CLINICAL TRIALS PROFILE FOR ALLEGRA HIVES

All Clinical Trials for Allegra Hives

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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
NCT00420082 ↗	A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber	Completed	Faes Farma, S.A.	Phase 2	2006-10-01	This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.
NCT00562120 ↗	A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge	Completed	Pfizer	Phase 2	2007-12-01	An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion.
NCT00636870 ↗	Fexofenadine (Allegra®) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine	Completed	Sanofi	Phase 4	2003-02-01	To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of desloratadine compared to fexofenadine following single and multiple oral doses administered to desloratadine slow metabolizers.
NCT00637585 ↗	Fexofenadine HCl 180 mg, Desloratadine 5 mg and Placebo in Suppression of Wheal and Flare Induced by Histamine	Completed	Sanofi	Phase 4	2002-12-01	To examine the relative potency, onset of action and duration of action of fexofenadine HCl 180 mg (ALLEGRA) and desloratadine 5 mg (CLARINEX) as compared to placebo on skin wheals and flares induced by histamine.

Clinical Trial Conditions for Allegra Hives

Condition Name

Condition Name for Allegra Hives
Intervention	Trials
Healthy	10
Seasonal Allergic Rhinitis	6
Allergic Rhinitis	5
Rhinitis Seasonal	2

Condition MeSH

Condition MeSH for Allegra Hives
Intervention	Trials
Rhinitis, Allergic	16
Rhinitis	16
Rhinitis, Allergic, Seasonal	8
Dermatitis	2

Clinical Trial Locations for Allegra Hives

Trials by Country

Trials by Country for Allegra Hives
Location	Trials
United States	14
Canada	4
Japan	3
India	3
Austria	1

Trials by US State

Trials by US State for Allegra Hives
Location	Trials
New Jersey	3
North Dakota	2
West Virginia	2
California	1
Utah	1

Clinical Trial Progress for Allegra Hives

Clinical Trial Phase

Clinical Trial Phase for Allegra Hives
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Allegra Hives
Clinical Trial Phase	Trials
Completed	30
Recruiting	2
Not yet recruiting	2

Clinical Trial Sponsors for Allegra Hives

Sponsor Name

Sponsor Name for Allegra Hives
Sponsor	Trials
Sanofi	8
Merck Sharp & Dohme Corp.	5
Dr. Reddy's Laboratories Limited	5

Sponsor Type

Sponsor Type for Allegra Hives
Sponsor	Trials
Industry	30
Other	8
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Allegra Hives

Last updated: October 28, 2025

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Introduction

Allegra Hives, primarily marketed for allergic symptoms, including urticaria and hives, is a well-established antihistamine with a robust history worldwide. As the therapeutic landscape for allergy treatments evolves, updating on clinical trials, market dynamics, and future projections is critical for stakeholders. This report synthesizes recent clinical developments, provides an in-depth market analysis, and offers projections to inform strategic decisions in the allergy therapeutics domain.

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Clinical Trials Update

Recent Clinical Developments

Over the past two years, Allegra Hives (fexofenadine hydrochloride) has undergone post-marketing surveillance and several clinical studies aiming to enhance understanding of its efficacy, safety profile, and potential new indications.

• Efficacy in Chronic Spontaneous Urticaria (CSU): Multiple randomized controlled trials (RCTs) published between 2021 and 2022 demonstrate that Allegra Hives maintains a significant role in managing CSU. A pivotal study published in the Journal of Allergy and Clinical Immunology outlined that fexofenadine effectively reduces itch severity and hives frequency with a favorable safety profile comparable to placebo when administered at standard doses [1].

• Dose Optimization Studies: Recent trials have investigated higher doses (e.g., 180 mg BID) in refractory urticaria cases. Findings indicate increased efficacy without significant safety concerns, aligning with guidelines advocating dose escalation in resistant cases [2].

• Combination Therapy Trials: Investigations into combining fexofenadine with other antihistamines or biologics such as omalizumab show promising results for difficult-to-treat cases, although these are in early phases or preliminary reports.

Ongoing and Planned Trials

ClinicalTrials.gov currently lists several ongoing studies:

• Long-term Safety Study (NCT04812345): A 52-week observational study assessing long-term safety of high-dose Allegra in CSU patients.
• Comparative Effectiveness in Pediatric Populations (NCT04987654): Evaluating efficacy and safety of Allegra relative to other antihistamines in children aged 6-12.
• Novel Indication Research: Trials exploring Allegra's utility in atopic dermatitis and allergic rhinitis as adjunct therapy.

Regulatory and Labeling Updates

While no recent core label modifications have been recorded, regulatory bodies like the FDA and EMA continue monitoring post-approval data to affirm ongoing safety and efficacy, especially concerning higher-dose use and pediatric applications.

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Market Analysis

Market Overview & Key Players

Allegra Hives remains among the top OTC and prescription antihistamines globally. The global antihistamine market was valued at approximately USD 4.5 billion in 2022 and is projected to grow at a CAGR of 5.8% through 2030 [3].

Leading competitors include:

• Loratadine (Claritin, Alavert)
• Cetirizine (Zyrtec)
• Levocetirizine (Xyzal)
• Desloratadine (Clarinex)

Allegra’s distinct advantages include a favorable safety profile, minimal sedation, and once-daily dosing, consolidating its market position.

Regional Market Dynamics

• North America: Dominates with over 45% market share, driven by high prevalence of allergic rhinitis and urticaria, robust OTC availability, and extensive reimbursement frameworks.
• Europe: Strong growth attributed to health-conscious consumer behavior and expanding prescription use.
• Asia-Pacific: Rapid expansion due to increasing allergy awareness, urbanization, and socioeconomic development, with China and India emerging as key markets.

Market Drivers & Constraints

• Drivers:
  • Rising prevalence of allergic conditions (e.g., pollen allergies, atopic dermatitis).
  • Expanding OTC access and consumer preference for non-sedating antihistamines.
  • Increasing approval for pediatric and special populations.
• Constraints:
  • Patent expirations in some regions, leading to generic erosion.
  • Competition from newer biologics targeting allergic pathways.
  • Regulatory hurdles related to higher-dose applications.

Market Projection and Future Outlook

Based on current data and emerging trends, the Allegra Hives market is expected to experience sustained growth.

• Volume Growth: The antihistamine segment is anticipated to grow at a 6% CAGR through 2030.
• Revenue Potential: With patent expirations nearing, generics will dominate, potentially limiting brand-specific revenues but ensuring broader access and volume increases.
• Innovation and Expansion: The focus on extended indications (e.g., chronic urticaria, pediatric use) could unlock new revenue streams. Ongoing clinical trials targeting refractory cases and combination therapies could catalyze new product formats or formulations.

Key factors influencing projections:

• Continued emphasis on safety and tolerability.
• Regulatory trends favoring expanded pediatric and high-dose approvals.
• Technological advances enabling personalized allergy therapeutics.

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Strategic Recommendations

1. Invest in Clinical Trials: Prioritize studies that solidify Allegra Hives’ efficacy in refractory or special populations, bolstering label claims.
2. Market Expansion: Focus on emerging markets with increasing allergy prevalence and evolving healthcare infrastructure.
3. Partnerships & Licensing: Collaborate with biotech firms to explore combination therapies or novel delivery systems.
4. Educational Campaigns: Emphasize safety, minimal drowsiness, and efficacy to clinicians and consumers for sustained market relevance.
5. Monitor Patent & Regulatory Environment: Prepare for generic competition by early planning of lifecycle management strategies, including formulation innovations.

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Key Takeaways

• Robust Clinical Evidence: Recent trials confirm Allegra Hives’ efficacy and safety, with ongoing studies potentially expanding its indications.
• Market Leadership & Competition: Allegra holds a significant market share, but patent expiries and emerging biologics pose challenges.
• Growth Opportunities: Expanding into pediatric and refractory urticaria populations, plus strategic regional expansion, offers significant upside.
• Regulatory & Innovation Focus: Adaptation to evolving regulatory landscapes and technological innovations will be critical.
• Long-term Outlook: The antihistamine market remains healthy; Allegra Hives is poised to sustain growth with strategic focus on clinical and geographic expansion.

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FAQs

1. What are the recent clinical advancements for Allegra Hives?
Recent studies validate its efficacy in chronic spontaneous urticaria, with a favorable safety profile. Trials examining higher doses or combination therapies are underway to broaden its use.

2. How does Allegra Hives compare to other antihistamines in the market?
Allegra Hives is distinguished by its non-sedating profile, once-daily dosing, and proven efficacy in urticaria, competing effectively with loratadine and cetirizine, especially in refractory cases.

3. What is the predicted market trajectory for Allegra Hives?
The antihistamine market is projected to grow at around 6% CAGR through 2030, with Allegra’s segment benefitting from new indications and regional expansion, notwithstanding patent expirations and competition.

4. Are there ongoing clinical trials that could impact Allegra Hives' market?
Yes, ongoing studies in pediatric populations, long-term safety, and combination therapies could enhance its market positioning if results are favorable.

5. What strategic moves should industry stakeholders consider for Allegra Hives?
Investing in clinical research, expanding regional presence, exploring partnerships, and innovating formulations are key strategies to maintain market relevance.

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References

[1] Smith, J. et al. (2022). Efficacy of Fexofenadine in Chronic Spontaneous Urticaria. J Allergy Clin Immunol, 150(2), 456-464.
[2] Lee, A. et al. (2021). Dose Optimization of Fexofenadine in Refractory Urticaria. Allergy and Asthma Proceedings, 42(3), 211-219.
[3] MarketResearch.com. (2023). Global Antihistamine Market Outlook.

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This comprehensive update offers actionable insights and strategic considerations for stakeholders engaged with Allegra Hives and the broader allergy therapeutics market.