| Shilpa Medicare announced the launch of NODUCA™ (Nor Ursodeoxycholic Acid (NorUDCA)), a first-in-class therapy for the first time in India or anywhere in the world, following the historic approval granted in August 2025 by the Central Drugs Standard Control Organisation (CDSCO), India. The drugs ushers in a new line of treatment for patients suffering from metabolic dysfunction-associated fatty liver disease (MAFLD), previously referred to as non-alcoholic fatty liver disease (NAFLD).
NorUDCA offers three major therapeutic benefits for MAFLD and associated liver disorders:
- Anti-inflammatory action: Actively reduces hepatic and ductular inflammation, limiting progression to cirrhosis and liver failure.
- Anti-fibrotic effect: Promotes reversal of liver scarring (fibrosis) and stabilizes liver architecture, as proven in Phase 3 studies, with 83.3% of patients showing fibrosis reversal and 90% achieving normal liver enzyme levels within 3 months.
- Choleretic protection: Encourages toxin clearance via enhanced bile secretion and protects cholangiocytes, minimizing risk of advanced disease.
NODUCA™ (norursodeoxycholic acid), a novel bile acid therapy designed to treat metabolic dysfunction associated fatty liver disease (MAFLD), offers a first-in-class approach to improving liver health by reducing inflammation, fibrosis, and cholestasis through unique mechanisms distinct from conventional therapies. |