CLINICAL TRIALS PROFILE FOR ALDACTONE

All Clinical Trials for ALDACTONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001202 ↗	Treatment of Boys With Precocious Puberty	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1985-01-01	This study is a continuation of two previous studies conducted at the NIH. The first study , "Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone Analog (D-Trp(6)-Pro(9)-Net-LHRH)" had less than optimal results. Some patients, all of whom were diagnosed with familial isosexual precocious puberty, had an inadequate response to the medication and were observed to have high levels of testosterone, advanced bone aging, and other complications of the disease. As a result these patients were enrolled in a second study In the second study, "Spironolactone Treatment for Boys with Familial Isosexual Precocious Puberty", - the patients received another medication, spironolactone (Aldactone). The drug blocked the effects of testosterone, -but bone age advancement did not improve. Some patients began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe these may be the effects of elevated levels of estrodiol (a form of the female hormone, estrogen). In the present study, testolactone is added to the drug regimen to block the production of estrogen. The study therefore uses spironolactone to prevent the action of the male hormones (androgen) and testolactone to block the production of female hormones (estrogen). Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the drug regimen once true puberty begins. This is because it is know that boys with familial male precocious puberty go into true puberty too early (despite treatment with spironolactone and testolactone), and when that happens, the spironolactone and testolactone are no longer as effective. The goal of the treatment is to delay sexual development until a more appropriate age and prevent short adult stature (height).
NCT00046553 ↗	Brain Receptor Function in Post-Traumatic Stress Disorder	Completed	National Institute of Mental Health (NIMH)		2002-09-01	The purpose of this study is to examine the function of cortisol receptors in post-traumatic stress disorder (PTSD). Patients with PTSD have neurobiological dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis function. High corticotrophin releasing hormone (CRH) levels and decreased hippocampal volume are major features of the disorder. The mechanisms responsible for these alterations are not known. This study will evaluate the function of cortisol receptors to determine their roles in maintaining PTSD HPA axis dysregulation. Three groups of subjects will take part in the study: Patients with PTSD, healthy control subjects who were exposed to trauma in the past and remained healthy and healthy control subjects who were never traumatized At study entry, the cerebral spinal fluid (CSF) of all participants will be sampled and evaluated. Participants will also undergo a magnetic resonance imaging (MRI) scan of the brain as well as eye blink trace conditioning and neuropsychological tests. Participants will be admitted to the Clinical Center for two nights on three different occasions. At each overnight visits, blood levels of stress hormones will be measured every hour for 26 hours after medication or placebo are given. This will be the end of the study for both groups of healthy control subjects, with the exception that they may be asked to repeat neuropsychologic and eye blink tests after 12 weeks. Participants with PTSD will receive paroxetine for 10 weeks. After 10 weeks these participants will be reevaluated in exactly the same way as before treatment (except they will not repeat the MRI scan).
NCT00123955 ↗	PIE II: Pharmacological Intervention in the Elderly II	Completed	National Institute on Aging (NIA)	Phase 3	2005-04-01	The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).
NCT00123955 ↗	PIE II: Pharmacological Intervention in the Elderly II	Completed	Wake Forest School of Medicine	Phase 3	2005-04-01	The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).
NCT00123955 ↗	PIE II: Pharmacological Intervention in the Elderly II	Completed	Wake Forest University	Phase 3	2005-04-01	The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).
NCT00188045 ↗	Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients	Terminated	University Hospital, Angers	Phase 4	1995-04-01	The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.
NCT00206232 ↗	Novel Treatment for Diastolic Heart Failure in Women	Completed	Baylor College of Medicine	Phase 4	2004-07-01	The purpose of the study is to collect information about the potential benefit and safety of low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine whether spironolactone can cause the patient's condition to improve.

Clinical Trial Conditions for ALDACTONE

Condition Name

Condition Name for ALDACTONE
Intervention	Trials
Heart Failure	7
Hypertension	2
Atrial Fibrillation	2
Diabetes Mellitus	2

Condition MeSH

Condition MeSH for ALDACTONE
Intervention	Trials
Heart Failure	12
Hypertension	4
Diabetes Mellitus	3
Fibrosis	3

Clinical Trial Locations for ALDACTONE

Trials by Country

Trials by Country for ALDACTONE
Location	Trials
United States	64
Mexico	3
France	3
United Kingdom	3
Belgium	2

Trials by US State

Trials by US State for ALDACTONE
Location	Trials
Texas	5
Maryland	5
Minnesota	4
Virginia	4
California	3

Clinical Trial Progress for ALDACTONE

Clinical Trial Phase

Clinical Trial Phase for ALDACTONE
Clinical Trial Phase	Trials
PHASE3	2
PHASE1	1
Phase 4	20

Clinical Trial Status

Clinical Trial Status for ALDACTONE
Clinical Trial Phase	Trials
Completed	21
Recruiting	10
Unknown status	8

Clinical Trial Sponsors for ALDACTONE

Sponsor Name

Sponsor Name for ALDACTONE
Sponsor	Trials
Vanderbilt University	3
Vanderbilt University Medical Center	3
Actinium Pharmaceuticals	2

Sponsor Type

Sponsor Type for ALDACTONE
Sponsor	Trials
Other	70
Industry	7
NIH	6

Last updated: May 6, 2026

ALDACTONE (spironolactone): Clinical Trials Update and Market Outlook

What is ALDACTONE in current clinical and regulatory terms?

ALDACTONE is the brand name for spironolactone, a mineralocorticoid receptor antagonist (MRA) used for indications such as hypertension, heart failure, edema, and hyperaldosteronism. In most major markets, spironolactone is off-patent and widely available as generic. As a result, “ALDACTONE clinical development” largely reflects new evidence generation (guideline-driven or investigator-initiated studies) rather than brand-level phase programs.

Actionable implication for investors and R&D planners: market dynamics are dominated by generic competition, pricing, and treatment protocol adoption, not by near-term brand patent expansion.

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What clinical trials currently matter for spironolactone/ALDACTONE evidence?

Across recent years, the most decision-relevant clinical “updates” for spironolactone have been driven by (a) outcomes in heart failure populations, (b) comparative performance versus other MRAs, and (c) use in resistant hypertension and mineralocorticoid excess states.

Key clinical trial themes seen in the literature and trial databases include:

• Heart failure with reduced ejection fraction and preserved ejection fraction: MRAs improve outcomes in appropriate phenotypes, with dosing and monitoring focused on hyperkalemia risk and renal function.
• Hyperkalemia management approaches that enable more consistent MRA use (often through patient selection, monitoring frequency, or adjunctive strategies).
• Resistant hypertension strategies that incorporate MRAs as add-on therapy.

Evidence anchor for market-relevant efficacy positioning: the mineralocorticoid receptor pathway is clinically validated by major heart failure outcomes programs (see sources below). This matters because it supports continued guideline and payer coverage, which stabilizes demand even in a generic environment.

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What is the near-term clinical “update” signal for ALDACTONE specifically?

Because spironolactone is generic, “update” signals that move demand are usually protocol and guideline reinforcement rather than new ALDACTONE-branded approvals. The most market-relevant updates typically come from:

• Guideline updates and performance evidence that reinforce MRA use in heart failure and resistant hypertension.
• Real-world dosing and safety practice that reduces discontinuation due to hyperkalemia.
• Comparative effectiveness discussions versus other MRAs (notably eplerenone) that shift prescriber preference by cost versus patient-specific tolerability.

Market takeaway: the clinical base case remains stable. The risk is not efficacy uncertainty; the risk is coverage pressure, price compression, and substitution patterns.

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How does spironolactone’s safety profile affect utilization and prescribing behavior?

The market for spironolactone is constrained primarily by tolerability and monitoring burden:

• Hyperkalemia risk in patients with reduced kidney function and in combination regimens.
• Endocrine adverse effects linked to steroid hormone receptor activity (e.g., gynecomastia in men), which can shift some prescribers toward alternative MRAs in specific patient segments.

These factors influence:

• Prescriber adoption intensity.
• Titration pace.
• Discontinuation rates.
• Comparative channel share versus eplerenone.

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Market Analysis and Projection for ALDACTONE (Spironolactone)

What does the market structure look like for ALDACTONE?

ALDACTONE faces a classic off-patent competitive structure:

• Generic spironolactone dominates volume.
• Pricing follows commodity-like dynamics with periodic shifts based on supply, reimbursement rates, and payer preferred drug lists.
• Channel demand is driven by clinical guideline adherence in heart failure and resistant hypertension and by ongoing lab monitoring workflows.

Strategic reality: brand-level differentiation is limited; competitive advantage is mostly about formulation availability, supply continuity, labeling alignment, and contracted payer access.

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What demand drivers support growth despite generic competition?

Demand for MRAs is supported by:

• Heart failure prevalence and chronic disease management intensity.
• Resistant hypertension diagnosis and treatment escalation that often includes MRAs after standard regimen failure.
• Clinical persistence when hyperkalemia risk is managed through monitoring and patient selection.

Growth in generic markets usually comes from:

• Population-level treatment penetration and better adherence to guideline-directed medical therapy.
• Switching from other MRAs based on cost and formulary status.
• Substitution between MRAs depending on endocrine tolerability vs renal safety balance.

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What could limit growth or accelerate substitution away from spironolactone?

Key headwinds include:

• Hyperkalemia and renal safety constraints that reduce initiation or force early discontinuation.
• Patient-level tolerability issues (endocrine effects) that can favor eplerenone in certain subgroups.
• Payer formulary dynamics: if eplerenone is preferred in some plans for tolerability reasons, it can divert share despite higher acquisition cost.
• Safety-monitoring capacity in real-world care settings, which affects persistence.

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What is a reasonable market projection framework (2025-2029)?

Given off-patent status, projections should be interpreted as category-level and unit-volume movement rather than brand premium growth.

A practical projection framework for spironolactone markets typically aligns with:

• Low-to-mid single-digit unit growth tied to disease prevalence and treatment penetration.
• Flat-to-declining average selling price driven by generic competition.
• Share fluctuations within MRAs based on formulary preference and patient tolerability patterns.

Baseline expectation: overall use of MRAs in heart failure remains resilient, so the category tends to maintain volume even as pricing compresses.

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How does clinical evidence map to payer and guideline behavior?

The clinical case for MRAs in heart failure is anchored by landmark outcomes trials and subsequent guideline integration. That evidence impacts reimbursement and formularies by:

• Reinforcing MRA inclusion as standard-of-care in eligible patients.
• Creating an expectation for monitoring and continuation pathways.

Evidence anchor: major heart failure outcome evidence includes:

• RALES (spironolactone in severe heart failure) and
• EPHESUS (eplerenone in post-MI heart failure) and
• EMPHASIS-HF (eplerenone in mild systolic heart failure), which together shaped modern MRA use and helped define patient selection logic. (Sources cited below.)

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Positioning and Competitive Implications

Where does spironolactone win?

Spironolactone tends to win on:

• Lowest acquisition cost in the MRA class.
• Strong guideline support for classic heart failure and resistant hypertension pathways.
• Broad prescriber familiarity and established dosing protocols.

Where does spironolactone lose?

It tends to lose on:

• Endocrine tolerability leading to discontinuation risk and preference for eplerenone.
• Hyperkalemia management burden, especially in patients with CKD or complex polypharmacy.
• Formulary restrictions if plans prioritize alternative MRAs for tolerability.

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Key Takeaways

• ALDACTONE = spironolactone, an off-patent MRA with stable clinical demand driven by heart failure and resistant hypertension treatment protocols.
• “Clinical trials updates” for ALDACTONE are usually evidence and protocol reinforcement, not new brand-level phase development.
• Market outcomes are dominated by generic pricing and payer/formulary dynamics, not by patent life-cycle.
• Demand growth is most likely to track treatment penetration and persistence, while revenue growth is constrained by price compression.
• Competitive share inside the MRA class is driven by renal safety management versus endocrine tolerability and formulary placement.

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FAQs

1. Is ALDACTONE currently under patent protection in major markets?
   Spironolactone is generally off-patent and widely available as generics across major markets, so brand protection is not the dominant market factor.

2. What are the biggest clinical reasons spironolactone use can be limited?
   The two dominant constraints are hyperkalemia risk and renal function monitoring, with endocrine tolerability affecting some patient segments.

3. Do recent trials change the efficacy position of MRAs in heart failure?
   Recent evidence primarily refines patient selection, monitoring, and persistence, rather than overturning the established MRA outcome benefit in appropriate heart failure populations.

4. How does spironolactone compare commercially to eplerenone?
   Spironolactone is usually lower cost, while eplerenone is often favored for better endocrine tolerability, affecting formulary placement and share.

5. What drives unit growth in a generic category like spironolactone?
   Unit growth is driven by disease prevalence, guideline adherence, and treatment penetration, with price largely determined by generic competition.

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References (APA)

[1] Pitt, B., Zannad, F., Remme, W. J., Cody, R., Castaigne, A., Perez, A., Palensky, J., Wittes, J., & others. (1999). The effect of spironolactone on morbidity and mortality in patients with severe heart failure (RALES). New England Journal of Medicine.
[2] Pitt, B., Remme, W., Zannad, F., Neaton, J. D., Martinez, F. A., & others. (2003). Eplerenone, a selective mineralocorticoid receptor antagonist, in patients with acute myocardial infarction complicated by heart failure and left ventricular dysfunction (EPHESUS). New England Journal of Medicine.
[3] Zannad, F., McMurray, J. J. V., Krum, H., van Veldhuisen, D. J., Hansson, L., Cherney, D., & others. (2011). Eplerenone in patients with systolic heart failure and mild symptoms (EMPHASIS-HF). New England Journal of Medicine.
[4] Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Drazner, M. H., Fonarow, G. C., Geraci, S. A., Horwich, T., Januzzi, J. L., & others. (2017). 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure. Journal of the American College of Cardiology.
[5] Williams, B., Mancia, G., Spiering, W., Agabiti Rosei, E., Azizi, M., Burnier, M., Clement, D. L., Coca, A., de Simone, G., Dominiczak, A. F., & others. (2018). 2018 ESC/ESH Guidelines for the management of arterial hypertension. European Heart Journal.