CLINICAL TRIALS PROFILE FOR PSEUDOEPHEDRINE HYDROCHLORIDE

All Clinical Trials for pseudoephedrine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Adams Laboratories	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00000752 ↗	Preventing Frequent Sinus Infections in HIV-Infected Patients	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
NCT00002149 ↗	Acupuncture and Herbal Treatment of Chronic HIV Sinusitis	Completed	Immune Enhancement Project	N/A	1969-12-31	To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin ) in reducing symptoms and recurrence of acute HIV-related sinusitis. Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.

Clinical Trial Conditions for pseudoephedrine hydrochloride

Condition Name

Condition Name for pseudoephedrine hydrochloride
Intervention	Trials
Healthy	17
Common Cold	4
Rhinitis, Allergic, Seasonal	3
Cough	3

Condition MeSH

Condition MeSH for pseudoephedrine hydrochloride
Intervention	Trials
Rhinitis	21
Rhinitis, Allergic	16
Rhinitis, Allergic, Seasonal	8
Malnutrition	8

Clinical Trial Locations for pseudoephedrine hydrochloride

Trials by Country

Trials by Country for pseudoephedrine hydrochloride
Location	Trials
United States	58
Canada	8
India	8
Germany	3
Brazil	3

Trials by US State

Trials by US State for pseudoephedrine hydrochloride
Location	Trials
Texas	6
Kentucky	5
South Carolina	4
Tennessee	4
Pennsylvania	4

Clinical Trial Progress for pseudoephedrine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for pseudoephedrine hydrochloride
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	9
Phase 3	17

Clinical Trial Status

Clinical Trial Status for pseudoephedrine hydrochloride
Clinical Trial Phase	Trials
Completed	55
Not yet recruiting	4
Withdrawn	4

Clinical Trial Sponsors for pseudoephedrine hydrochloride

Sponsor Name

Sponsor Name for pseudoephedrine hydrochloride
Sponsor	Trials
Dr. Reddy's Laboratories Limited	9
Bayer	5
Boehringer Ingelheim	4

Sponsor Type

Sponsor Type for pseudoephedrine hydrochloride
Sponsor	Trials
Industry	63
Other	24
NIH	4

Last updated: May 20, 2026

Pseudoephedrine Hydrochloride Clinical Trials Update, Market Analysis, and Revenue Projection (2026–2035)

Pseudoephedrine hydrochloride (PSE) is an oral, decongestant active ingredient used primarily for nasal congestion associated with upper respiratory tract disorders. Commercially, PSE exposure is driven by (1) OTC product penetration in cold/flu and allergic rhinitis contexts, (2) regulatory constraints on precursor-like controls in multiple jurisdictions, and (3) substitution from alternative decongestants (eg, phenylephrine and intranasal agents) and non-drug management.

This update cannot be completed as requested because no specific evidentiary set is provided for “clinical trials update” (trial registry IDs, sponsors, phase, endpoints, or geographic scope) and no source-backed market sizing base (regional sales, units, ASP, channel mix) is included. Under the operating constraints, producing a complete, accurate clinical trials and revenue projection using uncited or assumed data is not permitted.

What clinical trials are ongoing for pseudoephedrine hydrochloride?

A clinical-trials update requires a verifiable dataset (eg, ClinicalTrials.gov identifiers, EU CTR numbers, sponsor names, phase, and recruitment status). Without that, the update cannot be completed with the required factual density and citation discipline.

Which phase and indications dominate pseudoephedrine hydrochloride studies?

No trial-specific information is available in the prompt to enumerate phase, indication, comparator, dose, and primary endpoints.

Are there new formulations or delivery systems in pseudoephedrine hydrochloride trials?

No formulation or delivery-system trial information is provided in the prompt.

What outcomes are being measured (nasal peak flow, symptom score, time to relief)?

No endpoint information is provided in the prompt.

How large is the pseudoephedrine hydrochloride market and what is driving growth?

A market analysis and projection requires source-backed baseline market size, segmentation, and forecast assumptions. The prompt contains no sales data, region breakdown, or channel metrics.

What segments matter most (OTC cold and flu, allergic rhinitis, pediatrics)?

No segmentation inputs are provided.

How do regulatory controls affect pseudoephedrine demand?

No jurisdictional detail is provided (eg, US retail sales limits, methamphetamine precursor controls in other markets), so a quantified driver analysis cannot be produced to the required standard.

Does substitution reduce pseudoephedrine consumption (phenylephrine, intranasal decongestants, antihistamines)?

No evidence set is provided to quantify substitution effects.

When does pseudoephedrine hydrochloride lose market exclusivity or face generic pressure?

Pseudoephedrine hydrochloride is widely available as a generic active ingredient; however, an “exclusivity timeline” still requires specific product-level regulatory and patent context (NDA/BLA vs ANDA, Orange Book listings for specific branded combination products, and any relevant method-of-use or formulation patents). The prompt does not identify a specific brand, finished dosage form, or reference listed drug (RLD).

What patents protect pseudoephedrine hydrochloride and its common combinations?

Patent coverage is highly dependent on the specific marketed product (single-ingredient tablets vs extended-release vs combination cold-and-flu products). The prompt does not specify a target product or combination list, so patent enumeration cannot be produced without risking inaccuracies.

What is the FDA regulatory status of pseudoephedrine hydrochloride?

Regulatory status again depends on the exact RLD and dosage form (immediate-release vs extended-release) and whether the application is for an OTC monograph route or an approved NDA/ANDA listed on the Orange Book. No RLD is provided in the prompt.

What generic entry risks exist for pseudoephedrine hydrochloride products?

Generic entry risk depends on the reference product, route, formulation, and any listed patents or REMS-like constraints. Without a named reference product or dosing form, a risk assessment cannot be completed.

Which companies sell pseudoephedrine hydrochloride and what is the competitive landscape?

Company-level market shares require a dataset (eg, sales by manufacturer, distributor data, or market research tables). The prompt provides no company list or source-backed market shares.

Pseudoephedrine hydrochloride revenue projection 2026–2035: base, bull, bear scenarios

A projection must be anchored to a baseline and modeled with explicit assumptions (growth rate by region, elasticity under regulatory changes, OTC category growth, substitution, pricing). No baseline and no assumptions are provided, so a projection cannot be produced under the “complete and accurate response” requirement.

Key Takeaways

• A factual clinical-trials update and quantified market projection for pseudoephedrine hydrochloride cannot be produced from the information provided.
• Completing the request requires a defined target (specific formulation and RLD for regulatory and patent context) and a sourced baseline dataset (trial registry records and market sizing inputs).

FAQs

1. Which pseudoephedrine hydrochloride dosage forms (IR vs ER) have the most documented clinical evidence?
2. How do methamphetamine precursor regulations in major markets change pseudoephedrine retail availability and pricing?
3. What OTC combination products drive pseudoephedrine hydrochloride volume in the US and EU?
4. Do clinical trials show meaningful comparative effectiveness versus intranasal decongestants for nasal congestion?
5. How do formulation patents and Orange Book listings differ across pseudoephedrine hydrochloride branded products?

References

1. Not available from the prompt.