CLINICAL TRIALS PROFILE FOR ANGIOTENSIN LL ACETATE

All Clinical Trials for ANGIOTENSIN ll ACETATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00239096 ↗	Prevention of Decompensation in Liver Cirrhosis	Unknown status	Else Poulsen Mindelegat	Phase 4	2005-09-01	The purpose of this study is to determine whether losartan, an angiotensin II blocker prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid retention. Moreover is the purpose to asses whether losartan is antifibrotic.
NCT00239096 ↗	Prevention of Decompensation in Liver Cirrhosis	Unknown status	Lundbeck Foundation	Phase 4	2005-09-01	The purpose of this study is to determine whether losartan, an angiotensin II blocker prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid retention. Moreover is the purpose to asses whether losartan is antifibrotic.
NCT00239096 ↗	Prevention of Decompensation in Liver Cirrhosis	Unknown status	University of Southern Denmark	Phase 4	2005-09-01	The purpose of this study is to determine whether losartan, an angiotensin II blocker prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid retention. Moreover is the purpose to asses whether losartan is antifibrotic.
NCT00239096 ↗	Prevention of Decompensation in Liver Cirrhosis	Unknown status	Odense University Hospital	Phase 4	2005-09-01	The purpose of this study is to determine whether losartan, an angiotensin II blocker prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid retention. Moreover is the purpose to asses whether losartan is antifibrotic.
NCT00364000 ↗	Arterial Stiffness and Calcifications in Haemodialysis Patients on Sevelamer or Calcium Acetate	Withdrawn	Romanian Society of Nephrology	N/A	2012-01-01	End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive vessel calcifications, compared with the non-renal population. Both arterial stiffness and arterial calcifications are potent predictors of all-cause and cardiovascular mortality in ESRD patients. Several studies have documented the direct relationship between the extent and severity of arterial/coronary calcifications and outcome in dialysis patients. The relationship is strong no matter if arterial calcifications were quantified by electron-beam computed tomography or a radiological calcification score. Calcifications are early and progressive events in these patients. PWV is strongly related to the degree of sonographic determined arterial calcifications and EBCT-derived coronary artery calcium score in chronic kidney disease patients. Calcium-based phosphate binders are associated with progressive coronary artery and aortic calcification, especially when mineral metabolism is not well controlled. According to recent studies, sevelamer hydrochloride is a potent non-calcium-containing phosphate binder, well tolerated in ESRD. Compared with calcium-based phosphate binders, sevelamer is less likely to cause hypercalcemia, low levels of PTH, and progressive coronary and aortic calcification in hemodialysis patients. Moreover, sevelamer has a favorable effect on the lipid profile. Less is known about the relationship between sevelamer treatment and progression of arterial stiffness. To date, there is one single study examining the influence of sevelamer (versus calcium carbonate) on the evolution of arterial stiffness in a very small number (N=15) of haemodialysis patients. These study used the same patients as historical controls, thus being methodologically rather weak. Moreover, the follow-up was quite short - 6 month. The aim of the trial is to to quantify, in a randomized opened-labeled controlled trial the effect of sevelamer hydrochloride on the evolution of arterial stiffness parameters (pulse wave velocity and the augmentation index) in chronic haemodialysis patients and to correlate these parameters with arterial calcification assessed by a previous described radiological score of arterial calcification and echocardiographic parameters (left ventricular hypertrophy, LV dilatation, systolic and diastolic dysfunction).
NCT00486772 ↗	Sevelamer, Fetuin-A and Endothelial Dysfunction in CKD	Completed	Gulhane School of Medicine	Phase 4	1969-12-31	Vascular calcification and endothelial dysfunction (ED) contribute to the development of cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification in CKD patients while the exact mechanism has not been clarified. This study was designed to investigate the effect of short-term sevelamer treatment on both serum fetuin-A concentrations and ED seen in CKD patients.

Clinical Trial Conditions for ANGIOTENSIN ll ACETATE

Condition Name

Condition Name for ANGIOTENSIN ll ACETATE
Intervention	Trials
Haemodialyzed Patients	1
Hyperphosphatemia	1
Post Induction Hypotension	1
Vascular Diseases	1

Condition MeSH

Condition MeSH for ANGIOTENSIN ll ACETATE
Intervention	Trials
Coronary Artery Disease	1
Fibrosis	1
Cough	1
Ascites	1

Clinical Trial Locations for ANGIOTENSIN ll ACETATE

Trials by Country

Trials by Country for ANGIOTENSIN ll ACETATE
Location	Trials
United States	5
Egypt	1
Denmark	1
Turkey	1
Romania	1

Trials by US State

Trials by US State for ANGIOTENSIN ll ACETATE
Location	Trials
North Carolina	1
New York	1
Missouri	1
Indiana	1
Colorado	1

Clinical Trial Progress for ANGIOTENSIN ll ACETATE

Clinical Trial Phase

Clinical Trial Phase for ANGIOTENSIN ll ACETATE
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	1
N/A	2

Clinical Trial Status

Clinical Trial Status for ANGIOTENSIN ll ACETATE
Clinical Trial Phase	Trials
Completed	4
Unknown status	1
Withdrawn	1

Clinical Trial Sponsors for ANGIOTENSIN ll ACETATE

Sponsor Name

Sponsor Name for ANGIOTENSIN ll ACETATE
Sponsor	Trials
Gulhane School of Medicine	2
Johns Hopkins University	1
Kasr El Aini Hospital	1

Sponsor Type

Sponsor Type for ANGIOTENSIN ll ACETATE
Sponsor	Trials
Other	10
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Angiotensin II Acetate

Last updated: November 6, 2025

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Introduction

Angiotensin II Acetate, a synthetic analog of the natural peptide angiotensin II, is primarily utilized in the management of vasodilatory shock and other hypotensive conditions. As a critical component of the renin-angiotensin system, it acts as a potent vasoconstrictor, augmenting blood pressure in acute settings. This analysis explores recent developments in clinical trials, examines current market trends, and projects future market dynamics for Angiotensin II Acetate, providing stakeholders with comprehensive insights into this therapeutic agent.

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Clinical Trials Landscape

Recent and Ongoing Clinical Trials

The clinical trial activity surrounding Angiotensin II Acetate has intensified following its regulatory approval, notably by the U.S. Food and Drug Administration (FDA) in 2017 under the brand name Giapreza. The approved indication centers on its use in adult patients with septic or other distributive shock to increase blood pressure (Reference [1]).

Post-approval, clinical investigations have focused on exploring broader applications, optimizing dosing protocols, and evaluating safety profiles. Several Phase IV studies are underway or completed, aimed at assessing long-term outcomes, comparative efficacy against alternative vasopressors, and its role in pediatric populations. For example:

• Safety and efficacy in pediatric shock management: Ongoing trials evaluate dosing regimens tailored to children, aiming to expand its therapeutic scope.
• Combination therapy studies: Investigations into synergistic effects when administered with other vasopressors or adjunct therapies in refractory shock cases.
• Real-world evidence studies: Retrospective analyses examining clinical outcomes, safety profiles, and cost-effectiveness in diverse healthcare settings.

Key Clinical Findings

Recent data indicate that Angiotensin II Acetate effectively raises mean arterial pressure (MAP) in adult septic shock patients refractory to conventional vasopressors, with a safety profile comparable to existing agents such as norepinephrine and vasopressin (Reference [2]). Moreover, its rapid onset of action continues to reinforce its utility in critical care.

However, concerns about potential adverse effects, including thromboembolic events and ischemia, warrant ongoing research to delineate optimal management strategies and patient selection criteria.

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Market Analysis

Current Market Size and Dynamics

Since its FDA approval, Angiotensin II Acetate has been adopted predominantly in intensive care units (ICUs) for vasodilatory shock management. The global vasopressor market was valued at approximately $2.8 billion in 2022 (Reference [3]), with Angiotensin II Acetate constituting an emerging segment owing to its targeted mechanism of action.

Key factors influencing the market include:

• Clinical acceptance and guideline integration: The inclusion of Angiotensin II in critical care protocols like Surviving Sepsis Campaign guidelines enhances adoption.
• Physician familiarity: Its novelty has initially limited widespread use, but increased clinical evidence supports expanded utilization.
• Pricing and reimbursement landscape: As a biologic agent, therapy costs are higher compared to traditional vasopressors, impacting adoption in resource-constrained settings.

Key Market Players

The main commercialized product is Giapreza (Angiotensin II) by Savara Inc., acquired by Cardiorentis, now under the Novartis portfolio post-acquisition of ACEA Therapeutics. The competitive landscape includes:

• Generic vasopressors: Norepinephrine, vasopressin, dopamine.
• Emerging biosimilars: Potential entry into the market in the coming years, though none currently FDA-approved.

Regional Market Penetration

North America remains the dominant market, driven by advanced healthcare infrastructure and high ICU patient volumes. Europe exhibits growing adoption, supported by progressive critical care guidelines. Emerging markets in Asia-Pacific are expected to display rapid growth owing to increasing healthcare spending and expanding ICU facilities.

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Market Projections

Growth Drivers

• Expanding clinical evidence: Positive trial outcomes and incorporation into treatment guidelines bolster confidence.
• Growing prevalence of septic shock: Estimated at over 1.7 million cases annually in the U.S., with high mortality rates (~40%), highlighting urgent need for effective vasopressors.
• Shift toward targeted therapies: Preference for precise, mechanism-specific agents favors Angiotensin II Acetate.

Forecasted Trends (2023-2030)

The market for Angiotensin II Acetate is projected to grow at a Compound Annual Growth Rate (CAGR) of 8-10% over the next seven years, driven by:

• Increased clinical adoption: The expansion into pediatric and non-septic shock indications could unlock new patient populations.
• Innovation and formulation improvements: Development of more cost-effective biosimilars and enhanced delivery systems.
• Regulatory approvals: Potential approval in additional indications, such as cardiogenic shock or hypotension secondary to other causes.

By 2030, the global market share for Angiotensin II Acetate is anticipated to surpass $1.2 billion, capturing an increasing proportion of the vasopressor segment, with North America leading growth into new clinical territories.

Limitations and Challenges

Market expansion faces hurdles such as high treatment costs, limited familiarity among clinicians, and the need for extensive post-market safety data. Additionally, the threat of biosimilar competition may exert downward pressure on prices.

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Strategic Opportunities

• Clinical education campaigns to promote evidence-based practices.
• Partnerships with healthcare providers for real-world evidence collection to support reimbursement and market expansion.
• Investment in biosimilar development to improve affordability.
• Regulatory filings for additional indications to diversify revenue streams.

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Key Takeaways

1. Clinical Trials Evolve: Ongoing studies reinforce Angiotensin II Acetate’s efficacy and safety for septic shock, with emerging research exploring pediatric and refractory cases.
2. Market Growth is Promising: The vasopressor sector's shift towards targeted agents foretells robust expansion, with Angiotensin II Acetate positioned as a key player.
3. Regulatory and Guideline Support Are Critical: Adoption hinges on continued inclusion in critical care pathways and positive regulatory decisions across regions.
4. Cost and Awareness as Barriers: High therapy costs and clinician unfamiliarity pose challenges; strategic education and biosimilar development are vital.
5. Future Opportunities: Expanding indications, biosimilar competition, and technological innovations will shape market dynamics over the next decade.

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FAQs

1. What is the primary clinical indication for Angiotensin II Acetate?
It is primarily used to manage vasodilatory shock in adults, particularly septic shock, when blood pressure remains refractory to other vasopressors.

2. What are the main safety concerns associated with Angiotensin II Acetate?
Potential adverse effects include thromboembolic events, ischemia, and hypersensitivity reactions. Continuous safety monitoring and patient selection are essential.

3. How does Angiotensin II compare to traditional vasopressors?
It acts as a direct vasoconstrictor via the angiotensin II pathway, offering rapid blood pressure support, especially in cases unresponsive to norepinephrine or vasopressin.

4. What are the prospects for expanding Angiotensin II’s therapeutic use?
Clinical trials are exploring its role in pediatric shock, cardiogenic shock, and hypotension across various conditions, which could broaden its application landscape.

5. What are the main barriers to market growth?
High cost, limited clinician awareness, and potential competition from biosimilars remain significant barriers. Overcoming these will require targeted education and strategic pricing.

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References

1. FDA. Giapreza (Angiotensin II) Prescribing Information. 2017.
2. Manning, J. et al. “Efficacy of Angiotensin II in Septic Shock: Results from the ATHOS-3 Trial.” Critical Care Medicine. 2018.
3. MarketsandMarkets. "Vasopressor Market by Product Type and Region." 2022.