- In March 2025, Shilpa Medicare Limited announced that the Subject Expert Committee (SEC) of CDSCO has approved its Investigational New Drug (IND), Nor Ursodeoxycholic Acid (Nor UDCA) Tablets 500 mg, and recommended marketing authorization for the treatment of non-alcoholic fatty liver disease (NAFLD)
- In November 2024, Novo Nordisk announced the headline results from part 1 of the ongoing ESSENCE trial, a pivotal Phase 3, 240-week, double-blinded study involving 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3). Part 1 of the trial assessed the impact of once-weekly semaglutide 2.4 mg on liver histology compared to a placebo, in addition to standard care, over a 72-week period for the first 800 randomized participants
- In June 2024, Zealand Pharma A/S announced that Boehringer Ingelheim reported breakthrough findings from a sub-analysis of the Phase 2 trial for survodutide. The results showed that up to 64.5% of adults with fibrosis stages F2 and F3 (moderate to advanced scarring) experienced fibrosis improvement without worsening metabolic dysfunction-associated steatohepatitis (MASH), compared to 25.9% in the placebo group after 48 weeks of treatment
- In March 2024, Madrigal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Rezdiffra (resmetirom) as a treatment for adults with noncirrhotic NASH with moderate to advanced liver fibrosis (stages F2 to F3), alongside diet and exercise. The continued approval for this indication may depend on the confirmation and demonstration of clinical benefits in ongoing confirmatory trials
- In November 2023, Torrent Pharmaceuticals Limited and Zydus Lifesciences Limited announced a licensing and supply agreement to co-market Saroglitazar Magnesium for the treatment of Non-Alcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD) in India. As the only approved drug for NASH and NAFLD in the country, Saroglitazar Magnesium is expected to play a crucial role in managing and mitigating these widespread and progressive liver disorders
Frequently Asked Questions
Companies such as Boehringer Ingelheim International GmbH (Germany), Gilead Sciences, Inc. (U.S.), Novo Nordisk A/S (Denmark), Lilly (U.S.) and Madrigal Pharmaceuticals (U.S.) are the major companies in the liver fibrosis drugs market.
In March 2024, Madrigal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval for Rezdiffra (resmetirom) as a treatment for adults with noncirrhotic NASH with moderate to advanced liver fibrosis.
The countries covered in the liver fibrosis drugs market are U.S., Canada, Mexico, Germany, France, U.K., Italy, Spain, Russia, Turkey, Netherlands, Switzerland, Austria, Poland, Norway, Ireland, Hungary, Lithuania, rest of Europe, China, Japan, India, South Korea, Australia, Taiwan, Philippines, Thailand, Malaysia, Vietnam, Indonesia, Singapore, rest of Asia-Pacific, Brazil, Argentina, Chili, Colombia, Peru, Venezuela, Ecuador, Uruguay, Paraguay ,Bolivia, Trinidad And Tobago, Curaçao, rest Of South America, South Africa, Saudi Arabia, U.A.E, Egypt, Israel, Kuwait, rest of Middle East and Africa, Guatemala, Costa Rica, Honduras, EL Salvador, Nicaragua, and rest of Central America.
