Non-Alcoholic Steatohepatitis or NASH is a liver disorder that is characterized by the build-up of fat in liver in addition to inflammation and liver cell damage eventually progressing to cirrhosis. Currently lifestyle interventions are suggested for the treatment of NASH with no drugs having been approved for the condition.

Multiple drugs are at the last stages of clinical trials with promising interim results while many more drugs are in early and mid-phase of clinical studies. Until now with no drugs approved for the condition of non-alcoholic steatohepatitis, there existed a huge unmet medical need.

Poor performance of INDs tested for the condition of non-alcoholic steatohepatitis over the years has been attributed to poor preclinical models which has led to poor human translation of drug safety and efficacy in addition to use of conservative biomarkers during clinical trials.

If companies can truly overcome the challenge of human translation of drug potential in terms of efficacy and safety, then non-alcoholic steatohepatitis as a manageable condition would be conquered within the next decade.

The United States leads the way in the number of NASH-related patents published. The major challenge to demonstrate translation of clinical endpoint data in NASH trials has been to stop the disease progression to cirrhosis.