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.

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
Shock, Septic	3
Hypotension	3
Acute Kidney Injury	1

Clinical Trial Locations for GIAPREZA

Trials by Country

Trials by Country for GIAPREZA
Location	Trials
United States	10

Trials by US State

Trials by US State for GIAPREZA
Location	Trials
New Mexico	2
Illinois	2
North Carolina	2
New York	1
Arizona	1

Clinical Trial Progress for GIAPREZA

Clinical Trial Phase

Clinical Trial Phase for GIAPREZA
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	5
Phase 2	2

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
Kingman Regional Medical Center	1

Sponsor Type

Sponsor Type for GIAPREZA
Sponsor	Trials
Industry	8
Other	8
NIH	1

Clinical Trials Update, Market Analysis, and Projection for GIAPREZA (Angiotensin II)

Last updated: November 3, 2025

Introduction

GIAPREZA (angiotensin II) is a synthetic peptide developed by La Jolla Pharmaceutical Company, approved by the U.S. Food and Drug Administration (FDA) in December 2017 for increasing blood pressure in adult patients with septic or other vasodilatory shock who remain hypotensive despite initial treatment. As a critical agent in managing shock, its clinical development, market penetration, and future growth prospects are vital for stakeholders across healthcare, pharmaceutical, and investment sectors. This report provides a comprehensive update on recent clinical trials, evaluates the current market landscape, and projects future trends for GIAPREZA.

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Clinical Trials Update for GIAPREZA

Ongoing and Completed Clinical Trials

Since FDA approval, GIAPREZA has been subject to ongoing clinical evaluation to expand its indications, improve safety profiles, and optimize dosing strategies. Notably, the PRESERVES trial (NCT04121228) is an ongoing Phase IV study assessing long-term safety and efficacy in septic shock patients, with preliminary data suggesting positive outcomes in hemodynamic stabilization.

Furthermore, post-marketing surveillance has indicated areas for further investigation, including whether GIAPREZA reduces mortality rates compared to standard vasopressor therapies. These studies are crucial because vasopressors like norepinephrine have longstanding dominance in septic shock management.

Innovative Clinical Trials and Trials for Expanded Use

• Comparator Studies: Recent trials compare GIAPREZA directly with traditional agents such as vasopressin, aiming to demonstrate superiority or non-inferiority in restoring blood pressure and reducing adverse effects.

• Combination Therapy Research: Trials are evaluating the synergistic potential of GIAPREZA with other vasopressors or adjuncts to optimize shock management protocols.

• Expanded Indications: Phase II studies are exploring GIAPREZA's efficacy in other forms of shock, including cardiogenic shock and hemorrhagic shock, recognizing the universal need for effective vasopressors.

Regulatory Updates

While FDA approval was limited to septic and vasodilatory shock, recent requests for expanded indications are under review. The company’s engagement with regulatory agencies underscores a strategy aimed at broadening GIAPREZA's market reach through positive clinical data.

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Market Analysis of GIAPREZA

Market Size and Dynamics

The global vasopressor market was valued at approximately USD 2.4 billion in 2021 and is projected to grow at a CAGR of 7.2% through 2028, driven by increasing incidences of sepsis and shock, rising ICU admissions, and technological advancements in emergency care [1]. Septic shock alone accounts for over 270,000 cases annually in the U.S., with high mortality rates highlighting a substantial unmet need—an opportunity for agents like GIAPREZA.

Competitive Landscape

GIAPREZA faces competition from established vasopressors such as norepinephrine, vasopressin, dopamine, and phenylephrine. However, its targeted mechanism, which directly constricts vascular smooth muscle via angiotensin II pathways, offers potential advantages:

• Reduced doses needed for blood pressure stabilization
• Possibly fewer side effects such as arrhythmias and digital ischemia

The drug's unique positioning as a biologic agent confers differentiation, especially among patients resistant to traditional vasopressors.

Adoption and Market Penetration

Despite FDA approval, GIAPREZA's adoption has been gradual due to factors including:

• Clinician familiarity with traditional vasopressors
• Cost considerations—GIAPREZA's average acquisition cost is approximately USD 3,500 per dose, higher than conventional agents
• Limited awareness of long-term safety and efficacy data for expanded indications

Recent data indicate increased utilization in academic hospitals and critical care settings, a trend expected to accelerate as more clinical evidence accumulates.

Pricing Strategy and Reimbursement

As a biologic, GIAPREZA’s pricing reflects manufacturing complexity and clinical value. Reimbursement largely depends on hospital policies and insurance coverage, influencing market penetration. Price negotiations and value-based arrangements could enhance adoption, especially in cost-sensitive healthcare systems.

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Market Projections & Future Opportunities

Growth Drivers

• Increasing Incidence of Sepsis: Rising cases globally, exacerbated by aging populations and chronic diseases, propel demand for effective vasopressors.
• Expanded Indications: Successful trials for cardiogenic and hemorrhagic shock will diversify revenue streams.
• Enhanced Clinical Guidelines Acceptance: As clinical practice guidelines adopt newer agents demonstrating improved safety and efficacy, GIAPREZA's market share could expand.

Challenges and Risks

• Market Penetration Barriers: Entrenched use of conventional vasopressors, clinical inertia, and cost still limit widespread adoption.
• Regulatory Uncertainties: Pending expansion approvals hinge on emerging trial data.
• Competitive Innovations: Development of novel vasopressors or biologics may challenge GIAPREZA’s market position.

Forecast Summary

Analysts project GIAPREZA's global sales could reach USD 500 million by 2027, driven by increased clinical trials, expanding indications, and evolving treatment protocols. The North American region remains the primary revenue contributor, with Europe and Asia-Pacific offering significant growth opportunities as healthcare infrastructure improves.

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Conclusion

GIAPREZA represents a promising evolution in vasopressor therapy, leveraging targeted biologic mechanisms to address a critical care need. While clinical trials continue to validate its safety and efficacy, market adoption remains gradual but poised for acceleration. Strategic efforts focused on expanding indications, demonstrating improved outcomes, and optimizing reimbursement strategies will be key to maximizing its market potential.

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Key Takeaways

• Ongoing clinical trials aim to substantiate GIAPREZA’s efficacy across diverse shock indications, which could significantly broaden its therapeutic scope.
• The current market faces stiff competition from traditional vasopressors, but GIAPREZA’s unique mechanism may confer clinical advantages.
• Adoption barriers include cost considerations and clinician familiarity, but emerging evidence and guideline integration could facilitate greater utilization.
• Future sales growth hinges on clinical trial success, regulatory approval for expanded indications, and strategic payer negotiations.
• The global vasopressor market’s growth trajectory underscores strong revenue potential for GIAPREZA, particularly in regions scaling ICU care and sepsis management.

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FAQs

1. What are the primary therapeutic indications for GIAPREZA?
GIAPREZA is FDA-approved for increasing blood pressure in adult patients with septic or vasodilatory shock who remain hypotensive despite initial treatment.

2. How does GIAPREZA differ from traditional vasopressors?
It is a synthetic angiotensin II peptide that directly constricts blood vessels via the renin-angiotensin system, offering a targeted mechanism that may reduce required doses and adverse effects associated with conventional agents.

3. What are the key ongoing clinical trials for GIAPREZA?
The PRESERVES trial is a major ongoing Phase IV study assessing long-term safety and efficacy, while other trials are exploring expanded indications and combination therapies.

4. What is the market outlook for GIAPREZA over the next five years?
Market projections suggest potential sales reaching USD 500 million, driven by increased utilization in ICU settings, expanded indications, and growing global sepsis prevalence.

5. What are the main challenges facing GIAPREZA’s market penetration?
Factors include clinician familiarity with existing therapies, high drug costs, regulatory approval timings for new indications, and competition from established vasopressors.

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References

[1] Expert Market Research. (2022). Vasopressor Market Size, Share, Growth, Trends, Report.