India’s Central Drugs Standard Control Organisation (CDSCO) has approved the Phase 3 clinical trial results of Shilpa Medicare’s investigational new drug (IND) Nor-ursodeoxycholic acid (Nor-UDCA) Tablets 500 mg. And its Subject Expert Committee (SEC) has recommended the grant of marketing authorization for the treatment of non-alcoholic fatty liver disease (NAFLD).

NAFLD, a metabolic liver disorder, is increasingly recognized as a public health concern, affecting around 25% of the global population—approximately 1.2 billion people. In India alone, the estimated patient pool is over 188 million. If untreated, NAFLD can progress to non-alcoholic steatohepatitis (NASH), a more severe and potentially fatal liver condition.

Shilpa Medicare’s novel formulation, SMLNUD07, was evaluated in a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial to determine the safety and efficacy of Nor-UDCA at a dose of 1500 mg/day over 24 weeks. The study enrolled 165 NAFLD patients across India.

According to the company, the trial met all primary efficacy endpoints. Notably, 83.3% of participants demonstrated reversal of liver fibrosis, and nearly 90% achieved normalization of elevated alanine transaminase (ALT) levels within 12 weeks. No serious adverse events were reported.

The company believes Nor-UDCA could represent a first-in-class treatment for NAFLD in India, citing advantages over existing ursodeoxycholic acid (UDCA), such as enhanced bile flow, resistance to amidation, anti-inflammatory properties, and anti-fibrotic effects.

Commenting on the development, Shilpa Medicare’s Managing Director, Vishnukant Bhutada, said the approval exemplifies the company’s commitment to “innovating for affordable healthcare” and noted plans to engage with global regulatory authorities for international expansion.

If granted final approval, Nor-UDCA could be launched in India during the upcoming financial year.