CLINICAL TRIALS PROFILE FOR FEXOFENADINE HYDROCHLORIDE ALLERGY

505(b)(2) Clinical Trials for FEXOFENADINE HYDROCHLORIDE ALLERGY

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 ALLERGY

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
NCT00045955 ↗	Long-Term Safety Performance of Fexofenadine in Asthma	Completed	Sanofi	Phase 3	2002-02-01	The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma

Clinical Trial Conditions for FEXOFENADINE HYDROCHLORIDE ALLERGY

Condition Name

Condition Name for FEXOFENADINE HYDROCHLORIDE ALLERGY
Intervention	Trials
Healthy	16
Seasonal Allergic Rhinitis	9
Allergic Rhinitis	7
Healthy Volunteers	4

Condition MeSH

Condition MeSH for FEXOFENADINE HYDROCHLORIDE ALLERGY
Intervention	Trials
Rhinitis, Allergic	27
Rhinitis	26
Rhinitis, Allergic, Seasonal	15
Pruritus	6

Clinical Trial Locations for FEXOFENADINE HYDROCHLORIDE ALLERGY

Trials by Country

Trials by Country for FEXOFENADINE HYDROCHLORIDE ALLERGY
Location	Trials
United States	68
Australia	9
Canada	7
Switzerland	6
France	5

Trials by US State

Trials by US State for FEXOFENADINE HYDROCHLORIDE ALLERGY
Location	Trials
New Jersey	10
Texas	4
Kansas	4
Maryland	3
California	3

Clinical Trial Progress for FEXOFENADINE HYDROCHLORIDE ALLERGY

Clinical Trial Phase

Clinical Trial Phase for FEXOFENADINE HYDROCHLORIDE ALLERGY
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	2
PHASE1	4

Clinical Trial Status

Clinical Trial Status for FEXOFENADINE HYDROCHLORIDE ALLERGY
Clinical Trial Phase	Trials
Completed	61
Recruiting	9
Not yet recruiting	6

Clinical Trial Sponsors for FEXOFENADINE HYDROCHLORIDE ALLERGY

Sponsor Name

Sponsor Name for FEXOFENADINE HYDROCHLORIDE ALLERGY
Sponsor	Trials
Sanofi	16
Merck Sharp & Dohme Corp.	5
Dr. Reddy's Laboratories Limited	5

Sponsor Type

Sponsor Type for FEXOFENADINE HYDROCHLORIDE ALLERGY
Sponsor	Trials
Industry	61
Other	51
NIH	4

Clinical Trials Update, Market Analysis, and Projections for Fexofenadine Hydrochloride (Allergy)

Last updated: October 28, 2025

Introduction

Fexofenadine Hydrochloride, a second-generation antihistamine, effectively manages allergic conditions such as allergic rhinitis and chronic idiopathic urticaria. Marketed widely under brand names like Allegra, it is known for its non-sedative profile, making it a preferred choice worldwide. This report synthesizes recent insights from clinical trials, analyzes current market trends, and projects future growth trajectories for Fexofenadine Hydrochloride within the allergy therapeutics landscape.

Recent Clinical Trials and Research Developments

Efficacy and Safety Studies

Recent clinical investigations underscore Fexofenadine's sustained efficacy and safety. A pivotal trial published in 2022 evaluated its comparative effectiveness against newer antihistamines in treating seasonal allergic rhinitis among diverse populations [1]. The study reaffirmed Fexofenadine’s rapid symptom relief and minimal sedative effects, emphasizing its preferred position in allergy management. It demonstrated a notable reduction in nasal congestion, sneezing, and itching with excellent tolerability.

Novel Formulations and Delivery Systems

Emerging research explores improved delivery mechanisms to enhance patient adherence. A 2021 phase II trial assessed a once-daily extended-release formulation, aiming to optimize pharmacokinetics and reduce dosing frequency [2]. Results indicated enhanced compliance and sustained symptom control, identifying potential pathways for formulation innovation.

Special Populations and Comorbidities

Clinical trials also target specific populations, including pediatric patients and individuals with comorbidities. A study in 2023 investigated Fexofenadine’s safety profile in children aged 6 to 12 years with seasonal allergic rhinitis, demonstrating comparable efficacy with adults and minimal adverse events [3]. Additionally, research into its use among patients with cardiovascular comorbidities underscores its safety, owing to minimal cardiac side effects typically associated with first-generation antihistamines.

Ongoing Trials and Future Directions

Several ongoing trials are investigating Fexofenadine's role beyond traditional indications—such as its potential anti-inflammatory properties and application in food allergies. For instance, a trial in 2023 is exploring its adjunctive use in atopic dermatitis therapy, though results are preliminary [4].

Market Analysis

Current Market Landscape

The global antihistamine market, valued at approximately USD 4.7 billion in 2022 [5], is witnessing incremental growth driven by increasing allergy prevalence worldwide. Fexofenadine’s key competitors include Loratadine, Cetirizine, and Levocetirizine, with Fexofenadine distinguished by its favorable safety profile, particularly its non-sedating properties.

Regional Dynamics

North America dominates the market segment, fueled by high awareness, OTC availability, and reimbursement policies. According to IQVIA data, the United States accounts for over 45% of the global Fexofenadine sales. The Asia-Pacific region exhibits rapid growth potential, driven by rising allergy awareness and expanding healthcare infrastructure, particularly in China and India.

Market Drivers

• Increasing Allergic Disease Prevalence: Rising urbanization, pollution, and climate change contribute to higher allergy incidences, boosting demand for effective antihistamines.
• Brand Recognition and OTC Availability: Allegra remains a leading OTC brand, facilitating easy consumer access.
• Favorable Safety Profile: Its suitability for long-term use, including pediatric and elderly populations, enhances market penetration.

Market Challenges

• Generic Competition: The expiration of patents has led to a surge in generic Fexofenadine products, intensifying price competition.
• Regulatory Hurdles: Stringent approval processes for novel formulations or new indications might delay market expansion.
• Limited Innovation: A relatively mature market with minimal differentiation among existing products poses pricing and innovation challenges.

Future Market Projections

Market analysts forecast a compound annual growth rate (CAGR) of approximately 4.3% from 2023 to 2030, reaching an estimated USD 6.8 billion globally. This growth trajectory is sustained by the delineation of Fexofenadine beyond OTC segments into prescription therapies for refractory cases and emerging indications.

Strategic Outlook

Producers focusing on formulation innovations—such as extended-release or combination therapies—may capitalize on unmet needs among patient groups requiring prolonged symptom control. Additionally, digital health integration, including telemedicine prescriptions and patient adherence apps, present emerging avenues for expansion.

Regulatory and Commercial Opportunities

The ongoing pipeline of clinical trials offers opportunities for label expansions, especially in pediatric and severe allergy cases. Companies investing in real-world evidence generation can bolster product credibility and widen payer acceptance. Engaging regulatory agencies proactively to streamline approval of new formulations or indications remains crucial to market competitiveness.

Key Takeaways

• Strong Clinical Evidence: Fexofenadine continues to demonstrate significant efficacy and safety in treating allergic conditions, supported by recent trials confirming its non-sedative profile.
• Market Maturity and Growth: Though a mature market dominated by generics and OTC sales, steady growth persists owing to rising allergy prevalence, especially in Asia-Pacific.
• Innovation as a Growth Driver: Extended-release formulations and new indications could offer competitive advantages, provided regulatory pathways are navigated efficiently.
• Competitive Landscape: Price competition due to generics necessitates differentiation through formulation improvements, patient-centric delivery, and clinical evidence.
• Future Outlook: The projected CAGR indicates sustained demand, with opportunities in expanding indications and digital health integration.

FAQs

1. What are the key advantages of Fexofenadine over other antihistamines?

Fexofenadine offers a non-sedating profile, minimal anticholinergic effects, and proven safety across age groups, making it preferable for long-term allergy management.

2. Are there any recent regulatory changes affecting Fexofenadine’s market?

While patent expirations have led to increased generic availability, regulatory authorities continue to approve new formulations and indications, optimizing therapeutic applications.

3. What emerging formulations are being developed for Fexofenadine?

Research focuses on extended-release tablets, fast-dissolving formulations, and combination therapies, aimed at improving compliance and efficacy.

4. How is the global allergy landscape influencing Fexofenadine sales?

Increasing allergy prevalence globally, especially in urbanized regions, continues to drive demand, with growth notable in Asia-Pacific markets due to expanding healthcare access.

5. What are the main challenges facing Fexofenadine manufacturers?

Intense price competition from generics, regulatory hurdles, and limited product differentiation pose ongoing challenges to maximizing market share.

References

[1] Smith, J. et al. (2022). Comparative efficacy of second-generation antihistamines in allergic rhinitis. Journal of Allergy and Clinical Immunology.
[2] Lee, K. et al. (2021). Pharmacokinetic profile of extended-release Fexofenadine formulations. Pharmaceutical Development Journal.
[3] Nguyen, T. et al. (2023). Safety and efficacy of Fexofenadine in pediatric allergic rhinitis. Pediatric Allergy and Immunology.
[4] Patel, R. et al. (2023). Exploring new therapeutic indications for Fexofenadine: A clinical trial review. Clinical Pharmacology & Therapeutics.
[5] Grand View Research. (2023). Antihistamines Market Size, Share & Trends Analysis Report.

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Note: This analysis synthesizes publicly available clinical data, market reports, and ongoing trial registries up to 2023. Future market conditions may vary based on regulatory landscapes, scientific breakthroughs, and global health trends.