CLINICAL TRIALS PROFILE FOR PSEUDOEPHEDRINE SULFATE

All Clinical Trials for 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Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis	Withdrawn	Azidus Brasil	Phase 3	2010-01-01	The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine +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.
NCT01293201 ↗	Trial of STAHIST in Seasonal Allergic Rhinitis	Completed	Magna Pharmaceuticals, Inc.	Phase 3	2011-03-01	The overall development plan is to show that the combination of tried-and-proven decongestant/antihistamine ingredients (pseudoephedrine hydrochloride and chlorpheniramine maleate), plus a very small amount of belladonna alkaloids (.24 mg atropine sulfate) is a comprehensive, safe and effective B.I.D. drug treatment regimen, indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Treated symptoms include nasal congestion, sneezing, rhinorrhea, itchy nose, itchy/watery eyes, and post nasal drip syndrome [reduction in tickly cough (acute or chronic), mucus in the back of the throat, sore throat, and hoarseness]. Considering the favorable safety and efficacy results of Phase 1 and Phase 2, the purpose of Phase 3 is to assess and compare the safety and efficacy of the study drug in a larger group comparatively with a placebo control group. Objectives: A) To report and compare total symptom scores (TSS) by SAR subjects rating the efficacy of STAHIST vs. placebo in relieving nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip over the two-week study period. B) Report any side effects or adverse drug reactions and rate the severity of any incident. C) Compare and report each symptom score, total nasal symptom scores (TNSS), and post-nasal drip symptom scores (PND-S) between the two study arms.
NCT01373138 ↗	Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions	Completed	Dr. Reddy's Laboratories Limited	Phase 1	2006-04-01	This is an open label randomised, 2-way crossover, comparative bioequivalence study.

Clinical Trial Conditions for pseudoephedrine sulfate

Condition Name

Condition Name for pseudoephedrine sulfate
Intervention	Trials
Healthy	3
Clinical Pharmacology	2
Rhinitis, Allergic	1
Seasonal Allergic Rhinitis	1

Condition MeSH

Condition MeSH for pseudoephedrine sulfate
Intervention	Trials
Rhinitis, Allergic	3
Rhinitis	3
Malnutrition	2
Rhinitis, Allergic, Seasonal	1

Clinical Trial Locations for pseudoephedrine sulfate

Trials by Country

Trials by Country for pseudoephedrine sulfate
Location	Trials
United States	8
Canada	4
Brazil	1

Trials by US State

Trials by US State for pseudoephedrine sulfate
Location	Trials
New Jersey	2
Indiana	1
Georgia	1
Texas	1
South Carolina	1

Clinical Trial Progress for pseudoephedrine sulfate

Clinical Trial Phase

Clinical Trial Phase for pseudoephedrine sulfate
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 1	3

Clinical Trial Status

Clinical Trial Status for pseudoephedrine sulfate
Clinical Trial Phase	Trials
Completed	7
Withdrawn	1

Clinical Trial Sponsors for pseudoephedrine sulfate

Sponsor Name

Sponsor Name for pseudoephedrine sulfate
Sponsor	Trials
Bayer	3
Ranbaxy Laboratories Limited	2
Azidus Brasil	1

Sponsor Type

Sponsor Type for pseudoephedrine sulfate
Sponsor	Trials
Industry	8

Pseudoephedrine Sulfate: Clinical Trials Update, Market Analysis, and 2026–2035 Projection

Last updated: April 26, 2026

What is pseudoephedrine sulfate and how is it positioned commercially?

Pseudoephedrine sulfate is a widely used oral decongestant for nasal congestion associated with upper respiratory infections and allergic rhinitis. Commercial positioning is dominated by:

• Generic-only supply across most major markets
• Formulation differentiation (immediate-release tablets vs extended-release, and fixed-dose combinations with antihistamines or other actives)
• Retail channel focus in over-the-counter (OTC) segments

Core regulatory constraint: pseudoephedrine is regulated as a precursor used in illicit manufacturing of methamphetamines, which drives distribution controls, recordkeeping, and purchase limits in the US and other jurisdictions. Those controls shape the commercial ceiling more than patent exclusivity.

Clinical trials update: what is in active development?

No complete, decision-grade clinical-trials update can be produced from the provided information. A proper update requires a verifiable mapping of:

• active recruiting or active-not-recruiting studies,
• trial phase (1–4),
• endpoints,
• sponsors,
• geographies,
• and brand/formulation details (mono vs combinations; IR vs ER).

With no study-level dataset supplied, a complete and accurate “clinical trials update” cannot be generated.

What does the pseudoephedrine sulfate market look like today?

A decision-grade market view for pseudoephedrine sulfate depends on region-by-region OTC volume and unit pricing, plus channel mix and regulatory impact on sales velocity. Without the required market dataset in the prompt, a complete and accurate market analysis cannot be produced.

What can be stated as hard commercial reality, without relying on missing dataset specifics:

• Pricing power is structurally limited by generic competition.
• Demand correlates with respiratory seasonality (cold and flu season in temperate markets) and allergy season.
• Revenue growth is constrained by regulatory purchase limits and product substitution to alternative decongestants or delivery formats (including intranasal agents).
• Formulation and combination strategy is the main route to incremental share rather than new molecular entities.

Market drivers and constraints that move pseudoephedrine sulfate sales

Demand drivers

• Seasonal incidence of upper respiratory symptoms and allergic rhinitis
• OTC self-medication behavior and convenience of oral decongestants
• Combination products that bundle pseudoephedrine with antihistamines or analgesics

Supply and commercial constraints

• Precursor regulations that reduce effective retail throughput
• Generic price compression
• Product substitution to intranasal decongestants (short-term), antihistamines (for allergic rhinitis), and saline-based or barrier approaches depending on market practice

Projection: 2026–2035 revenue and volume outlook

A credible projection requires inputs that are not present in the prompt (current market size by region, growth baselines, expected regulatory changes, and formulation-level growth). Without those, a complete and accurate forecast cannot be generated.

Business implications for R&D and investment

Even without a quantified projection, pseudoephedrine sulfate has a distinct investment profile compared with prescription-only drugs:

• R&D ROI typically concentrates in formulations and combination products rather than new mechanisms.
• Regulatory strategy dominates because product access is tied to precursor controls.
• Distribution advantage can outweigh clinical differentiation because the molecule is mature and generic.

Key Takeaways

• Pseudoephedrine sulfate is a mature OTC decongestant with commercial value driven primarily by formulation and channel execution, not patent exclusivity.
• Regulatory precursor controls are a structural constraint on retail throughput and sales velocity.
• A complete clinical-trials update and quantified market forecast cannot be produced from the information provided.

FAQs

1. Is pseudoephedrine sulfate still being developed in new clinical trials?
   A complete active-trials update cannot be generated without a trial register dataset.

2. Why do pseudoephedrine sales depend on regulation more than innovation?
   Precursor controls affect purchasing limits and distribution, which constrain volume regardless of clinical novelty.

3. What are the main ways companies differentiate pseudoephedrine OTC products?
   Delivery format (IR vs ER) and combination formulations with other OTC actives.

4. How does generic competition affect pseudoephedrine profitability?
   It compresses pricing and shifts profit toward scale, formulation niches, and channel execution.

5. What is the most likely growth lever through 2035?
   For generic-led molecules, growth typically comes from formulation mix and regional channel share rather than new molecular breakthroughs.

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References (APA)

[1] United States Drug Enforcement Administration. (n.d.). Combat methamphetamine production (pseudoephedrine/ephedrine regulated products). DEA.
[2] U.S. Food and Drug Administration. (n.d.). Regulation of OTC products containing pseudoephedrine/ephedrine (precursor controls). FDA.