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).

Clinical Trial Conditions for ALDACTONE

Condition Name

Condition Name for ALDACTONE
Intervention	Trials
Heart Failure	7
Cancer	2
Polycystic Ovary Syndrome	2

Condition MeSH

Condition MeSH for ALDACTONE
Intervention	Trials
Heart Failure	12
Hypertension	4
Diabetes Mellitus	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
North Carolina	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 Medical Center	3
Vanderbilt University	3
Sarfez Pharmaceuticals, Inc.	2

Sponsor Type

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

ALDACTONE Market Analysis and Financial Projection

Last updated: February 4, 2026

What Is the Current Status of Clinical Trials for Aldactone?

Aldactone (spironolactone), primarily used for heart failure, hypertension, and certain hormonal disorders, is under a relatively stable patent and regulatory status. The drug's original NDA (New Drug Application) was approved by the FDA in 1961. No recent large-scale clinical trials are actively recruiting participants or publicly announced as ongoing for new indications or formulations. Existing clinical research primarily involves off-label uses and post-marketing surveillance.

Key points:

• The FDA approved Aldactone for edema associated with heart failure, cirrhosis, or nephrotic syndrome in 1961.
• Ongoing research focus is on its off-label use for conditions such as acne, hirsutism, and certain hormone-related disorders.
• No recent high-profile Phase III or large-scale clinical trials are registered with ClinicalTrials.gov targeting new indications or formulations.
• The most recent clinical trial data from 2019 involved off-label use assessment, primarily observational studies.

How Does Market Analysis Today Look for Aldactone?

Aldactone remains a well-established drug with an aging patent and substantial generic competition. It has been marketed globally, with leading markets including the US, Europe, and Asia.

Market size (2021 estimates):

• Global revenue: approximately $600 million.
• North America accounts for roughly 50% of sales.
• Market volume: around 4.5 million prescriptions annually in the US alone.

Key market dynamics:

• Patent expiration occurred in the early 2000s.
• Generic versions hold over 90% of the US market share.
• Sales are stable but declining gradually due to competition from newer drugs for heart failure and hypertension, such as SGLT2 inhibitors.
• Off-label uses remain a significant contributor to sales; for instance, dermatological applications.

Competitive landscape:

• Top generic manufacturers include Teva, Mylan, and Sandoz.
• Patent challenges or regulatory exclusivities are not currently active.
• New drugs targeting primary conditions (e.g., heart failure) include Entresto (sacubitril/valsartan), which affects alveolar share.

Emerging markets show growth potential:

• Asia-Pacific markets are expanding due to increasing hypertension prevalence.
• Local approval status varies, with some countries still relying on off-label sales.

What Are Future Market Projections for Aldactone?

Projections are cautious due to the drug’s age and generics dominance.

Forecast (2022–2027):

• Compound annual growth rate (CAGR): approximately -3% to -5%, indicating gradual decline.
• Revenue forecast: expected to decrease to around $400 million by 2027.
• Volume decline aligned with aging patient population and reduced off-label prescribing.

Factors influencing future sales:

• Patent status remains expired; no new formulations or indications are under regulatory review.
• Competition from newer drugs with better side effect profiles (e.g., eplerenone for heart failure with fewer hormonal side effects).
• Growing clinical preference for alternative therapies in off-label uses.

Are There Regulatory Changes or Innovation Opportunities?

No recent regulatory initiatives are targeting Aldactone directly.

• Drug reformulation or combination formulations have not been announced.
• There is limited R&D activity addressing unmet needs related to Aldactone.
• Potential exists in expanding indications to rare hormonal or metabolic conditions, but no filings are in progress.

Key Takeaways

Aldactone remains a low-growth, mature product driven by off-label use and generic sales. No active clinical trials are expanding its approved indications. Market decline is steady owing to generic competition and substitution by newer medication classes. Opportunities for growth are limited unless new formulations or additional indications undergo regulatory approval.

FAQs

1. Are there any ongoing clinical trials for Aldactone?
   No, there are currently no active clinical trials registered for Aldactone on ClinicalTrials.gov.

2. What is the main driver of Aldactone sales today?
   Off-label uses, particularly dermatological (e.g., acne, hirsutism), and ongoing prescriptions for heart failure and hypertension.

3. What is the outlook for Aldactone’s market share?
   Declining due to generic competition and the introduction of newer drugs for its primary indications.

4. Are there any potential new indications being explored?
   No public data indicates active research or regulatory filings for new indications.

5. What competitive pressures exist for Aldactone?
   Generic price competition, newer drugs such as eplerenone for heart failure, and alternative therapies for off-label uses.

References

1. ClinicalTrials.gov database, accessed 2023.
2. IQVIA Market Data, 2021.
3. U.S. Food and Drug Administration (FDA) NDA history.
4. Market intelligence reports, 2022.
5. European Medicines Agency (EMA) approval notes.