Zydus Therapeutics, a subsidiary of Zydus lifesciences, said on Friday that his Saroglitazar examination had showed positive results in the late study of the study in patients with primary biliary cholangitis (PBC), which is a rare chronic liver disease.
The company plans to submit an application for approval of USFDA regulatory approval in the first quarter of 2026, the company said in the edition. Saroglitazar has been approved in India since 2020 for the treatment of non -alcoholic greasy liver (NAFLD) and its progressive forms, NASH (non -alcoholic steatohepatitis).
Epics-III phase 2 (B)/3 clinical study tested how safe and effective the Saroglitazar for adults who could not tolerate or did not benefit from ursodeoxycholic acid (UDCA), which is the usual treatment.
The study found that almost half of the patients receiving Saroglitazar have achieved a significant improvement in the key features of the liver compared to placebo patients. The drug was generally well tolerated, with side effects balanced between those on saroglitazar and those in the placebo group.
The drug also met a key secondary goal, with several patients to achieve full normalization of alkaline phosphatase, a marker associated with disease progression.
The study enrolled 149 patients in several centers and tested 1 mg daily dose of drug. The company said the complete results would be presented at the upcoming scientific congress.
Saroglitazar is the first drug of its kind, which shows strong phase 3 results in PBC patients, and could offer a valuable new option for those who need alternatives, said Zydus Pankaj Patel.
The drug received a quick designation and a drug designation for an orphaned FDA for PBC treatment.
PBC is a rare, progressive autoimmune disease that gradually destroys the bile ducts, leading to the accumulation of bile in the liver. This can lead to fibrosis, cirrhosis and need to transplant liver or death. Clinical symptoms include itching and fatigue that can be serious.
USFDA called it a rare disease that affects less than 200,000 people. The company currently estimates that a quarter of a million adult patients in the US has a PBC.
Zydus Therapeutics is an American clinical phase that focuses on a biopharmaceutical company focused on specialization that develops the treatment of rare and serious liver diseases. According to its website, the company also develops Saroglitazar as an examination treatment of non -alcoholic steatohepatitis around the world.
Saroglitazar was the first Indian completely completely indigenous new chemical entity to be approved on the domestic market in 2013. It was originally approved and launched for the treatment of diabetes with a lipid surplus and later approved for the treatment of liver in 2020.
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