Ikaria acquires NDA and IND for Lucassin for treatment of hepatorenal syndrome (HRS) Type 1

Ikaria Holdings, Inc. announced it has acquired the New Drug Application (NDA) and the Investigational New Drug (IND) application to Lucassin (terlipressin for injection) from Orphan Therapeutics, assuming all future development and ownership of the drug in North America and Australia. HRS Type 1 is the development of kidney failure in patients with late-stage liver cirrhosis in the absence of any other cause. It is an orphan-designated condition and is characterized by rapid onset of renal failure with a high mortality rate that exceeds 80% within three months.

Lucassin is a synthetic vasopressin analogue that acts via the vasopressin V1 receptor as a systemic vasoconstrictor, mainly in the splanchnic (abdominal) circulation, which appears to increase effective arterial volume and improves renal blood flow, thereby improving renal function in patients with HRS.


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