Future of Treatment for Nonalcoholic Steatohepatitis: Can the Use of Safe, Evidence-Based, Clinically Proven Supplements Provide the Answer to the Unmet Need?

The epidemic of nonalcoholic fatty liver disease (NAFLD) has created a real and unmet therapeutic need. The long regulatory pathway and the focus on selected subsets of patients with established and advanced disease are some of the current obstacles to providing effective treatment for the majority of NAFLD patients. The complexity of the disease pathogenesis, which involves multiple mechanisms, requires targeting of more than one pathway or a combination-based therapy. Although the drugs being developed may prevent progression to cirrhosis or may decrease negative liver outcomes, their effects on cardiometabolic health and cancer prevention remain unknown. Providing expensive compounds to a large proportion of the population for long-term use would place an economic burden on health care providers. Thus, there is a missed opportunity for early intervention in the course of the disease, by providing agents that improve cardiometabolic status and the progression of fatty liver toward steatohepatitis. Several natural supplements have the potential to meet these needs. This review discusses some of the major obstacles to drug development for NASH treatment. Milestones in bringing evidenced-based, scientifically proven, patent-protected, clinically tested, safe compounds to patients with NAFLD or NASH within a relatively short period of time are presented. The regulatory, intellectual property, manufacturing, and clinical development steps, along with applicable timelines, are discussed. These compounds may provide a possible solution to the challenges associated with the treatment of the majority of patients.