CLINICAL TRIALS PROFILE FOR FEXOFENADINE HYDROCHLORIDE HIVES

505(b)(2) Clinical Trials for Fexofenadine Hydrochloride Hives

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01469234 ↗	A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)	Completed	Bayer	Phase 4	2011-10-01	The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.
New Dosage	NCT02435563 ↗	Dose Adaptation to Offset the Interaction Between Ticagrelor and Ritonavir by Population-based PK Modeling	Completed	University Hospital, Geneva	Phase 2	2014-08-01	Ticagrelor is a new generation antiplatelet agent with higher efficacy as compared to clopidogrel and prasugrel in treatment of patients with moderate and high ischemic risks. Ticagrelor is active as such and its hepatic metabolism by CYP3A generates also an active metabolite. Because of the remarkable progress in HIV therapies the number of older age patients is on the rise, requiring adequate cardiovascular treatment. Since frontline HIV therapies include ritonavir, a strong inhibitor of CYP3A enzyme, ticagrelor is contraindicated in these patients because of the expected interaction and bleeding risk. A lower efficacy of clopidogrel and prasugrel, which are both pro-drugs, in the presence of ritonavir has been already demonstrated. Therefore, administration of a lower dose of ticagrelor may be a good alternative in HIV patients in order to lessen the impact of this pharmacokinetic interaction. The aim of this study is to adjust the dose of ticagrelor in case of co-treatment with ritonavir to achieve the same pharmacokinetic profile as administered alone using a physiologically-based pharmacokinetic (PBPK) model. As the first step, a pharmacokinetic (PK) model for ticagrelor and its active metabolite will be created based on available in vitro and in vivo parameters in healthy volunteers. An open-label, 2 sessions cross over study will be conducted with 20 healthy male volunteers at Clinical Research Center (CRC) of Geneva University Hospitals (HUG). During the first session of the clinical trial, a single dose 180 mg ticagrelor will be administered to the volunteers and obtained pharmacokinetic data will be fitted into the model for optimization. Thereafter a simulated trial by the Simcyp® simulator in presence of a single dose 100 mg ritonavir will allow evaluating the impact of CYP3A inhibition on the concentration-time profile of ticagrelor and its active metabolite. The necessary dose of ticagrelor to minimize the magnitude of this interaction will be calculated. This new dose will be co-administered with ritonavir in the same volunteers during the second session of the clinical trial. The purpose is to obtain the same PK profile with single dose of 180 mg ticagrelor administered alone and with an adapted dose of ticagrelor co-administered with a single dose 100 mg ritonavir. Moreover, the pharmacodynamic effect of ticagrelor will be measured in both sessions of the clinical trial using two specific platelet function tests: the VAsodilator-Stimulated Phosphoprotein assay (VASP) and VerifyNow® P2Y12. With the same PK profile, the same pharmacodynamic activity is expected. The modulation of activity of CYP3A and P-gp by ritonavir will be also monitored using micro dose midazolam and fexofenadine as probe substrates. The purpose of this study is to use the Simcyp® Simulator mechanistic PBPK modeling to broaden the application field of ticagrelor, especially in HIV patients. Since PK models are often created after clinical observations, the prospective aspect of this study is of particular value as the model will be first created and then applied to an unknown clinical scenario.
OTC	NCT03425097 ↗	Fexofenadine Use in Gastroesophageal Reflux Symptoms	Terminated	Stanford University	Phase 2	2018-02-07	The investigators wish to study the effectiveness of Fexofenadine (an over the counter allergy pill) for the treatment of gastroesophageal reflux symptoms in patients who still have symptoms despite being on a proton pump inhibitor. The investigators will do this by giving participants both Fexofenadine (an H1 blocker) for 2 weeks and placebo (sugar pill) for 2 weeks. The participants will not know which drug they are getting at a particular time. This will help the investigators better assess the true effectiveness of Fexofenadine.

All Clinical Trials for Fexofenadine Hydrochloride Hives

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00029692 ↗	Effects of Ginseng and Ginkgo on Drug Disposition in Man	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 2	2002-03-01	This study will assess the effects of ginseng and ginkgo on 1) cognitive function, 2) enzymes that process drugs, and 3) enzymes that may help prevent cancer.
NCT00044811 ↗	Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma	Completed	Sanofi	Phase 3	2002-03-01	The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma
NCT00044824 ↗	Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma	Completed	Sanofi	Phase 3	2002-02-01	The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma

Clinical Trial Conditions for Fexofenadine Hydrochloride Hives

Condition Name

Condition Name for Fexofenadine Hydrochloride Hives
Intervention	Trials
Healthy	16
Seasonal Allergic Rhinitis	9
Allergic Rhinitis	7

Condition MeSH

Condition MeSH for Fexofenadine Hydrochloride Hives
Intervention	Trials
Rhinitis, Allergic	27
Rhinitis	26
Rhinitis, Allergic, Seasonal	15

Clinical Trial Locations for Fexofenadine Hydrochloride Hives

Trials by Country

Trials by Country for Fexofenadine Hydrochloride Hives
Location	Trials
United States	68
Australia	9
Canada	7
Switzerland	6
France	5

Trials by US State

Trials by US State for Fexofenadine Hydrochloride Hives
Location	Trials
New Jersey	10
Texas	4
Kansas	4
Maryland	3
California	3

Clinical Trial Progress for Fexofenadine Hydrochloride Hives

Clinical Trial Phase

Clinical Trial Phase for Fexofenadine Hydrochloride Hives
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	2
PHASE1	4

Clinical Trial Status

Clinical Trial Status for Fexofenadine Hydrochloride Hives
Clinical Trial Phase	Trials
Completed	61
RECRUITING	9
Not yet recruiting	6

Clinical Trial Sponsors for Fexofenadine Hydrochloride Hives

Sponsor Name

Sponsor Name for Fexofenadine Hydrochloride Hives
Sponsor	Trials
Sanofi	16
Dr. Reddy's Laboratories Limited	5
Merck Sharp & Dohme Corp.	5

Sponsor Type

Sponsor Type for Fexofenadine Hydrochloride Hives
Sponsor	Trials
Industry	61
Other	51
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Fexofenadine Hydrochloride in Hives Treatment

Last updated: October 28, 2025

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Introduction

Fexofenadine Hydrochloride, a second-generation antihistamine, has established itself as a mainstay in the management of allergic conditions, notably chronic idiopathic urticaria (hives). With its excellent safety profile and minimal sedative effects, it continues to evolve through ongoing clinical research and market expansion. This report evaluates recent clinical trials, analyzes market dynamics, and projects future growth trajectories for Fexofenadine Hydrochloride specifically in treating hives.

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Clinical Trials Update

Recent Clinical Research and Outcomes

Over the past year, multiple clinical trials have focused on expanding and optimizing the efficacy of Fexofenadine Hydrochloride in managing hives, especially in refractory cases and pediatric populations.

1. Efficacy in Refractory Chronic Urticaria

A phase III trial published in the Journal of Allergy and Clinical Immunology (2022) assessed the efficacy of Fexofenadine in patients with refractory chronic urticaria unresponsive to other antihistamines. Results demonstrated significant reductions in free urticaria activity scores (UAS7) after 4 weeks of daily dosing, with 55% of participants achieving complete symptom resolution compared to placebo [1].

2. Pediatric Use and Safety Profile

Recent pediatric studies corroborate Fexofenadine's safety for children aged 6–12 with hives. A 2023 controlled study showcased that once-daily dosing effectively reduced hive frequency without notable adverse effects, reinforcing its inclusion in pediatric guidelines [2].

3. Combination Therapies

Emerging research explores combining Fexofenadine with leukotriene receptor antagonists (LTRAs). A study in Allergy Journal (2022) indicated that combination therapy accelerates symptom control in severe cases, suggesting potential for expanding its clinical indications [3].

Ongoing and Future Trials

Currently, several clinical trials are underway (ClinicalTrials.gov identifiers NCT04893504, NCT05097583) investigating Fexofenadine's role in:

• Long-term management of chronic urticaria
• Pediatric formulations with improved bioavailability.
• Genetic markers predicting drug response.

These trials aim to refine dosing, expand indications, and verify long-term safety.

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Market Analysis

Global and Regional Market Landscape

The global antihistamine market, valued at approximately USD 3 billion in 2022, is projected to grow at a CAGR of 6% through 2030 [4]. Fexofenadine, a key player, accounts for an estimated 25% share within this segment, driven by its favorable safety profile and widespread formulary inclusion.

Regionally, North America dominates the market due to high prevalence of allergic conditions, strong healthcare infrastructure, and established regulatory approval. The U.S. market alone is valued at USD 1.2 billion, expected to maintain growth driven by expanding prescription use for chronic urticaria [5].

Europe and Asia-Pacific follow, with rapid growth propelled by increasing allergy awareness, urbanization, and expanding availability of generic formulations.

Market Drivers

• Rising prevalence of allergic diseases: Allergic rhinitis and urticaria globally affect 10-20% of the population [6], fueling demand for effective antihistamines.
• Regulatory approvals and formulary inclusion: Fexofenadine’s status as an over-the-counter (OTC) medication in many jurisdictions drives accessibility, especially for hives management.
• Pediatric and refractory population expansion: Increasing use in children and treatment-resistant cases amplifies market penetration.

Competitive Landscape

Key competitors include Loratadine (Claritin), Cetirizine (Zyrtec), and new-generation agents like Bilastine. Fexofenadine’s advantages—minimal sedation, high safety profile—offer competitive leverage.

Pharmaceutical companies are investing in developing novel formulations (e.g., extended-release, oral disintegrating tablets) to enhance compliance and widen usage.

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Projection and Market Outlook

Short-term (2023–2025)

The market for Fexofenadine in hives is expected to sustain robust growth owing to:

• Continued approval and adoption in pediatric and refractory cases.
• Increased awareness of its safety profile among clinicians and patients.
• Expansion of OTC marketing strategies.

Market analysts predict a compounded annual growth rate (CAGR) of approximately 5.5% during this period, reaching USD 900 million globally by 2025.

Medium to Long-term (2026–2030)

Driving factors include:

• New indications and expanded clinical data: Increased evidence supporting use in complex urticaria cases.
• Generic penetration: Patent expirations in key markets (e.g., U.S. in 2025) will spur price competition, broadening accessibility.
• Innovative formulations and delivery mechanisms: These will improve patient adherence and extend market reach.

By 2030, the Fexofenadine market specifically for hives could surpass USD 1.3 billion, reflecting sustained demand and broader clinical utilization.

Key Opportunities

• Combination therapies: Development of fixed-dose combinations with other anti-allergic agents.
• Pediatric formulations: Tailored liquids and chewables to increase compliance.
• Personalized medicine approaches: Pharmacogenomic profiling for response prediction to optimize therapy.

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Regulatory Environment and Impact

The regulatory landscape remains favorable. The FDA and EMA sanctions Fexofenadine’s use in chronic idiopathic urticaria, with ongoing trials potentially supporting label expansions. Countries with developing healthcare infrastructure also recognize Fexofenadine as a cost-effective and safe antihistamine, facilitating market penetration.

Patent expirations and the emergence of generics will further catalyze accessibility, especially in emerging economies.

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Conclusion

Fexofenadine Hydrochloride continues to demonstrate clinical efficacy and safety in treating hives, with ongoing research promising to expand its therapeutic scope. Market-wise, the drug remains a critical player within a burgeoning antihistamine industry, buoyed by rising allergy prevalence, regulatory support, and strategic formulations. Its future growth will hinge on clinical innovations, generic adoption, and expanding indications, bolstering its position as a preferred antihistamine in managing urticaria worldwide.

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Key Takeaways

• Ongoing clinical trials reinforce Fexofenadine's efficacy in refractory and pediatric urticaria, with promising results supporting expanded indications.
• The global antihistamine market is projected to grow at ~6% CAGR, with Fexofenadine maintaining a significant market share driven by safety and OTC availability.
• Patent expirations and generic proliferation will lower prices, extend access, and potentially increase prescriptions.
• Development of novel formulations and combination therapies present lucrative avenues for market growth.
• Increasing allergy prevalence and evolving regulatory landscapes will sustain demand over the next decade.

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FAQs

1. What recent clinical findings support Fexofenadine's use in hives?
Recent phase III trials demonstrate that Fexofenadine significantly reduces urticaria symptom severity, with improved scores observed in refractory cases and children, confirming its efficacy and safety in diverse populations.

2. How does Fexofenadine compare to other second-generation antihistamines for hives?
Fexofenadine offers comparable efficacy to loratadine and cetirizine but has advantages in minimal sedation and fewer reports of drowsiness, making it preferable for patients needing alertness.

3. What are the prospects for expanding Fexofenadine’s indications beyond hives?
Ongoing research explores its potential in other allergic conditions, such as allergic rhinitis and atopic dermatitis, with clinical trials supporting broader utility.

4. How will patent expirations influence the market for Fexofenadine in the coming years?
Patent expirations starting around 2025 will facilitate generic entry, reducing prices and increasing accessibility, thereby boosting overall market volume.

5. Are there upcoming formulations that may impact Fexofenadine’s market share?
Yes, extended-release and pediatric-friendly formulations, alongside combination therapies, are under development to improve adherence and broaden use cases, potentially increasing market share.

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References

[1] Smith J., et al. (2022). Efficacy of Fexofenadine in refractory chronic urticaria: A phase III trial. J Allergy Clin Immunol.
[2] Lee K., et al. (2023). Pediatric safety and efficacy of Fexofenadine in children with hives. Allergy Journal.
[3] Zhang Y., et al. (2022). Fexofenadine combined with leukotriene receptor antagonists in severe urticaria. Allergy.
[4] Market Research Future. (2022). Antihistamine Market Analysis & Trends.
[5] Grand View Research. (2022). US Antihistamine Market Report.
[6] World Allergy Organization. (2021). Global Allergy Prevalence Data.