Here's why Shilpa Medicare share price jumped 8% in trade on February 13

The spike in Shilpa Medicare's stock price came after the company announced the approval of its Investigational New Drug (IND) - Nor Ursodeoxycholic Acid Tablets 500 mg, by CDSCO

Shilpa Medicare share price: Pharmaceutical company Shilpa Medicare share price soared as much as 7.97 per cent to hit an intraday high of Rs 713.90 per share on Thursday, February 13, 2025. 

 

The spike in Shilpa Medicare’s stock price came after the company announced the approval of its Investigational New Drug (IND) – Nor Ursodeoxycholic Acid Tablets 500 mg, by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).

 

The Committee further recommended the grant of marketing authorisation for this IND, aimed at treating non-alcoholic fatty liver disease (NAFLD).

 

“We are very pleased with this approval from the 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 regulatory authorities in the EU and the USA to seek scientific advice for introduction of this novel product internationally,” said Vishnukant Bhutada, managing director of Shilpa Medicare.

 

 

NAFLD is the most prevalent liver disease worldwide, affecting an estimated 25 per cent of the global population (approximately 1.2 billion people), and about 188 million individuals in India. If left untreated, NAFLD can progress into a more severe form known as non-alcoholic steatohepatitis (NASH), which can have fatal consequences.

 

Shilpa Medicare had previously completed phase-3 clinical studies of this novel product, SMLNUD07 – Nor Ursodeoxycholic Acid (Nor UDCA) tablets, and presented the results to the SEC. The trial was titled “A phase - III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study” and aimed to evaluate the safety and efficacy of Nor Ursodeoxycholic Acid 500 mg in patients with NAFLD.

 

The phase-3 trial was conducted at multiple centers across India with a total of 165 NAFLD patients. The study design was randomised, placebo-controlled, and double-blinded, providing robust and reliable results. No serious adverse events were reported, and the treatment was well tolerated at the dose of 1500 mg per day for 24 weeks.

 

The phase-3 trial met all the primary efficacy endpoints outlined in the clinical trial protocol, demonstrating a major improvement in fatty liver stage. Liver fibrosis was reversed in a substantial majority of participants (83.3 per cent) and stabilised in the remaining participants within 24 weeks of treatment. Additionally, elevated alanine transaminase (ALT) levels in NAFLD patients were normalised in approximately 90 per cent of participants within 12 weeks.

 

These results suggest that Nor UDCA has the potential to become a new standard of care in treating NAFLD, offering major improvements in liver function restoration. 

 

Nor UDCA will be a first-in-class treatment option for NAFLD, with notable advantages over traditional UDCA, including enhanced choleretic effects, resistance to amidation, anti-inflammatory properties, and reduced fibrosis.

 

About Shilpa Medicare

 

Shilpa Medicare, established in 1987, engages in manufacturing niche active pharmaceutical ingredients (APIs), intermediates, and formulations. The company also offers contract research and manufacturing services to various clients. 

 

At 2:20 PM, shares of Shilpa Medicare were trading 1.63 per cent higher at Rs 672 per share. In comparison, BSE Semsex was trading 0.07 per cent higher at 76,227.25.