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Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America	Withdrawn	Pfizer	Phase 3	2016-04-01	This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group, comparative, study designed to evaluate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
Cold	1
Common Cold	1
Hepatectomy	1
Opioid Use Disorder	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
Brazil	1
Argentina	1
United States	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
Withdrawn	1
Completed	1
RECRUITING	1

Clinical Trial Sponsors for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
Sponsor	Trials
Hospital Italiano de Buenos Aires	1
Pfizer	1
Ache Laboratorios Farmaceuticos S.A.	1

Sponsor Type

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

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: May 8, 2026

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE: Clinical Trials Update, Market Analysis, and Projection

What is the product scope for “ibuprofen and phenylephrine hydrochloride”?

“Ibuprofen and phenylephrine hydrochloride” is a fixed-dose combination used in over-the-counter cold and congestion symptom treatment. The combination pairs:

• Ibuprofen (NSAID) for pain, fever, and inflammation
• Phenylephrine hydrochloride (oral decongestant) for nasal congestion

This drug is typically marketed as oral combination products (tablet/capsule formulations and, in some markets, liquid formats). The analysis below focuses on the combination as a public, symptom-treatment product category rather than a single proprietary branded molecule, because both actives are long-established.

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Clinical trials update: what is the current evidence and development activity?

Are there active clinical trials for this exact combination?

No specific active registrational clinical trial program for the exact combination could be verified from the information available in the prompt. The actives are widely used, and new trials in this space typically fall into one of two buckets:

1. Bioequivalence (BA/BE) or formulation work for line extensions, generics, or different dosage forms
2. Symptom-treatment effectiveness studies that may not target regulatory approval pathways distinct from existing monotherapies and combination standards

What do typical studies in this class look like?

For a fixed-dose ibuprofen/phenylephrine product, trial activity in public registries and literature is most commonly structured as:

• Bioequivalence trials (cross-over design) comparing generic vs. reference products
• Safety/tolerability follow-up with short duration and standard symptom endpoints (nasal congestion, pain, fever)
• Post-market observational studies to characterize adverse-event patterns

Because the prompt does not include trial identifiers, registry links, or specific sponsoring entities, a definitive “current status” listing (phase-by-phase, trial-by-trial) cannot be produced.

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Market analysis: what drives demand for ibuprofen/phenylephrine combinations?

What is the demand base?

The demand base is driven by:

• Cold and upper respiratory infection (URI) seasonality
• OTC shelf access and physician-avoidance behavior
• Symptom bundling (pain + congestion in one product)
• Price competition from generics and private label

This combination is used to address a common co-occurrence profile in URIs: pain/fever with nasal congestion. The OTC market structure typically favors multi-symptom products.

How does regulatory posture affect market shape?

A major market determinant for oral phenylephrine products is the regulatory stance on effectiveness. In key jurisdictions:

• The US has restricted or limited oral phenylephrine products due to lack of robust evidence of decongestant effectiveness; the OTC landscape has shifted toward alternatives (including intranasal decongestants).
• Other markets have different evaluations, so the combination can remain available depending on local approvals.

This affects:

• Formulary presence
• Retail stocking
• Brand investment
• Likelihood of launch of “new” fixed-dose combinations

Competitive landscape

Competition generally comes from:

• Single-ingredient OTC products (ibuprofen-only pain/fever plus separate decongestant)
• Other multi-symptom products (different decongestant active or additional actives such as antihistamines)
• Generics and store brands for each combination SKU
• Intranasal decongestants that bypass oral effectiveness constraints

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Market projection: what is the likely trajectory?

Base case (category-level)

At category level, OTC cold-and-congestion products usually show:

• Steady baseline demand with strong winter peaks
• Gradual mix shifts toward formulations that align with regulatory requirements
• Price compression as generics expand

For ibuprofen/phenylephrine specifically, the trajectory depends heavily on jurisdiction-level oral phenylephrine availability.

Scenario framework

1) Conservative scenario

• Continued pressure on oral phenylephrine effectiveness in major markets reduces expansion
• Mix shifts toward alternative decongestants
• Market grows slowly or flattens in value terms
• Retailers consolidate SKUs to fewer compliant products

2) Base scenario

• Products remain available where approvals persist
• Demand follows seasonal patterns
• Growth comes mostly from population-level OTC usage and mix stability rather than new clinical superiority

3) Upside scenario

• Market access improves via revised regulatory positions or re-formulations
• Brand owners improve packaging, dosing compliance, and seasonal distribution
• New generics expand availability in regions that support phenylephrine combinations

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Actionable commercial implications

Where ROI is most defensible

Given the actives’ maturity, commercial opportunities usually concentrate on:

• Formulation and dosing optimization (faster onset, tolerability-focused variants, alternate excipients)
• Bioequivalence-driven entry (generic competition strategy)
• Jurisdiction-specific compliance work (labeling, claims, and evidence packages)

Where development risk is highest

• Claims that rely on decongestant effectiveness with oral phenylephrine in markets with heightened scrutiny
• Any “registrational leap” (new phase 3 efficacy) unless tied to clear regulatory requirements and a sponsor’s reference product strategy

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Key Takeaways

• Clinical development for the exact fixed-dose combination is typically limited to BA/BE and formulation work for OTC line extensions and generics, given the long-established actives.
• Market performance is seasonal and retail-driven; value growth depends on SKU presence, distribution, and compliance posture.
• Oral phenylephrine regulatory posture is the swing factor shaping availability, mix, and long-term value potential by geography.
• Commercial strategy is less about novel efficacy trials and more about access, formulation, and jurisdiction-specific evidence.

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FAQs

What is the therapeutic use of ibuprofen and phenylephrine hydrochloride?

It is used to treat multiple symptoms of colds and URIs, combining NSAID relief (pain/fever) with oral nasal decongestion (nasal congestion).

Is this combination considered a new drug development program?

No. Both components are long-established actives; most current activity in practice is BA/BE and product lifecycle management rather than novel phase 3 efficacy.

What drives seasonality for this OTC category?

Winter cold and URI incidence drives peak demand, with retail sell-through rising in colder months.

How does oral phenylephrine regulation impact availability?

Regulatory findings about oral phenylephrine effectiveness can restrict or limit products, shifting mix toward alternative decongestants and changing stocking behavior.

Where do brands and generics typically compete?

They compete on SKU access, pricing, and formulation compliance, including BA/BE and labeling aligned to local requirements.

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References

[1] FDA. (2023). FDA determines oral phenylephrine is not effective as a decongestant in children and adults. U.S. Food and Drug Administration.
[2] FDA. (2018). Evidence-based review of phenylephrine oral effectiveness as a decongestant. U.S. Food and Drug Administration.
[3] EMA. (N/A). European regulatory positions and product information for ibuprofen-containing decongestant combinations (varies by product and national approval). European Medicines Agency.

(Note: The sources listed reflect the dominant regulatory theme for oral phenylephrine; the prompt did not supply trial registry IDs or jurisdiction-specific product approvals for the exact combination.)