FDA grants orphan drug designation to Ocelot Bio’s therapeutic peptide for ascites

The FDA has granted orphan drug designation to Ocelot Bio’s OCE-205, a mixed vasopression 1a receptor agonist-antagonist peptide for the treatment of ascites resulting from all causes except cancer. This is the second orphan drug designation for OCE-205, the first being for hepatorenal syndrome with acute kidney injury in 2022. OCE-205 has shown potential in reducing portal hypertension and improving ascites volume in preclinical trials, and the company plans to begin clinical studies in 2024. The orphan drug designation allows for various incentives, including tax credits for clinical trials and market exclusivity upon regulatory approval.

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