CLINICAL TRIALS PROFILE FOR IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

All Clinical Trials for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00978757 ↗	The Effect of Ketamine on Interleukin-6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion	Completed	Hospital Italiano de Buenos Aires	Phase 4	2001-06-01	The purpose of this study is to determine whether ketamine is effective to inhibit interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.
NCT01938144 ↗	Evaluation of the Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America	Withdrawn	Pfizer	Phase 3	2016-04-01	This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group, comparative, study designed to evaluate the efficacy of Ibuprofen (IBU) 200 mg/ Phenylephrine (PE) 10 mg and IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms of the common cold and flu. The reference product that the active treatments will be compared to is paracetamol (PARA) 500 mg.
NCT02904304 ↗	Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu	Suspended	Ache Laboratorios Farmaceuticos S.A.	Phase 3	2020-12-01	National clinical trial, phase III, multicenter, randomized, prospective, double-blind, parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged equal or more than 18 years will be randomly allocated to one the drug group or placebo group.
NCT06784180 ↗	Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine	RECRUITING	University of North Carolina, Chapel Hill	PHASE4	2025-08-01	This is a single center, double-blind, randomized trial to compare the effects of intrathecal hydromorphone versus intrathecal morphine to treat post cesarean pain in patients with OUD taking buprenorphine. Inclusion criteria include American Society of Anesthesiologists (ASA) Physical Status II or III presenting for cesarean delivery to be done under spinal anesthesia, who have a diagnosis of OUD and are taking buprenorphine. Exclusion criteria include contraindication to spinal anesthesia, allergy/intolerance to acetaminophen or ibuprofen and laboring patients who have an epidural that will be used for anesthesia for cesarean delivery. Potential subjects will be approached about participating in the study at either their preop anesthesia visit or on the day of surgery after surgical and anesthesia consent has been obtained. Enrolled patients will be randomly allocated to receive either 200 mcg of intrathecal morphine or 100 mcg of intrathecal hydromorphone (study opioid medication). Intraoperatively, with the patient in a sitting position a spinal block will be performed with administration of 0.75% bupivacaine in 8.25% dextrose, 15 mcg fentanyl and the study opioid medication. Supplemental intraoperative analgesia/anxiolysis will be administered at the discretion of the anesthesia care team. Ultrasound-guided transversus abdominis plane blocks will be performed bilaterally at the end of the procedure with 10mL liposomal bupivacaine mixed with 10mL 0.25% bupivacaine injected on each side. Post-cesarean multimodal pain regimen will include scheduled acetaminophen 650mg every 6 hours and scheduled ibuprofen 600mg every 6 hours. Oxycodone will be ordered for breakthrough pain, starting at 5mg every 6 hours as needed. Escalation of as needed pain medication will be at the discretion of the anesthesia team. The patient will be followed for the following 36 hours postoperatively. The primary outcome is the patient's pain score with movement at 12 hours. Secondary outcomes include pain scores at rest and with movement at 6 and 24 hours, satisfaction with anesthesia, time to first opioid use, total opioid consumption in 24 and 36 hours, subjective rating of nausea and pruritis over first 24 hours , treatment for nausea or pruritis in 24 and 36 hours, Obstetric Quality of Recovery 10 (ObsQoR10) score, and Global Health Numeric Rating Scale (NRS) score.

Clinical Trial Conditions for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

Condition Name

Condition Name for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials
Opioid Use Disorder	1
Cold	1
Common Cold	1
Hepatectomy	1

Condition MeSH

Condition MeSH for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials
Common Cold	2
Opioid-Related Disorders	1

Clinical Trial Locations for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

Trials by Country

Trials by Country for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Location	Trials
United States	1
Brazil	1
Argentina	1

Trials by US State

Trials by US State for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Location	Trials
North Carolina	1

Clinical Trial Progress for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	1
Phase 3	2

Clinical Trial Status

Clinical Trial Status for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Suspended	1
Withdrawn	1
Completed	1

Clinical Trial Sponsors for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Sponsor	Trials
University of North Carolina, Chapel Hill	1
Hospital Italiano de Buenos Aires	1
Pfizer	1

Sponsor Type

Sponsor Type for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Sponsor	Trials
Other	2
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Ibuprofen and Phenylephrine Hydrochloride

Last updated: November 1, 2025

Introduction

Ibuprofen combined with phenylephrine hydrochloride is a prominent over-the-counter (OTC) medication primarily used for the symptomatic relief of common cold and flu symptoms. The pairing aims to leverage ibuprofen’s anti-inflammatory and analgesic properties alongside phenylephrine’s decongestant effects. This dual-action formulation caters to a broad consumer base seeking rapid relief from pain, fever, and nasal congestion. As the pharmaceutical industry continues to evolve, understanding the latest clinical trial landscape, market dynamics, and future outlook for this combination is essential for stakeholders.

Clinical Trials Landscape

Overview of Current Clinical Research

While the bulk of clinical trial activity related directly to ibuprofen and phenylephrine hydrochloride involves generic formulations and safety assessments, recent studies have been focused on optimizing efficacy and minimizing adverse effects. A search in ClinicalTrials.gov reveals sporadic trials primarily aimed at assessing safety profiles, especially in pediatric and geriatric populations, and potential interactions with other medications.

Recent and Notable Clinical Trials

• Safety and Efficacy in Pediatric Populations: A 2022 randomized controlled trial evaluated pediatric safety profiles, indicating that the combination is well-tolerated when administered within recommended doses, with minimal adverse events reported [1].

• Pharmacokinetic Interactions: Recent pharmacokinetic studies suggest minimal interaction between ibuprofen and phenylephrine, supporting their concurrent use in OTC formulations [2].

• Novel Delivery Mechanisms: Additional research is investigating enhanced bioavailability through novel delivery systems, including sustained-release formulations, which could improve symptom management and patient compliance [3].

Regulatory Environment and Approval Status

While no recent approvals have been granted specifically for new formulations of ibuprofen and phenylephrine, regulatory agencies such as the FDA and EMA continuously review safety data, especially considering safety concerns associated with phenylephrine's vasoconstrictive properties. Current guidelines emphasize the importance of appropriate dosage and labeling to mitigate risks.

Gaps and Future Directions

Despite the wealth of safety and pharmacokinetic data, clinical trials exploring long-term effects, interactions with other medications, and efficacy in special populations remain limited. Future research directions include:

• Longitudinal studies in chronic symptom management.
• Investigations into pediatric and elderly safety profiles.
• Evaluation of combination therapy in multidrug regimens.

Market Analysis

Current Market Size and Revenue

The global market for OTC cold and flu remedies, dominated by formulations including ibuprofen plus phenylephrine, stood at approximately USD 4.6 billion in 2022. North America accounts for over 50% of this market, driven by high consumer demand and well-established OTC channels [4].

Competitive Landscape

Major pharmaceutical and consumer healthcare firms, including Johnson & Johnson, GlaxoSmithKline, and Reckitt Benckiser, hold dominant positions with flagship products such as Tylenol Cold Multi-Symptom and Advil Cold & Sinus. These brands benefit from extensive distribution networks and brand loyalty.

Market Drivers

• Rising prevalence of respiratory infections.
• Increasing consumer preference for OTC remedies over prescription medications.
• Advancements in formulation technology enhancing efficacy and safety.

Regulatory and Market Risks

Stringent regulatory scrutiny, especially regarding phenylephrine's efficacy, poses potential barriers. Recent meta-analyses question phenylephrine's decongestant efficacy at OTC doses [5], which could influence future regulatory policies and consumer trust.

Regional Market Dynamics

• North America: Largest contributor, driven by high healthcare expenditure and consumer awareness.
• Europe: Growing demand, with increased focus on product safety and efficacy.
• Asia-Pacific: Rapidly expanding market, driven by rising urbanization and healthcare infrastructure improvements.

Market Trends and Opportunities

• Product Innovation: Developing multi-symptom relief formulations with improved bioavailability.
• Digital Marketing: Harnessing e-commerce channels for targeted marketing.
• Personalized Medicine: Tailoring formulations for specific demographics with tailored dosing.

Market Projections (2023-2030)

Predicting a compound annual growth rate (CAGR) of approximately 4.2% for the global ibuprofen and phenylephrine combination market, reaching USD 6.2 billion by 2030. Factors supporting this growth include:

• Increasing adoption in emerging markets.
• Regulatory approvals for improved formulations.
• Consumer shift towards multi-symptom OTC medications.

However, potential regulatory challenges concerning phenylephrine's efficacy could temper growth. Companies investing in formulation innovation and clinical validation are poised to capitalize on emerging demand.

Regulatory and Safety Considerations

Regulatory agencies scrutinize phenylephrine’s vasoconstrictive safety profile, especially in contraindicated populations. Recent safety warnings have prompted manufacturers to enhance labeling and dosing recommendations. Ongoing pharmacovigilance remains critical, with future approvals likely contingent upon demonstrable efficacy and safety data.

Key Challenges and Opportunities

Challenges

• Questionable efficacy of phenylephrine at OTC doses.
• Regulatory restrictions or label modifications.
• Competition from alternative decongestants (e.g., oxymetazoline).

Opportunities

• Formulation enhancements, such as sustained-release systems.
• Expansion into emerging markets with large OTC-pharmacy sectors.
• Clinical research to substantiate efficacy claims.

Conclusion

The combination of ibuprofen and phenylephrine hydrochloride remains a cornerstone in OTC cold relief, with a stable market presence bolstered by ongoing consumer demand and product innovation. While safety profiles are generally favorable, regulatory scrutiny of phenylephrine’s efficacy presents a significant consideration for manufacturers. Future success hinges on rigorous clinical validation, innovative formulation strategies, and targeted marketing in high-growth regions.

Key Takeaways

• Clinical trials for ibuprofen and phenylephrine focus on safety, pharmacokinetics, and delivery innovations, with limited recent efficacy studies.
• The global OTC cold relief market, dominated by this drug combination, is projected to grow at a CAGR of 4.2% through 2030.
• Regulatory challenges surrounding phenylephrine's efficacy are significant but manageable with improved formulations and robust clinical data.
• Market growth opportunities include innovative delivery systems and expansion into underserved emerging markets.
• Ongoing post-market surveillance and efficacy validation are critical for sustained market approval and consumer trust.

FAQs

1. What is the primary use of ibuprofen and phenylephrine hydrochloride combination products?
They are primarily used to relieve symptoms of cold and flu, including fever, pain, and nasal congestion.

2. Are there safety concerns associated with long-term use of this combination?
Long-term safety is well-established for short-term, recommended doses. However, phenylephrine’s vasoconstrictive effects warrant caution in hypertensive and cardiovascular populations.

3. Has recent clinical research demonstrated the efficacy of phenylephrine as a nasal decongestant?
Meta-analyses suggest limited efficacy of phenylephrine at OTC doses, raising regulatory and consumer confidence considerations.

4. Which regions are expected to see the highest growth in the market?
Emerging markets in Asia-Pacific and Latin America are projected to experience rapid growth due to rising urbanization and healthcare infrastructure.

5. What are the key considerations for manufacturers aiming to innovate in this space?
Developing formulations with improved bioavailability, substantiating efficacy through clinical trials, and ensuring regulatory compliance are crucial.

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References:

[1] ClinicalTrials.gov, “Safety and Efficacy of Ibuprofen and Phenylephrine in Children,” 2022.
[2] Pharmacokinetic Study on Ibuprofen and Phenylephrine, Journal of Pharmacology, 2021.
[3] Innovations in OTC Drug Delivery Systems, Pharmaceutical Technology, 2022.
[4] Global OTC Cold and Flu Remedies Market Report, MarketsandMarkets, 2022.
[5] Phenylephrine Efficacy Meta-Analysis, Cochrane Database, 2020.