Shilpa Medicare Limited — Important, 13-02-2025: General Updates

Shilpa Medicare has received approval from the Subject Expert Committee of CDSCO for its IND - Nor Ursodeoxycholic Acid Tablets 500 mg aimed at treating Non-alcoholic fatty liver disease (NAFLD). NAFLD affects approximately 188 million people in India and can lead to severe complications if untreated. The completed Phase 3 clinical trial involved 165 patients and showed significant improvements, with 83.3% of participants experiencing a reversal in liver fibrosis after 24 weeks. Additionally, about 90% normalized elevated alanine transaminase (ALT) levels within 12 weeks. This first-in-class treatment is poised to enhance liver function in NAFLD patients, with plans to seek marketing authorization soon. Shilpa aims to expand internationally following approval in India, highlighting its commitment to affordable healthcare and addressing unmet needs in this patient population.