Shilpa Medicare has rolled out a breakthrough treatment for metabolic dysfunction-associated fatty liver disease (MAFLD) with the launch of NODUCA™ (Nor Ursodeoxycholic Acid). This marks a global first, as the company becomes the only player worldwide to introduce NorUDCA tablets for MAFLD after securing a historic approval from the CDSCO in August 2025.
The therapy is being positioned as a first-in-class solution for a condition that affects one in four people globally and nearly 188 million individuals in India alone. MAFLD, earlier known as NAFLD, has long lacked effective and targeted treatment options, making this launch a notable milestone for liver healthcare.
What sets NorUDCA apart is its ability to work through unique mechanisms that go beyond the scope of conventional therapies. It helps reduce liver inflammation, supports reversal of fibrosis, and improves bile flow, which together boost overall liver function. Phase 3 clinical studies done in India showed exceptional results, with more than eighty percent of patients experiencing fibrosis reversal and almost all seeing their liver enzyme levels return to normal within just three months of treatment. The drug demonstrated strong safety data as well, with no serious adverse events and good long-term tolerability at the 1500 mg daily dosage.
With the commercial rollout now underway, Shilpa Medicare is launching NODUCA™ under its own brand in India while also partnering with three other companies that will introduce the therapy under their respective brands. The company is simultaneously preparing to seek global regulatory approvals so that patients worldwide can access this new treatment option.
