Renal dysfunction is a frequent complication in patients admitted to intensive care units (ICUs), associated with high morbidity and mortality. Current therapeutic options to prevent this condition are limited and lack robust scientific evidence. This pilot study consists of a multicenter, blinded, randomized clinical trial, unprecedented in the literature to date, aiming to fill this knowledge gap and offer new therapeutic perspectives to improve renal outcomes in critically ill patients admitted to the ICU.

Start Date10 Apr 2025

Sponsor / Collaborator

Associacao Beneficente Siria

NCT06426407

/ Not yet recruitingNot ApplicableIIT

Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator

The goal of this observational study is to learn about blood pressure response to the vasopressor drug vasopressin in people with septic shock.
The main questions it aims to answer are:
* Are the levels of molecules showing communication between cells different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?
* Are measurements found on echocardiography (heart ultrasound) different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication?
Participants will be asked to contribute one or two blood samples. Participants who are ordered the drug vasopressin will contribute two blood samples. Both samples will be about two tablespoons for a total of about four tablespoons. One sample will be drawn before starting vasopressin infusion and the second sample will be drawn between one and six hours after starting the vasopressor drug infusion. At the same time points, advanced echocardiography pictures will be taken. Participants who are not ordered the drug vasopressin and only ordered the drug norepinephrine will contribute only one sample. At the time the sample is collected, advanced echocardiography pictures will be taken. This research also involves analyzing data obtained during the participant's hospital stay.

Start Date01 Apr 2025

Sponsor / Collaborator

The Cleveland Clinic Foundation

NCT06709573

/ Not yet recruitingPhase 4IIT

Clinical Decision Support Assistance to Randomize Patients to Early or Late Adjunctive Vasopressin in Septic Shock

The goal of the CASPER-Pilot study is to develop clinical decision support (CDS) technology within Epic to randomize patients with septic shock to early versus standard of care vasopressin initiation. The primary aim of this study will be to test the hypothesis that CDS technology can be utilized to create two distinct cohorts of patients reflecting different times of vasopressin initiation based on norepinephrine dose requirements. Secondarily, this study will evaluate the proportion of patients whose norepinephrine dose at the time of vasopressin initiation is within the specified range for the intervention arm they were randomized to. Other outcomes of evaluation will include adherence to the developed CDS technology and comparison of clinical outcomes between the two treatment arms.

Start Date01 Mar 2025

Sponsor / Collaborator

The Cleveland Clinic Foundation

100 Clinical Results associated with Vasopressin

100 Translational Medicine associated with Vasopressin

100 Patents (Medical) associated with Vasopressin

23,907

Literatures (Medical) associated with Vasopressin

01 Dec 2025·IMMUNOLOGIC RESEARCH

Arginine vasopressin (AVP) treatment increases the expression of inhibitory immune checkpoint molecules in monocyte-derived dendritic cells

Article

Author: Naseri, Bahar ; Baradaran, Behzad ; Ghahramanipour, Zahra ; Sohrabi, Sepideh ; Karimzadeh, Hadi ; Mardi, Amirhossein ; Baghbani, Elham ; Masoumi, Javad

Arginine vasopressin (AVP) has disparate impacts on immune responses by divergent receptors on cells including DCs. This study was conducted with the aim of investigating the impact of AVP on the maturation and expression of the inhibitory immune checkpoint molecules in tolerogenic monocyte-derived DCs. CD14 marker was used to separate monocytes from peripheral blood mononuclear cells (PBMCs) by MACS method. To differentiate monocytes from DCs, we utilized GM-CSF and IL-4 cytokines. Tolerogenic DCs were generated using vitamin D3 and dexamethasone. We added LPS and AVP to the culture medium on day 6 after incubation of DCs at 37 °C. Finally, we assessed the surface molecules by flow cytometry and used real-time PCR to evaluate the expression of genes related to the inhibitory immune checkpoints. Based on the obtained data, AVP increased the expression of CD11c (P ≤ 0.0001), HLA-DR (P ≤ 0.01), and CD86 (P ≤ 0.01) in AVP-mDCs. Also, the expression of all the immune checkpoint genes including CTLA-4 (P ≤ 0.001), BTLA (P ≤ 0.001), PDL-1 (P ≤ 0.05), B7H7 (P ≤ 0.001), LAG3 (P ≤ 0.01), and VISTA (P ≤ 0.001) in AVP-mDCs was increased in comparison to the control group. Vasopressin caused the generation of mature and tolerogenic DCs. Our data may help to consider AVP-mDCs to take part in autoimmune disease therapy, transplanted tissue rejection impedance, and allergies.

01 Jul 2025·DOMESTIC ANIMAL ENDOCRINOLOGY

Exploring the relationship between plasma and salivary levels of oxytocin, vasopressin, and cortisol in beagles: A preliminary study

Article

Author: Yoon, Minjung ; Jung, Youngwook ; Yang, Kayoung

Oxytocin, vasopressin, and cortisol are widely used as biomarkers to assess the temperament or emotional state of dogs. Typically, these levels are measured in blood; however, this invasive procedure can induce acute pain and stress. Considering the welfare of dogs, it is necessary to replace these procedures with noninvasive methods. Saliva sampling has emerged as a promising, noninvasive alternative for measuring hormonal levels. Nonetheless, it remains unclear whether saliva samples accurately reflect plasma hormonal levels in dogs. The objective of this study was to evaluate the correlations of oxytocin, vasopressin, and cortisol levels between plasma and saliva samples. We simultaneously collected blood and saliva samples from fifteen beagles, aged six, including eleven females and four sterilized males. Due to the limited availability of saliva samples, each analysis was performed on 5-11 dogs. Hormonal levels were quantified using commercial ELISA kits. Linear regression analysis and Pearson's correlation coefficient were used for statistical analysis. Our findings revealed no significant correlation between oxytocin or vasopressin levels in the plasma and salivary samples. However, a significant positive correlation was observed between cortisol levels in plasma and saliva samples. Additionally, oxytocin and vasopressin levels were positively correlated in both plasma and saliva samples. A positive correlation was found between the plasma cortisol and oxytocin levels, whereas no correlation was observed between the salivary cortisol and oxytocin levels. This study provides a foundation for understanding hormonal relationships across different matrices, contributing to the development of alternative sampling methods that prioritize animal welfare.

01 Jun 2025·JOURNAL OF MOLECULAR GRAPHICS & MODELLING

Potential P-glycoprotein (P-gp) inhibitors from SuperDRUG2 database toward reversing multidrug resistance in cancer treatment: Database mining, molecular dynamics, and binding energy estimations

Article

Author: Shoeib, Tamer ; Tallima, Hatem ; Abdelrahman, Alaa H M ; Abdeljawaad, Khlood A A ; Mekhemer, Gamal A H ; El-Tayeb, Mohamed A ; Hegazy, Mohamed-Elamir F ; Sidhom, Peter A ; Sayed, Shaban R M ; Ibrahim, Mahmoud A A

P-glycoprotein (P-gp) transporter is included in the failure of various carcinoma chemotherapeutics because of the multidrug resistance (MDR) phenomenon, in which the chemotherapeutic drugs are eliminated from target cells. Consequently, inhibiting P-gp transporter function is a prospective strategy for cancer treatment. In the current study, the SuperDRUG2 database containing >4600 pharmaceutical compounds was virtually screened toward the P-gp transporter utilizing the docking predictions. For inhibitors with a docking score lower than -10.5 kcal/mol, molecular dynamics (MD) simulations were performed, accompanied by binding energy evaluations using the MM-GBSA approach. In accordance with the MM-GBSA//100 ns MD, angiotensin amide (SD003508), terlipressin (SD002603), argipressin (SD002535), and lanreotide (SD001365) exhibited potential binding affinities against the P-gp transporter with ΔG_binding < -120.0 kcal/mol. The outstanding consistency of the investigated inhibitors inside the P-gp binding pocket was shown by the post-dynamics analyses. Additionally, MD simulations of the inhibitor-P-gp complexes in a POPC membrane environment were conducted to mimic the physiological conditions. These results demonstrated that angiotensin amide, terlipressin, argipressin, and lanreotide are promising P-gp inhibitors and deserve additional in-vitro/in-vivo studies.

News (Medical) associated with Vasopressin

13 Mar 2025

·www.prnewswire.com

Endo Reports Fourth-Quarter and Full-Year 2024 Financial Results

Endo achieved 2024 revenues and adjusted EBITDA expectations, while progressing the Company's strategic priorities XIAFLEX® hit record revenues of $516 million in 2024, up 9% versus 2023 The Company provides 2025 revenue guidance of $1,775 to $1,860 million and adjusted EBITDA guidance of $620 to $650 million MALVERN, Pa., March 13, 2025 /PRNewswire/ -- Endo, Inc. ("Endo" or the "Company") (OTCQX: NDOI) today reported financial results for the fourth quarter and full-year ended December 31, 2024. "We ended the year strong, with XIAFLEX® annual revenues exceeding $500 million for the first time and the successful launch of ADRENALIN® ready-to-use premixed bags," said Scott Hirsch, Interim Chief Executive Officer. "These milestones, along with the strategic realignment of our sterile product pipeline and the two recently announced transformative transactions, underscore our commitment to deliver growth and shareholder value." Separately, the Company announced that it has entered into a definitive agreement to combine with Mallinckrodt plc in a cash and stock transaction. ENDO FOURTH-QUARTER FINANCIAL PERFORMANCE (in thousands) CONSOLIDATED RESULTS Total revenues in fourth-quarter 2024 were $467 million, a decrease of 6% compared to $498 million in fourth-quarter 2023. This decrease was primarily attributable to competitive pressure across the Generic Pharmaceuticals and Sterile Injectables segments. Net Loss in fourth-quarter 2024 was $349 million, compared to a net loss of $2,441 million in fourth-quarter 2023. This change was driven by fourth-quarter 2023 adjustments to estimated allowed claims, including with respect to certain litigation matters and debt obligations that were reduced to actual payments upon emergence from the Chapter 11 process in second-quarter 2024. This was partially offset by fourth-quarter 2024 asset impairment charges and the application of fresh start accounting. Adjusted Net Income in fourth-quarter 2024 was $70 million, compared to $151 million in fourth-quarter 2023. This change was primarily due to increased interest and income tax expenses in fourth-quarter 2024. Adjusted EBITDA in fourth-quarter 2024 was $164 million, compared to $166 million in fourth-quarter 2023. This change was primarily driven by decreased revenues, partially offset by higher adjusted gross margin due to changes in segment and product mix. SEGMENT RESULTS Branded Pharmaceuticals segment revenues in fourth-quarter 2024 were $247 million, compared to $246 million in fourth-quarter 2023. XIAFLEX® revenues were $148 million in both fourth-quarter 2024 and fourth-quarter 2023. Fourth-quarter 2023 results included the benefit of a one-time reserve reversal of approximately $14 million following application of the final Inflation Reduction Act vial-wastage rebate determination to XIAFLEX®. Fourth-quarter 2024 XIAFLEX® revenues were primarily driven by an 8% increase in volume due to strong underlying demand. Sterile Injectables segment revenues in fourth-quarter 2024 were $92 million, compared to $96 million in fourth-quarter 2023. This change was primarily driven by competitive pressure on VASOSTRICT®, partially offset by the resolution of previously disclosed temporary supply disruptions. During fourth-quarter 2024, the Company launched three sterile injectable products, including ADRENALIN® ready-to-use (RTU) premixed bags, the first and only FDA-approved, manufacturer-prepared epinephrine premixed IV bags. Generic Pharmaceuticals segment revenues in fourth-quarter 2024 were $111 million, compared to $139 million in fourth-quarter 2023. This change was primarily attributable to competitive pressure across a number of products, mainly dexlansoprazole delayed-release capsules, partially offset by increased revenues from lidocaine patch 5%. International Pharmaceuticals segment revenues in fourth-quarter 2024 were $17 million, compared to $17 million in fourth-quarter 2023. BALANCE SHEET AND LIQUIDITY As of December 31, 2024, Endo had $387 million in unrestricted cash and cash equivalents. Net cash provided by operating activities in fourth-quarter 2024 was $30 million, compared to $115 million in fourth-quarter 2023. This change was primarily driven by increased interest and tax payments in fourth-quarter 2024 compared to fourth-quarter 2023. FINANCIAL GUIDANCE Endo is providing the following financial guidance for the full year ending December 31, 2025 based on Endo's current views, beliefs, estimates and assumptions. Guidance for the full year 2025 includes the International Pharmaceuticals business and will be updated following completion of the divestiture. All financial expectations provided by Endo are forward-looking, and actual results may differ materially from such expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements." CONFERENCE CALL INFORMATION Endo and Mallinckrodt will host a joint conference call to discuss the proposed transaction and their respective fourth quarter and full year 2024 results today, March 13, 2025, at 8:00 a.m. ET. The webcast may be accessed through this webcast link or from the Investor Relations section of the Company's website at investor.endo.com/events. To access the call through a conference line, participants may dial 800-836-8184 (U.S. and Canada toll-free) or 646-357-8785 (outside the U.S.). Participants are advised to join 10 minutes prior to the scheduled start time. A replay of the webcast will be available following the event. FINANCIAL SCHEDULES The following table presents unaudited Total Revenues, Net (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Operations (dollars in thousands): The following table presents unaudited Total Revenues, Net (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Operations (dollars in thousands): The following table presents the unaudited Condensed Consolidated Balance Sheet (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Cash Flow data (dollars in thousands): SUPPLEMENTAL FINANCIAL INFORMATION Non-GAAP Financial Measures To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain financial information of Endo, Inc. in this release that are not prescribed by or prepared in accordance with GAAP. The Company utilizes these non-GAAP financial measures as supplements to financial measures determined in accordance with GAAP when evaluating operating performance and the Company believes that these measures will be used by certain investors to evaluate operating results. The Company believes that presenting these non-GAAP financial measures provides useful information about performance across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable, as more fully described in the reconciliation tables below. Despite the importance of these measures to management in goal setting and performance measurement, the Company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income (unlike GAAP net income and its components) may differ from, and may not be comparable to, the calculation of similar measures of other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance. These non-GAAP financial measures should not be viewed in isolation or as substitutes for, or superior to, financial measures calculated in accordance with GAAP. Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant. The tables below provide reconciliations of certain of the non-GAAP financial measures included in this release to their most directly comparable GAAP metrics. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section. Reconciliation of Net Loss (GAAP) to EBITDA (non-GAAP) and Adjusted EBITDA (non-GAAP) The following table provides a reconciliation of Net Loss (GAAP) to Adjusted EBITDA (non-GAAP) (in thousands): Reconciliation of Net Loss (GAAP) to Adjusted Net Income (non-GAAP) The following table provides a reconciliation of Endo's Net Loss (GAAP) to Adjusted Net Income (non-GAAP) (in thousands): Reconciliation of Select Other Adjusted Income Statement Data (non-GAAP) The following tables provide detailed reconciliations of select other income statement data for Endo, Inc. between the GAAP and non-GAAP measure (in thousands): Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures About Endo Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to the statements by Mr. Hirsch and any statements relating to financial guidance, expectations, plans or projections, supply disruptions, pipeline development or realignment, product launches and submissions, strategic priorities, the combination with Mallinckrodt, improving performance, revenue growth, competition, demand and any other statements that refer to expected, estimated, predicted or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are examples of forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: with respect to the announced combination with Mallinckrodt, necessary governmental and regulatory approvals, satisfaction of closing conditions and shareholder approval; changes in competitive, market or regulatory conditions; changes in legislation or regulations; global political changes, including those related to the new U.S. presidential administration; our use of artificial intelligence and data science; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; our ability to develop and expand our product pipeline and to launch new products and to continue to develop the market for XIAFLEX® and other branded, sterile injectable or generic products; the effectiveness of advertising and other promotional campaigns; and the timely and successful implementation of business development opportunities and/or any other strategic priorities. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K and Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. Copies of the Company's press releases and additional information about the Company are available at or you can contact the Company's Investor Relations Department at [email protected]. ##### SOURCE Endo, Inc. 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Financial Statement

15 Oct 2024

·www.globenewswire.com

BioVie Receives Notice of Allowance for Japan Patent Application Covering Novel Liquid Formulation of Terlipressin

Patents covering BioVie’s terlipressin liquid formulation now secured in the United States, India, Japan and Chile, and are pending in eight additional markets Liquid formulation has demonstrated room-temperature stability for up to 24 months, representing an important advantage for treating patients with cirrhosis and ascites in the home-care setting CARSON, Nev., Oct. 15, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that it has received a Notice of Allowance from the Japan Patent Office for patent application no. 2021-569344 entitled "Formulations of Terlipressin." This Notice of Allowance is expected to result in the issuance of a Japanese patent in 2 to 3 weeks once administrative processes are completed. The allowed claims cover a novel liquid formulation of terlipressin acetate that has stability at room temperature for two years and can be packaged in a pre-filled syringe. The patent supports BioVie’s liquid formulation of terlipressin for development of a more patient-centric ambulatory treatment regimen for patients with ascites and hepatic failure in the US. Patients with cirrhosis and ascites have large volumes of fluid accumulate in the abdomen (often exceeding 5 liters) due to liver and kidney dysfunction. Patients that progress to refractory ascites face a one-year survival rate of approximately 50%1. To date, there is no approved medical therapy specifically for refractory ascites. Management of these patients is based upon procedures such as large-volume paracentesis and TIPS, which only provide temporary relief, lack disease-modifying effects, and lead to frequent life-threatening complications. "Terlipressin is a drug used in over 40 countries to treat related complications of liver cirrhosis that was only recently approved in the US as a lyophilized powder for in-hospital use, which requires reconstitution with sterile sodium chloride and refrigerated storage conditions for proper administration,” said Cuong Do, BioVie’s President and CEO. “Our novel liquid formulation of terlipressin is stable at room temperature for up to 24 months, offering an important advantage for treating patients with cirrhosis and ascites, particularly in the home-care setting. The pre-filled syringe format can improve dosing convenience and safety. The receipt of this patent will significantly strengthen BIV201’s intellectual property protection and increase the value proposition behind our BIV201 program.” In addition to the recent notice of allowance received for US and Japan, BioVie has received patent protection for its liquid formulation of terlipressin in India and Chile, and has patents pending in Australia, Canada, China, Europe, Hong Kong, South Korea, Mexico and Brazil. About Ascites and Cirrhosis Ascites (the excessive build-up of fluid in the abdomen) is the most common complication of advanced (“decompensated”) liver cirrhosis and can be life-threatening. In advanced liver cirrhosis, the liver becomes “clogged” and blood accumulates in the region below (called the splanchnic bed). With blood pooling below the liver, the blood volume in the arteries decreases and the person with cirrhosis experiences low effective blood volume. In an effort to correct this situation, the brain sends signals via the renin-angiotensin-aldosterone system (RAAS) to the kidneys to retain extreme amounts of water and salt to attempt to reflexively increase the blood volume in the arteries. The excess liquid weeps from the lymphatic system and collects in the abdomen – which is when ascites appears. Advanced liver cirrhosis is most-commonly caused by the progression of NASH (non-alcoholic steatohepatitis), alcoholism, and infection with Hepatitis B & C. Chronic liver disease (“CLD”), including cirrhosis, and is responsible for the death of 42,000 Americans each year. As a population, people diagnosed with both liver cirrhosis and ascites are frequently readmitted to the hospital frequently each year, incurring an estimated $5 billion in annual treatment costs.2 About BIV201BIV201 (terlipressin for continuous infusion) is a prefilled syringe or vial with BioVie’s patented liquid formulation of terlipressin acetate. A synthetic analogue of vasopressin, terlipressin has been studied extensively overseas and is approved in more than 40 countries for in-hospital treatment of two deadly conditions related to ascites (bleeding esophageal varices, (“BEV”) and hepatorenal syndrome, (“HRS”). Terlipressin has the potential to reduce the presence of ascites in the abdomen through vasoconstricting the blood vessels where the blood is pooling, hence restoring blood flow through the kidneys and liver. This reduces portal vein pressure and increases blood volume in the arteries. Consequently, the body may respond by shutting down the RAAS system which has been generating the ascites. Terlipressin, a medication employed in over 40 countries to manage complications associated with liver cirrhosis, has recently gained U.S. approval as a lyophilized powder that requires reconstitution with sodium chloride and refrigerated storage up to 48 hours for proper administration. BioVie’s unique liquid formulation of terlipressin has demonstrated stability, not only under refrigerated conditions, but also at room temperature for up to 24 months, which can be an important advantage for treating patients with cirrhosis and ascites, particularly in the home-care setting. The Company has received patent protection for its liquid formulation of terlipressin in India and Chile; a notice of allowance in the US and Japan; and patents are pending in Australia, Canada, China, Europe, Hong Kong, South Korea, Mexico and Brazil. In the US, BioVie has secured Orphan Drug designation and Fast Track status covering the use of BIV201 (continuous infusion terlipressin) for the treatment of ascites due to liver cirrhosis. BIV201 also has an Orphan drug designation for treating HRS and BioVie has reached agreement with the FDA on the design, duration, dosing and endpoints of a Phase 3 trial to evaluated BIV201 for the treatment of HRS-AKI (acute kidney injury) that could potentially be sufficient to support a New Drug Application (“NDA”) filing with the FDA. About BioVie Inc.BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders (Long COVID, Alzheimer's disease and Parkinson’s disease) and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of extracellular signal-regulated kinase and the transcription factor, Nuclear factor- kB, and the associated neuroinflammation and insulin resistance but not ERK and NFkB homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both neuroinflammation and insulin resistance are drivers of AD and PD. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the reduction of further decompensation in participants with liver cirrhosis and ascites. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit www.bioviepharma.com. Forward-Looking StatementsThis press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. References1 Gines P, Quintero E, Arroyo V, et al. Compensated cirrhosis: natural history and prognostic factors. Hepatology 1987; 7: 122–128. 2 Mortimer R, Volk M., Mortimer S, et al. U.S. hospitalization burden of patients with cirrhosis and ascites receiving paracentesis. Presented as a poster presentation, Liver Meeting, Nov 2022, Washington DC For Investor Relations Inquiries:Bruce MackleManaging Director, LifeSci Advisors, LLCbmackle@lifesciadvisors.com For Media Relations Inquiries:Melyssa WeibleManaging Partner, Elixir Health Public Relationsmweible@elixirhealthpr.com

Orphan DrugFast TrackDrug ApprovalPhase 3

01 Oct 2024

·www.globenewswire.com

BioVie Receives Notice of Allowance for United States Patent Application Covering Novel Liquid Formulation of Terlipressin

Patents covering BioVie’s terlipressin liquid formulation now secured in the United States, India and Chile, and are pending in nine additional markets Formulation has demonstrated room-temperature stability for up to 24 months, representing an important advantage for treating patients with cirrhosis and ascites in the home-care setting CARSON CITY, Nev., Oct. 01, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 17/611,478 entitled "Formulations of Terlipressin." This Notice of Allowance is expected to result in the issuance of a US patent once administrative processes are completed. The allowed claims cover a novel liquid formulation of terlipressin acetate that has stability at room temperature for two years and can be packaged in a pre-filled syringe. BioVie expects the resulting patent will be approved for listing in the Orange Book. The patent supports BioVie’s liquid formulation of terlipressin for development of a more patient-centric ambulatory treatment regimen for patients with ascites and hepatic failure in the US. Patients with cirrhosis and ascites have large volumes of fluid accumulate in the abdomen (often exceeding 5 liters) due to liver and kidney dysfunction. Patients that progress to refractory ascites face a one-year survival rate of approximately 50%1. To date, there is no approved medical therapy specifically for refractory ascites. Management of these patients is based upon procedures such as large-volume paracentesis and TIPS, which only provide temporary relief, lack disease-modifying effects, and lead to frequent life-threatening complications. "Terlipressin is a drug used in over 40 countries to treat related complications of liver cirrhosis that was only recently approved in the US as a lyophilized powder for in-hospital use, which requires reconstitution with sterile sodium chloride and refrigerated storage conditions for proper administration,” said Cuong Do, BioVie’s President and CEO. “Our novel liquid formulation of terlipressin is stable at room temperature for up to 24 months, offering an important advantage for treating patients with cirrhosis and ascites, particularly in the home-care setting. The pre-filled syringe format can improve dosing convenience and safety. The receipt of this patent will significantly strengthen BIV201’s intellectual property protection and increase the value proposition behind our BIV201 program.” In addition to the US, BioVie has received patent protection for its liquid formulation of terlipressin in India and Chile, and has patents pending in Australia, Canada, China, Europe, Hong Kong, Japan, South Korea, Mexico and Brazil. About Ascites and Cirrhosis Ascites (the excessive build-up of fluid in the abdomen) is the most common complication of advanced (“decompensated”) liver cirrhosis and can be life-threatening. In advanced liver cirrhosis, the liver becomes “clogged” and blood accumulates in the region below (called the splanchnic bed). With blood pooling below the liver, the blood volume in the arteries decreases and the person with cirrhosis experiences low effective blood volume. In an effort to correct this situation, the brain sends signals via the renin-angiotensin-aldosterone system (RAAS) to the kidneys to retain extreme amounts of water and salt to attempt to reflexively increase the blood volume in the arteries. The excess liquid weeps from the lymphatic system and collects in the abdomen – which is when ascites appears. Advanced liver cirrhosis is most-commonly caused by the progression of NASH (non-alcoholic steatohepatitis), alcoholism, and infection with Hepatitis B & C. Chronic liver disease (“CLD”), including cirrhosis, and is responsible for the death of 42,000 Americans each year. As a population, people diagnosed with both liver cirrhosis and ascites experience frequent hospital readmissions each year, incurring an estimated $5 billion in annual treatment costs.2 About BIV201BIV201 (terlipressin for continuous infusion) is a prefilled syringe or vial with BioVie’s patented liquid formulation of terlipressin acetate. A synthetic analogue of vasopressin, terlipressin has been studied extensively overseas and is approved in more than 40 countries for in-hospital treatment of two deadly conditions related to ascites (bleeding esophageal varices, “BEV” and hepatorenal syndrome, “HRS”). Terlipressin has the potential to reduce the presence of ascites in the abdomen through vasoconstricting the blood vessels where the blood is pooling, hence restoring blood flow through the kidneys and liver. This reduces portal vein pressure and increases blood volume in the arteries. Consequently, the body may respond by shutting down the RAAS system which has been generating the ascites. Terlipressin, a medication employed in over 40 countries to manage complications associated with liver cirrhosis, has recently gained U.S. approval as a lyophilized powder that requires reconstitution with sodium chloride and refrigerated storage up to 48 hours for proper administration. BioVie’s unique liquid formulation of terlipressin has demonstrated stability, not only under refrigerated conditions, but also at room temperature for up to 24 months, which can be an important advantage for treating patients with cirrhosis and ascites, particularly in the home-care setting. The Company has received patent protection for its liquid formulation of terlipressin in India and Chile; a notice of allowance in the US; and patents are pending in Australia, Canada, China, Europe, Hong Kong, Japan, South Korea, Mexico and Brazil. In the US, BioVie has secured Orphan Drug designation and Fast Track status covering the use of BIV201 (continuous infusion terlipressin) for the treatment of ascites due to liver cirrhosis. BIV201 also has an Orphan drug designation for treating HRS and BioVie has reached agreement with the FDA on the design, duration, dosing and endpoints of a Phase 3 trial to evaluated BIV201 for the treatment of HRS-AKI (acute kidney injury) that could potentially be sufficient to support an NDA filing. About BioVie Inc.BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders (Long COVID, AD and PD) and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of AD and PD. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the reduction of further decompensation in participants with liver cirrhosis and ascites. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit www.bioviepharma.com. Forward-Looking StatementsThis press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. References1 Gines P, Quintero E, Arroyo V, et al. Compensated cirrhosis: natural history and prognostic factors. Hepatology 1987; 7: 122–128. 2 Mortimer R, Volk M., Mortimer S, et al. U.S. hospitalization burden of patients with cirrhosis and ascites receiving paracentesis. Presented as a poster presentation, Liver Meeting, Nov 2022, Washington DC For Investor Relations Inquiries:Bruce MackleManaging Director, LifeSci Advisors, LLCbmackle@lifesciadvisors.com For Media Relations Inquiries:Melyssa WeibleManaging Partner, Elixir Health Public Relationsmweible@elixirhealthpr.com

Orphan DrugFast TrackPhase 3Drug Approval

100 Deals associated with Vasopressin

External Link

KEGG	Wiki	ATC	Drug Bank
D02983	Vasopressin	H01BA01	DB00067

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Abdomen distended	Australia	Link Medical Products Pty Ltd.	09 Jun 2017
Shock	United States	Endo Operations Ltd.	17 Apr 2014
Bleeding esophageal varices	Japan	Daiichi Sankyo Co., Ltd.	01 Nov 1959
Diabetes Insipidus	Japan	Daiichi Sankyo Co., Ltd.	01 Nov 1959
Flatulence	Japan	Daiichi Sankyo Co., Ltd.	01 Nov 1959

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04501861 (CTgov)	Phase 3	Heart Diseases	153	Vasopressin (The Use of Vasopressin)	mzmvpryxmh(jlcjphfacy) = bkbainkctn uvurzrthbq (cwfjmisgfz, 0.086) View more	-	09 Jan 2025
				Norepinephrine (The Use of Norepinephrine)	mzmvpryxmh(jlcjphfacy) = gxbomszdte uvurzrthbq (cwfjmisgfz, 0.094) View more
NCT02975999 (CTgov)	Phase 2/3	Univentricular Heart \| Pleural Effusion	12	Vasopressin (Vasopressin)	okipsvtvyd(pctxfixmlt) = kocikwrdmf grgfepdiqh (ycosnlfziv, 307.03) View more	-	09 Oct 2024
				Normal Saline (Normal Saline)	okipsvtvyd(pctxfixmlt) = stmdjrxhyp grgfepdiqh (ycosnlfziv, 140.29) View more
ATS2024	Not Applicable	Diabetes Insipidus, Neurogenic	-	Vasopressin infusion	gjrqkfwvdi(kdrgxoazqc) = uciwqurhun xsocyglplh (bnvhcufttf ) View more	-	19 May 2024
				D5W and free water	gjrqkfwvdi(kdrgxoazqc) = kdzqzjvusx xsocyglplh (bnvhcufttf ) View more
NCT04463394 (Pubmed \| Pediatr Crit Care Med)	Early Phase 1	-	28	Vasopressin	twqhhfczux(dzbuusfvgj) = vyvusswccv qmxijqydga (uaqkkjefrv ) View more	-	18 Jul 2023
ATS2023	Not Applicable	Diabetes Insipidus	-	Vasopressin infusion	iwembreyel(kduausuomp) = vzpioqmnju voahubusft (itlhpwhsxv ) View more	-	21 May 2023
				Norepinephrine infusion	vziycywuui(psyqwirwde) = xjpivjocyn yryfugdbdb (pzzjthjdrm ) View more
NCT03636451 (CTgov)	Phase 3	Abortion, Habitual \| Pain \| Abortion, Missed	114	2 units of vasopressin paracervical block (20cc 1% Lidocaine With 2 Units of Vasopressin Paracervical Block)	fhmplgdmnk(sxgllprtbl) = ydqolmiure bvbvbmxwdg (qndursnass, gucsbagtmf - pogpfepatq) View more	-	20 Apr 2023
				40cc buffered 0.5% lidocaine+2 units of vasopressin paracervical block (40cc Buffered 0.5% Lidocaine With 2 Units of Vasopressin Paracervical Block)	fhmplgdmnk(sxgllprtbl) = adkuwwqrie bvbvbmxwdg (qndursnass, jjxwbndvmf - hrignathcz) View more
ASN2022	Not Applicable	-	-	Desmopressin (dDAVP)	ousbzinovy(fieqrhaftw) = spjaievnkc lxtnjfxqju (ugvuayqjip ) View more	-	03 Nov 2022
				Vehicle (Veh)	vppcgoovnj(gawtwngobu) = oiyagetvno adpsjxwmsc (kuebmgfoum )
NCT05439460 (CTgov)	Phase 4	Pulmonary hypertensive crisis \| Pulmonary Arterial Hypertension	15	phenylephrine (Phenylephrine)	wanpilltjd(qrmysipswe) = bfnsxwevzw krdbbfnccu (bhqgpsxkus, 0.7) View more	-	05 Aug 2022
				Arginine Vasopressin (Arginine Vasopressin)	wanpilltjd(qrmysipswe) = qrvgxtprtx krdbbfnccu (bhqgpsxkus, 0.41) View more
ATS2022	Not Applicable	Out-Of-Hospital Cardiac Arrest	869	Vasopressin-Corticosteroid-Epinephrine (VCE) combination	gmpdeljstf(qisqgryoix): OR = 0.5 (95% CI, 0.08 - 3), P-Value = 0.45 View more	Positive	15 May 2022
				Epinephrine (Placebo group)
ATS2022	Not Applicable	Shock, Septic	-	Vasopressin infusion	yxkithhlhc(drsjbfqcti) = Within two days of starting vasopressin, the sodium decreased acutely to 114 mmol/L. The vasopressin infusion was held, and within one day, the sodium promptly returned to a normal level of 140 mmol/L and remained within normal limits throughout the admission. The patient suffered no sequalae from the acute drop in sodium, and no further intervention was required. odogjamyjp (zohxnglwsd )	-	15 May 2022
				Norepinephrine infusion

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