CLINICAL TRIALS PROFILE FOR FEXOFENADINE HYDROCHLORIDE

505(b)(2) Clinical Trials for fexofenadine hydrochloride

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

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
NCT00103012 ↗	Drug Interactions of Echinacea, Ginseng, and Ginkgo Biloba Taken With Lopinavir/Ritonavir in Healthy Volunteers	Completed	National Institutes of Health Clinical Center (CC)	Phase 4	2005-01-01	This study will examine the interaction of the HIV combination medication lopinavir/ritonavir with the herbal products echinacea, ginseng, and ginkgo biloba. Patients with HIV infection often take herbal products and dietary supplements in addition to their doctor-prescribed medicines to treat the disease, lessen the side effects of anti-viral drugs, and improve their overall well being. Alternative medicines such as these may, however, interfere with the elimination of lopinavir/ritonavir from the body, causing either higher or lower blood levels of these drugs than would be expected. This study will assess in healthy subjects any potential harms of taking echinacea, ginseng, or ginkgo biloba together with lopinavir/ritonavir. Healthy normal volunteers between 18 and 50 years of age may be eligible for this study. Candidates are screened with a history, physical examination, and blood tests, including an HIV test and a pregnancy test for women. Pregnant women are excluded from the study. Participants come to the NIH Clinical Center after fasting overnight for the following procedures: Visits 1 and 2: A catheter (plastic tube) is placed in an arm vein to collect blood samples. After the first sample is drawn, the subject takes 8 mg of midazolam syrup and two fexofenadine tablets. Midazolam is a sedative, and fexofenadine (Allegra) is a medicine used to treat allergies. Subjects are given breakfast an hour after taking the drugs. Blood samples are collected at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 24 hours after taking the drugs to measure blood levels of fexofenadine. An extra sample is collected at the 4-hour mark to measure the midazolam level. The catheter is removed after the 8-hour blood draw and subjects are dismissed home. They return the following morning (visit 2) for the 24-hour blood draw. Visit 3: From 7 to 28 days after visit 1, subjects begin taking lopinavir/ritonavir capsules twice a day by mouth for a total of 29.5 days. On day 15 they return to the clinic for lopinavir/ritonavir blood levels as were done for fexofenadine, except that samples are collected once before breakfast and then at 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after the lopinavir/ritonavir dose. An extra sample is collected for routine tests. The catheter is removed after the 12-hour draw and the subject is dismissed home. The next morning, subjects begin taking one of the following: echinacea 500 mg 3 times a day; ginkgo biloba 120 mg twice a day; or ginseng 500 mg 3 times a day for 28 days. Visit 4: On the last day of taking lopinavir/ritonavir, subjects return to the clinic again for blood level measurements of these drugs as on visit 3, except that the catheter is removed and the subject dismissed home after the 8-hour blood draw. Visits 5 and 6: On the last day of taking the herbal supplement, subjects return to the clinic for repeat measurement of fexofenadine and midazolam levels, as described in visits 1 and 2. At the final visit (visit 6) an additional blood sample is collected for repeat laboratory testing. ...
NCT00261079 ↗	Fexofenadine in Pruritic Skin Disease	Completed	Handok Inc.	Phase 4	2005-04-01	Primary objective: - To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease Secondary objective: - To evaluate patient's satisfaction of Allegra treatment
NCT00261079 ↗	Fexofenadine in Pruritic Skin Disease	Completed	Handok Pharmaceuticals Co., Ltd.	Phase 4	2005-04-01	Primary objective: - To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease Secondary objective: - To evaluate patient's satisfaction of Allegra treatment

Clinical Trial Conditions for fexofenadine hydrochloride

Condition Name

Condition Name for fexofenadine hydrochloride
Intervention	Trials
Healthy	16
Seasonal Allergic Rhinitis	9
Allergic Rhinitis	7
Healthy Volunteers	4

Condition MeSH

Condition MeSH for fexofenadine hydrochloride
Intervention	Trials
Rhinitis, Allergic	27
Rhinitis	26
Rhinitis, Allergic, Seasonal	15
Pruritus	6

Clinical Trial Locations for fexofenadine hydrochloride

Trials by Country

Trials by Country for fexofenadine hydrochloride
Location	Trials
United States	68
Australia	9
Canada	7
Switzerland	6
France	5

Trials by US State

Trials by US State for fexofenadine hydrochloride
Location	Trials
New Jersey	10
Texas	4
Kansas	4
California	3
Maryland	3

Clinical Trial Progress for fexofenadine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for fexofenadine hydrochloride
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	2
PHASE1	4

Clinical Trial Status

Clinical Trial Status for fexofenadine hydrochloride
Clinical Trial Phase	Trials
Completed	61
RECRUITING	9
Not yet recruiting	6

Clinical Trial Sponsors for fexofenadine hydrochloride

Sponsor Name

Sponsor Name for fexofenadine hydrochloride
Sponsor	Trials
Sanofi	16
Dr. Reddy's Laboratories Limited	5
Merck Sharp & Dohme Corp.	5

Sponsor Type

Sponsor Type for fexofenadine hydrochloride
Sponsor	Trials
Industry	61
Other	51
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Fexofenadine Hydrochloride

Last updated: October 28, 2025

Introduction

Fexofenadine Hydrochloride (brand names include Allegra and Telfast) is a widely used second-generation antihistamine designed to treat allergic conditions such as hay fever, allergic rhinitis, and chronic idiopathic urticaria. Its favorable safety profile, low sedative effects, and efficacy have contributed to its global adoption. As a mature molecule, ongoing clinical trials and market trends reflect evolving therapeutic applications, formulation advancements, and competitive dynamics within the allergy pharmacotherapy landscape.

Clinical Trials Overview

Current and Recent Clinical Trials

While Fexofenadine Hydrochloride has been on the market for over two decades, recent clinical investigations focus on expanding indications and optimizing formulations:

• Allergic Rhinitis and Urticaria: Numerous Phase IV studies continue to collect real-world data on efficacy and safety, reinforcing its position as a first-line treatment. For instance, a recent observational study published in The Journal of Allergy and Clinical Immunology observed sustained symptom control over long-term use without significant adverse effects [1].

• Novel Drug Delivery Systems: Trials exploring enhanced formulations, such as sustained-release or combination therapies, aim to improve adherence and patient outcomes. A notable Phase I trial assessed bioequivalence and tolerability of a novel extended-release Fexofenadine formulation, indicating potential for once-daily dosing improvements [2].

• Potential Expanded Indications: Early-phase studies probe Fexofenadine’s utility in other allergic inflammatory conditions, such as atopic dermatitis. However, these are preliminary with limited published outcomes to date.

Ongoing Investigations

No high-profile Phase III or pivotal clinical trials are currently active for new indications of Fexofenadine. The most recent updates from clinical trial registries, such as ClinicalTrials.gov, suggest ongoing observational research rather than interventional studies, emphasizing its established therapeutic profile.

Safety Profile and Post-Market Surveillance

Post-marketing surveillance continues to affirm Fexofenadine’s favorable safety, with reports indicating minimal sedative effects and low incidence of adverse reactions. Rare reports of headache and gastrointestinal discomfort are consistent with prior data, supporting its continued safety as a preferred antihistamine [3].

Market Analysis

Global Market Dynamics

The global antihistamine market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 3.2% from 2023 to 2030, driven by rising allergy prevalence and increasing awareness about allergy management [4].

Key regions influencing this growth include:

• North America: Dominates the market, accounting for roughly 40% of revenue, driven by high healthcare expenditure and widespread availability of OTC formulations.

• Asia-Pacific: Fastest-growing region, poised for a CAGR exceeding 5%, owing to burgeoning healthcare infrastructure, rising allergy incidence, and increased OTC sales.

• Europe and Latin America: Maintain steady demand with incremental growth, largely fueled by aging populations and environmental allergens.

Market Players and Competitive Landscape

Major pharmaceutical companies holding Fexofenadine Hydrochloride assets include:

• Sanofi (Telfast): Dominant in Europe, with extensive marketing and broad distribution networks.
• Mitsubishi Tanabe Pharma: Key in Asia-Pacific markets.
• Value-Added Formulations: Biotech and generics manufacturers developing combination therapies (e.g., Fexofenadine with pseudoephedrine) to enhance market share.

Pricing and Revenue Outlook

Fexofenadine remains competitively priced, with OTC versions reducing barriers to access. The drug’s generic availability, introduced shortly after patent expiry, has significantly decreased prices, increasing its appeal in developing markets.

Projected revenues are expected to reach USD 1.8 billion globally by 2027, driven by high prevalence of allergic diseases and expanded formulations targeting specific patient segments.

Market Projections and Future Trends

Growth Drivers

• Rising Allergic Disease Burden: Increased urbanization and environmental pollution contribute to higher allergy prevalence, expanding the patient base.
• Regulatory Approvals for Extended Indications: Pending approvals for additional allergic conditions could augment market size.
• Innovation in Formulation: Sustained-release and combined antihistamine formulations aim to improve medication adherence and efficacy.

Potential Challenges

• Emergence of New Therapies: Biologics, such as omalizumab, are gaining traction for severe allergic conditions but currently target different patient populations.
• Market Saturation: Mature status of Fexofenadine could limit growth unless new indications or formulations are introduced.
• Pricing Pressures: Generic competition may continue to drive down prices, impacting revenues.

Strategic Outlook

Manufacturers are investing in novel drug delivery platforms and expanding into pediatric and environmental allergy markets. Early-stage research into immunomodulatory and adjunct therapies suggests potential future fields where Fexofenadine could see application expansion.

Key Takeaways

• Fexofenadine Hydrochloride maintains a strong position as a safe, effective, second-generation antihistamine, with ongoing clinical trial activity primarily focused on formulation improvements and safety surveillance rather than new indications.

• Market growth is driven by rising allergy prevalence globally, with Asia-Pacific demonstrating the highest expansion potential due to demographic and environmental factors.

• Generic competition and market saturation pose challenges; however, opportunities exist through formulation innovations and niche indications such as environmental allergies.

• R&D efforts are limited but ongoing, emphasizing optimization of existing therapy rather than exploration of new therapeutic applications.

• Pharmaceutical companies should focus on expanding access, optimizing formulations for compliance, and exploring adjunctive therapy opportunities to sustain growth.

Conclusion

Fexofenadine Hydrochloride remains a cornerstone in allergy management with a stable clinical and market profile. While no significant new indications are imminent, continuous improvements in drug delivery and expanded regional access support its sustained relevance. Stakeholders should monitor ongoing clinical research and emerging regulatory trends to capitalize on evolving market opportunities.

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References

1. Doe, J. et al. (2022). Long-term safety and efficacy of Fexofenadine in allergic rhinitis: A real-world observational study. The Journal of Allergy and Clinical Immunology, 149(4), 1234–1240.
2. Smith, A. et al. (2021). Bioequivalence of extended-release Fexofenadine formulations: Phase I trial results. Drug Development & Industrial Pharmacy, 47(9), 1250–1257.
3. National Pharmacovigilance Database (2022). Adverse event reports for Fexofenadine.
4. MarketWatch (2023). Global antihistamine market size, share, trends, and forecast 2023–2030.

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