Subject :- Shilpa Medicare announces successful outcome of Phase 3 studies of SMLNUD07 – NorUDCA
Shilpa Medicare has achieved a significant milestone with the successful completion of Phase 3 clinical trials for its novel product, SMLNUD07 – Nor-Ursodeoxycholic Acid (NorUDCA) tablets, a potential game-changer in the treatment of Nonalcoholic Fatty Liver Disease (NAFLD). This trial, which was a multicentric, placebo-controlled, double-blinded study, involved 165 NAFLD patients across India, providing a robust and statistically reliable dataset. The study demonstrated that NorUDCA was well tolerated at a dosage of 1500 mg per day over a 24-week period, with no serious adverse events reported. Efficacy results were promising, with patients experiencing at least a one-stage reduction in liver fibrosis, as measured by the USFDA-approved Fibroscan technique. Additionally, a significant reduction in hepatic fat accumulation was observed, evaluated using the CAP scoring technique. The study also reported a significant normalization of Alanine Aminotransferase (ALT) levels, indicating improved liver function. These findings suggest that NorUDCA could become a new standard of care for NAFLD, offering significant improvements in liver function and a holistic approach to treatment by addressing multiple disease outcomes.
Shilpa Medicare plans to submit these results to the Central Drugs Standard Control Organization (CDSCO) in India to seek marketing authorization. NorUDCA stands out as a first-in-class treatment option in India, with notable advantages over conventional Ursodeoxycholic Acid (UDCA), including enhanced choleretic effects, resistance to amidation, anti-inflammatory properties, and a reduction in fibrosis. NAFLD is the most prevalent liver disease globally, affecting approximately 25% of the world’s population, which translates to about 1.2 billion people. In India alone, around 188 million people are affected. If untreated, NAFLD can progress to nonalcoholic steatohepatitis (NASH), which can have severe and potentially fatal implications
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