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A pivotal Phase 3 trial of BIV201 (continuous infusion terlipressin) in ascites patients

Trial Profile

A pivotal Phase 3 trial of BIV201 (continuous infusion terlipressin) in ascites patients

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 28 Oct 2024

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At a glance

  • Drugs Terlipressin (Primary)
  • Indications Ascites
  • Focus Registrational; Therapeutic Use
  • Sponsors BioVie

Most Recent Events

  • 23 Oct 2024 According to an BioVie media release, Company is also continuing partnering discussions for bezisterim's geographic rights, and plans to commence an ascites Phase 3 trial for BIV201 (continuous infusion terlipressin) upon identifying a suitable partner.
  • 11 Mar 2024 According to an BioVie media release, this trial is in preparation following FDA feedback with guidance on development path. The program is delayed pending partnership funding.
  • 13 Nov 2023 According to a BioVie media release, this trial is expect to initiate in Q2 2024.

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