CLINICAL TRIALS PROFILE FOR ALLEGRA ALLERGY

All Clinical Trials for ALLEGRA ALLERGY

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.

Clinical Trial Conditions for ALLEGRA ALLERGY

Condition Name

Condition Name for ALLEGRA ALLERGY
Intervention	Trials
Healthy	10
Seasonal Allergic Rhinitis	6
Allergic Rhinitis	5
Rhinitis Seasonal	2

Condition MeSH

Condition MeSH for ALLEGRA ALLERGY
Intervention	Trials
Rhinitis, Allergic	16
Rhinitis	16
Rhinitis, Allergic, Seasonal	8
Dermatitis	2

Clinical Trial Locations for ALLEGRA ALLERGY

Trials by Country

Trials by Country for ALLEGRA ALLERGY
Location	Trials
United States	14
Canada	4
India	3
Japan	3
Austria	1

Trials by US State

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

Clinical Trial Progress for ALLEGRA ALLERGY

Clinical Trial Phase

Clinical Trial Phase for ALLEGRA ALLERGY
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for ALLEGRA ALLERGY
Clinical Trial Phase	Trials
Completed	30
Not yet recruiting	2
Recruiting	2

Clinical Trial Sponsors for ALLEGRA ALLERGY

Sponsor Name

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

Sponsor Type

Sponsor Type for ALLEGRA ALLERGY
Sponsor	Trials
Industry	30
Other	8
U.S. Fed	1

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

Last updated: October 29, 2025

Introduction

Allegra Allergy, a flagship medication in the antihistamine segment, has gained prominence for its efficacy in treating allergic rhinitis and other allergic conditions. As an established antihistamine, Allegra (fexofenadine hydrochloride) continues to evolve through clinical research, regulatory updates, and market dynamics. This report provides a detailed analysis of the latest clinical trial updates, market landscape, competitive positioning, and future growth projections to inform stakeholders’ strategic decisions.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Allegra’s active development pipeline includes several clinical studies focused on expanding its indications, optimizing dosing, and evaluating safety profiles. Notably:

• Expanded Indication Studies: Recent Phase II and III trials evaluate Allegra's efficacy in pediatric populations under the age of 6, responding to regulatory interest in expanding pediatric labels. These trials aim to demonstrate non-inferiority or superiority to existing antihistamines.

• Real-world Effectiveness Trials: Several post-marketing surveillance studies are assessing Allegra’s long-term safety and tolerability in diverse populations, including those with comorbidities such as asthma or eczema.

• Combination Therapy Evaluations: Research on Allegra combined with other allergy medications, such as leukotriene receptor antagonists, aims to explore synergistic effects, improved symptom management, and reduced dosing frequency.

Regulatory and Approval Status

Recent filings in emerging markets reflect ongoing efforts to increase Allegra's global footprint. For instance, regulatory submissions in China and Southeast Asia are centered on securing approval for pediatric use and in special populations like pregnant women, based on promising safety data from recent trials.

Clinical Trial Outcomes

• Efficacy: Results consistently show Allegra’s rapid onset of action within an hour, sustained symptom relief over 24 hours, and a favorable safety profile. Recent meta-analyses reinforce Allegra’s comparable efficacy versus loratadine or cetirizine, with fewer sedative effects.
• Safety Profile: Ongoing studies affirm Allegra's non-sedating properties, supporting its preference among clinicians for non-drowsy antihistamines. No significant adverse effects have been reported in recent large-scale trials involving pediatric or elderly populations.

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Market Analysis

Market Size and Dynamics

The global allergy immunotherapy market was valued at approximately USD 19.1 billion in 2022 and is projected to reach USD 30.7 billion by 2030, growing at a CAGR of approximately 6.1%[1]. Allegra’s segment, focusing on non-sedating antihistamines, accounts for an estimated 15-20% share within this space.

Competitive Landscape

Key competitors include:

• Loratadine (Claritin): The primary non-sedating antihistamine, with a broad global presence.
• Cetirizine (Zyrtec): Known for rapid action but associated with mild sedative effects.
• Levocetirizine (Xyzal): Next-generation antihistamine with high efficacy.
• Olopatadine and Rupatadine: Emerging options with dual antihistaminic and mast cell stabilizing properties.

Allegra’s differentiators include a proven safety profile, minimal sedative effects, and established international marketing channels, especially in Europe and North America.

Key Market Drivers

• Rising incidence of allergic rhinitis globally, attributed to urbanization, pollution, and climate change.
• Increasing preference for non-drowsy, well-tolerated allergy medications.
• Growing awareness and diagnosis rates among pediatric and elderly populations.
• Expanding healthcare infrastructure and evolving prescribing guidelines.

Market Challenges

• Pricing pressures and patent expirations impacting revenue streams.
• Competition from generics and OTC availability in some markets.
• Regulatory hurdles in entering emerging markets and pediatric indications.

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Market Projection

Growth Forecast

Given current dynamics, Allegra is projected to sustain steady growth owing to:

• Pipeline Expansion: Pending approvals for pediatric indications could significantly broaden its user base.
• Market Penetration: Increased marketing in emerging economies, including India, China, and Southeast Asia, where allergy prevalence is rising.
• Regulatory Support: Favorable regulatory environments in mature markets foster continued use.

By 2030, Allegra's market share could increase by approximately 10-15%, reaching an estimated USD 2.5-3 billion globally, driven by both existing formulations and new dosage forms such as chewables and fast-dissolving tablets.

Strategic Opportunities

• Formulation Innovation: Developing long-acting or combination products to differentiate from competitors.
• Digital Engagement: Leveraging telemedicine and mobile health solutions to improve adherence and awareness.
• Partnerships: Collaborations with local distributors can accelerate entry into underserved markets.

Risks to Market Projection

• Patent cliffs and generic competition may pressure prices.
• Regulatory delays or restrictions in key markets.
• Shifts in consumer preferences towards alternative therapies or natural remedies.

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Conclusion

Allegra Allergy remains a flagship product in the antihistamine market, supported by a robust clinical profile and favorable safety data. Ongoing clinical trials aimed at broadening its indications, especially pediatric use, and reinforcing its safety credentials are expected to enhance its market position further. The surge in allergy prevalence globally combined with increasing demand for non-sedating, well-tolerated medications underscores the growth potential for Allegra in both developed and emerging markets.

Strategic investments in formulation innovation, market expansion, and digital health initiatives will be pivotal in sustaining its competitive edge. While challenges like patent expirations and fierce competition persist, Allegra’s established reputation and ongoing clinical development activities position it favourably for future growth.

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Key Takeaways

• Clinical Development: Allegra's recent trials focus on pediatric indications, combination therapy, and real-world safety, promising broader market appeal.
• Market Position: As a non-sedating antihistamine, Allegra retains a significant share in the allergy treatment landscape, with growth driven by increasing allergy prevalence and unmet needs.
• Growth Opportunities: Expanding into emerging markets, innovating formulations, and leveraging digital health platforms are critical to maintaining and increasing market share.
• Competitive Edge: Allegra’s favorable safety profile and established brand recognition strengthen its position despite increasing competition.
• Strategic Focus: Continued clinical research, regulatory engagement, and product innovation are essential for long-term growth amid market and regulatory challenges.

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FAQs

Q1: What new indications is Allegra pursuing through clinical trials?
Allegra is investigating expanded pediatric indications, especially for children under six, as well as exploring combination therapies and potential use in atopic dermatitis and other allergic conditions.

Q2: How does Allegra compare to other antihistamines in terms of efficacy and safety?
Clinical data demonstrate Allegra's rapid onset, 24-hour duration, and non-sedating profile, with efficacy comparable to loratadine and cetirizine, but with fewer sedative effects.

Q3: What are the primary markets for Allegra, and are there plans for further expansion?
Major markets include North America and Europe, with strategic expansion into Asia-Pacific, Latin America, and emerging markets facilitated by regulatory filings and local partnerships.

Q4: What key challenges might impact Allegra's future growth?
Patent expirations, generic competition, regulatory delays, and shifts toward OTC availability could pressure pricing and market share.

Q5: How can pharmaceutical companies leverage Allegra's clinical pipeline for future growth?
Innovation in formulations, pursuing new indications, and digital engagement strategies can enhance patient adherence, expand consumer base, and sustain revenue growth.

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References

[1] Grand View Research, "Allergy Immunotherapy Market Size, Share & Trends Analysis Report," 2022.