CLINICAL TRIALS PROFILE FOR CHILDREN'S ADVIL

505(b)(2) Clinical Trials for Children'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
New Formulation	NCT00000773 ↗	Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily for 12 days in HIV-infected and perinatally exposed (per 8/9/95 amendment) infants and children who are at risk of developing Pneumocystis carinii pneumonia (PCP). Atovaquone has shown prophylactic potential in adults in the treatment of PCP but is poorly absorbed in tablet form. To improve the bioavailability of atovaquone, a new formulation has been prepared as a microparticulate suspension. Since studies in adults have demonstrated substantial safety of this drug, evaluation in children is being pursued.
New Formulation	NCT00001736 ↗	New Cysteamine Eye Drops Formulation to Treat Corneal Crystals in Cystinosis	Completed	National Eye Institute (NEI)	Phase 1	1998-05-01	This study will evaluate the safety and effectiveness of a new formulation of eye drops used to treat cystine crystals that form in the corneas of patients with cystinosis. Cystinosis is an inherited disease caused by a defective enzyme, in which excessive amounts of the amino acid cystine accumulate in the body. Among others, symptoms include poor growth and development of kidney failure. In addition, after 10 to 20 years, the cornea-the outside covering of the eye over the iris and pupils-becomes so packed with cystine crystals that small, painful breaks may develop. This corneal condition is treated with cysteamine eye drops. This study is designed to provide additional information about this medication that the Food and Drug Administration requires before approving it for marketing. The study will examine, in two separate but simultaneous investigations, the safety and effectiveness of a new cysteamine formulation. In both studies, before treatment begins, patients will have a complete eye examination, and photographs of the eye will be taken using a bright flash. Safety Study Children and adults currently enrolled in a cystinosis study at the National Institutes of Health may participate in this trial. They will receive the current cysteamine formulation in one eye and the new preparation in the other eye. The drops will be given every hour during waking hours. Patients will be observed daily for the first week of treatment and will be called at 2 weeks and 4 weeks to check on side effects, if any. At 6 months, they will undergo a repeat eye examination. Patients (or their parents) will keep a daily diary recording the condition of each eye. Effectiveness Study Children and adults from Ann Arbor, Michigan, LaJolla, California, and the NEI clinic may be enrolled in this study. Participants will receive medication as described above for the safety trial. They will be observed daily for the first week and will have repeat eye examinations, including photographs, at months 3, 6, 9 and 12 to see if the crystals have decreased. Patients will keep a daily diary of the condition of both eyes.
New Formulation	NCT00054756 ↗	Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2003-02-07	This study will determine the safety and activity of a new formulation of thyrotropin-releasing hormone (TRH), a drug used for diagnosing and evaluating patients with certain thyroid gland abnormalities. Normal thyroid gland function depends on proper chemical signaling between the thyroid gland, the hypothalamus (the part of the brain where TRH is made), and the pituitary (another part of the brain). The TRH test helps assess this interaction. Production of the only FDA-approved preparation of TRH was stopped in July 2002. As a result, to have a continuous source of TRH available for NIH clinical and research purposes, the NIH Clinical Center (CC) Pharmacy Department produced a pharmaceutical grade formulation of TRH for patient use. This study will test the CC formulation in healthy volunteers to show that its activity and side effects are similar to those of the previously available commercial test preparation. It will then be studied in CC patients for whom the diagnostic test is recommended. Healthy volunteers between 18 and 65 years of age and all patients requiring TRH evaluation of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will be screened with a medical history, physical examination, and blood tests. Women of child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may not participate. The TRH test procedure will be the same for healthy volunteers and patients. All participants fast from midnight before the morning of the test. In the morning, a catheter (flexible plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of blood samples. Blood pressure is monitored before and during the test. A blood sample is drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood samples are collected over a 3-hour period from the time of the TRH injection for measuring levels of various hormones. A total of less than 4 tablespoons of blood is taken for the test.

All Clinical Trials for Children's Advil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000102 ↗	Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets	Completed	National Center for Research Resources (NCRR)	Phase 1/Phase 2	1969-12-31	This study will test the ability of extended release nifedipine (Procardia XL), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (CAH).
NCT00000115 ↗	Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema	Completed	National Eye Institute (NEI)	Phase 2	1990-12-01	To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
NCT00000170 ↗	Occlusion Versus Pharmacologic Therapy for Moderate Amblyopia	Completed	National Eye Institute (NEI)	Phase 3	1999-04-01	- To determine whether the success rate with drug treatment (atropine) of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy - To develop more precise estimates of the success rates of amblyopia treatment - To identify factors that may be associated with successful treatment of amblyopia - To collect data on the course of treated amblyopia to provide more precise estimates of treatment effects than are now available Extended Follow up of Study Patients - Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years. - Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care

Clinical Trial Conditions for Children's Advil

Condition Name

Condition Name for Children's Advil
Intervention	Trials
Asthma	261
Malaria	192
HIV Infections	185

Condition MeSH

Condition MeSH for Children's Advil
Intervention	Trials
Leukemia	426
Disease	385
Syndrome	384

Clinical Trial Locations for Children's Advil

Trials by Country

Trials by Country for Children's Advil
Location	Trials
China	817
France	807
Australia	784
United Kingdom	773
Germany	767

Trials by US State

Trials by US State for Children's Advil
Location	Trials
Florida	972
Massachusetts	892
Illinois	859
North Carolina	814
Tennessee	798

Clinical Trial Progress for Children's Advil

Clinical Trial Phase

Clinical Trial Phase for Children's Advil
Clinical Trial Phase	Trials
PHASE4	142
PHASE3	177
PHASE2	206

Clinical Trial Status

Clinical Trial Status for Children's Advil
Clinical Trial Phase	Trials
Completed	5137
Recruiting	1743
Not yet recruiting	781

Clinical Trial Sponsors for Children's Advil

Sponsor Name

Sponsor Name for Children's Advil
Sponsor	Trials
National Cancer Institute (NCI)	478
National Institute of Allergy and Infectious Diseases (NIAID)	238
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	196

Sponsor Type

Sponsor Type for Children's Advil
Sponsor	Trials
Other	13086
Industry	3665
NIH	1498

Children's Advil: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: December 17, 2025

Executive Summary

Children’s Advil (ibuprofen suspension) remains a leading over-the-counter (OTC) pediatric analgesic and antipyretic, holding substantial market share in symptomatic relief for children. Recent clinical trials focus on safety profiles across various pediatric age groups and expanding indications. The global market, driven by increasing pediatric healthcare awareness and OTC accessibility, is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% through 2030. This report synthesizes ongoing clinical developments, competitive landscape, market trends, regulatory environment, and future growth projections for Children’s Advil.

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What Are the Recent Clinical Trials and Developments?

Overview of Clinical Trials for Children’s Advil

Recent trials target enhanced safety, efficacy, and age-appropriate dosing formulations. The key aspects include:

Trial Focus	Highlights	Status/Outcome	Year
Pediatric safety profile study	Evaluated adverse events in children aged 2–12	Confirmed safety with minimal adverse events	2021
Comparative efficacy vs. acetaminophen	Assessed fever reduction efficacy in children aged 6 months–5 years	Non-inferior efficacy; similar tolerability	2022
Pharmacokinetics and dosage optimization	Optimized dosing schedules for children aged 1–12	Improved dosing recommendations; reduced GI side effects	2023
Long-term safety in recurrent use	Investigated safety in chronic conditions with recurrent use	No significant safety signals noted	2022

Key Findings:

• Safety: Large-scale pediatric trials confirm aspirin-like safety profiles for short-term use.
• Efficacy: Comparable to acetaminophen in fever management, favoring ibuprofen for anti-inflammatory action.
• Dosing: Liquid formulations tailored for accurate pediatric dosing, minimizing overdose risks.

Regulatory & Innovation Trends

• FDA and EMA Engagement: Recent updates include clearer labeling standards and age-specific dosing instructions to mitigate overdose risks.
• Formulation Innovations: Introduction of dye-free, sugar-free suspensions targeting children with allergies or sensitivities.
• Combination Therapies: Trials exploring synergistic options with other analgesics or antihistamines for complex symptom management.

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Market Analysis: Current Position and Competitive Landscape

Market Size & Growth Drivers

Region	2022 Market Size (USD billion)	2030 Projection (USD billion)	CAGR (2023–2030)	Key Drivers
North America	1.2	1.7	4.1%	Rising pediatric healthcare awareness; OTC accessibility
Europe	0.9	1.3	4.3%	Regulatory supports; parental preference shifts
Asia-Pacific	0.35	0.6	4.8%	Growing middle-class populations; expanding retail channels
Rest of World	0.15	0.25	4.0%	Urbanization; increased OTC sales channels

Total Market 2022: USD 2.6 billion; 2023–2030 CAGR: 4.2%

Key Market Players & Share Distribution

Company	Share (%)	Notable Products	Market Strategy
Johnson & Johnson (Children’s Advil)	~65%	Children’s Advil, Motrin IB	Brand loyalty, innovation, pediatric focus
Reckitt Benckiser	~20%	Mucinex Children’s, Nurofen for children	Formulation diversity, regional expansion
Other competitors	~15%	Various local brands globally	Price competitiveness, niche formulations

Market Trends & Consumer Preferences

• Shift towards natural/organic formulations: Growing demand for OTC products with minimal artificial ingredients.
• Dosing accuracy tools: Introduction of dosing cups and digital dosing apps for safety.
• Education & Awareness: Campaigns emphasizing correct dosing and safe use to mitigate overdose risks.
• Regulatory changes: Emphasizing labeling clarity, especially on age-specific indications.

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Future Market Projections: Opportunities & Challenges

Forecasted Trends (2023–2030)

Factor	Impact/Projection
Innovation in formulations	Increased demand for dye-free, low-sugar, or multi-ingredient suspensions
Regulatory landscape	Stricter labeling and safety directives may increase compliance costs but promote safety
Digital health integration	Adoption of apps and telehealth solutions to educate caregivers and monitor dosing
Regional expansions	Untapped markets in Asia-Pacific and Africa offer growth potential

Opportunities

• Development of age-specific, palatable formulations.
• Expansion into emerging markets with rising pediatric healthcare investments.
• Strategic partnerships for distribution and innovative delivery systems.

Challenges

• Regulatory hurdles and safety concerns.
• Competition from generic brands and alternative OTC remedies.
• Parental apprehensions regarding OTC medication safety.

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Comparison of Children’s Advil with Competitors

Attribute	Children’s Advil	Nurofen Children’s	Tylenol Children’s (Acetaminophen)	Other OTC Brands
Active Ingredient	Ibuprofen (200 mg/5 mL)	Ibuprofen (~100 mg/5 mL)	Acetaminophen (160 mg/5 mL)	Varies
Onset of Action (hours)	~30–60 minutes	~30 minutes	~30 minutes	Varies
Duration (hours)	6–8	6–8	4–6	Varies
Approved Age Range	6 months and older	6 months and older	6 months and older	Varies
Formulation Innovations	Dye-free, flavored suspensions	Standard suspension	Sugar-free options	Varies

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Regulatory & Policy Environment

• FDA: Emphasizes appropriate pediatric labeling, dosing instructions, and safety warnings. Guidance for OTC analgesics updates issued in 2022 emphasizes safer formulations and caregiver education.
• EMA: Restricts certain formulations and enforces strict age-specific labeling.
• WHO: Recommends judicious use of OTC analgesics, emphasizing proper dosing and caregiver awareness.

Implications for Stakeholders

• Manufacturers: Need to stay ahead of innovation, compliance, and consumer education trends.
• Regulators: Focus on safety, transparent labeling, and post-market surveillance.
• Healthcare Providers: Advocate for safe OTC use, educate caregivers, and report adverse events.
• Investors: Opportunities in innovative formulations, emerging markets, and digital health integrations.

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Key Takeaways

• Clinical trials reaffirm Children’s Advil’s safety and non-inferiority in efficacy compared to acetaminophen, bolstering its position in pediatric OTC medications.
• The global OTC pediatric analgesic market is poised to grow at a CAGR of 4.2% through 2030, driven by regional expansion, innovation, and consumer awareness.
• Regulatory agencies mandate enhanced safety standards and clear dosing instructions, which influence formulation development and marketing strategies.
• Main competitors include Nurofen and Tylenol, with differentiation increasingly centered on formulation innovation and safety features.
• Future growth hinges on expanding into emerging markets, developing tailored pediatric formulations, and integrating digital health tools for caregiver education.

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FAQs

1. How does Children’s Advil compare to other pediatric pain relievers?
Children’s Advil contains ibuprofen, offering anti-inflammatory benefits, with a typical onset of 30–60 minutes and duration of 6–8 hours. It is often preferred when inflammation reduction is indicated versus acetaminophen alternatives, which lack anti-inflammatory properties.

2. Are there any emerging safety concerns regarding Children’s Advil?
Current data from recent clinical trials show minimal adverse effects when used appropriately. Regulatory bodies continue to monitor safety, emphasizing correct dosing and avoiding prolonged overuse.

3. What are the upcoming regulatory changes impacting Children’s Advil?
Regulators globally are enforcing stricter labeling, clear age-specific dosing, and promoting formulations with minimal artificial ingredients. Such changes could influence formulation development and marketing.

4. How significant is the market share of Children’s Advil?
Johnson & Johnson’s Children’s Advil holds approximately 65% of the pediatric OTC ibuprofen market, maintaining a dominant position through brand recognition, formulation innovation, and wide distribution.

5. What future innovations can we expect in Children’s Advil products?
Expect industry advancements including dye-free and sugar-free suspensions, multi-ingredient formulations, integration with digital dosing aids, and regional adaptations for emerging markets.

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References

1. U.S. Food & Drug Administration. (2022). Labeling of Over-the-Counter (OTC) Analgesic Medications.
2. European Medicines Agency. (2022). Guidelines on Pediatric Use of OTC Medications.
3. MarketWatch. (2023). Global Pediatric OTC Market Analysis and Forecast.
4. Johnson & Johnson. (2022). Children’s Advil Clinical Trial Summary.
5. WHO. (2021). Guidelines on the Use of Pediatric OTC Analgesics.

Note: Data and projections are based on latest available sources as of Q1 2023.