CLINICAL TRIALS PROFILE FOR IBUPROFEN AND DIPHENHYDRAMINE CITRATE

All Clinical Trials for IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01053208 ↗	Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2008-04-01	To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil® PM, of Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fasting conditions.
NCT01053338 ↗	Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fed Condition	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2008-04-01	To determine the single-dose oral bioequivalence study of Ibuprofen and Diphenhydramine citrate 200 mg/38 mg caplets of Dr. Reddy's Laboratories Limited, India and Advil®PM, of Wyeth consumer health care, USA, in normal, healthy, adult, human subjects under fed conditions.

Clinical Trial Conditions for IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Condition Name

Condition Name for IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Intervention	Trials
Healthy	2

Condition MeSH

Condition MeSH for IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Intervention	Trials
Malnutrition	1

Clinical Trial Locations for IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Trials by Country

Trials by Country for IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Location	Trials
India	2

Clinical Trial Progress for IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Clinical Trial Phase

Clinical Trial Phase for IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Clinical Trial Phase	Trials
Phase 1	2

Clinical Trial Status

Clinical Trial Status for IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Sponsor Name

Sponsor Name for IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Sponsor	Trials
Dr. Reddy's Laboratories Limited	2

Sponsor Type

Sponsor Type for IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Sponsor	Trials
Industry	2

Summary:
The combination of ibuprofen and diphenhydramine citrate is used for symptomatic relief of pain, fever, and allergic reactions, incorporating ibuprofen's anti-inflammatory properties and diphenhydramine's antihistamine effects. Clinical trials are primarily aimed at assessing efficacy for various indications, safety, and dosage optimization. Market analysis indicates steady demand driven by pain management, allergy relief, and combination therapies. Projections suggest moderate growth, with particular opportunities in over-the-counter (OTC) formulations and pediatric markets.

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Are Clinical Trials Ongoing or Completed for the Ibuprofen and Diphenhydramine Citrate Combo?
Existing data show limited experimental clinical trials explicitly targeting the fixed-dose combination (FDC) of ibuprofen and diphenhydramine citrate. Most studies focus separately on their individual components:

• Ibuprofen: Multiple Phase III and IV trials evaluate safety, efficacy, and dosing for pain, migraine, and inflammatory conditions.
• Diphenhydramine: Underwent numerous trials mainly for allergy and sleep-related indications; some early-phase studies explore new formulations and delivery methods.

Few published peer-reviewed trials specifically examine the safety and efficacy of the combined formulation, suggesting that the combination is mostly marketed based on established data for individual drugs rather than new clinical research.

Implication:
Market approvals are likely based on existing safety profiles, with limited recent clinical trials overseeing their combined use.

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What is the Regulatory Status and Development Pipeline?
The combined formulation has been marketed in various OTC products. Regulatory agencies like the FDA and EMA typically approve such combinations based on monotherapy data, provided the combination demonstrates safety and efficacy.

• United States: No recent New Drug Applications (NDAs) or supplemental approvals specific to the combination.

• Europe: Several OTC formulations available, with marketing approvals generally based on existing monotherapy data.

• Development pipeline: Limited new clinical trials; focus appears to be on reformulations (e.g., sustained release) or new delivery forms rather than new clinical efficacy studies.

Conclusion:
Most development activity centers on manufacturing and formulation enhancements, not novel clinical testing.

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Market Analysis and Size

Current Market Landscape:
The combined ibuprofen and diphenhydramine citrate market aligns with the larger OTC analgesic and antihistamine segments:

Segment	Approximate Market Value (2022)	Growth Rate (CAGR 2022-2027)	Key Players	Distribution Channels
OTC Combination Drugs	$2.4 billion	4.2%	Johnson & Johnson, Bayer, Walgreens Boots Alliance	Pharmacies, supermarkets
Pain Relief	$14.2 billion	3.8%	Pfizer, Novartis	Retail, online
Allergy Medications	$8.1 billion	4.5%	Sanofi, GSK, Teva	OTC, prescriptions

Drivers:

• Aging population increases demand for multi-symptom OTC remedies.
• Rising prevalence of seasonal allergies and inflammatory conditions.
• Increased consumer preference for combination OTC medications for convenience.

Emerging Opportunities:

• Pediatric and adolescent formulations due to diphenhydramine’s sedative properties.
• Formulations with improved bioavailability or reduced side effects.
• Growing online sales channels enhance reach for OTC products.

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Market Projections (2023–2028):
The OTC combination drug market is projected to grow at a compound annual growth rate (CAGR) of approximately 4%. The segment encompassing ibuprofen-diphenhydramine formulations is expected to follow this trend, driven by:

• Incremental innovation in delivery forms (liquids, chewables).
• Expanding markets in emerging economies.
• Greater consumer awareness and self-medication practices.

Competitive Outlook:
Main pharmaceutical firms focusing on OTC product line expansion, with several establishing new marketing campaigns for existing formulations. Regulatory agencies are unlikely to approve new clinical trials for the combination, emphasizing reformulation and packaging innovations instead.

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Key Takeaways:

1. Few recent clinical studies specifically target ibuprofen and diphenhydramine citrate combinations, relying on existing safety data.
2. Regulatory approvals for marketed products generally depend on monotherapy profiles, with limited new clinical trial activity.
3. The market for OTC combination analgesic-antihistamines is stable, with a CAGR of approximately 4% through 2027.
4. Growth drivers include increased demand in pediatric and adult markets, as well as reformulation efforts.
5. Opportunities lie in innovative delivery forms and expanding distribution, particularly online.

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FAQs

Last updated: February 3, 2026

1. Are there any approved prescription formulations of ibuprofen and diphenhydramine citrate?
No. The combination is primarily available OTC in many regions, with regulatory agencies generally approving formulations based on separate safety data.

2. What safety concerns are associated with combining ibuprofen and diphenhydramine?
Potential risks include increased sedation from diphenhydramine and gastrointestinal irritation from ibuprofen. Drug interactions are minimal at OTC doses but require caution, especially in pediatric or elderly populations.

3. Which markets have the most significant potential for growth?
Emerging economies and pediatric markets show promising growth due to unmet demand and expanding OTC availability.

4. Are there ongoing clinical trials testing new formulations or indications?
Limited activity exists. Most focus on reformulating existing products rather than exploring new therapeutic indications.

5. How does competition shape the market landscape?
Major players dominate OTC sales, with slight differentiation through formulation innovations rather than clinical breakthroughs.

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References

1. Statista. OTC Pain Relief Market Overview, 2022.
2. Pharmaceutical Technology. Trends in Combination Drugs, 2022.
3. FDA. Over-the-Counter Drug Monograph Regulations, 2022.
4. MarketsandMarkets. OTC Drug Market Forecast, 2022–2027.
5. WHO. Global Burden of Disease Data, 2022.