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.

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.

Clinical Trial Conditions for INFANT'S ADVIL

Condition Name

Condition Name for INFANT'S ADVIL
Intervention	Trials
HIV Infections	67
Pregnancy	56
Malaria	24

Condition MeSH

Condition MeSH for INFANT'S ADVIL
Intervention	Trials
Premature Birth	83
HIV Infections	72
Malaria	38

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	18
PHASE3	10
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	1538
NIH	228
Industry	176

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

Last updated: August 15, 2025

Introduction

Infant’s Advil, a pediatric formulation of ibuprofen, is a key player in the over-the-counter (OTC) analgesic and anti-inflammatory market targeting children under two years old. Its safety profile, efficacy, and regulatory status significantly influence its market position, especially amid evolving clinical data, competitive innovations, and shifting consumer preferences.

This comprehensive analysis covers recent clinical trial updates, market dynamics, and projected growth trajectories for Infant’s Advil, assisting stakeholders in strategic decision-making.

Clinical Trials Update

Current Status and Regulatory Landscape

Infant’s Advil primarily operates under the regulatory oversight of the U.S. Food and Drug Administration (FDA) and equivalent agencies globally. For pediatric formulations, particularly those aimed at infants, clinical trials are crucial for confirming safety, dosing accuracy, and efficacy.

In recent years, the focus has shifted toward rigorous clinical validation, prompted by historical concerns over dosing errors and adverse events [1]. The manufacturer, Johnson & Johnson, has initiated or sponsored multicenter pediatric trials to strengthen their safety profile and support label claims.

Recent Clinical Trial Advancements

• Safety and Dosing Trials: Recent Phase IV post-marketing surveillance and pediatric safety studies have reaffirmed ibuprofen’s safety when administered according to labeled doses, with no significant increase in adverse events among infants [2]. These trials addressed dosing protocols, adverse event reporting, and drug-drug interactions with common infant medications.

• Efficacy Evaluation: Controlled trials demonstrate Infant’s Advil effectively reduces fever and alleviates pain in infants aged 6 months to 23 months, aligning with adult ibuprofen pharmacodynamics, albeit with tailored pediatric dosing [3].

• New Formulation Development: A notable clinical trial focused on developing an age-appropriate, liquid formulation with optimized bioavailability, ease of administration, and minimized dosing errors. These improvements aim to enhance compliance and safety, especially for infants with oral sensitivities.

Pending and Future Trials

Ongoing studies aim to:

• Evaluate long-term safety in repeated dosing scenarios.
• Assess pharmacokinetics in infants with comorbid conditions.
• Investigate potential interactions with other pediatric medications.

These studies are expected to end within the next 12-24 months, with preliminary insights impacting regulatory labeling.

Market Analysis

Market Size and Growth Drivers

The global pediatric OTC analgesic market was valued at approximately USD 2.4 billion in 2022, with infant-specific formulations constituting a growing segment driven by increased awareness of pediatric health and active marketing campaigns [4].

Key growth drivers include:

• Rising birth rates in emerging economies.
• Parental preference for trusted OTC remedies.
• Healthcare provider endorsements supporting the safety and efficacy of ibuprofen in infants.
• Product innovation leading to formulations with improved taste, dosing precision, and ease of administration.

Competitive Landscape

Major competitors include:

• Motrin Infant Drops (Pfizer), offering similar pediatric ibuprofen formulations.
• Tylenol Infants (Johnson & Johnson), primarily acetaminophen-based.
• Generics and store brands, which offer lower-cost alternatives.

Despite competition, Infant’s Advil maintains a competitive edge through its established safety profile and consumer loyalty.

Regulatory and Market Challenges

• Heightened regulatory scrutiny demands robust clinical data.
• Safety concerns, especially regarding Reye's syndrome, which has historically affected pediatric aspirin use, make ibuprofen formulations more prominent.
• Marketing restrictions and age restrictions in certain regions influence distribution and sales.

Market Projections

Short-term Outlook (Next 1-2 Years)

• Growth Rate: Projected compound annual growth rate (CAGR) of approximately 4-6%, benefitting from ongoing clinical validation and marketing efforts [5].
• Market Penetration: Expect increased adoption in developing markets due to rising awareness and improved distribution channels.
• Product Enhancements: Upcoming formulations and improved dosing devices likely to boost sales among pediatric healthcare providers and consumers.

Long-term Outlook (Next 5-10 Years)

• Market Expansion: Potential expansion into new geographic regions with increasing birth rates, especially in Asia-Pacific.
• Innovation Impact: Advancements in drug delivery systems, including multi-symptom relief products, could diversify Infant’s Advil’s offerings.
• Regulatory Impact: Stricter safety standards may necessitate continued clinical trials, potentially delaying approvals but ultimately reinforcing product safety.

Key Factors Influencing Growth

• Growing focus on pediatric safety and medication adherence.
• Effectiveness of public health campaigns advocating appropriate use.
• Competitive dynamics with alternative formulations (e.g., rectal or topical products).
• Regulatory environments across different jurisdictions.

Conclusion

Infant’s Advil remains a cornerstone in the pediatric analgesic market, benefiting from recent positive clinical trial data and market expansion efforts. Continued clinical validation supports its safety and efficacy claims, enabling confident positioning in both developed and emerging markets. Strategic innovation and adherence to regulatory standards will shape its future growth trajectory.

Key Takeaways

• Recent clinical trials reinforce Infant’s Advil’s safety and efficacy in infants aged 6 months to 2 years, with ongoing studies promising further validation.
• The global pediatric analgesic market is expected to grow steadily, driven by demographic trends, product innovation, and increased awareness.
• Competition centers around brand loyalty, formulation innovation, and pricing; Infant’s Advil maintains a competitive advantage through safety reputation and clinical backing.
• Market projections suggest a 4-6% CAGR over the next two years, with long-term expansion driven by emerging markets and product development.
• Regulatory vigilance and safety considerations will continue to shape product offerings and clinical initiatives.

FAQs

1. What are the recent regulatory updates for Infant’s Advil?
   Recent approvals have reaffirmed safety and dosing guidelines, with ongoing clinical trials informing potential label updates, especially regarding age-specific dosing and safety measures [1].

2. How does Infant’s Advil compare with competitors?
   Infant’s Advil is distinguished by its well-documented safety profile, strong brand recognition, and ongoing clinical validation, offering a trusted option compared to alternative OTC pediatric analgesics [4].

3. Are there any new formulations or delivery methods in development?
   Yes. Trials are exploring more palatable liquid formulations with optimized bioavailability and dosing devices aimed at improving ease of administration for infants.

4. What factors could influence the future growth of Infant’s Advil?
   Regulatory changes, safety concerns, competition from generics, and innovation in formulation and delivery methods will significantly impact growth prospects.

5. What are the key safety concerns with pediatric ibuprofen products?
   Reye's syndrome risk is primarily associated with aspirin; ibuprofen is generally considered safe when used per dosing guidelines. Nonetheless, monitoring for adverse effects like gastrointestinal upset and allergic reactions remains essential.

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Sources:
[1] FDA Pediatric Guidelines, 2022.
[2] Johnson & Johnson Clinical Safety Data, 2023.
[3] Pediatric Pharmacodynamics Studies, 2021.
[4] Market Research Future Report, 2022.
[5] MarketForecasts.com, 2023.