CLINICAL TRIALS PROFILE FOR LORATADINE; PSEUDOEPHEDRINE SULFATE

All Clinical Trials for LORATADINE; PSEUDOEPHEDRINE SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00837915 ↗	Bioequivalnce Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fasting Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2002-06-01	The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) Loratadine 10mg /Pseudoephedrine Sulfate 240 mg Extended-Release Tablets, in a fully replicated design, under fasting conditions.
NCT00845546 ↗	Bioequivalence Study of Loratadine / Pseudoephedrine Sulfate 10/ 240 mg Extended-Release Tablets Under Fed Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2002-06-01	The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Schering (Claritin-D® 24 hour) 10 mg Loratadine/240 mg Pseudoephedrine Sulfate Extended-Release Tablets, in a fully replicated design, under fed conditions.
NCT01055756 ↗	Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis	Withdrawn	Azidus Brasil	Phase 3	2010-01-01	The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and laboratory (nasal flow) down through time.
NCT03443843 ↗	A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure	Completed	Bayer	Phase 4	2018-02-21	The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms.
NCT03517930 ↗	A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects	Completed	Bayer	Phase 1	2018-04-17	To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering-Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.
NCT03517943 ↗	A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects	Completed	Bayer	Phase 1	2018-04-24	To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering- Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.

Clinical Trial Conditions for LORATADINE; PSEUDOEPHEDRINE SULFATE

Condition Name

Condition Name for LORATADINE; PSEUDOEPHEDRINE SULFATE
Intervention	Trials
Clinical Pharmacology	2
Healthy	2
Allergic Rhinitis	1
Rhinitis, Allergic	1

Condition MeSH

Condition MeSH for LORATADINE; PSEUDOEPHEDRINE SULFATE
Intervention	Trials
Rhinitis, Allergic	2
Rhinitis	2
Malnutrition	2

Clinical Trial Locations for LORATADINE; PSEUDOEPHEDRINE SULFATE

Trials by Country

Trials by Country for LORATADINE; PSEUDOEPHEDRINE SULFATE
Location	Trials
Canada	3
United States	2
Brazil	1

Trials by US State

Trials by US State for LORATADINE; PSEUDOEPHEDRINE SULFATE
Location	Trials
New Jersey	2

Clinical Trial Progress for LORATADINE; PSEUDOEPHEDRINE SULFATE

Clinical Trial Phase

Clinical Trial Phase for LORATADINE; PSEUDOEPHEDRINE SULFATE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for LORATADINE; PSEUDOEPHEDRINE SULFATE
Clinical Trial Phase	Trials
Completed	5
Withdrawn	1

Clinical Trial Sponsors for LORATADINE; PSEUDOEPHEDRINE SULFATE

Sponsor Name

Sponsor Name for LORATADINE; PSEUDOEPHEDRINE SULFATE
Sponsor	Trials
Bayer	3
Ranbaxy Laboratories Limited	2
Azidus Brasil	1

Sponsor Type

Sponsor Type for LORATADINE; PSEUDOEPHEDRINE SULFATE
Sponsor	Trials
Industry	6

LORATADINE; PSEUDOEPHEDRINE SULFATE Market Analysis and Financial Projection

Last updated: April 24, 2026

Loratadine + Pseudoephedrine Sulfate (Oral) Clinical Trials, Market Analysis, and Projection

What clinical trials exist for loratadine + pseudoephedrine sulfate?

No complete, source-backed, drug-specific clinical trials update can be produced from the information available in this chat. The combination product is widely marketed in multiple jurisdictions, but without trial identifiers, registries, dates, phase details, or sponsor data tied specifically to loratadine + pseudoephedrine sulfate (as opposed to loratadine alone, pseudoephedrine alone, or other combination formulations), a complete and accurate trials update cannot be authored.

How is the market structured for loratadine + pseudoephedrine sulfate?

Market structure must be source-verified to support investment-grade projections. In this chat, there are no provided data points for: unit sales, pricing, channel mix (retail vs clinic), geography, competitive set by active ingredient, regulatory status by country, or historical growth rates.

What can be stated without fabricating metrics:

• The combination targets allergic symptoms plus nasal congestion (antihistamine plus decongestant).
• The product sits within the OTC and switch-to-OTC disease-state category spanning seasonal allergic rhinitis and common cold-related congestion patterns, depending on label claims by jurisdiction.
• Competitive pressure commonly comes from fixed-dose alternatives (other antihistamine + decongestant combinations), intranasal therapies, and antihistamine monotherapy depending on country reimbursement and OTC formulation rules.

However, producing a market analysis with numbers (TAM/SAM/SOM, CAGR, regional shares, growth drivers, headwinds, and projection years) requires market research or registry/label datasets that are not present here.

What is the projection for market size and growth?

A complete and accurate market projection cannot be produced because this requires at minimum one of the following: (i) baseline market size for the combination, (ii) historical sales/volume series, or (iii) validated comparable-mapping methodology to a sourced dataset. None of these inputs are available in the chat.

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Actionable investment lens (what matters for this combination)

Even without numeric projections, the decision drivers for this combination class are consistent and operational:

Regulatory and labeling constraints that determine access

• Pseudoephedrine is subject to stricter controls than many decongestants in multiple markets. That affects:
  • point-of-sale access
  • patient suitability thresholds
  • distribution logistics and loss factors
• OTC vs behind-the-counter classification shifts the addressable market.

Clinical and payer reality

• Patients often tolerate antihistamine monotherapy for allergy symptoms and shift to intranasal corticosteroids or intranasal antihistamines for congestion and rhinorrhea, reducing incremental demand for combined oral therapy where intranasals are available and labeled.

Formulation substitution risk

• Fixed-dose combinations face substitution from:
  • single-ingredient products
  • multi-symptom cold products
  • decongestant-free antihistamines plus separate congestion treatments

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Key Takeaways

• A clinical trials update with complete, drug-specific evidence cannot be generated from the data provided in this chat.
• A market analysis and numeric projection cannot be generated without source-backed inputs for sales, geography, channel mix, and competitive set.
• For investment decisions, the combination’s addressable opportunity is tightly linked to pseudoephedrine regulatory access, label claims, and substitution pressure from intranasal options and monotherapies.

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FAQs

1. Is loratadine + pseudoephedrine sulfate considered an OTC or prescription product in major markets?
   Classification varies by jurisdiction and local regulatory regimes for pseudoephedrine-controlled substances.

2. What symptom targets drive demand for this combination?
   Allergy symptoms from loratadine plus nasal congestion relief from pseudoephedrine.

3. What are the main competitive threats to this combination?
   Antihistamine monotherapy, intranasal therapies, and other oral fixed-dose or multi-symptom products.

4. Why does pseudoephedrine regulation matter for market sizing?
   Access restrictions and distribution controls materially change effective retail availability and sales conversion.

5. Can clinical trials for loratadine alone be used to infer combination performance?
   No, combination-specific efficacy, safety, dose interactions, and endpoints can differ and must be supported by combination-labeled evidence.

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References

No source documents were provided in the chat to cite for clinical trials or market sizing.