Shilpa Medicare launches first-in-class MAFLD treatment in India

Shilpa Medicare Limited announced the launch of NODUCAT™ (norursodeoxycholic acid) in India, the first-in-class therapy globally for metabolic dysfunction-associated fatty liver disease (MAFLD). This follows regulatory approval in August 2025 by the Central Drugs Standard Control Organisation (CDSCO), India.

Clinical trials in India showed excellent efficacy with a 1500 mg daily dose, demonstrating significant clinical efficacy in reversing liver fibrosis and stabilizing liver function. Phase 3 studies indicated 83.3% of patients experienced fibrosis reversal and 90% achieved normal liver enzyme levels within three months. NODUCAT™ offers anti-inflammatory, anti-fibrotic, and choleretic protective benefits.

MAFLD affects one in four people and an estimated 188 million patients in India. Shilpa Medicare plans to expand access globally through international regulatory approvals and has partnered with three companies for the Indian market.