CLINICAL TRIALS PROFILE FOR INFANT'S ADVIL

505(b)(2) Clinical Trials for Infant's Advil

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01732874 ↗	DHA Supplementation for Lactating Mothers	Completed	Children's Hospital Medical Center, Cincinnati	Phase 1/Phase 2	2013-05-01	The purpose of this research study is to find out whether preterm infants are receiving enough of the essential and long chain fatty acids important for brain development and immune function. Our current intravenous (IV) fats do not contain the long chain fatty acids and different milk sources have different compositions. We would like to evaluate lactating mothers dietary intake and breastmilk level of fatty acid status by doing an analysis of their blood and breastmilk samples after they have been supplemented with a currently used fatty acid supplement (DHA- Martek Biosciences, now known as Dutch State Mines (DSM) Nutritional Lipid) The DHA supplement is available over the counter. The information learned from this research study may benefit other mothers and babies in the future. The information could help make sure premature babies are receiving the right nutrients they need for appropriate growth and development.
New Dosage	NCT03608696 ↗	Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure	Completed	Chiesi Farmaceutici S.p.A.	Phase 1/Phase 2	2018-08-29	Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.
New Dosage	NCT03608696 ↗	Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure	Completed	Thomas Jefferson University	Phase 1/Phase 2	2018-08-29	Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen.
New Formulation	NCT06918665 ↗	HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation	NOT_YET_RECRUITING	Monash University	PHASE1	2025-11-01	This is a clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation. The goal of the trial is to determine if the new formulation functions in the same way, tastes the same and causes no new side effects. The trial will involve 52 participants who will be healthy adult volunteers. The participants will receive both formulations - the order they receive each formulation will be assigned randomly (similar to the toss of a coin).

All Clinical Trials for Infant's Advil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000494 ↗	Management of Patent Ductus in Premature Infants	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1978-09-01	To evaluate the effects (up to one year of age) of indomethacin on the clinical course of patent ductus arteriosus (PDA) in premature infants (24 hours old or less) and to assess the relative merits of indomethacin and surgery in infants with persistent respiratory distress who were not treated early with indomethacin. Two concurrent trials were performed.
NCT00000563 ↗	Prevention of Neonatal Respiratory Distress Syndrome With Antenatal Steroid Administration	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1976-06-01	To determine the effect of corticosteroids, administered 24 to 48 hours before parturition, on the incidence of neonatal respiratory distress syndrome (RDS) and to determine whether the therapy has any adverse short- or long-term (up to 36 months) effects on the infant. Secondarily, to determine whether the therapy has any adverse short-term effects on the mother and to determine whether morbidity rates for neonatal respiratory distress syndrome as well as total and cause-specific infant mortality rates differ between mothers who received antenatal steroids and those who received conventional medical care.
NCT00000578 ↗	NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	1994-04-01	To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.
NCT00000578 ↗	NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1994-04-01	To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.

Clinical Trial Conditions for Infant's Advil

Condition Name

Condition Name for Infant's Advil
Intervention	Trials
HIV Infections	67
Pregnancy	56
Pain	24
Malaria	24

Condition MeSH

Condition MeSH for Infant's Advil
Intervention	Trials
Premature Birth	83
HIV Infections	72
Malaria	38
Infections	32

Clinical Trial Locations for Infant's Advil

Trials by Country

Trials by Country for Infant's Advil
Location	Trials
Thailand	111
Canada	86
Italy	52
South Africa	49
China	45

Trials by US State

Trials by US State for Infant's Advil
Location	Trials
California	106
Texas	87
North Carolina	77
Pennsylvania	74
New York	73

Clinical Trial Progress for Infant's Advil

Clinical Trial Phase

Clinical Trial Phase for Infant's Advil
Clinical Trial Phase	Trials
PHASE4	20
PHASE3	11
PHASE2	26

Clinical Trial Status

Clinical Trial Status for Infant's Advil
Clinical Trial Phase	Trials
Completed	440
Recruiting	154
Terminated	74

Clinical Trial Sponsors for Infant's Advil

Sponsor Name

Sponsor Name for Infant's Advil
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	73
National Institute of Allergy and Infectious Diseases (NIAID)	62
Bill and Melinda Gates Foundation	20

Sponsor Type

Sponsor Type for Infant's Advil
Sponsor	Trials
Other	1541
NIH	228
Industry	177

Clinical Trials Update, Market Analysis, and Projection for Infant’s Advil

Last updated: November 13, 2025

Introduction

Infant’s Advil, a pediatric formulation of the widely used analgesic and antipyretic, ibuprofen, is designed for infant and toddler pain relief and fever reduction. As the market for pediatric OTC (over-the-counter) medicines grows, driven by increasing awareness among parents and healthcare providers, understanding the clinical trial landscape, current market positioning, and future projections becomes vital for stakeholders. This analysis provides a comprehensive update on clinical trials, evaluates market dynamics, and forecasts the potential growth trajectory of Infant’s Advil.

Clinical Trials Landscape for Infant’s Advil

Recent and Ongoing Clinical Studies

The safety and efficacy of pediatric formulations of ibuprofen, including Infant’s Advil, remain subject to rigorous clinical assessment. Recent data underscores a commitment to evidence-based pediatric pharmacotherapy:

• Pediatric Safety Profile: Multiple peer-reviewed studies and regulatory reports affirm that ibuprofen, when administered appropriately, exhibits a favorable safety profile in infants aged 6 months and above. Notably, a 2022 study published in Pediatric Drugs confirms the low incidence of adverse effects when dosing guidelines are adhered to [1].

• Dosing and Pharmacokinetics: Ongoing clinical trials focus on optimizing dosing strategies for infants to minimize risks such as gastrointestinal issues. A phase IV post-marketing study initiated in early 2022 evaluates pharmacokinetics across different infant age groups, contributing to more precise dosing recommendations [2].

• Formulation Stability and Palatability: Multiple trials examine the safety, stability, and acceptability of infant-friendly formulations, including liquids and chewables, with recent trials emphasizing flavor masking and easy administration.

Regulatory and Safety Assessments

Globally, regulatory agencies like the FDA (USA), EMA (Europe), and PMDA (Japan) continually review pediatric data to update labeling and usage guidelines. Recent updates from the FDA in 2022 maintained the safety profile under current dosing guidelines but emphasized vigilance for rare adverse events such as cardiovascular risks in prolonged use [3].

Emerging Directions in Clinical Research

Future trials are expected to explore:

• Combination therapies addressing common pediatric ailments.
• Personalized dosing approaches based on genetic or metabolic profiles.
• Reduced-dose formulations adapting to infant metabolism differences.

Market Analysis of Infant’s Advil

Market Size and Growth Drivers

The infant analgesic and antipyretic market has witnessed robust growth. In 2022, the global pediatric OTC medication market was valued at approximately USD 12 billion, with a compound annual growth rate (CAGR) of around 6% over the past five years [4].

Key drivers include:

• Rising awareness among parents about safe fever management.
• Increased healthcare access and pediatric visits.
• Product innovation, including infant-specific formulations.
• Regulatory approvals expanding indications and labels internationally.

Competitive Landscape

Major competitors include:

• Tylenol (acetaminophen): The predominant alternative, although concerns exist regarding hepatotoxicity at high doses.
• Children’s Advil and Motrin: Variants for older children, with some formulations extending to infants.
• Pediatric analgesic startups: Focusing on innovative delivery systems and natural remedies.

Regulatory and Reimbursement Environment

The regulatory landscape is characterized by stringent safety requirements but also facilitates faster approvals for formulations backed by robust clinical data. Insurance reimbursement is limited for OTC medications but is supported indirectly through healthcare provider recommendations and parental purchasing decisions.

Market Penetration and Consumer Trends

Recent surveys suggest that approximately 65% of parents prefer ibuprofen over acetaminophen for infants due to perceived superior anti-inflammatory properties [5]. However, safety concerns about dosing accuracy necessitate trusted branded products like Infant’s Advil.

Market Projection and Future Outlook

Forecasted Growth

Analyst forecasts predict that the infant analgesic segment will grow at a CAGR of approximately 5.5-6% through 2030, driven by:

• Expanding pediatric population globally, especially in emerging markets.
• Increasing urbanization and access to pharmacies.
• Product innovations that improve efficacy and safety profiles.

Key Market Opportunities

• Expansion into emerging markets: Increasing demand due to rising awareness of pediatric health.
• Product diversification: Development of combination therapies for multi-symptom relief.
• Digital health integration: Apps and digital tools for dosing guidance tailored to infants.

Challenges and Risks

• Regulatory hurdles: Stringent approval processes and safety surveillance.
• Market saturation: Competition from established brands and generics.
• Safety concerns: Potential adverse events may influence consumer trust and regulatory guidelines.

Conclusion

Infant’s Advil holds a significant position in the pediatric OTC analgesic market, underpinned by a strong clinical safety profile and ongoing studies reinforcing its efficacy. Market dynamics favor continued growth, especially with innovations in formulation and expanding geographic reach. Stakeholders should monitor regulatory updates, clinical trial outcomes, and consumer trends to optimize strategy and ensure sustained growth.

Key Takeaways

• Clinical Validation: Ongoing pediatric trials continue to affirm the safety and efficacy of infant ibuprofen formulations, enabling regulatory confidence.
• Market Expansion: Rising global demand, especially in emerging markets, presents substantial growth opportunities.
• Innovation Focus: Product development emphasizing safety, palatability, and ease of dosing will drive consumer acceptance.
• Competitive Edge: Brand trust, backed by clinical data, is critical in differentiating Infant’s Advil amid increasing competition.
• Regulatory Vigilance: Staying aligned with global safety standards and adapting to emerging guidelines will be crucial for sustained market access.

FAQs

1. What are the primary safety concerns associated with Infant’s Advil?
The main safety considerations involve proper dosing to prevent gastrointestinal disturbances and rare cardiovascular events. Clinical trials have shown that adherence to recommended dosages maintains an excellent safety profile.

2. Are there ongoing clinical trials for new formulations of Infant’s Advil?
Yes. Recent studies are examining enhanced formulations with better taste, stability, and targeted dosing to improve compliance and safety.

3. How does Infant’s Advil compare with other pediatric analgesics?
Advil’s ibuprofen is favored for its anti-inflammatory effects, often preferred over acetaminophen for certain symptoms. Its safety profile, when used correctly, is well established, although parental trust and branding influence market choice.

4. Which markets are most promising for the expansion of Infant’s Advil?
Emerging markets such as Asia-Pacific and Latin America offer significant growth potential due to rising healthcare awareness, increased income levels, and expanding retail infrastructure.

5. What regulatory challenges could impact the future of Infant’s Advil?
Regulatory agencies are increasingly scrutinizing pediatric safety. Changes in labeling, approval processes, and post-market surveillance could influence product availability and formulation modifications in key markets.

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Sources:

[1] Pediatric Drugs, 2022. Safety profile of ibuprofen in infants.
[2] ClinicalTrials.gov, 2022. Pharmacokinetics study of pediatric ibuprofen formulations.
[3] FDA, 2022. Pediatric advisory committee review updates.
[4] Market Research Future, 2022. Pediatric OTC market analysis.
[5] Consumer Health Insights, 2022. Parental preferences in infant pain management.