[{"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 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":"Real-World Data of Terlipressin in Hospitalized Patients in U.K. with Hepatorenal Syndrome Type 1 (HRS-1) Published in Alimentary Pharmacology and Therapeutics","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"BioVie","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioVie Advances the BIV201 Clinical Program and Prefilled Syringe","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US Committee Backs Terlipressin Approval for HRS-1","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"BioVie","sponsor":"ThinkEquity","pharmaFlowCategory":"D","amount":"$18.0 million","upfrontCash":"Undisclosed","newsHeadline":"BioVie Announces Closing of Public Offering of Common Stock","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt Announces Data at Kidney Week 2020 Reimagined that Showed A Potential for Reduced Need for Renal Replacement Therapy for Patients with Hepatorenal Syndrome Type 1 (HRS-1) Treated with Terlipressin","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 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 Data from a Multicenter Post HOC Analysis of Terlipressin in Patients with Hepatorenal Syndrome-Acute Kidney Injury","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Nephrology","graph2":"Phase III"},{"orgOrder":0,"company":"BioVie","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioVie Receives FDA Guidance for Phase 3 Clinical Trial of BIV201 in HRS-AKI","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt Presents Results on Real World Treatment Patterns and Outcomes in Hospitalized Patients with Esophageal Variceal Hemorrhage and Liver Cirrhosis Treated with Terlipressin at the American College of Gastroenterology Annual Scientific Meeting","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Approved"},{"orgOrder":0,"company":"BioVie","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioVie Hosting Key Opinion Leader Webinar on Complications of Advanced Liver Cirrhosis and BIV201 Phase 2b Clinical Trial Update","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt Provides a Regulatory Update on Terlipressin","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase III","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase III"},{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Syndrome","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved"},{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt to Present Data on Terlipressin in Adult Patients with Hepatorenal Syndrome (HRS) at the European Association for the Study of the Liver (EASL) 2022 International Liver Congress","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved"},{"orgOrder":0,"company":"BioVie","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioVie Announces Patent Issuance Covering Ascites Treatment with BIV201","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt Receives U.S. FDA Approval for Terlivaz\u00ae (terlipressin) for injection for the Treatment of Hepatorenal Syndrome (HRS)","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved"},{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt to Present Data on TERLIVAZ\u00ae (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gastroenterology (ACG) Annual Scientific Meeting","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved"},{"orgOrder":0,"company":"Mallinckrodt Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mallinckrodt to Present Data on TERLIVAZ\u00ae (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Association for the Study of Liver Diseases (AASLD) 2022 Liver Meeting","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Approved"},{"orgOrder":0,"company":"BioVie","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioVie Announces the Pausing of Patient Enrollment in Ascites Phase 2b Trial, Encouraging Efficacy Data is Announced, Initiating FDA Discussions to Conduct Pivotal Registrational Trial","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Terlipressin
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.