Shilpa Medicare Reports Positive Phase 3 Results for NorUDCA Tablet

On August 26, 2024, Shilpa Medicare Limited announced the successful completion of Phase-3 clinical trials for its innovative product, SMLNUD07 – Nor Ursodeoxycholic Acid (NorUDCA) tablets.

This new treatment is expected to transform the management of Nonalcoholic Fatty Liver Disease (NAFLD). The trial, a multicentric, placebo-controlled, double-blind study involving 165 NAFLD patients across India, provided robust data with no serious adverse events reported. The treatment, administered at a dose of 1500 mg daily for 24 weeks, was well tolerated.

The results showed significant improvements: a notable reduction in liver fibrosis and decreased fat accumulation in the liver. Liver fibrosis was assessed using the USFDA-approved “Fibroscan” technique, while fat accumulation was measured with the CAP scoring method. The study also demonstrated a significant normalisation of Alanine Aminotransferase (ALT) levels, providing a comprehensive view of the treatment’s efficacy.

These findings suggest that NorUDCA could establish a new standard of care for NAFLD, offering substantial benefits in restoring liver function. Shilpa Medicare Ltd intends to submit these Phase-3 results to the CDSCO in India to seek marketing authorisation. NorUDCA is expected to be a groundbreaking treatment for NAFLD in India, offering advantages over existing UDCA treatments, including enhanced choleretic effects, resistance to amidation, anti-inflammatory properties, and reduced fibrosis.

NAFLD is a prevalent liver condition affecting approximately 25% of the global population (about 1.2 billion people), with around 188 million cases in India. If left untreated, NAFLD can progress to nonalcoholic steatohepatitis (NASH), which can have severe health consequences.

Commenting on the significant development, the Managing Director of Shilpa Medicare Limited, Mr Vishnukant Bhutada, said, “We are very pleased with the successful Phase III trials outcome for this unique product addressing the unmet need of patients suffering from NAFLD with a potential first line of treatment. This development exemplifies Shilpa’s constant endeavour to work towards introducing novel first-of-its-kind pharmaceutical products that help improve the healthcare requirements of a large patient pool.”

On August 26, 2024, the share price of Shilpa Medicare Ltd opened at ₹699.90, touching the day’s high at ₹777.90, as of 10:58 AM on the NSE.

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