Our
Focus
Understanding MASH
MASH
(without fibrosis)
MASH
(without fibrosis F1/F2)
MASH (F3)
MASH + compensated cirrhosis (F4CC)
MASH + decompensated cirrhosis
When excess fat accumulates in the liver, it triggers inflammation and cellular injury. Over time, the liver attempts to repair itself, generating fibrosis, scar tissue that progressively replaces healthy liver cells. Fibrosis is staged from F0 (no fibrosis) to F4 (cirrhosis). If scarring continues unchecked, the liver loses its ability to function, and may result in cirrhosis, liver failure, and the need for transplantation.
Approximately 30% of adults worldwide have some degree of fat accumulation in the liver. Of those, roughly one in four will develop MASH — a progression driven by the same forces fuelling the global rise in obesity and type 2 diabetes
Advanced fibrosis in MASH is not a stable state. 1 in 5 patients will progress to cirrhosis, irreversible scarring that permanently impairs liver function, and that progression can occur in as little as 2 years.2
MASH is the #1 cause of liver transplantation in women3 in the US.
But MASH is not solely a liver disease.
MASH does not occur in isolation. It is closely associated with obesity, type 2 diabetes, dyslipidaemia, and insulin resistance, systemic conditions that drive fat accumulation in the liver and perpetuate a cycle of inflammation and cellular injury.
It is also increasingly understood as a manifestation of broader cardiometabolic dysfunction, with consequences that extend throughout the body:
It significantly elevates the risk of cardiovascular events4
It increases the risk of chronic kidney disease.
It deepens insulin resistance, creating a self-reinforcing cycle of metabolic and hepatic deterioration
Without intervention, MASH can lead to cirrhosis (permanent scarring), liver failure, or an aggressive form of liver cancer. For many, it eventually leads to the need for a liver transplant.
And it’s a growing global challenge. Roughly 30% of adults worldwide have some level of fat in their liver. Of those, about one in four will develop MASH. And the number continues to climb as rates of diabetes and obesity also rise.
Patient Resources
Living With MASH
MASH (metabolic dysfunction-associated steatohepatitis) is a serious and progressive form of liver disease that affects millions of people worldwide. It often starts as a buildup of fat in the liver, which can lead to inflammation and permanent scarring (fibrosis).
MASH is often called a “silent” disease because it can progress for years without obvious signs. However, many people living with MASH do feel its effects, including:
- Persistent fatigue (feeling very tired).
- A dull ache or discomfort in the upper right abdomen.
- Lower energy levels in daily life.
MASH is a systemic disease, frequently occurring in the context of type 2 diabetes and cardiometabolic risk.
Support and Community
You don’t have to navigate MASH alone. Connecting with others and finding reliable information can make a big difference in managing the lifestyle changes and uncertainty that come with a diagnosis.
The following independent organizations provide excellent educational materials, patient support networks, and advocacy opportunities:
Looking for clinical trials?
Joining a clinical trial may be the best way to access our medicine while contributing to research that could help millions.
Expanded Access Policy
Inventiva is developing lanifibranor, an investigational medicinal product that is not authorized for use in any country. Currently, lanifibranor is available to patients participating in clinical trials.
Inventiva may, in certain countries and in accordance with applicable laws, consider requests from qualified healthcare professionals for access to investigational medicinal product outside of clinical trials. Expanded Access, also sometimes called “compassionate use”, is a regulatory pathway that may allow a patient with a chronically or seriously debilitating disease, or life-threatening condition to access an investigational medicine outside of a clinical trial under strict conditions.
There is no expanded access program in place for Lanifibranor. Approvals for expanded access requests are granted only in exceptional cases and conditioned on relevant regulatory approval.
Criteria for Consideration in the Expanded Access Program:
- The patient has a chronically or seriously debilitating disease or life-threatening condition.
- The patient cannot be treated satisfactorily by an authorized medicinal product.
- The patient cannot join an existing clinical trial.
- A doctor believes the potential benefits outweigh the risks.
- Providing the medicine will not interfere with our ability to complete the clinical trials.
How to Request Access
Requests must be made by a licensed doctor. If you are a patient, please speak with your doctor about your options. Doctors may submit a formal request to: EAP@inventivapharma.com. We typically review these requests within 15 business days.
References
- 1Noureddin M, Vipani A, Bresee C, Todo T, Kim IK, Alkhouri N, et al. NASH leading cause of liver transplant in women: updated analysis of indications for liver transplant and ethnic and gender variances. Am J Gastroenterol. 2018;113(11):1649–1659. DOI: https://doi.org/10.1038/s41395-018-0088-6
- 2Loomba R, Adams LA. The 20% rule of NASH progression: the natural history of advanced fibrosis and cirrhosis caused by NASH. Hepatology. 2019;70(6):1885–1888. DOI: 10.1002/hep.30943
- 3Noureddin M, Vipani A, Bresee C, Todo T, Kim IK, Alkhouri N, et al. NASH leading cause of liver transplant in women: updated analysis of indications for liver transplant and ethnic and gender variances. Am J Gastroenterol. 2018;113(11):1649–1659. DOI: https://doi.org/10.1038/s41395-018-0088-6
- 4Targher G, et al. MASLD: a systemic metabolic disorder with cardiovascular and malignant complications. Gut. 2024. PMID: 38228377