Addressing the unmet needs of nonalcoholic steatohepatitis

A breakthrough could be on the horizon

Categories: For Healthcare Professionals, [Nonalcoholic Steatohepatitis (NASH), Drug development, Fatty liver disease]

With a prevalence of 24% worldwide, nonalcoholic fatty liver disease (NAFLD) is now the most common liver disorder and is characterized by the buildup of excess fat in the livers of people who drink little to no alcohol. Nonalcoholic steatohepatitis (NASH) is the most severe form of NAFLD. The histopathological hallmark of NASH is hepatic steatosis, which often leads to liver fibrosis.

The rate of NASH among people with NAFLD increased almost 2-fold between 2005 and 2010, going from 33% to 59% of cases. Nonalcoholic steatohepatitis is regularly a reason for liver transplantation; in the United States, it is second only to chronic hepatitis C. It is estimated that NASH will be the most common reason for liver transplantation in all Western countries by 2020. 

The NASH drug pipeline: we’re making headway

Surprisingly, despite such a high prevalence worldwide, there is no pharmacologic treatment approved specifically for NASH. However, thanks to our increased understanding of the multifaceted pathogenesis of NASH, the drug pipeline continues to grow. A broad array of potential new drugs is currently under development, many of which are designed to decrease liver fat, inflammation, insulin resistance, and/or mitochondrial dysfunction. Other investigational therapies aim to reduce fibrosis progression. To date, completed Phase 2 NASH clinical trials have shown improvements in slowing the progression of liver fibrosis, but not all potential new drugs have managed to reduce insulin resistance and obesity. 

The NASH drug pipeline looks promising, with more and more compounds with different mechanisms of action being tested. A breakthrough drug for NASH is expected to address all the pathogenetic mechanisms, or combination therapy will need to be considered.

The future of NASH therapy: we need you!

IQVIA is aiding the NASH drug development process by running multiple clinical trials to find suitable pharmacologic treatments specifically for NASH. You can become part of our experience by referring your patients to IQVIA-managed NASH clinical trials. contains updates on clinical trials and recent medical advances. You can register to receive news about NASH and related IQVIA clinical trials or find trials that might interest your patients. Also, see Referring your patients into clinical trials to read about why and how you should refer patients.


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