CLINICAL TRIALS PROFILE FOR GIAPREZA

All Clinical Trials for Giapreza

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03431077 ↗	A Study of LJPC-501 in Pediatric Patients With Hypotension	Completed	La Jolla Pharmaceutical Company	Phase 2	2018-02-11	The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) or reduction in sum norepinephrine (NE) equivalent dosing, at Hour 2 after the start of LJPC-501, in pediatric patients who remain hypotensive despite receiving fluid therapy and vasopressor therapy. In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, the change in MAP over 24 hours after the start of LJPC-501, the change in serum lactate concentrations, and the change in Pediatric Logistic Organ Dysfunction (PELOD) scores.
NCT03733145 ↗	Angiotensin II in General Anesthesia	Recruiting	La Jolla Pharmaceutical Company	Phase 1	2019-10-03	Hypotension in adult patients undergoing general anesthesia is common. This can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. This may be worse in patients with underlying essential hypertension and worse in patients taking Angiotensin Converting Enzyme Inhibitors (ACE) and Angiotensin Receptor Blockers (ARBs). Intravenous (IV) administration of Ang II may be an effective treatment of hypotension in this patient population.
NCT03733145 ↗	Angiotensin II in General Anesthesia	Recruiting	Wake Forest University Health Sciences	Phase 1	2019-10-03	Hypotension in adult patients undergoing general anesthesia is common. This can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. This may be worse in patients with underlying essential hypertension and worse in patients taking Angiotensin Converting Enzyme Inhibitors (ACE) and Angiotensin Receptor Blockers (ARBs). Intravenous (IV) administration of Ang II may be an effective treatment of hypotension in this patient population.
NCT04048707 ↗	Angiotensin 2 for Hepatorenal Syndrome	Not yet recruiting	University of California, Los Angeles	Phase 2	2021-07-01	Hepatorenal syndrome (HRS) is a disease in which patients with cirrhosis (end stage liver failure) develop secondary kidney injury and failure. The current treatment available in the United States is a combination of octreotide and midodrine, which are meant to decrease the release of those hormones and raise the blood pressure, respectively, which would increase blood flow to the kidneys. Angiotensin 2 (Ang2) is a new vasopressor drug that was approved by the FDA in December 2017 for patients with low blood pressure and has been shown to have similar effects to octreotide and midodrine. This study will investigate whether Ang2 reverses HRS among patients admitted to the intensive care unit (ICU) at Ronald Reagan Medical Center. Our study population will be patients with HRS who are already or will be admitted to the ICU. HRS will be defined by new internationally accepted guidelines published by the International Club of Ascites. All patients who are consented will undergo an Ang2 response trial, where low-dose Ang2 will be administered for 4 hours to see how the patients respond. This will help us characterize the nature of the patients' kidney failure for later analysis. Patients will then be randomized into the control group or the study group. Patients in the control group will receive octreotide (a subcutaneous injection) and midodrine (an oral drug). Patients in the study group will continue receiving intravenous infusion of Ang2. Patients in both groups will also receive albumin, a protein found commonly in human blood. Treatment will continue in both groups for four days, until complete reversal of HRS, dialysis, or death. Our primary outcome will be rate of reversal of HRS, defined as improvement in kidney function.
NCT04529005 ↗	Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients	Completed	La Jolla Pharmaceutical Company	Phase 4	2020-08-13	The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.
NCT04529005 ↗	Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients	Completed	University of Illinois at Chicago	Phase 4	2020-08-13	The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.

Clinical Trial Conditions for Giapreza

Condition Name

Condition Name for Giapreza
Intervention	Trials
Septic Shock	3
Sepsis	2
Distributive Shock	2
Shock	2

Condition MeSH

Condition MeSH for Giapreza
Intervention	Trials
Shock	6
Hypotension	3
Shock, Septic	3
Shock, Surgical	1

Clinical Trial Locations for Giapreza

Trials by Country

Trials by Country for Giapreza
Location	Trials
United States	9

Trials by US State

Trials by US State for Giapreza
Location	Trials
Illinois	2
North Carolina	2
New Mexico	2
Texas	1
Ohio	1

Clinical Trial Progress for Giapreza

Clinical Trial Phase

Clinical Trial Phase for Giapreza
Clinical Trial Phase	Trials
Phase 4	5
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Giapreza
Clinical Trial Phase	Trials
Not yet recruiting	3
Recruiting	3
Completed	2

Clinical Trial Sponsors for Giapreza

Sponsor Name

Sponsor Name for Giapreza
Sponsor	Trials
La Jolla Pharmaceutical Company	7
University of New Mexico	2
Wake Forest University Health Sciences	1

Sponsor Type

Sponsor Type for Giapreza
Sponsor	Trials
Industry	7
Other	7
NIH	1

GIAPREZA: Clinical Trials, Market Analysis, and Projections

Introduction to GIAPREZA

GIAPREZA (angiotensin II) is a significant advancement in the treatment of septic or other distributive shock, particularly in critically ill patients. It is the only FDA-approved branded drug specifically for this indication, making it a crucial component in the management of sepsis.

Clinical Trials Overview

The efficacy and safety of GIAPREZA were primarily evaluated in the ATHOS-3 clinical trial.

ATHOS-3 Trial Design and Outcomes

• Study Structure: ATHOS-3 was an international, randomized, double-blind, placebo-controlled study involving 321 patients with distributive shock[1][3][5].
• Primary Endpoint: The trial measured the percentage of patients who achieved either a mean arterial pressure (MAP) ≥ 75 mmHg or a ≥ 10 mmHg increase in MAP without an increase in baseline vasopressor therapy at 3 hours. GIAPREZA significantly outperformed the placebo, with 70% of patients achieving the target MAP compared to 23% in the placebo group[3].
• Rapid MAP Response: The median time to reach target MAP was 5 minutes, and 70% of patients who achieved target MAP did so within the first 30 minutes of treatment at doses ≤5 ng/kg/min[1].
• Vasopressor Reduction: Patients on GIAPREZA required consistently lower mean doses of background vasopressors during the first 48 hours[1].
• Survival Benefit: An exploratory post hoc analysis showed that early use of GIAPREZA plus standard of care was associated with improved survival compared to placebo plus standard of care[1].

Safety and Adverse Events

While GIAPREZA has shown significant efficacy, it also comes with notable safety considerations.

Adverse Reactions

• Thromboembolic Events: There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients receiving GIAPREZA (13% vs. 5% in the placebo group)[1][5].
• Other Adverse Reactions: Common adverse reactions included thrombocytopenia, tachycardia, fungal infection, delirium, acidosis, hyperglycemia, and peripheral ischemia[5].

Concurrent VTE Prophylaxis

Given the increased risk of thromboembolic events, concurrent venous thromboembolism (VTE) prophylaxis is recommended[5].

Market Analysis

Current Market Landscape

• Standard of Care: The current standard of care for sepsis involves antibiotics and vasopressors, with GIAPREZA being the only FDA-approved branded drug specifically for this condition[2].
• Market Size and Growth: The global sepsis therapeutics market is estimated at $4.6 billion in 2023 and is projected to reach $7.1 billion by 2030, growing at a CAGR of 6.4%[2].

Geographic Market Performance

• North America and Asia-Pacific: The U.S. market is estimated at $1.5 billion, while China is forecast to grow at a CAGR of 7.3%. Other notable markets include Japan and Canada, growing at 4.1% and 4.9% respectively[2].
• Europe: Germany is forecast to grow at approximately 5% CAGR[2].

Financial Performance and Projections

Revenue Growth

• Innoviva's Financials: Innoviva reported a significant increase in net product revenues, driven by the growth of GIAPREZA. In the first quarter of 2024, GIAPREZA contributed $12.1 million to the company's net product sales, representing a 66% year-over-year growth[4].

Market Outlook

• Robust Growth: The market outlook for sepsis therapeutics is positive, with robust growth expected globally, particularly in North America and the Asia-Pacific region[2].

Challenges and Opportunities

Limited Therapeutic Options

Despite the positive market outlook, the sepsis therapeutics market faces challenges due to limited therapeutic options. This emphasizes the need for continued research and development to expand treatment choices[2].

Emerging Treatments

Promising treatments, including new nanoparticles and other innovations, are emerging, indicating a dynamic market with ongoing advancements[2].

Key Takeaways

• Efficacy in Clinical Trials: GIAPREZA has demonstrated significant efficacy in raising MAP and reducing vasopressor needs in critically ill patients.
• Safety Considerations: While effective, GIAPREZA is associated with an increased risk of thromboembolic events, necessitating concurrent VTE prophylaxis.
• Market Growth: The global sepsis therapeutics market is growing, with GIAPREZA playing a crucial role in this expansion.
• Financial Performance: Innoviva's financials reflect the strong growth of GIAPREZA, contributing significantly to the company's revenue.

FAQs

What is GIAPREZA used for?

GIAPREZA is used to increase blood pressure in adults with septic or other distributive shock.

What were the key findings of the ATHOS-3 trial?

The ATHOS-3 trial showed that GIAPREZA significantly increased MAP and reduced the need for vasopressors, with 70% of patients achieving target MAP within 3 hours.

What are the common adverse reactions associated with GIAPREZA?

Common adverse reactions include thromboembolic events, thrombocytopenia, tachycardia, fungal infection, delirium, acidosis, hyperglycemia, and peripheral ischemia.

How is the global sepsis therapeutics market projected to grow?

The global sepsis therapeutics market is estimated to grow from $4.6 billion in 2023 to $7.1 billion by 2030, at a CAGR of 6.4%.

What is the current market size of GIAPREZA in the U.S.?

The U.S. market for sepsis therapeutics, where GIAPREZA is a key player, is estimated at $1.5 billion.

References

1. GIAPREZA Efficacy and Trial Design. GIAPREZA.com.
2. Global Sepsis Therapeutics Strategic Research Report 2023-2024. BusinessWire.
3. Drug Trials Snapshots: GIAPREZA. FDA.gov.
4. Innoviva Reports First Quarter 2024 Financial Results. Innoviva Investor Relations.
5. Safety & Adverse Events | GIAPREZA. GIAPREZA.com.

Last updated: 2024-12-31