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Mallinckrodt’s Phase III Kidney Failure Trial Hits Primary Endpoint

The data position Mallinckrodt to file for US FDA approval of terlipressin early next year. Mallinckrodt thinks the drug could generate sales of $300m a year, helping it to mitigate its challenges.

Human Kidneys, 2d rendering
• Source: Shutterstock

A Phase III trial of Mallinckrodt PLC’s terlipressin in adults with a type of progressive kidney failure has hit its primary endpoint.

The study enrolled 300 patients with hepatorenal syndrome type 1 (HRS-1) and randomized them to receive intravenous delivery of vasopressin analogue terlipressin or placebo

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