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.
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.

Clinical Trial Conditions for ALLEGRA ALLERGY

Condition Name

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

Condition MeSH

Condition MeSH for ALLEGRA ALLERGY
Intervention	Trials
Rhinitis, Allergic	16
Rhinitis	16
Rhinitis, Allergic, Seasonal	8
Rhinitis, Allergic, Perennial	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
Korea, Republic of	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

ALLEGRA ALLERGY Market Analysis and Financial Projection

Last updated: April 28, 2026

Allegra Allergy (fexofenadine) Clinical Trials Update, Market Analysis and Projection

What is Allegra Allergy and what is its regulatory status?

Allegra Allergy is the brand name for fexofenadine, a second-generation oral H1 antihistamine indicated for relief of:

• Seasonal allergic rhinitis (SAR)
• Perennial allergic rhinitis (PAR)

Fexofenadine is marketed in multiple strengths and formulations (commonly 30 mg, 60 mg, 120 mg, 180 mg in the US for oral use, with generic availability in most markets). The clinical and regulatory backbone is an older first wave of filings, with later activity dominated by formulation, exposure, labeling maintenance, and lifecycle studies rather than new MoA.

What is the clinical trials update for fexofenadine (Allegra)?

Across public registries, the most visible “trial activity” around fexofenadine in recent years tends to be:

• Bioequivalence studies for generics and formulation variants
• Pharmacokinetic (PK) studies in specific populations (age, renal impairment, drug interaction contexts)
• Comparative efficacy/safety studies against other antihistamines in allergic rhinitis

Because fexofenadine’s core efficacy and safety profile is established and generic competition is extensive, the active pipeline is typically incremental rather than registrational novelty.

Clinical-trials activity pattern (high level)

• Phase 1–2 activity: Predominantly PK/BD (bioavailability/bioequivalence), dose-form comparisons, and population PK.
• Phase 3 activity: Limited for new registrational indications; when present, it is usually comparative or formulation-linked rather than new clinical endpoints.
• Operational endpoints: Symptom score improvement for allergic rhinitis, quality-of-life measures, and controlled assessment of tolerability.

Key point for business assessment Recent “updates” are largely registry-level entries rather than a new mechanism or a new indication with a clear path to market expansion.

What endpoints and patient populations dominate fexofenadine studies?

Across allergic rhinitis studies for fexofenadine, common structures include:

• Population: Adults and adolescents with SAR or PAR; many studies also include pediatric subsets for pediatric labeling stewardship
• Primary endpoints: Nasal symptom scores and total symptom scores (itching/sneezing/runny nose), typically measured over defined daily windows
• Safety monitoring: Somnolence, vital signs, ECG when relevant to antihistamine classes, and adverse event rates

The drug’s established clinical differentiation is consistent: low sedation relative to first-generation antihistamines, acceptable safety profile, and once-daily convenience for approved strengths.

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How big is the antihistamine market where Allegra competes?

What market segment does Allegra Allergy sit in?

Allegra competes in the OTC and prescription oral antihistamine segment for allergic rhinitis. It also competes across the broader antihistamine landscape that includes:

• Other second-generation H1 antihistamines (e.g., cetirizine, loratadine, levocetirizine)
• Novel delivery and combination products (spray/combination regimens)
• Direct-to-consumer brand competition after generics erode branded pricing power

What drives demand?

Demand is driven by:

• Seasonal allergy prevalence and household coverage of over-the-counter medicines
• Preference for once-daily dosing and reduced sedation profiles
• Switching costs determined by symptom control and tolerability

What does pricing pressure look like for fexofenadine brands?

With extensive generic entry, brand-level market performance tends to track:

• OTC promotional cycles
• Retail inventory management
• Formulation differentiation (where it exists)
• Private label and store brand substitution

In most developed markets, the practical market ceiling for brand Allegra is constrained by generic competition.

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What is the competitive landscape versus other oral antihistamines?

Which competitors most directly pressure Allegra’s share?

Fexofenadine competes most intensely against second-generation oral antihistamines with entrenched retail presence:

• Cetirizine
• Levocetirizine
• Loratadine
• Desloratadine

Competitive dimensions that matter to consumers and payers:

• perceived or measured sedation differences
• speed of onset (where products are positioned that way)
• tolerance and duration of effect
• pricing and availability (dominant for OTC)

Because fexofenadine’s differentiation is largely “low sedation plus efficacy,” the market often re-routes to whichever option is cheaper or better positioned in store and online channels.

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What is the market projection for Allegra Allergy (fexofenadine)?

What projection logic applies to fexofenadine as a mature drug?

For mature, off-patent molecules with widespread generics:

• Growth usually comes from volume stability, category growth (allergic rhinitis prevalence), and mix effects (OTC versus prescription, and formulation changes).
• Branded revenue grows slowly or declines unless brand promo and channel execution offsets generic pricing compression.

Projection framework for a business plan

1. Category growth: Moderate expansion driven by seasonality intensity and consumer penetration.
2. Share stability: Brand likely holds modest share where brand trust and low-sedation messaging persist.
3. Price decline: Continues under generic and private-label pressure.
4. Net effect: Low-single-digit growth or flat revenue for brand; stable or slightly growing unit volume depending on channel mix.

Base case outlook (directional, maturity-consistent)

• Units: likely stable to slightly rising in regions with stronger OTC penetration.
• Revenue for branded “Allegra Allergy”: likely flat to modest decline in many markets unless promotional spend and channel placement expand.
• Market share: constrained by substitution to equivalent-dose second-generation antihistamines.

This is consistent with the clinical maturity profile: no broad new indication expansion is evident from registrational-level development activity.

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What about lifecycle strategy: formulations, dosing, and labeling?

What lifecycle levers typically move fexofenadine performance?

• Formulation variants that improve palatability, dosing convenience, or adherence
• Pediatric stewardship where labeling supports younger age groups
• Renal impairment dosing guidance that improves appropriate use
• Drug-drug interaction positioning to reduce misuse

For fexofenadine specifically, lifecycle value is more likely in execution and channel management than in fundamental clinical differentiation.

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Key Takeaways

• Clinical pipeline for Allegra (fexofenadine) is primarily incremental: PK, bioequivalence, population studies, and comparative programs typical of mature antihistamines rather than new registrational breakthroughs.
• Market dynamics are dominated by generic substitution and OTC pricing pressure across oral second-generation antihistamines.
• Projection: branded revenue for Allegra Allergy is likely flat to slightly down in price-driven environments, with unit stability supported by persistent allergic rhinitis demand and consumer preference for low-sedation second-generation antihistamines.

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FAQs

1) Is Allegra Allergy likely to gain a new indication soon?

The current development posture around fexofenadine is consistent with incremental lifecycle and comparative work rather than a clear near-term path to a new indication.

2) How does fexofenadine differentiate versus cetirizine or loratadine?

The most consistent differentiator is lower sedation positioning for second-generation use, with efficacy that is broadly competitive in allergic rhinitis symptom control.

3) What type of studies dominate recent fexofenadine trial activity?

Bioequivalence/PK and other formulation- or population-focused studies, with fewer registrational Phase 3 efforts.

4) What is the key risk to branded Allegra revenue?

Ongoing generic and private-label substitution and retailer price compression.

5) What would improve the outlook for Allegra Allergy?

Sustained channel execution, promo effectiveness, and any meaningful differentiation through formulation or market access that preserves a premium over generics.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug Trials Snapshots: Allegra (fexofenadine hydrochloride). FDA. https://www.fda.gov/drugs/drug-trials-snapshots
[2] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov
[3] FDA. (n.d.). Labeling information for fexofenadine products (resource index). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/