[{"orgOrder":0,"company":"Ortho Regenerative Technologies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ortho Regenerative Technologies Receives Clinical Hold Letter from The U.S. FDA","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Undisclosed","graph2":"Ortho Regenerative Technologies"},{"orgOrder":0,"company":"Revive Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Revive Therapeutics Files for FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Revive Therapeutics"},{"orgOrder":0,"company":"Revive Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Revive Therapeutics Receives FDA Orphan Drug Designation for Bucillamine in the Prevention of Ischemia-Reperfusion Injury During Liver Transplantation","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"IND Enabling","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Revive Therapeutics"}]
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The ODD validates strategy in pursuing novel uses of Bucillamine, a cysteine derivative reactivating this endogenous defense against oxidant injury for rare disorders and life-threatening conditions, including infectious diseases and preventing IRI.
Revive believes the use of Bucillamine during liver transplantation has the potential to be a safe and effective approach to address the unmet medical need for a novel strategy to limit or prevent ischemia–reperfusion injury (IRI) during liver transplantation.
FDA has requested additional CMC
related information on Ortho Regenerative's Investigational New Drug application to begin a phase I/II clinical trial for ORTHO-R, its drug/biologic combination product candidate used as an adjunct to SOC surgery in rotator cuff tear repair.