Giapreza (LJPC-501) / Innoviva - LARVOL DELTA

Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension (clinicaltrials.gov) - P4 | N=30 | Enrolling by invitation | Sponsor: Todd Sweberg

New P4 trial • Hypotension • Pediatrics

Comparison of Angiotensin II (Giapreza®) Use in Kidney Transplantation Between Black and Non-Black Patients. (PubMed, Biomedicines) - "As baseline weight was significantly higher in Black patients and associated with duration of usage, perhaps the metabolic differences in our Black patients led to the observed differences. Regardless, longer durations of vasopressors were associated with delayed graft function, making this an area of utmost importance for continued investigation."

Journal • Hypotension • Transplantation

Angiotensin Receptor Blockade Does Not Decrease Synthetic Angiotensin II (Giapreza®) Effectiveness in Perioperative Hypotension Surrounding Kidney Transplant. (PubMed, Biomedicines) - "Hospital and ICU stay length, safety, and adverse drug events were also similar. Contrary to theoretical concerns and observations in other distributive shock populations, no significant hemodynamic or clinical differences were observed in the response to AT2S in patients with pre-transplant ARB use."

Journal • Cardiovascular • Hypertension • Hypotension • Transplantation

Gland Pharma gets US FDA approval for hypotension treatment drug Angiotensin II (Business Standard) - "Gland Pharma said that it has received approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Angiotensin II Acetate Injection. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) GIAPREZA of La Jolla Pharma LLC. This product is indicated for increasing the blood pressure in adults with septic or other distributive shock....According to IQVIA, the product had US sales of approximately $58 million for the twelve months ending March 2025."

ANDA • Sales • Hypotension • Septic Shock

DARK-Sepsis: Serum Biomarkers to Predict Response to Angiotensin II in Septic Shock (clinicaltrials.gov) - P4 | N=40 | Completed | Sponsor: University of New Mexico | Recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Mar 2025 | Trial primary completion date: Jun 2025 ➔ Mar 2025

Biomarker • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Septic Shock

Angiotensin II in General Anesthesia (clinicaltrials.gov) - P4 | N=31 | Completed | Sponsor: Wake Forest University Health Sciences | Recruiting ➔ Completed | N=60 ➔ 31

Enrollment change • Trial completion • Anesthesia • Cardiovascular • Hypertension • Hypotension

Angiotensin II in General Anesthesia (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Wake Forest University Health Sciences | Phase classification: P1 ➔ P4

Phase classification • Anesthesia • Cardiovascular • Hypertension • Hypotension

ASSESSING UTILIZATION OF PLASMA EXCHANGE IN ECMO FOR CALCIUM CHANNEL BLOCKER INGESTIONS (SCCM 2025) - "Of the patients who received PE, all received high dose vasoactives (epinephrine, norepinephrine, vasopressin) and high dose insulin and glucagon therapy. Other therapies trialed for select patients pre-ECMO cannulation included calcium infusion (80%), methylene blue (60%), giapreza (40%), lipid sink (40%), and hydrocortisone (20%)... Data about ingestions and required support is difficult to analyze due to number of confounding variables, data from this patient cohort indicates PE may be associated with reduced duration of ECMO for CCB ingestions when compared to the average from adult studies."

Cardiovascular • CNS Disorders • Depression • Pediatrics • Psychiatry

Comparison of Angiotensin II Giapreza Use for Perioperative Hypotension surrounding Kidney Transplantation between Black and nonBlack Patients (ASHP 2024) - No abstract available

Clinical • Hypotension • Transplantation

Angiotensin II as a Vasopressor for Perioperative Hypotension in Solid Organ Transplant. (PubMed, Biomedicines) - "Synthetic angiotensin II (AT2S-[Giapreza]) is a novel vasopressor indicated for distributive shock with a unique mechanism of action as an angiotensin receptor agonist restoring balance to an often-disrupted renin angiotensin aldosterone system...While the data, to date, are limited, AT2S has demonstrated safety in case reports, pilot studies, and small series in the kidney, liver, heart, and lung transplant populations. There are physiologic and hemodynamic reasons why AT2S could be a more utilized agent in these populations, but further investigation is warranted."

Journal • Review • Anesthesia • Atrial Fibrillation • Cardiovascular • Hepatology • Hypotension • Solid Organ Transplantation • Transplantation

Efficacy and Safety of Perioperative Angiotensin II Versus Phenylephrine as a First-Line Continuous Infusion Vasopressor in Kidney Transplant Recipients. (PubMed, Clin Transplant) - "Among kidney transplant recipients, ATII may be a suitable first-line alternative compared with phenylephrine in the perioperative period for hypotension management with a reduced need for additional vasopressor support. Allograft benefits were observed in patients with prolonged CIT."

Clinical • Journal • Retrospective data • Cardiovascular • Hypotension • Transplantation

DARK-Sepsis: Serum Biomarkers to Predict Response to Angiotensin II in Septic Shock (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: University of New Mexico | Trial completion date: Oct 2024 ➔ Jun 2025 | Trial primary completion date: Sep 2024 ➔ Jun 2025

Biomarker • Trial completion date • Trial primary completion date • Infectious Disease • Septic Shock

Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Kingman Regional Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Infectious Disease • Inflammation • Septic Shock • Systemic Inflammatory Response Syndrome

Angiotensin II in General Anesthesia (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Wake Forest University Health Sciences | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Anesthesia • Cardiovascular • Hypertension • Hypotension

ANTHEM: Angiotensin 2 for Hepatorenal Syndrome (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: University of California, Los Angeles | N=48 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Acute Kidney Injury • Chronic Kidney Disease • Fibrosis • Hepatology • Immunology • Nephrology • Renal Disease

Real-World Evaluation of Angiotensin II Use in the Treatment of Shock (SCCM 2024) - "Introduction: Angiotensin II (ATII) (Giapreza) is a vasoconstrictor used for the treatment of vasodilatory shock... ATII did not increase MAP as effectively shown in the ATHOS-3 study results. Education is needed to assure patients with vasodilatory shock are initiated properly at an appropriate dose."

Clinical • HEOR • Real-world • Real-world evidence • Cardiovascular • Septic Shock

Angiotensin 2 in Takotsubo Cardiomyopathy and Hypertrophic Outflow Tract Obstruction (SCCM 2024) - " This case demonstrates the usage of Giapreza, a novel angiotensin 2 receptor agonist, to increase afterload and reduce an LVOT obstruction caused by Takotsubo cardiomyopathy. By increasing peripheral vascular resistance, Giapreza shows promise as a therapeutic agent for managing LVOTOs."

Acute Coronary Syndrome • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertrophic Cardiomyopathy • Hypotension • Obstructive Hypertrophic Cardiomyopathy • Pain

AngLT-1: Angiotensin II in Liver Transplantation (clinicaltrials.gov) - P2/3 | N=50 | Recruiting | Sponsor: University of California, San Francisco | Trial completion date: Sep 2024 ➔ Sep 2026 | Trial primary completion date: Sep 2023 ➔ Sep 2025

Trial completion date • Trial primary completion date • Hepatology • Transplantation

Hemodynamic Response to Angiotensin-II When Used as the Second Vasopressor Agent for Septic Shock (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Kingman Regional Medical Center

New P4 trial • Immunology • Infectious Disease • Inflammation • Septic Shock • Systemic Inflammatory Response Syndrome

DARK-Sepsis: Serum Biomarkers to Predict Response to Angiotensin II in Septic Shock (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: University of New Mexico | Trial completion date: Oct 2023 ➔ Oct 2024 | Trial primary completion date: Sep 2023 ➔ Sep 2024

Biomarker • Trial completion date • Trial primary completion date • Infectious Disease • Septic Shock

Angiotensin II in General Anesthesia (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Wake Forest University Health Sciences | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Anesthesia • Cardiovascular • Hypertension • Hypotension • TNS3

DARK-Sepsis: Serum Biomarkers to Predict Response to Angiotensin II in Septic Shock (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: University of New Mexico

Biomarker • New P4 trial • Infectious Disease • Septic Shock

Angiotensin II vs. Vasopressin in Septic Shock (clinicaltrials.gov) - P4 | N=0 | Withdrawn | Sponsor: University of New Mexico | N=40 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Septic Shock

EXTENDED-USE STABILITY DATA OF ANGIOTENSIN II INFUSIONS (SCCM 2023) - "Introduction: Angiotensin II (Giapreza) is a parenteral vasopressor indicated for the treatment of hypotension in adults with distributive shock... Diluted angiotensin II demonstrated stability under two of the three extended storage criteria based on turbidity and pH assessments. Further information about concentration retention is needed to support extended stability. Final conclusions will be determined after final angiotensin II concentrations are reviewed and reported."

Hypotension • Transplantation

Angiotensin II for Distributive Shock (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: Northwestern University | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Transplantation