CLINICAL TRIALS PROFILE FOR ALLEGRA

All Clinical Trials for Allegra

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

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Allegra

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Allegra

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Allegra

Sponsor Name

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

Sponsor Type

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

Allegra (Fexofenadine): Clinical Trials, Market Analysis, and Future Projections

Last updated: February 6, 2026

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What is the current status of Allegra in clinical trials?

Allegra (fexofenadine) has not been involved in recent pivotal clinical trials since its initial approval. The drug, developed by Sanofi, was approved by the FDA in 1996 for allergic rhinitis and urticaria. Clinical development activities have shifted from new trials to real-world evidence, biosimilar approaches, and combination therapies. The last recorded clinical trial of note was in 2013, assessing its efficacy in pediatric populations.

The focus in recent years has been on post-marketing surveillance and comparative effectiveness studies. No recent phase trials evaluating new indications or formulations are publicly listed on ClinicalTrials.gov.

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How does Allegra perform in the current antihistamine market?

Market share and sales data:

• Global antihistamine market (2022): Estimated at $8.5 billion.
• Fexofenadine’s share: Historically, Allegra accounted for a significant portion of this segment, around 34% of antihistamine sales in the U.S. in 2022, translating to approximately $2.9 billion.
• Market leader status: Allegra remains a top-prescribed second-generation antihistamine alongside loratadine and cetirizine.

Key competitive factors:

• Efficacy and safety profile: Fexofenadine is non-sedating, with fewer central nervous system side effects versus first-generation antihistamines.
• Formulations: Oral tablets, with some extended-release formulations.
• Pricing pressures: Increasing availability of generic fexofenadine has decreased prices and reduced profit margins for branded Allegra.

Patent status:

• Allegra’s primary patents expired in 2015. Generics entered the market, eroding its market share.
• Sanofi's exclusivity ended, allowing widespread generic distribution.

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What are the future market projections for Allegra?

Market size forecast (2023-2028):

• The antihistamine market is expected to grow at a compound annual growth rate (CAGR) of 3.2%, reaching approximately $11 billion globally by 2028.
• Fexofenadine is projected to maintain a 25% share of this market, driven by its efficacy and safety profile.

Impact of biosimilars and new entrants:

• No biosimilars for Allegra exist, as it is a small-molecule drug.
• Newer antihistamines with improved formulations or combined products are gaining market share, including allergen immunotherapy adjuncts.
• The trend favors generics, further pressuring branded sales.

Regulatory and reimbursement landscape:

• Increased insurance cost-containment measures favor generics.
• Certain markets, such as the U.S. and EU, see more favorable reimbursement for leading second-generation antihistamines.

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Are there upcoming clinical developments or new indications?

No official records indicate ongoing clinical trials for Allegra. The company has shifted focus toward improving formulations or exploring combination therapies rather than novel indications. Research into allergic conditions continues, but Allegra itself remains a foundational, off-patent drug.

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Summary of strategic considerations

• Market remains sizable but highly competitive.
• Patent expiry has resulted in significant generic penetration.
• Future growth depends on market acceptance of generics and potential new formulations or combinations.
• Sanofi's R&D efforts do not currently prioritize Allegra for new indications.

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Key Takeaways

• Allegra has a history of extensive clinical testing but no recent pivotal trials.
• The antihistamine market is growing slowly, with generics dominating sales.
• Allegra maintains a strong safety profile, aiding its continued relevance.
• Market share has declined due to patent expiration, but sales remain substantial.
• Future growth depends on formulary positioning and potential combination therapies rather than novel clinical indications.

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FAQs

1. Is Allegra still under patent protection?
No. Its primary patents expired in 2015, allowing generics to enter the market.

2. Are there any new clinical trials planned for Allegra?
Currently, no publicly announced trials explore new indications or formulations for Allegra.

3. How does Allegra compare to newer antihistamines?
Allegra offers a non-sedating profile with a proven safety record. Newer agents, like desloratadine, have similar profiles and may offer slight advantages in onset or duration.

4. What is the outlook for Allegra’s market share?
Its market share is likely to decline gradually due to generic competition, but sales will persist given brand loyalty and established efficacy.

5. How might future regulatory changes influence Allegra?
Reimbursement policies favoring generics and patent expirations will continue to pressure branded sales, unless new formulations or combination products are developed.

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Citations
[1] ClinicalTrials.gov, "Fexofenadine Clinical Trials," accessed 2023.
[2] IQVIA, "Global Antihistamine Market Data," 2022.
[3] FDA Labeling for Allegra, 1996-2022.