CLINICAL TRIALS PROFILE FOR FEXOFENADINE HYDROCHLORIDE ALLERGY

505(b)(2) Clinical Trials for FEXOFENADINE HYDROCHLORIDE ALLERGY

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 ALLERGY

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 ALLERGY

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for FEXOFENADINE HYDROCHLORIDE ALLERGY

Trials by Country

Trials by Country for FEXOFENADINE HYDROCHLORIDE ALLERGY
Location	Trials
United States	68
Australia	9
Canada	7
Switzerland	6
France	5

Trials by US State

Trials by US State for FEXOFENADINE HYDROCHLORIDE ALLERGY
Location	Trials
New Jersey	10
Texas	4
Kansas	4
Maryland	3
California	3

Clinical Trial Progress for FEXOFENADINE HYDROCHLORIDE ALLERGY

Clinical Trial Phase

Clinical Trial Phase for FEXOFENADINE HYDROCHLORIDE ALLERGY
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	2
PHASE1	4

Clinical Trial Status

Clinical Trial Status for FEXOFENADINE HYDROCHLORIDE ALLERGY
Clinical Trial Phase	Trials
Completed	61
Recruiting	9
Not yet recruiting	6

Clinical Trial Sponsors for FEXOFENADINE HYDROCHLORIDE ALLERGY

Sponsor Name

Sponsor Name for FEXOFENADINE HYDROCHLORIDE ALLERGY
Sponsor	Trials
Sanofi	16
Merck Sharp & Dohme Corp.	5
Dr. Reddy's Laboratories Limited	5

Sponsor Type

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

Fexofenadine Hydrochloride Allergy: Clinical Trials Update, Market Analysis, and Market-Entry Projections

Last updated: July 27, 2026

Fexofenadine hydrochloride (H1-antihistamine for allergic rhinitis and urticaria) has a mature market with limited late-stage innovation. Public clinical activity is dominated by bioequivalence and formulation-related studies, while most IP-driven differentiation is formulation and method-adjacent rather than new active-ingredient breakthroughs. Market growth is steady but incremental, driven by generics, OTC penetration, and continued demand in seasonal allergy cycles.

What clinical trials are currently active for fexofenadine hydrochloride allergy?

Public “allergy” labeling is generally supported by historical phase 3 evidence for fexofenadine and the broader antihistamine class. Recent activity in public registries most commonly clusters around:

• Bioequivalence (BE) for generic or authorized generics
• Formulation and dissolution/PK bridging (immediate vs extended exposure)
• Food-effect and crossover PK studies
• Safety/tolerability in specific populations (commonly pediatrics or renally impaired cohorts)

Featured-scheme answer: Most current clinical trial visibility for fexofenadine is BE and formulation/PK work rather than new randomized superiority trials versus other antihistamines.

Which endpoints do recent fexofenadine studies use?

Typical endpoints in BE and PK bridging include:

• Cmax and AUC for systemic exposure
• Tmax
• Half-life and renal clearance markers (when renal-subgroup designs exist)
• Safety endpoints: TEAEs, ECG parameters (if required), labs, vital signs

What trial designs dominate?

• Single-dose, randomized, open-label crossover BE
• Multiple-dose crossover BE for extended-exposure products
• Parallel safety cohorts for tolerability or special populations

What does this imply for innovation timelines?

When the bulk of activity is BE/formulation, a late-stage “pipeline catalyst” is less likely. Competitive advantage comes from product attributes (dose convenience, OTC access, distribution strength), not from new clinical differentiation.

Where is fexofenadine sold and who are the main commercial brands versus generics?

Fexofenadine is widely marketed as second-generation, non-sedating allergy therapy. Market structure is characterized by:

• Large generic share (multiple manufacturers)
• OTC and Rx channels with seasonal peaks
• Brand remnants focused on dosing convenience and channel placement

Featured-scheme answer: Fexofenadine’s market is structurally genericized; brand differentiation is usually channel and formulation convenience (dose frequency, pill strength, OTC availability), not novel therapeutic mechanisms.

Channel split: OTC vs prescription

• OTC access supports high market volume and rapid repeat purchasing during allergy season.
• Prescription remains important for chronic symptom control and for patients with clinician guidance.

Dose formats and typical dosing landscape

Common commercial presentations include:

• Tablets and orally disintegrating or rapid-dissolve formats (product-specific)
• Strengths usually aligned with regulatory labeling and BE strategies for generics

How big is the global and US fexofenadine hydrochloride allergy market, and what drives demand?

A high-level market view for fexofenadine is driven by:

• Seasonal allergic rhinitis prevalence and patient adherence
• Switch behavior within H1-antihistamine class (patients trade across brands/generics)
• Patient preference for non-sedating profiles
• OTC promotions and pharmacy shelf execution
• Aging demographics increasing chronic allergic symptom management

Featured-scheme answer: Demand is consistent and seasonal, with growth tied to population persistence in allergic conditions and substitution dynamics within second-generation antihistamines.

Key growth levers

• OTC channel expansion and retailer formula plans
• Pack-size optimization and seasonal merchandising
• Cost-driven share gains by generics and authorized generics
• Pediatric and compliance-focused formulations (where approved and supported)

What is the pricing and margin outlook for fexofenadine generics, and how will it affect competition?

Generics exert downward pressure on net pricing. Margin outcomes depend on:

• Number of ANDA competitors and distribution intensity
• Pharmacy benefit and OTC reimbursement economics
• Mix between store-brand generics, authorized generics, and branded remnants

Featured-scheme answer: Pricing pressure persists; competition remains volume-driven, not innovation-driven.

What happens when new BE products launch?

• Incremental competitive pressure at the shelf level
• Short-term promotional spikes
• Long-term consolidation into lowest-net-price SKUs

When does fexofenadine lose exclusivity, and what does that mean for generic entry risk?

Fexofenadine’s active ingredient is mature and widely genericized. Exclusivity is typically historical and has already been exhausted for the original active-ingredient launch. Ongoing IP constraints, when they exist, are usually limited to:

• Specific formulations (salt form not the only variable, but dosage form and release profile can be)
• Device or delivery attributes (if any)
• Method-of-use claims (less common for an established OTC-like indication, but can occur in secondary claims)

Featured-scheme answer: Generic entry risk is currently low at the “new ANDA” macro level because the API is broadly genericized. The key risk is incremental: product-specific formulation and method patents can delay a specific branded/extended/ODT launch rather than blocking the class.

What patents protect fexofenadine hydrochloride allergy products today, and which ones matter for launch?

For a mature drug like fexofenadine, the active ingredient is not the main patent blocker. Practical launch barriers most often come from:

• Formulation patents (release characteristics, dose uniformity strategies, stability)
• Composition patents tied to specific inactive ingredients or manufacturing approach
• Method-of-use patents for specific dosing regimens in subpopulations (rarer)
• Extension patents for particular dosage strengths or delivery formats

Featured-scheme answer: Patent estates that matter for entry are typically product-format-specific rather than blocking fexofenadine as a whole.

What to evaluate in any Orange Book-style review

Even without reproducing specific patent numbers here, the operative filters for launch timelines are:

• Patent type: composition vs formulation vs method of use
• Expiration and any listed pediatric exclusivity adjustments
• Litigation history tied to those listed patents
• Whether an applicant’s labeling and formulation “design-around” avoids infringement risk

How strong is the patent estate for fexofenadine hydrochloride allergy by dosage form?

Strength varies by:

• Whether the dosage form is a mainstream generic (low residual barriers)
• Whether it has a differentiated release profile (higher risk for formulation-patent contention)
• Whether it is tied to an OTC transition with brand-protected package economics (higher incentive to defend, even when the molecule is genericized)

Featured-scheme answer: Patent strength is generally medium-to-low for standard immediate-release tablets and low for most straightforward generic presentations. Higher for niche release formats if those formats retain pending or recently issued patents.

Which companies are most active in fexofenadine hydrochloride allergy supply and filings?

Competition typically includes:

• Large generic firms producing and distributing broad OTC portfolios
• ANDA filers focusing on BE efficiency and packaging differentiation
• Pharmacy channel brand producers (store-brand)

Featured-scheme answer: The market is dominated by multi-product generic incumbents with strong OTC distribution and contract manufacturing capacity.

What generic entry risks exist for fexofenadine hydrochloride allergy products?

Risks are not about molecule replacement. They are about:

• Formulation design around formulation patents for a specific brand format
• ANDA labeling alignment to avoid method-of-use infringement
• Patent-territory timing differences by filing jurisdiction (US vs other geographies)

Featured-scheme answer: Entry risk is highest for differentiated formats (ODT, modified-release, specialty dosing) and lowest for basic immediate-release tablets.

How does fexofenadine compare with other second-generation antihistamines for allergy in clinical and commercial outcomes?

Within the second-generation antihistamine class, comparative differentiation is typically:

• Patient preference influenced by prior use
• Perceived tolerability and symptom control consistency
• OTC access and price

Common competitors include:

• Cetirizine (often more sedating)
• Loratadine (less sedation than first-gen)
• Levocetirizine
• Desloratadine

Featured-scheme answer: fexofenadine’s commercial positioning relies on “non-sedating” preference and adherence, while competitive dynamics are dominated by net pricing and shelf execution.

What drives switching among these antihistamines?

• Cost and availability
• Past response during peak season
• Tolerability (sleepiness concerns)
• Clinician and pharmacist recommendations

What FDA regulatory status does fexofenadine have, and what does it mean for future approvals?

Fexofenadine is an established drug with:

• Existing approved labeling for allergic rhinitis and urticaria
• Continued lifecycle management through reformulations and generic approvals

Featured-scheme answer: The regulatory pathway for most new entrants is BE for generics/authorized generics; meaningful clinical novelty in new FDA approvals is less likely than for first-in-class drugs.

Market projection: What is the expected demand and revenue trajectory for fexofenadine hydrochloride over the next 5 years?

Projected trajectory for mature H1-antihistamines generally follows:

• Volume stability with seasonal peaks
• Net revenue growth limited by price erosion
• Margin compression for generics, with survivors shifting to packaging differentiation and channel exclusivity where available

Featured-scheme answer: Over a 5-year horizon, the market is likely to show modest growth in volume with flat-to-declining unit revenue, driven by substitution and price competition.

Scenario model (business-useful)

Given maturity and generic penetration, three scenario archetypes typically apply:

• Base case: Steady volume, continued price erosion, revenue grows low-single digits in nominal terms.
• Bull case: Strong OTC expansion and favorable seasonal severity lifts volume; modest nominal growth despite pricing pressure.
• Bear case: Increased generic competition and promotional intensity lowers net price faster than volume offsets, yielding flat nominal revenue.

(Prices and exact numerical values are not included because this request does not provide registry, sales, or competitive pricing datasets to anchor a quantitative forecast.)

What manufacturing and IP barriers could slow fexofenadine product launches?

Key barriers are practical, not clinical:

• BE execution and analytical method alignment
• Stability and dissolution profile control for each dosage form
• Patent-specific formulation constraints for differentiated formats
• Packaging and supply chain scale, especially for OTC demand surges

Featured-scheme answer: Launch speed is most sensitive to formulation development and BE readiness, not to clinical development cost.

Key Takeaways

• Clinical activity visibility for fexofenadine is mainly BE/PK/formulation, which reduces expectations for near-term “new clinical evidence” as a market catalyst.
• Commercial demand is steady and seasonal; growth is driven more by channel execution and OTC access than by therapeutic breakthroughs.
• Revenue outlook is constrained by ongoing generic price competition; market value growth is likely modest and volume-led.
• Patent-driven launch barriers, when present, are product-format-specific (formulation/dosage form) rather than blocking the active ingredient broadly.
• Entry risk is lowest for standard immediate-release formats and highest for differentiated release/format SKUs.

FAQs

1. Do new fexofenadine formulations typically require clinical phase 3 trials or only bioequivalence studies?
2. Which fexofenadine dosage forms tend to have the most patent and BE friction at launch?
3. How does seasonal allergic rhinitis impact quarterly demand for fexofenadine products?
4. What are the most common causes of ANDA delays for established antihistamines like fexofenadine?
5. How do OTC promotions and pharmacy contracting influence net pricing for fexofenadine generics?

References

1. FDA Orange Book. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. ClinicalTrials.gov. U.S. National Library of Medicine. https://clinicaltrials.gov/