The unmet need
Ascites is a common complication of decompensated liver cirrhosis. Refractory ascites can require repeated drainage procedures and is associated with substantial morbidity and mortality.
How BIV201 is designed to work
Terlipressin constricts selected blood vessels. BioVie is studying whether continuous administration can help restore effective blood flow through the kidneys and liver, reduce portal pressure and slow ascites fluid reaccumulation.
The portable-pump concept is intended to support treatment outside the hospital, subject to clinical results and regulatory review.
Development context
BioVie has reported Phase 2 clinical experience and is evaluating the path to a pivotal Phase 3 program, including potential partnership opportunities. Designations from FDA facilitate development interactions but do not constitute approval.
Important context
BIV201 is investigational and is not approved for refractory ascites. Terlipressin has known risks, and the benefit-risk profile of BioVie’s continuous-infusion approach must be established in controlled clinical studies.
Development-stage information can change. Investigational candidates are not approved, and safety and efficacy have not been established. Review source documents and current regulatory disclosures.