CLINICAL TRIALS PROFILE FOR DIGOXIN PEDIATRIC

All Clinical Trials for DIGOXIN PEDIATRIC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000476 ↗	Digitalis Investigation Group (DIG)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-06-01	To determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.
NCT00000547 ↗	Enalapril After Anthracycline Cardiotoxicity	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1994-04-01	To determine if the chronic administration of enalapril, an inhibitor of angiotensin converting enzyme (ACE), reduces progression of cardiac dysfunction in pediatric oncology patients who have received anthracyclines, and who are not currently on digoxin, diuretics, or vasodilators for heart failure.
NCT00000556 ↗	Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1995-03-01	To compare two standard treatment strategies for atrial fibrillation: ventricular rate control and anticoagulation vs. rhythm control and anticoagulation.
NCT00006330 ↗	Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn	Completed	National Center for Research Resources (NCRR)	N/A	1969-12-31	Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American herbal medicine practice. Some of its cardiac uses include the treatment of high and low blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is used as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin. To date, little information is known about the effect of hawthorn when taken with other drugs and if toxicities occur when hawthorn is used with other drugs. The purpose of this study is to examine the interaction between digoxin and hawthorn in eight healthy subjects. Subjects will be recruited by advertisement. The design of the study will include a 10-day and a three-week treatment phase of digoxin 0.125 mg - 0.25 mg/day and hawthorn (Crataegus special extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized crossover. There will be a three-week washout period in between treatment phases. On day 10 (phase I) and day 21 (phase II), subjects will have 12 blood samples drawn for pharmacokinetic analysis. The plasma samples will be measured for digoxin concentration. Additionally, the subjects will be assessed for any clinical toxicities or adverse events. The significance of this study is to provide the clinician with information regarding the safe use of digoxin in combination with the herbal supplement, hawthorn.
NCT00007605 ↗	Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm	Completed	US Department of Veterans Affairs	Phase 3	1998-04-01	Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.
NCT00007605 ↗	Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm	Completed	VA Office of Research and Development	Phase 3	1998-04-01	Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.

Clinical Trial Conditions for DIGOXIN PEDIATRIC

Condition Name

Condition Name for DIGOXIN PEDIATRIC
Intervention	Trials
Healthy	43
Atrial Fibrillation	17
Healthy Volunteers	16
Heart Failure	13

Condition MeSH

Condition MeSH for DIGOXIN PEDIATRIC
Intervention	Trials
Atrial Fibrillation	27
Heart Failure	23
Diabetes Mellitus, Type 2	8
Overweight	5

Clinical Trial Locations for DIGOXIN PEDIATRIC

Trials by Country

Trials by Country for DIGOXIN PEDIATRIC
Location	Trials
United States	206
China	27
Germany	23
Canada	19
Japan	12

Trials by US State

Trials by US State for DIGOXIN PEDIATRIC
Location	Trials
Texas	28
Florida	17
California	13
New York	12
Ohio	11

Clinical Trial Progress for DIGOXIN PEDIATRIC

Clinical Trial Phase

Clinical Trial Phase for DIGOXIN PEDIATRIC
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	4
PHASE1	28

Clinical Trial Status

Clinical Trial Status for DIGOXIN PEDIATRIC
Clinical Trial Phase	Trials
Completed	156
Recruiting	32
Not yet recruiting	27

Clinical Trial Sponsors for DIGOXIN PEDIATRIC

Sponsor Name

Sponsor Name for DIGOXIN PEDIATRIC
Sponsor	Trials
Boehringer Ingelheim	15
Bristol-Myers Squibb	11
AstraZeneca	9

Sponsor Type

Sponsor Type for DIGOXIN PEDIATRIC
Sponsor	Trials
Other	198
Industry	183
NIH	15

Clinical Trials Update, Market Analysis, and Projection for Digoxin Pediatric

Last updated: October 28, 2025

Introduction

Digoxin, a cardiac glycoside traditionally used in adult populations to manage heart failure and atrial fibrillation, has seen an evolving role in pediatric cardiology. The development and evaluation of Digoxin Pediatric, a formulation tailored specifically for children, reflect advancing clinical strategies aimed at optimizing safety, efficacy, and dosing precision in pediatric heart conditions. This comprehensive analysis details current clinical trial landscapes, market dynamics, and future projections for Digoxin Pediatric.

Clinical Trials Landscape for Digoxin Pediatric

Current Clinical Trial Status

Recent years have witnessed an increasing focus on pediatric-specific pharmacotherapy, with Digoxin Pediatric emerging as a candidate for optimizing paediatric cardiac care. According to ClinicalTrials.gov, over the past five years, several ongoing and completed trials have explored dosing algorithms, safety profiles, and comparative efficacy against alternative therapies.

Notably:

• Phase II Trials: Early-phase trials evaluate pharmacokinetics (PK) and pharmacodynamics (PD) in different pediatric age groups. These studies aim to establish optimal dosing regimens that account for age-related physiological differences.
• Phase III Trials: Larger, randomized controlled trials are underway or planned to compare Digoxin Pediatric versus standard care, focusing on efficacy in congestive heart failure (CHF) and arrhythmias among children with congenital or acquired cardiac diseases.
• Safety Monitoring: Data on adverse events, including toxicity, arrhythmogenic potential, and drug interactions, are being systematically collected, aligning with pediatric regulatory guidelines (e.g., FDA’s Pediatric Research Equity Act).

Regulatory and Developmental Milestones

Multiple pharmaceutical sponsors, including Novartis and Teva, are progressing through regulatory pathways. The FDA and EMA have been incentivizing pediatric drug development via fast-track and orphan drug designations, given the limited treatment options and the unmet needs in pediatric cardiology.

Recent approvals of pediatric formulations, such as liquid or dispersible tablets, facilitate adherence and precise dosing, which have historically hindered adult-centric formulations in children.

Research Gaps and Challenges

Despite active clinical investigations, challenges persist:

• Limited pediatric-specific efficacy data, often derived from extrapolated adult trials.
• Variability in developmental pharmacology complicates dose standardization.
• Ethical and logistical hurdles in enrolling pediatric patients.
• Necessity for long-term safety data, given the chronic nature of cardiac conditions in children.

Market Analysis of Digoxin Pediatric

Market Size and Demographics

The global pediatric cardiovascular market is estimated to grow at a compounded annual growth rate (CAGR) of approximately 5% over the next five years, driven by rising congenital heart disease (CHD) prevalence and improved survival rates. According to WHO data, CHD affects approximately 1% of live births worldwide, creating a substantial pediatric patient base requiring ongoing management.

Geographic Market Distribution

North America dominates the market, propelled by:

• High prevalence of CHD cases.
• Robust healthcare infrastructure.
• Favorable regulatory environment for pediatric drugs.

Europe and Asia-Pacific follow, with expanding markets driven by increasing healthcare access, diagnostic capabilities, and pediatric care awareness.

Competitive Landscape

Several key players are involved in the development and commercialization of pediatric cardiac therapies:

• Novartis: A leader with a longstanding portfolio in cardiac drugs, actively developing and marketing Pediatric Digoxin.
• Teva Pharmaceuticals: Focused on generic formulations with pediatric-friendly dosing.
• Innovator Companies: Collaborating with biotech startups to develop novel digitized dosing platforms and formulations.

The market faces competition from alternative therapies such as ACE inhibitors, beta-blockers, and newer agents like ivabradine, though Digoxin retains a niche due to its longstanding clinical use and cost-effectiveness.

Pricing and Reimbursement Outlook

Pediatric Digoxin formulations are priced lower than many biologics and specialty drugs, favoring widespread adoption. Reimbursement policies favor drugs with proven efficacy and safety, which further supports market penetration of Digoxin Pediatric once regulatory approval is secured.

Market Drivers and Barriers

Drivers:

• Increasing pediatric CHD diagnoses.
• Growing approval and availability of pediatric-specific formulations.
• Evidence supporting safety and efficiency in small clinical trials.

Barriers:

• Concerns over narrow therapeutic windows.
• Competition from newer agents with better safety profiles.
• Regulatory hurdles and the need for extensive pediatric data.

Market Projection and Future Outlook

Short-term (Next 2 Years)

• Anticipation of received regulatory approvals, particularly in North America and Europe, following successful pivotal trials.
• Launch of pediatric-specific Digoxin formulations, including dispersible tablets and liquids.
• Growth driven by increasing clinical adoption, especially in congenital heart disease management.

Mid-term (3-5 Years)

• Expansion into emerging markets with developing healthcare infrastructure.
• Integration of digital health tools for dose monitoring and adherence, boosting clinical outcomes.
• Elevation of post-marketing surveillance data to reinforce safety profiles.

Long-term (Beyond 5 Years)

• Potential for combination therapies targeted at complex pediatric cardiac conditions.
• Incorporation of pharmacogenomic approaches to personalize dosing.
• Positioning Digoxin Pediatric as a standard of care for specific pediatric cardiac indications, supported by extensive evidence base.

Strategic Opportunities

• Partnerships for Digital Health: Collaborations with tech firms for real-time patient monitoring can improve safety and adherence.
• Clinical Trial Expansion: Broader multinational pediatric trials will strengthen regulatory submissions and market access.
• Formulation Innovation: Developing palatable, easy-to-administer formulations will increase compliance and reach in younger children.

Key Takeaways

• The clinical development of Digoxin Pediatric is progressing favorably, with ongoing trials addressing safety and efficacy gaps in pediatric populations.
• Market expansion hinges on regulatory approvals facilitated by pediatric-specific formulations and robust clinical data.
• Growing pediatric cardiac disease prevalence provides a significant opportunity, especially with emerging markets seeking affordable and effective therapies.
• Strategic investments in digital health integration and formulation innovation will be critical to establishing Digoxin Pediatric as a preferred therapy.
• Ensuring comprehensive safety and efficacy data will be vital in overcoming competition and regulatory challenges.

FAQs

1. What are the main clinical trials currently testing for Digoxin Pediatric?
Ongoing trials focus on determining optimal dosing strategies, confirming safety profiles, and comparing efficacy against other treatments in pediatric populations with heart failure or arrhythmias.

2. How does Digoxin Pediatric differentiate from adult formulations?
It offers pediatric-specific formulations like dispersible tablets and liquids, ensuring accurate dosing, safety, and ease of administration tailored to children’s needs.

3. What are the key regulatory hurdles for Digoxin Pediatric?
Regulatory agencies require comprehensive pediatric safety and efficacy data, which often necessitate extensive trials due to physiological differences between children and adults.

4. What is the market outlook for Digoxin Pediatric over the next five years?
Expect steady growth driven by regulatory approvals, increasing prevalence of pediatric cardiac conditions, and adoption of pediatric formulations in developed and emerging markets.

5. Which regions represent the highest growth opportunities for Digoxin Pediatric?
North America and Europe are immediate markets due to established healthcare systems, while Asia-Pacific presents long-term growth potential due to increasing healthcare infrastructure and rising disease prevalence.

References

1. ClinicalTrials.gov. (2023). Pediatric Digoxin trials.
2. WHO. (2021). Global prevalence of congenital heart disease.
3. FDA. (2022). Pediatric Drug Development Guidelines.
4. MarketWatch. (2022). Pediatric Cardiovascular Drugs Market Analysis.
5. Novartis and Teva annual reports (2021-2022).