Shilpa Medicare receives CDSCO SEC Nod for IND Nor UDCA tablets for NAFLD treatment

Shilpa Medicare has announced that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has approved its Investigational New Drug (IND) Nor Ursodeoxycholic Acid (Nor UDCA) Tablets 500 mg. The committee has also recommended granting marketing authorisation for the treatment of non-alcoholic fatty liver disease (NAFLD).

NAFLD is currently the most prevalent liver disease globally, affecting approximately 25 percent of the world population. According to estimates, around 1.2 billion people are affected globally, with about 188 million people in India living with NAFLD. If not managed in time, NAFLD can advance to non-alcoholic steatohepatitis (NASH), a more severe form of the disease.

Shilpa Medicare had previously completed phase 3 clinical trials of its novel formulation, SMLNUD07 – Nor UDCA Tablets. The company submitted results from the trial titled “A phase – III, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Parallel Group Study” to the SEC. The study evaluated the safety and efficacy of Nor UDCA 500 mg in patients diagnosed with NAFLD.

The trial was conducted across multiple centres in India with 165 participants. It followed a double-blind, placebo-controlled protocol designed to deliver statistically significant and reliable data. According to Shilpa Medicare, the treatment was well tolerated at a daily dose of 1500 mg over a 24-week period, and no serious adverse events were recorded.

The trial met all primary efficacy endpoints. Results showed a significant improvement in fatty liver stage among participants. The data indicated that liver fibrosis stage reversed in 83.3 percent of patients and stabilised in the remainder over 24 weeks of treatment. Additionally, the study observed that elevated alanine transaminase (ALT) levels normalised in approximately 90 percent of participants within the first 12 weeks.

The company noted that Nor UDCA may emerge as a first-in-class treatment option for NAFLD in India. Compared to conventional UDCA, Nor UDCA demonstrates potential advantages such as enhanced choleretic effect, resistance to amidation, anti-inflammatory properties, and reduced fibrosis.

Commenting on the development, Vishnukant Bhutada, Managing Director, Shilpa Medicare Ltd, said, “We are very pleased with this approval from SEC and hope to get the marketing approval soon. We are committed to working closely with regulatory authorities to bring this innovative treatment to patients as quickly as possible and are hopeful of launching it in India in the coming financial year. This NCE molecule approval exemplifies the true spirit of Shilpa, ‘Innovating for affordable healthcare’ keeping in mind the unmet needs of a large patient pool. Based on the approval in India, we plan to reach out to global regulatory authorities to seek scientific advice for introduction of this novel product internationally.”

Shilpa Medicare plans to pursue marketing authorisation in India while simultaneously engaging with global regulatory agencies to explore international expansion for Nor UDCA.