Zydus gets USFDA nod for clinical trials of Sarolitazar
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New Delhi: Zydus Cadila has received US health regulator's nod to initiate phase II clinical trials of Sarolitazar, its new drug for treating high fat levels in body due to diabetes, obesity, and sedentary habits.
"United States Food and Drug Administration (USFDA) has endorsed company's plan to initiate a phase II clinical trial of Saroglitazar in patients with severe hypertriglyceridemia," Zydus Cadila said in a statement.
This 12-week trial will evaluate three doses of Saroglitazar in the strengths of 1 mg, 2 mg and 4 mg versus placebo, it added.
"The primary endpoint of the study is percent change in triglycerides from baseline after 12 weeks of dosing," Zydus Cadila said.
The company's Chairman and Managing Director Pankaj Patel said: "This development is a significant milestone for Zydus. Patients with severe hypertriglyceridemia often have to take multiple medications because of associated diabetes or fatty liver disease."
"United States Food and Drug Administration (USFDA) has endorsed company's plan to initiate a phase II clinical trial of Saroglitazar in patients with severe hypertriglyceridemia," Zydus Cadila said in a statement.
This 12-week trial will evaluate three doses of Saroglitazar in the strengths of 1 mg, 2 mg and 4 mg versus placebo, it added.
"The primary endpoint of the study is percent change in triglycerides from baseline after 12 weeks of dosing," Zydus Cadila said.
The company's Chairman and Managing Director Pankaj Patel said: "This development is a significant milestone for Zydus. Patients with severe hypertriglyceridemia often have to take multiple medications because of associated diabetes or fatty liver disease."
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