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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR FEXOFENADINE HYDROCHLORIDE


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505(b)(2) Clinical Trials for Fexofenadine Hydrochloride

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fexofenadine Hydrochloride

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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fexofenadine Hydrochloride

Condition Name

Condition Name for Fexofenadine Hydrochloride
Intervention Trials
Healthy 16
Seasonal Allergic Rhinitis 9
Allergic Rhinitis 6
Pruritus 3
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Condition MeSH

Condition MeSH for Fexofenadine Hydrochloride
Intervention Trials
Rhinitis, Allergic 26
Rhinitis 26
Rhinitis, Allergic, Seasonal 15
Pruritus 5
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Clinical Trial Locations for Fexofenadine Hydrochloride

Trials by Country

Trials by Country for Fexofenadine Hydrochloride
Location Trials
United States 67
Australia 7
Switzerland 6
France 5
Canada 5
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Trials by US State

Trials by US State for Fexofenadine Hydrochloride
Location Trials
New Jersey 10
Texas 4
Maryland 3
Kansas 3
California 3
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Clinical Trial Progress for Fexofenadine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Fexofenadine Hydrochloride
Clinical Trial Phase Trials
Phase 4 30
Phase 3 10
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Fexofenadine Hydrochloride
Clinical Trial Phase Trials
Completed 57
Recruiting 7
Not yet recruiting 6
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Clinical Trial Sponsors for Fexofenadine Hydrochloride

Sponsor Name

Sponsor Name for Fexofenadine Hydrochloride
Sponsor Trials
Sanofi 16
Merck Sharp & Dohme Corp. 5
Dr. Reddy's Laboratories Limited 5
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Sponsor Type

Sponsor Type for Fexofenadine Hydrochloride
Sponsor Trials
Industry 57
Other 47
NIH 4
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Fexofenadine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Fexofenadine Hydrochloride

Fexofenadine hydrochloride is a second-generation antihistamine widely used for the treatment of allergic conditions such as allergic rhinitis, urticaria, and other allergy-related symptoms. It is known for its non-drowsy effects, making it a preferred choice for many patients.

Clinical Trials and Efficacy

Recent Meta-Analysis

A recent meta-analysis published in 2023 updated the evidence on the efficacy and safety of fexofenadine hydrochloride. This study involved double-blind, placebo-controlled, randomized clinical trials focusing on allergic rhinitis. The results showed that fexofenadine significantly reduced total symptom scores (TSS) and morning instantaneous TSS compared to the placebo group. The study concluded that fexofenadine maintains its beneficial profile for treating allergic conditions, with a favorable safety profile similar to that of the placebo group[3].

Ongoing Clinical Trials

An ongoing clinical trial at the University of California, San Francisco, is investigating the effect of sodium lauryl sulfate (SLS), a common excipient, on the absorption of fexofenadine hydrochloride. This Phase 1 study aims to determine if SLS affects the pharmacokinetic parameters of fexofenadine by measuring its concentrations in plasma and stool samples. The trial is expected to provide insights into how excipients can influence drug absorption[4].

Market Analysis

Global Market Size and Growth

The global fexofenadine hydrochloride market was valued at USD 3.5 billion in 2023 and is projected to reach USD 4.5 billion by 2031, growing at a compound annual growth rate (CAGR) of 3.5% from 2024 to 2031. This growth is driven by the increasing incidence of allergy disorders, advancements in pharmaceutical formulations, and the expanding healthcare infrastructure[2].

Regional Market Share

  • North America: Holds more than 40% of the global revenue, with a market size expected to grow at a CAGR of 3.0% from 2024 to 2031[5].
  • Europe: Accounts for over 30% of the global revenue, with a CAGR of 3.3% from 2024 to 2031[5].
  • Asia-Pacific: Represents around 23% of the global revenue, with the fastest growth rate at a CAGR of 6.8% from 2024 to 2031[5].
  • Latin America and Middle East & Africa: These regions hold smaller but significant shares, with growth rates of 4.2% and 4.5%, respectively[5].

Market Segments

The market is segmented based on application (allergy treatment, cold & flu medications, nasal congestion, dermatological treatments) and product forms (tablets, capsules, oral suspension, powder). The urticaria treatment segment is one of the fastest-growing categories, driven by fexofenadine's efficacy in treating chronic idiopathic urticaria[2][5].

Funding and Accessibility

Full Funding in New Zealand

From February 1, 2025, fexofenadine hydrochloride 120 mg and 180 mg tablets will be fully funded in New Zealand, eliminating the patient part charge that was previously applicable. The Fexaclear brand, supplied by AFT, will be the Principal Supply brand from July 1, 2025, to June 30, 2027. This decision is expected to benefit approximately 2,300 people in the first year and over 12,000 people in the next five years[1].

Key Drivers of Market Growth

Increasing Prevalence of Allergies

The rising incidence of allergy disorders such as hay fever and chronic urticaria is a significant driver of the fexofenadine hydrochloride market. As more people seek effective and non-drowsy antihistamines, the demand for fexofenadine is expected to increase[2].

Advancements in Pharmaceutical Formulations

Continuous improvements in pharmaceutical formulations have enhanced the effectiveness and availability of fexofenadine hydrochloride. These advancements make the drug more appealing to consumers seeking reliable allergy relief solutions[2].

Expanding Healthcare Infrastructure

The growth in healthcare infrastructure and the increasing availability of over-the-counter drugs make allergy treatments more accessible and affordable for a wider population. This expansion contributes significantly to the market's growth trajectory[2].

Consumer Preferences

Fexofenadine hydrochloride's non-drowsy composition is a key factor in its popularity. Consumers prefer this drug because it provides symptom relief without the sedative effects associated with first-generation antihistamines[2][3].

Challenges and Future Considerations

Regulatory Changes

Changes in regulatory policies and funding decisions, such as the full funding of fexofenadine hydrochloride in New Zealand, can significantly impact market dynamics. These changes can affect the availability and affordability of the drug, influencing market growth[1].

Competitive Landscape

The fexofenadine hydrochloride market is competitive, with multiple brands and formulations available. The delisting of certain brands, such as the Telfast brand of fexofenadine hydrochloride 120 mg tablets from July 1, 2025, can alter market shares and consumer preferences[1].

Key Takeaways

  • Clinical Efficacy: Fexofenadine hydrochloride has been proven to be highly effective in treating allergic conditions with a favorable safety profile.
  • Market Growth: The global market is expected to grow at a CAGR of 3.5% from 2024 to 2031, driven by increasing allergy prevalence and advancements in pharmaceutical formulations.
  • Regional Variations: North America, Europe, and Asia-Pacific are significant markets, with Asia-Pacific showing the fastest growth rate.
  • Accessibility: Full funding in regions like New Zealand enhances the drug's accessibility and affordability.
  • Consumer Preferences: The non-drowsy nature of fexofenadine hydrochloride is a key driver of its popularity.

FAQs

What is the expected growth rate of the fexofenadine hydrochloride market from 2024 to 2031?

The fexofenadine hydrochloride market is expected to grow at a CAGR of 3.5% from 2024 to 2031[2].

Which region holds the largest share of the global fexofenadine hydrochloride market?

North America holds more than 40% of the global revenue[5].

What is the primary driver of the fexofenadine hydrochloride market growth?

The increasing prevalence of allergy disorders and advancements in pharmaceutical formulations are primary drivers of market growth[2].

Will fexofenadine hydrochloride be fully funded in New Zealand?

Yes, from February 1, 2025, fexofenadine hydrochloride 120 mg and 180 mg tablets will be fully funded in New Zealand, eliminating the patient part charge[1].

What is the significance of the non-drowsy composition of fexofenadine hydrochloride?

The non-drowsy composition of fexofenadine hydrochloride makes it a preferred choice for consumers seeking effective allergy relief without sedative effects[2][3].

Sources

  1. Pharmac New Zealand: Decision to fully fund fexofenadine hydrochloride 120 mg and 180 mg tablets for people with allergies.
  2. Market Research Intellect: Fexofenadine Hydrochloride Market Size, Share and Trends.
  3. PubMed: Update meta-analysis on the efficacy and safety issues of fexofenadine hydrochloride.
  4. UCSF Clinical Trials: Excipient Effect on Drug Absorption in Humans.
  5. Cognitive Market Research: Fexofenadine market will grow at a CAGR of 4.80% from 2024 to 2031.

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