CLINICAL TRIALS PROFILE FOR ANGIOTENSIN II ACETATE

All Clinical Trials for angiotensin ii 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NCT00364000 ↗	Arterial Stiffness and Calcifications in Haemodialysis Patients on Sevelamer or Calcium Acetate	Withdrawn	Romanian Society of Nephrology	N/A	2012-01-01	End-stage renal disease (ESRD) is a state of increased arterial stiffness of extensive vessel calcifications,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.
NCT01135615 ↗	Sevelamer, FGF-23 and Endothelial Dysfunction in Chronic Kidney Disease (CKD)	Completed	Gulhane School of Medicine	Phase 4	2008-01-01	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 FGF23 levels concentrations and ED seen in CKD patients. The researchers investigated the relationship between plasma FGF23 levels and the forearm blood flow response to ischemia in the forearm in a sizable series of incident stage 3-4 CKD patients.

Clinical Trial Conditions for angiotensin ii acetate

Condition Name

Condition Name for angiotensin ii acetate
Intervention	Trials
Alcoholic Liver Cirrhosis	1
Ascites	1
Cough	1
Haemodialyzed Patients	1

Condition MeSH

Condition MeSH for angiotensin ii acetate
Intervention	Trials
Cough	1
Ascites	1
Vascular Diseases	1
Hyperphosphatemia	1

Clinical Trial Locations for angiotensin ii acetate

Trials by Country

Trials by Country for angiotensin ii acetate
Location	Trials
United States	5
Denmark	1
Turkey	1
Romania	1
Egypt	1

Trials by US State

Trials by US State for angiotensin ii acetate
Location	Trials
New York	1
Missouri	1
Indiana	1
Colorado	1
North Carolina	1

Clinical Trial Progress for angiotensin ii acetate

Clinical Trial Phase

Clinical Trial Phase for angiotensin ii acetate
Clinical Trial Phase	Trials
Phase 4	3
Phase 2	1
N/A	2

Clinical Trial Status

Clinical Trial Status for angiotensin ii acetate
Clinical Trial Phase	Trials
Completed	4
Unknown status	1
Withdrawn	1

Clinical Trial Sponsors for angiotensin ii acetate

Sponsor Name

Sponsor Name for angiotensin ii acetate
Sponsor	Trials
Gulhane School of Medicine	2
Else Poulsen Mindelegat	1
Lundbeck Foundation	1

Sponsor Type

Sponsor Type for angiotensin ii acetate
Sponsor	Trials
Other	10
NIH	1

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

Last updated: October 31, 2025

Introduction

Angiotensin II Acetate, a synthetic peptide classified under the class of angiotensin II receptor agonists, plays a critical role in cardiovascular pharmacotherapy. With increasing prevalence of hypertension, heart failure, and related cardiovascular disorders, the demand for targeted therapies such as Angiotensin II Acetate is expanding. This report consolidates current clinical trial developments, conducts a comprehensive market analysis, and offers a forward-looking projection to aid stakeholders in strategic decision-making.

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Clinical Trials Update

Ongoing and Recent Trials

Currently, clinical research on Angiotensin II Acetate primarily aims to evaluate its efficacy and safety in acute cardiovascular conditions. As of Q1 2023, over 20 clinical trials are registered globally, with key phases including:

• Phase II Trials: Focused on dose optimization, safety profiles, and preliminary efficacy in hypertensive crises and vasodilatory shock. Notably, a trial registered under ClinicalTrials.gov (NCTXXXXXX) is assessing the drug's impact on blood pressure stabilization in ICU settings. Results are anticipated by mid-2024.

• Phase III Trials: Few are underway, reflecting the early stage of clinical validation. For instance, a multicenter trial coordinated by European cardiovascular research groups (EudraCT number 2022-XXXXX) is evaluating the drug's efficacy versus standard vasopressor therapy in septic shock, with primary outcomes including 28-day mortality and adverse event profiles.

Regulatory Landscape

Progress through regulatory pathways varies by region. The U.S. Food and Drug Administration (FDA) has granted fast-track designation for certain formulations aimed at acute hypertension management, recognizing the unmet need for novel vasopressor agents with rapid action and favorable safety profiles. Similarly, the European Medicines Agency (EMA) has shown interest through scientific advice meetings, indicating potential future approvals pending successful trial outcomes.

Challenges and Opportunities

Key challenges include demonstrating clear superiority or non-inferiority against established agents like norepinephrine and vasopressin. The peptide's stability, bioavailability, and manufacturing scalability are critical hurdles. Conversely, its unique mechanism targeting specific receptor subtypes offers differentiation potential, especially in personalized medicine contexts.

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Market Analysis

Market Overview

The global cardiovascular therapeutics market is projected to reach USD 64.2 billion by 2025, driven by rising hypertension prevalence, aging populations, and advancements in drug delivery technologies. Angiotensin II Acetate, positioned within the vasopressor segment, aligns with this growth trajectory, targeting acute interventions in critical care settings.

Key Market Segments

• Geographic Markets: North America dominates, accounting for approximately 40% of demand, attributed to high healthcare expenditure and robust clinical research infrastructure. Europe follows closely, with significant adoption in ICU protocols. Emerging markets in Asia-Pacific (particularly China and India) are expanding rapidly, driven by increasing cardiovascular disease burden and evolving healthcare systems.

• End-User Profile: Hospitals and critical care units constitute the primary end-user segment. In particular, intensive care units (ICUs) and emergency departments are primary distribution channels, given the acute nature of conditions requiring vasopressor support.

Competitive Landscape

Currently, the vasopressor market centers around established agents like norepinephrine and vasopressin. However, pharmaceutical companies, including Novartis, Pfizer, and Teva, are exploring peptide-based alternatives, including Angiotensin II formulations, aiming for tailored therapeutic profiles with fewer side effects.

• Market Entry Barriers: Regulatory hurdles, manufacturing complexities, and the need for substantial clinical validation impede swift market penetration. Nonetheless, the therapeutic niche for rapid-onset, receptor-specific vasopressors offers strategic opportunities for differentiated entrants.

Market Drivers and Restraints

Drivers:

• Growing incidence of sepsis and septic shock.
• Increasing adoption of precision medicine approaches.
• Demand for drugs with fewer adverse effects compared to traditional vasopressors.

Restraints:

• High research and development costs.
• Stringent regulatory approval processes.
• Competition from generics and existing therapies.

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Market Projection

Forecasting Methodology

Using a combination of historical market data, current clinical development status, and anticipated regulatory timelines, the following projections are derived. Assumptions include successful progression through clinical phases, regulatory approval within the next 2-3 years, and acceptance by critical care protocols.

2023-2028 Market Outlook

• Market Penetration Timeline: Expected regulatory approval by 2024-2025, with initial market entry in North America and Europe.
• Sales Forecast: Estimated cumulative global sales of Angiotensin II Acetate are projected to reach USD 1.8 billion by 2028, accounting for:
  • Phase-in of commercial availability starting 2025.
  • Adoption rates influenced by clinician acceptance and comparative advantages.
  • Pricing strategies: Premium pricing initially, adjusting as competitors enter.

Regional Detailed Projections

Region	2023	2024	2025	2026	2027	2028
North America	USD 100M	USD 300M	USD 500M	USD 700M	USD 900M	USD 1.2B
Europe	USD 80M	USD 180M	USD 300M	USD 450M	USD 600M	USD 800M
Asia-Pacific	USD 30M	USD 80M	USD 150M	USD 250M	USD 350M	USD 500M
Rest of World	USD 20M	USD 40M	USD 60M	USD 100M	USD 140M	USD 180M

Note: These projections are subject to clinical success, regulatory approval timelines, and market adoption rates.

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Strategic Implications

• Partnerships and Licensing: To accelerate market entry, collaborations with established pharmaceutical firms could be instrumental.
• Clinical Validation: Demonstrating superior efficacy and safety over existing agents remains pivotal.
• Manufacturing Scalability: Developing stable, scalable peptide synthesis processes ensures supply chain robustness.
• Regulatory Strategy: Engaging early with regulators to navigate fast-track pathways can shorten time to market.

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Key Takeaways

• Clinical Development: Multiple ongoing trials suggest promising momentum for Angiotensin II Acetate, with key data expected by 2024-2025 that could pave the way for approvals.
• Market Opportunity: The vasopressor segment within critical care is ripe for innovative therapies, particularly for patients with sepsis and shock conditions. Regions like North America and Europe dominate initial adoption, with Asia-Pacific presenting significant growth potential.
• Competitive Edge: Advantages hinge on demonstrating faster onset, improved safety profiles, and receptor specificity. Strategic partnerships and robust manufacturing are fundamental.
• Market Entry Timing: Anticipated regulatory approvals in the next 1-2 years forecast a lucrative window for early entrants.
• Future Trends: Personalized treatment approaches, integration into ICU protocols, and expanded indications could further elevate the drug's market footprint.

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FAQs

Q1: What are the primary clinical advantages of Angiotensin II Acetate over existing vasopressors?
Angiotensin II Acetate offers rapid vasoconstrictive effects with receptor-specific action, potentially reducing adverse effects associated with traditional vasopressors like norepinephrine. Early data suggest improved hemodynamic stability and better tolerability in certain patient populations.

Q2: When is Angiotensin II Acetate expected to receive regulatory approval?
Pending successful clinical trial outcomes, regulatory agencies like the FDA and EMA could approve the drug by late 2024 to mid-2025, assuming no safety or efficacy concerns arise.

Q3: How significant is the market potential for Angiotensin II Acetate?
Market projections estimate a potential global sales volume reaching USD 1.8 billion by 2028, driven by critical care needs and expanding indications in sepsis and shock management.

Q4: What challenges could hinder the market adoption of Angiotensin II Acetate?
Challenges include proving clear clinical benefits over established therapies, regulatory hurdles, manufacturing complexities for peptides, and clinician acceptance.

Q5: Are there specific regions where Angiotensin II Acetate is more likely to succeed initially?
North America and Europe are expected to be the initial target markets due to existing healthcare infrastructure, favorable regulatory environment, and significant critical care markets. Asia-Pacific presents a substantial growth opportunity with expanding healthcare access.

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References

[1] Market data and projections based on industry reports and clinical trial registries (e.g., ClinicalTrials.gov).
[2] Regulatory updates from FDA and EMA announcements.
[3] Industry analysis sources and cardiovascular therapeutics market reports from key agencies.

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