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Details:
BIV201 (terlipressin diacetate), a vasopressin agonist, it increases systemic vascular resistance, particularly in the splanchnic area, resulting in a decrease of portal pressure. It reduces ascites fluid buildup.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIV201
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 13, 2023
Details:
TERLIVAZ® (terlipressin), is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome involving rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Terlivaz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
TERLIVAZ (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Terlivaz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
Terlivaz (terlipressin) is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Terlivaz
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2022
Details:
Teripress (Terlipressin) is an analogue of vasopressin used as a vasoactive drug in the management of hypotension which has been found to be effective when norepinephrine fails.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Teripress
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2022
Details:
BIV201 (continuous infusion terlipressin), drug used in over 40 countries to treat related complications of liver cirrhosis appears to reduce ascites fluid build-up and may extend the period of time between required paracenteses.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIV201
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2022
Details:
Teripress (Terlipressin) is an investigational agent, to treat adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function, an acute and life-threatening condition.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Teripress
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
Details:
U.S. FDA issued a CRL regarding the Company's NDA seeking approval for Teripress (terlipressin) to treat adults with hepatorenal syndrome, an acute and life-threatening syndrome and its safety and effectiveness have not yet been established by FDA.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Teripress
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2022
Details:
A subsequent randomized, controlled Phase 2b trial with target enrollment of 30 subjects is currently underway, with 20 refractory ascites patients expected to receive BIV201 therapy compared to 10 patients who will receive standard-of-care (regular paracentesis procedures).
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIV201
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2021
Details:
Terlipressin is one of the accepted vasoactive therapies recommended by the European Association for the Study of the Liver guidelines, which recommends that vasoconstrictive therapy should be initiated as soon as acute variceal bleeding is suspected and before endoscopy.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Gastroenterology Product Name: Teripress
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2021
Details:
BioVie recently commenced a Phase 2b clinical study of BIV201 in ascites due to liver cirrhosis. Pursuing the development of BIV201 for HRS-AKI represents a strong strategic fit with the ascites program.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIV201
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2021
Details:
The overall response rate among patients treated with terlipressin, including complete responses and partial responses was 73% and differed between the mild and moderate groups compared to the severe group.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
Post-hoc, pooled analyses of three Phase 3 trials found HRS-1 patients treated with terlipressin was associated with less RRT up to Day 90 versus placebo.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2020
Details:
The Company intends to use the net proceeds from the offering primarily to fund clinical trials of its lead product candidate BIV201 and for working capital and other general corporate purposes.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: BIV201
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: ThinkEquity
Deal Size: $18.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 23, 2020
Details:
Terlipressin is a vasopressin analogue which, in clinical trials, was shown to be effective at HRS-1 reversal, which includes three components: renal function improvement, avoidance of dialysis and short-term survival.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2020
Details:
The study found that terlipressin was associated with an improvement in kidney function among HRS-1 patients as measured by a reduction in serum creatinine (SCr).
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Nephrology Product Name: Teripress
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
BioVie has received guidance from the US Food and Drug Administration regarding the next clinical trial design for BIV201 (continuous infusion terlipressin) in patients with refractory ascites due to liver cirrhosis.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
Terlipressin would be the first FDA-approved treatment option in the United States for adult patients with HRS-1, a life-threatening condition, if approved.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2020
Details:
The terlipressin NDA is based, in part, on results from the Phase 3 CONFIRM trial, and the culmination of a sustained, 17-year effort to develop terlipressin for potential use in the U.S. and Canada.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Nephrology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2020
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