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# FDA Orphan Status for BioVie Ascites Therapy
- URL: https://www.fdaweb.com/fda-orphan-status-for-biovie-ascites-therapy/
- Published: 2016-09-09T12:00:00.000Z
- Updated: 2026-09-14T21:30:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136759

FDA has granted BioVie an orphan drug designation for BIV201 for treating ascites due to all causes except cancer. The company currently is preparing an IND, with plans to begin a U.S. clinical trial next year. The active ingredient in BIV201 is a potent vasoconstrictor, and its mechanism of action yields the potential to treat an array of life-threatening diseases, including type 1 hepatorenal syndrome, esophageal variceal bleeds, and sepsis, the company says.

Ascites is described by the company as a common complication of advanced liver cirrhosis. Currently, no therapies are approved by FDA for treating ascites, and an estimated 40% of patients die within two years of diagnosis, it says.