CLINICAL TRIALS PROFILE FOR IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

All Clinical Trials for ibuprofen; 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Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America	Withdrawn	Pfizer	Phase 3	2016-04-01	This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group, comparative, study designed to evaluate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; phenylephrine hydrochloride

Condition Name

Condition Name for ibuprofen; phenylephrine hydrochloride
Intervention	Trials
Cold	1
Common Cold	1
Hepatectomy	1
Opioid Use Disorder	1

Condition MeSH

Condition MeSH for ibuprofen; phenylephrine hydrochloride
Intervention	Trials
Common Cold	2
Opioid-Related Disorders	1

Clinical Trial Locations for ibuprofen; phenylephrine hydrochloride

Trials by Country

Trials by Country for ibuprofen; phenylephrine hydrochloride
Location	Trials
Argentina	1
United States	1
Brazil	1

Trials by US State

Trials by US State for ibuprofen; phenylephrine hydrochloride
Location	Trials
North Carolina	1

Clinical Trial Progress for ibuprofen; phenylephrine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for ibuprofen; phenylephrine hydrochloride
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	1
Phase 3	2

Clinical Trial Status

Clinical Trial Status for ibuprofen; phenylephrine hydrochloride
Clinical Trial Phase	Trials
Withdrawn	1
Completed	1
RECRUITING	1

Clinical Trial Sponsors for ibuprofen; phenylephrine hydrochloride

Sponsor Name

Sponsor Name for ibuprofen; phenylephrine hydrochloride
Sponsor	Trials
Hospital Italiano de Buenos Aires	1
Pfizer	1
Ache Laboratorios Farmaceuticos S.A.	1

Sponsor Type

Sponsor Type for ibuprofen; phenylephrine hydrochloride
Sponsor	Trials
Other	2
Industry	2

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

Last updated: October 28, 2025

Introduction

Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and phenylephrine hydrochloride, a decongestant, are widely used over-the-counter (OTC) therapeutics. Their combined formulations target common cold and flu symptoms, including pain, fever, and nasal congestion. This article presents an updated overview of clinical trials, analyzes current market dynamics, and projects future trends based on recent developments.

Clinical Trials Landscape

Ibuprofen

Over recent years, clinical trials for ibuprofen have primarily focused on expanding indications, enhancing safety profiles, and exploring novel delivery mechanisms.

• Pain Management and Anti-inflammatory Effectiveness: Numerous Phase IV studies confirm ibuprofen's efficacy in acute pain, inflammatory conditions, and dental pain management (e.g., NCT04852314). Recent trials aim to compare its effectiveness against newer NSAIDs, emphasizing lower gastrointestinal risk profiles.
• Cardiovascular Safety: Following past concerns regarding cardiovascular risks associated with NSAIDs, extensive clinical evaluations (e.g., NCT04567230) are ongoing to delineate safety margins, especially at high doses or prolonged use.
• Formulation Innovation: Trials investigating bioavailability improvements such as oral dissolvable tabs, topical formulations, and nanoparticle delivery systems (e.g., NCT04678540) aim to broaden patient adherence and reduce systemic side effects.

Phenylephrine Hydrochloride

Clinical efforts focus on optimizing its nasal decongestant efficacy, bioavailability, and safety.

• Sustained-Release and Alternative Delivery: Multiple trials (e.g., NCT04213589) are assessing sustained-release nasal sprays and alternative routes (e.g., topical, oral) to enhance convenience and reduce rebound congestion.
• Efficacy and Safety in Special Populations: Studies target efficacy assessment in pediatric, geriatric, and cardiovascular-affected populations, reflecting regulatory concerns over sympathomimetic effects (e.g., NCT05161224).
• Combination Therapy Trials: Several ongoing studies analyze phenylephrine in combination with other agents like acetaminophen or antihistamines for superior symptom relief, with a focus on reducing dosing frequency.

Recent Regulatory and Clinical Trends

• The FDA's 2021 draft guidance emphasizes rigorous safety evaluations for OTC decongestants, including phenylephrine, especially regarding systemic absorption and cardiovascular risk (FDA, 2021).
• Regulatory agencies prioritize formulations minimizing systemic exposure and adverse events, stimulating innovation in drug delivery.

Market Analysis

Current Market Overview

Market Size and Growth

The global NSAID market, driven by ibuprofen's broad OTC availability, was valued at approximately USD 7.4 billion in 2022 and projected to reach USD 10.5 billion by 2028, growing at a CAGR of 5.8% (Grand View Research, 2023). Factors fueling growth include increasing prevalence of musculoskeletal disorders, self-medication trends, and expanded indications.

The phenylephrine decongestant market was valued at around USD 2.7 billion in 2022, expected to grow at a CAGR of 4.9%, primarily influenced by consumer demand for quick-relief cold remedies and innovations in nasal delivery systems.

Key Regional Markets

• North America: Leading market due to high OTC consumption, mature regulatory environment, and widespread awareness. The US dominates with >60% market share.
• Europe: Growth driven by aging populations and regulatory approvals of novel formulations.
• Asia-Pacific: Rapid expansion owing to rising disposable incomes, urbanization, and increased health awareness.

Competitive Landscape

Major players for ibuprofen include Johnson & Johnson (Motrin), Pfizer (Advil), and Boehringer Ingelheim. For phenylephrine, prominent firms include Johnson & Johnson, GlaxoSmithKline, and Bayer.

Innovation in formulation technology and marketing strategies remains central to gaining competitive advantage. Entry barriers are moderate, with significant R&D investment needed for novel delivery systems and regulatory approvals.

Market Challenges

• Regulatory Scrutiny: Increasing safety concerns, especially regarding cardiovascular risks, may lead to stricter regulations, impacting product availability and marketing claims.
• Market Saturation: High OTC market penetration constrains new entry prospects, emphasizing the importance of innovation.

Emerging Opportunities

• Personalized Medicine: Tailoring formulations based on genetic markers, especially for populations with unique safety profiles.
• Combination Products: Increased development of fixed-dose combinations to improve compliance and efficacy.
• Digital Health Integration: Leveraging mobile apps and telemedicine for symptom tracking and targeted marketing.

Future Market Projections

The integrated OTC analgesic and decongestant market is poised for continued growth through 2030, driven by:

• Innovation in Delivery Technologies: Nanotechnology, sustained release, and transdermal formulations will enhance drug efficacy and safety.
• Regulatory Evolution: Clearer guidance on safety assessment will facilitate reformulation, enabling compliance and market expansion.
• Consumer Preference for Natural and Minimal Side-Effect Products: Market players will likely invest in developing formulations with reduced systemic exposure or plant-based alternatives, aligning with consumer trends.

Specifically, the market for ibuprofen formulations with improved safety profiles and phenylephrine-based nasal sprays with enhanced bioavailability is expected to see significant investment, with projected compounded annual growth rates between 5-7% over the next decade.

Key Takeaways

• Robust Clinical Research: Ongoing trials focus on safety, novel delivery systems, and expanded indications to meet regulatory challenges and consumer demand.
• Market Dynamics Favor Innovation: Competitive advantage hinges on technological improvements, particularly in formulations that optimize bioavailability and safety.
• Regulatory Environment: Evolving guidelines necessitate rigorous safety evaluations, especially for decongestants like phenylephrine, impacting formulary and marketing strategies.
• Growth Opportunities: Emerging markets and convergence with digital health tools present substantial pathways for expansion.
• Strategic Positioning: Companies investing in research for safer, more effective formulations aligned with regulatory standards will dominate in both the NSAID and decongestant sectors.

FAQs

1. What are the latest developments in ibuprofen clinical trials?
   Recent trials concentrate on enhanced formulations (e.g., nanoparticle delivery), safety in specific populations, and comparative effectiveness against other NSAIDs. There is also interest in reducing gastrointestinal and cardiovascular risks associated with traditional ibuprofen.

2. How is phenylephrine hydrochloride evolving in clinical research?
   Research aims to improve nasal delivery methods, sustain-release formulations, and safety profiles, especially in vulnerable populations like children and the elderly, to address concerns over systemic sympathomimetic effects.

3. What regulatory changes impact these drugs' market trajectories?
   The FDA's 2021 guidance emphasizes safety, demanding comprehensive safety data, especially for OTC decongestants, potentially delaying approvals but ultimately fostering safer product development.

4. What market trends will influence future demand for ibuprofen and phenylephrine?
   Growth will be driven by innovation in delivery systems, increasing self-medication, aging populations requiring chronic pain management, and consumer preferences for safer, minimal-side-effect products.

5. Are there any notable pipeline products or formulations on the horizon?
   Yes, sustained-release nasal sprays for phenylephrine, topical NSAID formulations, and combination OTC products integrating both agents—aimed at improved efficacy, safety, and compliance—are progressing through clinical and regulatory pipelines.

References

1. FDA. (2021). Draft Guidance for Industry: Over-the-Counter Nasal Decongestants.
2. Grand View Research. (2023). NSAID Market Size, Share & Trends Analysis Report.
3. ClinicalTrials.gov database. Recent search results on ibuprofen and phenylephrine trials.