Hepatorenal syndrome

OCE-205

OCE-205 is an investigational selective vasopressin V1a receptor mixed agonist/antagonist with no V2 receptor activity.[47]Bagger Y, Ravis WR, Harris G, et al. OCE-205, a novel, selective vasopressin receptor mixed agonist-antagonist: safety, tolerability, and pharmacokinetics/pharmacodynamics from a phase 1 study in healthy volunteers. Clin Drug Investig. 2023 Sep;43(9):709-17. https://link.springer.com/article/10.1007/s40261-023-01299-y http://www.ncbi.nlm.nih.gov/pubmed/37606870?tool=bestpractice.com ​ It has been found to be safe and well tolerated with mild to moderate adverse effects reported in one phase 1 study in healthy volunteers.[47]Bagger Y, Ravis WR, Harris G, et al. OCE-205, a novel, selective vasopressin receptor mixed agonist-antagonist: safety, tolerability, and pharmacokinetics/pharmacodynamics from a phase 1 study in healthy volunteers. Clin Drug Investig. 2023 Sep;43(9):709-17. https://link.springer.com/article/10.1007/s40261-023-01299-y http://www.ncbi.nlm.nih.gov/pubmed/37606870?tool=bestpractice.com ​ The US Food and Drug Administration (FDA) has granted orphan drug designation to OCE-205 for the treatment of hepatorenal syndrome. A phase 2 trial evaluating participants who have developed HRS-acute kidney injury (HRS-AKI) as a complication of cirrhosis with ascites is in progress.[48]ClinicalTrials.gov. A study of OCE-205 in participants with cirrhosis with ascites who developed hepatorenal syndrome-acute kidney injury. ClinicalTrials.gov Identifier: NCT05309200. Dec 2023 [internet publication]. https://clinicaltrials.gov/study/NCT05309200