IVA-337’s clinical and commercial performance?
• What is IVA-337’s clinical trial status in each individual indications such as Fibrosis, Non-alcoholic steatohepatitis, Non-alcoholic fatty liver disease, and Type 2 diabetes mellitus and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the IVA-337 Manufacturers?
• What are the key designations that have been granted to IVA-337 for potential indications? How are they going to impact IVA-337’s penetration in various geographies?
• What is the current and forecasted IVA-337 market scenario for potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of IVA-337 in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to IVA-337 for potential indications?
• Which are the late-stage emerging therapies under development for the treatment of potential indications?
• How cost-effective is IVA-337? What is the duration of therapy and what are the geographical variations in cost per patient?