CLINICAL TRIALS PROFILE FOR FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

All Clinical Trials for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01133470 ↗	Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2007-02-01	The purpose of this study is to 1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets. 2. Monitor the adverse events and ensure the safety of subjects.
NCT01133483 ↗	Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2007-04-01	The purpose of this study is to 1. Compare and evaluate the single dose, crossover, bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets and Allegra-D 24 hr tablets. 2. Monitor the adverse events and ensure the safety of subjects.
NCT01306721 ↗	Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis	Completed	Sanofi	Phase 3	2011-02-01	Primary Objective: - To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg - pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg - pseudoephedrine HCl 120 mg combination (FEX60/PSE120) versus fexofenadine HCl 60 mg (FEX60) in patients with seasonal allergic rhinitis (SAR). Secondary Objectives: - To evaluate the efficacy of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60 on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), eye symptom, and daily activity impairment. - To assess the safety of a twice-daily FEX60/PSE60 and FEX60/PSE120 versus FEX60.
NCT02175485 ↗	Evaluation of Efficacy of Dellegra in Exposure Unit	Completed	Sanofi	Phase 4	2014-06-01	Primary Objective: To collect and analyze clinical data of Allergic Rhinitis patients' Total Nasal Symptom Score (TNSS) change after Dellegra internal use under high density pure Japanese cedar pollen exposure. Secondary Objective: To collect and analyze clinical data of Allergic Rhinitis patients' change in Total Symptom Score (TSS) and amount of nasal discharge, safety, and overall patients' impression about efficacy of Dellegra after Dellegra internal use under high density pure Japanese cedar pollen exposure.

Clinical Trial Conditions for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Condition Name

Condition Name for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Intervention	Trials
Healthy	2
Rhinitis Allergic	2
Rhinitis Seasonal	1

Condition MeSH

Condition MeSH for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Intervention	Trials
Rhinitis, Allergic	3
Rhinitis	3
Rhinitis, Allergic, Seasonal	1
Malnutrition	1

Clinical Trial Locations for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Trials by Country

Trials by Country for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Location	Trials
Japan	2
India	2

Clinical Trial Progress for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	1

Clinical Trial Sponsors for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor	Trials
Sanofi	3
Dr. Reddy's Laboratories Limited	2

Sponsor Type

Sponsor Type for FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor	Trials
Industry	5

Last updated: April 25, 2026

Clinical Trials Update, Market Analysis, and Projection for Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

What is the current clinical-trial landscape for fexofenadine plus pseudoephedrine?

No complete, current clinical-trials update can be produced from the provided input. The drug combination’s trial activity is fragmented across jurisdictions and sponsor-controlled datasets, and a precise update requires access to current trial registries (e.g., ClinicalTrials.gov/WHO ICTRP), plus trial-level status, endpoints, and dates. Without those sources in the prompt, any “current” claims would be incomplete.

How is this combination marketed, and where does it fit commercially?

Fexofenadine hydrochloride plus pseudoephedrine hydrochloride is a marketed combination used for symptomatic relief of allergic rhinitis and nasal congestion. Commercial performance is driven by:

• Seasonality (spring and fall peaks)
• Formulation positioning (extended-release vs immediate-release product forms; fixed-dose combinations)
• OTC and behind-the-counter access (country-specific)
• Competing cold/allergy bundles (antihistamine-only and decongestant-only products)

A defensible market analysis and projection requires concrete, source-backed inputs that are not present in the prompt: category size (allergic rhinitis, decongestants, combination cold/allergy), region splits, unit shares, pricing/brand penetration, and regulatory access. Without these, market sizing or forecast numerics would be unsupported.

What drives demand for a fixed-dose antihistamine/decongestant combination?

Demand for fexofenadine + pseudoephedrine is typically correlated with:

• Allergic rhinitis prevalence in the target geography
• Consumer preference for “combined symptom relief” versus single-agent therapy
• Regulatory and policy constraints on pseudoephedrine (sales restrictions and supply-chain controls)
• Safety and tolerability positioning versus older decongestant combinations

This demand profile matters for projections because pseudoephedrine access is a key gating variable for retail velocity, especially in markets with tighter dispensing rules.

What are the key market risks and sensitivities?

For business planning, the major sensitivities are:

• Pseudoephedrine supply and regulatory enforcement (controls can reduce availability even if demand stays constant)
• Switching costs driven by label claims, consumer switching, and alternative OTC brands
• Pricing pressure from generics or therapeutically equivalent fixed-dose combinations
• Patent and exclusivity posture of specific branded products (not the molecule in isolation)

How should a market projection be built in practice for this combination?

A credible projection model for fexofenadine hydrochloride plus pseudoephedrine hydrochloride must use observable drivers:

• Geography-level diagnosis prevalence or symptom incidence (rhinitis)
• OTC category share and mix (antihistamine-only vs combination)
• Decongestant access constraints (pseudoephedrine sales rules by country and year)
• Pricing and promotional intensity
• Competitive set dynamics (direct fixed-dose competitors and substitute product classes)

The prompt does not supply the quantitative base inputs required to generate those projections.

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Key Takeaways

• A current clinical-trials update cannot be issued from the provided information without trial-registry and trial-status sources.
• A numeric market analysis and forward projection cannot be produced without market sizing inputs, region/brand share, pricing, and category dynamics sources.
• For forecasting, pseudoephedrine access constraints and fixed-dose combination positioning are the primary commercial sensitivities.

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FAQs

1) Is fexofenadine plus pseudoephedrine approved for allergic rhinitis in all major markets?

Approval exists in multiple markets for symptom relief of allergic rhinitis with nasal congestion, but exact indications and formulations are country-specific.

2) What is the main market driver for this combination?

Combined symptom relief demand, amplified during peak allergy seasons, and moderated by pseudoephedrine access rules.

3) Do clinical outcomes differ materially from using antihistamine alone?

The decongestant component targets nasal congestion, so total symptom relief can differ by endpoint design and study population.

4) What most impacts sales volume?

Retail availability and regulatory controls on pseudoephedrine, plus OTC channel execution and pricing versus alternatives.

5) How should investors treat the pseudoephedrine regulatory risk in projections?

As a gating variable that can cap sales regardless of underlying demand, it should be modeled at the geography and time level.

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References

[1] No sources were provided in the prompt to cite.