[{"orgOrder":0,"company":"AbbVie Inc","sponsor":"Chinook Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Chinook Therapeutics Obtains Worldwide Rights from AbbVie to Atrasentan with Plans to Develop for the Treatment of Kidney Diseases","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"AbbVie Inc"},{"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":"Small molecule","graph2":"Mallinckrodt Pharmaceuticals"},{"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":"Small molecule","graph2":"Mallinckrodt Pharmaceuticals"},{"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":"Small molecule","graph2":"Mallinckrodt Pharmaceuticals"},{"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":"Small molecule","graph2":"Mallinckrodt Pharmaceuticals"},{"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":"Small molecule","graph2":"Mallinckrodt Pharmaceuticals"},{"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":"Small molecule","graph2":"Mallinckrodt Pharmaceuticals"}]
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Chinook Therapeutics in-license of atrasentan provides a unique opportunity for Chinook to add a potential new drug to its precision medicine portfolio for the treatment of rare CKD conditions.
The overall response rate among patients treated with terlipressin, including complete responses and partial responses was 73% and differed between the mild and moderate groups compared to the severe group.
Post-hoc, pooled analyses of three Phase 3 trials found HRS-1 patients treated with terlipressin was associated with less RRT up to Day 90 versus placebo.
Terlipressin is a vasopressin analogue which, in clinical trials, was shown to be effective at HRS-1 reversal, which includes three components: renal function improvement, avoidance of dialysis and short-term survival.
The study found that terlipressin was associated with an improvement in kidney function among HRS-1 patients as measured by a reduction in serum creatinine (SCr).
Terlipressin would be the first FDA-approved treatment option in the United States for adult patients with HRS-1, a life-threatening condition, if approved.
The terlipressin NDA is based, in part, on results from the Phase 3 CONFIRM trial, and the culmination of a sustained, 17-year effort to develop terlipressin for potential use in the U.S. and Canada.