[{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt Completes Rolling Submission of New Drug Application to the FDA","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt Announces U.S. FDA Filing Acceptance of New Drug Application for Terlipressin to Treat Hepatorenal Syndrome Type 1","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"April 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Find Clinical Drug Pipeline Developments & Deals for Terlipressin Acetate
BIV201 (terlipressin diacetate), a vasopressin agonist, it increases systemic vascular resistance, particularly in the splanchnic area, resulting in a decrease of portal pressure. It reduces ascites fluid buildup.
TERLIVAZ® (terlipressin), is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome involving rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.
TERLIVAZ (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.
Terlivaz (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.
Teripress (Terlipressin) is an analogue of vasopressin used as a vasoactive drug in the management of hypotension which has been found to be effective when norepinephrine fails.
BIV201 (continuous infusion terlipressin), drug used in over 40 countries to treat related complications of liver cirrhosis appears to reduce ascites fluid build-up and may extend the period of time between required paracenteses.
Teripress (Terlipressin) is an investigational agent, to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function, an acute and life-threatening condition.
U.S. FDA issued a CRL regarding the Company's NDA seeking approval for Teripress (terlipressin) to treat adults with hepatorenal syndrome, an acute and life-threatening syndrome and its safety and effectiveness have not yet been established by FDA.
A subsequent randomized, controlled Phase 2b trial with target enrollment of 30 subjects is currently underway, with 20 refractory ascites patients expected to receive BIV201 therapy compared to 10 patients who will receive standard-of-care (regular paracentesis procedures).
Terlipressin is one of the accepted vasoactive therapies recommended by the European Association for the Study of the Liver guidelines, which recommends that vasoconstrictive therapy should be initiated as soon as acute variceal bleeding is suspected and before endoscopy.
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