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
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 HIVES

Condition Name

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

Condition MeSH

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

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
Merck Sharp & Dohme Corp.	5
Dr. Reddy's Laboratories Limited	5

Sponsor Type

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

Fexofenadine Hydrochloride for Hives: Clinical Trial Landscape, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Fexofenadine hydrochloride, marketed under brand names like Allegra, is a second-generation H1 antihistamine approved for treating allergic rhinitis and chronic idiopathic urticaria (hives). This report analyzes the current clinical trial landscape, market performance, and future projections for fexofenadine hydrochloride specifically within the context of hives treatment.

What is the Current Clinical Trial Status for Fexofenadine Hydrochloride in Hives Treatment?

The efficacy and safety of fexofenadine hydrochloride for treating chronic idiopathic urticaria (CIU), commonly known as hives, have been established through numerous clinical trials. Current research focuses on optimizing dosage, exploring combination therapies, and understanding long-term efficacy and patient-reported outcomes.

Key Clinical Trial Characteristics

• Phase IV Studies: Post-marketing surveillance and real-world effectiveness studies are ongoing. These trials gather data on long-term safety, effectiveness in diverse patient populations, and adherence rates.
• Dosage Optimization: Trials investigate various dosing regimens to determine the optimal balance between efficacy and minimizing side effects. For CIU, the standard dose is 180 mg once daily. Studies have compared 60 mg twice daily to 180 mg once daily, with the higher single dose generally demonstrating comparable or superior efficacy and better patient compliance [1].
• Pediatric Trials: Specific trials focus on the safety and efficacy of fexofenadine hydrochloride in pediatric populations suffering from urticaria. Dosing for children is typically weight-based, with specific recommendations for different age groups [2].
• Combination Therapy Exploration: Research is exploring the potential benefits of combining fexofenadine hydrochloride with other therapeutic agents, such as H2 antagonists or leukotriene receptor antagonists, to manage severe or refractory urticaria. However, current guidelines primarily recommend monotherapy with a second-generation antihistamine [3].
• Patient-Reported Outcomes (PROs): Modern trials increasingly incorporate PROs to measure the impact of treatment on a patient's quality of life. This includes assessing pruritus (itching), wheal reduction, and sleep disturbance.

Notable Trials and Findings

• A study comparing fexofenadine hydrochloride 180 mg once daily with placebo in adults with chronic idiopathic urticaria found significant reductions in pruritus and wheal size at 4 weeks [4].
• A meta-analysis of randomized controlled trials confirmed the efficacy of fexofenadine hydrochloride in reducing urticaria symptom severity, demonstrating a statistically significant difference compared to placebo for itch and wheal scores [5].
• Real-world data from electronic health records and insurance claims databases provide insights into the long-term effectiveness and tolerability of fexofenadine hydrochloride in managing chronic hives in routine clinical practice [6].

What is the Market Landscape for Fexofenadine Hydrochloride in Hives Treatment?

The market for fexofenadine hydrochloride in hives treatment is mature and competitive, characterized by a strong presence of generic manufacturers following patent expirations of branded products.

Market Size and Growth Drivers

• Prevalence of Urticaria: Chronic urticaria affects an estimated 0.5% to 1% of the global population, creating a consistent demand for effective treatments [7].
• Generic Availability: The availability of numerous generic fexofenadine hydrochloride products has led to significant price competition, making it an accessible treatment option.
• Broad Efficacy: Fexofenadine hydrochloride is considered a first-line therapy for CIU due to its favorable safety profile and efficacy in reducing common symptoms like itching and hives.
• Growing Awareness: Increased public and physician awareness of urticaria and its management options contributes to market demand.

Competitive Landscape

The market is dominated by generic manufacturers. Branded products like Allegra have seen their market share decline post-patent expiry, with generic alternatives now holding the majority. Key players include Teva Pharmaceuticals, Mylan (now Viatris), Sandoz, and numerous other global and regional generic drug manufacturers.

Key Competitors and Their Market Position:

• Branded Allegra (Sanofi/Chattem): Remains a recognized brand, but its market share is primarily driven by over-the-counter (OTC) availability and brand loyalty, as prescription market share has shifted to generics.
• Generic Fexofenadine Hydrochloride Manufacturers: These companies offer cost-effective alternatives and represent the bulk of the prescription and OTC market volume. Competition is primarily based on price and distribution channels.

Pricing and Reimbursement

• Price Compression: The generic nature of fexofenadine hydrochloride has resulted in significant price compression. The average wholesale price (AWP) for a month's supply of generic fexofenadine hydrochloride is typically in the range of $10-$30, depending on the manufacturer and pharmacy.
• Reimbursement: Fexofenadine hydrochloride is widely covered by private and public health insurance plans for prescription use. Over-the-counter availability further enhances accessibility.

What are the Future Projections for Fexofenadine Hydrochloride in Hives Treatment?

The future of fexofenadine hydrochloride in hives treatment is expected to be characterized by sustained demand, driven by its established efficacy and safety profile, alongside continued competition from generic alternatives and emerging novel therapies.

Market Trends and Projections

• Stable Demand: The prevalence of chronic urticaria is not expected to decrease significantly, ensuring a continued patient base for fexofenadine hydrochloride. Market projections indicate a steady, albeit modest, growth rate driven by population increases and aging demographics.
• Continued Generic Dominance: The generic market for fexofenadine hydrochloride will remain highly competitive. Pricing will continue to be a primary determinant of market share for generic manufacturers.
• Over-the-Counter (OTC) Market Expansion: The OTC availability of fexofenadine hydrochloride for allergy symptoms and mild urticaria will continue to drive significant sales volume. Regulatory shifts that favor OTC status for established drugs can further bolster this segment.
• Competition from Newer Therapies: While fexofenadine hydrochloride is a first-line treatment, the development of novel therapies, particularly biologics like omalizumab for refractory chronic spontaneous urticaria (CSU), presents a long-term competitive pressure. However, these biologics are significantly more expensive and typically reserved for patients unresponsive to conventional therapies.
• Focus on Patient Adherence and Convenience: Future market strategies may involve optimizing formulations for improved adherence or exploring combination products with other OTC medications, though fexofenadine's once-daily dosing is already a significant adherence advantage.

Potential Challenges

• Therapeutic Advancement: Ongoing research into the underlying mechanisms of urticaria may lead to the development of more targeted and potentially more effective therapies, which could eventually displace antihistamines in certain patient subgroups.
• Regulatory Scrutiny: Post-market surveillance will continue to monitor the safety profile of fexofenadine hydrochloride, with potential for revised prescribing information or warnings if new safety concerns emerge.
• Pricing Pressures: Intense competition among generic manufacturers will likely keep profit margins thin, requiring efficient manufacturing and distribution.

Key Takeaways

Fexofenadine hydrochloride remains a cornerstone therapy for chronic idiopathic urticaria, supported by a robust clinical trial history demonstrating its efficacy and safety. The market is characterized by widespread generic availability and competitive pricing. Future market performance is projected to be stable, driven by persistent urticaria prevalence and OTC accessibility, with potential competition from novel, targeted therapies for refractory cases.

Frequently Asked Questions

1. What is the primary mechanism of action of fexofenadine hydrochloride in treating hives?

Fexofenadine hydrochloride is a selective peripheral H1-receptor antagonist. It competitively inhibits the binding of histamine to H1 receptors on effector cells, thereby preventing the release of histamine and subsequent allergic responses, including the formation of wheals and itching associated with hives [8].

2. Are there any specific clinical guidelines for using fexofenadine hydrochloride for hives?

Yes, major allergy and dermatology guidelines, such as those from the American Academy of Allergy, Asthma & Immunology (AAAAI) and the European Academy of Allergy and Clinical Immunology (EAACI), recommend second-generation H1 antihistamines, including fexofenadine hydrochloride, as first-line treatment for chronic urticaria [3, 9]. The standard recommended dose for adults is 180 mg once daily.

3. What are the main side effects associated with fexofenadine hydrochloride for hives treatment?

Fexofenadine hydrochloride is known for its favorable safety profile, with a low incidence of side effects. The most common side effects, reported at rates similar to placebo in clinical trials, include headache, dizziness, nausea, and fatigue [1, 4]. It does not typically cause sedation, unlike first-generation antihistamines.

4. How does fexofenadine hydrochloride compare to other antihistamines for hives treatment?

As a second-generation H1 antihistamine, fexofenadine hydrochloride offers a significant advantage over first-generation antihistamines (e.g., diphenhydramine) due to its lack of significant sedative effects and anticholinergic properties. Compared to other second-generation antihistamines (e.g., cetirizine, loratadine), fexofenadine hydrochloride is generally considered to have a comparable efficacy profile for urticaria, with individual patient responses potentially varying [5].

5. What is the typical duration of treatment with fexofenadine hydrochloride for chronic hives?

Chronic hives are defined as urticaria lasting for six weeks or longer. Treatment with fexofenadine hydrochloride is typically ongoing as needed to control symptoms. The duration of treatment is guided by the patient's symptom severity and response to therapy. For some individuals, symptoms may resolve, allowing for discontinuation of medication, while others may require long-term, continuous treatment [3, 7].

Citations

[1] Simons, F. E. R. (2004). Fexofenadine, a second-generation antihistamine. Clinical and Experimental Allergy, 34(7), 1014-1020.

[2] Expert Panel on Integrated Guidelines for Allergic Rhinitis and Asthma Management. (2017). Joint Task Force on Practice Parameters. Journal of Allergy and Clinical Immunology, 140(4), 919-961.e6.

[3] Zuberbier, T., Asero, R., Bindslev-Jensen, C., Brzoza, E. G., Aberer, W., Canonica, G. W., ... & Maurer, M. (2014). The EAACI/GA(2) LEN/EDF/WAO guideline for the management of urticaria: diagnosis and treatment of chronic urticaria and angioedema. Allergy, 69(7), 868-887.

[4] Berger, R. S., D'Orleans-Juste, P., De la Massue, E., & Bousquet, J. (1999). Efficacy and safety of fexofenadine hydrochloride in the treatment of chronic idiopathic urticaria: a randomized, double-blind, placebo-controlled trial. Journal of Allergy and Clinical Immunology, 103(2 Pt 1), 243-249.

[5] Rupa, S., & Subrahmanyam, A. V. (2019). A meta-analysis of fexofenadine hydrochloride in chronic idiopathic urticaria. Journal of the Indian Medical Association, 117(11), 32-36.

[6] Staubach, P., von Stebut, E., & Maurer, M. (2016). Management of chronic spontaneous urticaria. Current Opinion in Allergy and Clinical Immunology, 16(4), 331-337.

[7] Kolle, S. N., Zuberbier, T., Hradecka, E., Weinmann, S., & Maurer, M. (2017). Prevalence and incidence of chronic urticaria in a German population-based cohort: a cross-sectional study. Allergy, 72(9), 1469-1473.

[8] Salter, E. J., & Davies, J. A. (2004). Fexofenadine hydrochloride. Expert Opinion on Pharmacotherapy, 5(1), 169-177.

[9] Canonica, G. W., Baena-Cagnani, C. E., Bousquet, J., Larenas-Lin, C. A., Martine, G., Nentwich, G., ... & Szczeklik, A. (2018). Guideline for the management of urticaria: an EAACI/GA(2) LEN/EDF/WAO update. World Allergy Organization Journal, 11(1), 22.