Shilpa Medicare Gains on Approval of Nor-Ursodeoxycholic Acid Tablets for NAFLD Treatment

Shilpa Medicare Limited has announced the approval of its Investigational New Drug (IND), Nor-Ursodeoxycholic Acid (Nor-UDCA) Tablets (500 mg), by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). The SEC has also recommended granting marketing approval for this drug, specifically for treating Non-Alcoholic Fatty Liver Disease (NAFLD). This condition affects a significant portion of the global and Indian population and can lead to severe complications if left untreated.

Clinical Trial and Efficacy Results

Shilpa Medicare conducted a Phase 3 clinical trial of Nor-UDCA, enrolling 165 NAFLD patients in a multicentric, placebo-controlled, double-blind study. The trial aimed to assess the safety and efficacy of Nor-UDCA at a daily dose of 1500 mg over 24 weeks. The study met all primary efficacy endpoints, demonstrating a significant reduction in fatty liver stage. Additionally, 83.3% of patients showed a reversal of liver fibrosis, and 90% experienced normalisation of elevated alanine transaminase (ALT) levels within 12 weeks. The treatment was well tolerated, with no serious adverse events reported.

Significance and Future Prospects

The approval of Nor-UDCA is a major development in the treatment of NAFLD, as it offers advantages over existing therapies. The drug exhibits an enhanced choleretic effect, resistance to amidation, anti-inflammatory properties, and the ability to reduce fibrosis. Shilpa Medicare aims to launch Nor-UDCA in India in the upcoming financial year, with plans to seek regulatory approvals in the European Union and the United States. The company views this achievement as part of its broader mission to provide innovative and affordable healthcare solutions.

Shilpa Medicare Share Performance

As of February 13, 2025, at 1:54 PM, the shares of Shilpa Medicare are trading at ₹675.05 per share, reflecting a surge of 2% from the previous day’s closing price. Over the past month, the stock has increased by 8% and over the last year it has surged by 84.19%.

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