Shilpa Medicare Gets CDSCO Nod for NAFLD Drug

13 Feb 2025 , 11:09 PM

Shilpa Medicare has received approval from the CDSCO for Nor Ursodeoxycholic Acid Tablets (500 mg) in the treatment of non-alcoholic fatty liver disease (NAFLD). The Subject Expert Committee of CDSCO has also recommended the drug be granted approval to be marketed in India, meaning it can be launched commercially.

In India alone, about 19 crore people suffer from NAFLD, A quarter of the world’s population is at risk of NAFLD. If left untreated, it can develop into dangerous non-alcoholic steatohepatitis (NASH).

Shilpa Medicare said it has completed Phase 3 trials for SMLNUD07 – Nor Ursodeoxycholic Acid (Nor UDCA) tablets in 165 NAFLD patients in India. The trials identified no serious adverse effects, and patients tolerated a daily dosage of 1500 mg for 24 weeks.

Key findings from the trial:

• At 24 weeks, liver fibrosis had reversed in 83.3% of patients and stabilized in the others.
• A total of 90% of patients achieved ALT normalization within 12 weeks, consistent with a significant improvement in liver function.

Vishnukant Bhutada, Managing Director of the company, said that the company plans to knock on the doors of the regulatory bodies in the EU and the USA for international expansion, after getting approval in India.