MAFLD Pandemic: Updates in Pharmacotherapeutic Approach Development

Area of Science:

• Hepatology and Gastroenterology
• Pharmacology and Drug Development
• Metabolic Diseases

Background:

• Metabolic-associated fatty liver disease (MAFLD) is a global pandemic affecting approximately one billion people worldwide.
• MAFLD is a progressive liver condition linked to metabolic disorders like obesity and type 2 diabetes, potentially leading to cirrhosis and liver cancer (HCC).
• Currently, limited pharmacologic options exist for MAFLD, necessitating a multidisciplinary approach to treatment development.

Purpose of the Study:

• To review the latest advancements in drug development for MAFLD.
• To highlight molecules closest to regulatory approval for treating MAFLD and metabolic-dysfunction-associated steatohepatitis (MASH).
• To underscore the urgent need for effective therapies targeting liver steatosis, fibrosis, and inflammation.

Main Methods:

• Literature review of recent clinical trials and regulatory approvals for MAFLD treatments.
• Analysis of drug candidates focusing on their efficacy in improving liver histology.
• Examination of the complex etiology and extrahepatic effects of MAFLD to inform treatment strategies.

Main Results:

• Saroglitazar (Lipaglyn®) was approved in India in 2020 for MASH.
• Rezdiffra™ received accelerated approval in the US for MASH in adults.
• Numerous molecules are in late-stage clinical trials, indicating a promising pipeline for MAFLD pharmacotherapy.

Conclusions:

• The landscape of MAFLD treatment is rapidly evolving with recent drug approvals.
• Intensified research and clinical trials are expected to yield several new approved therapies in the near future.
• Developing drugs that address steatosis, fibrosis, and inflammation is key for successful MAFLD treatment and regulatory authorization.