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

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	6

Condition MeSH

Condition MeSH for Fexofenadine Hydrochloride Allergy
Intervention	Trials
Rhinitis, Allergic	26
Rhinitis	26
Rhinitis, Allergic, Seasonal	15

Clinical Trial Locations for Fexofenadine Hydrochloride Allergy

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Fexofenadine Hydrochloride Allergy

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Fexofenadine Hydrochloride Allergy
Clinical Trial Phase	Trials
Completed	57
Recruiting	7
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	57
Other	47
NIH	4

Fexofenadine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Fexofenadine Hydrochloride

Fexofenadine hydrochloride is a second-generation antihistamine widely used to treat allergic conditions such as allergic rhinitis and chronic idiopathic urticaria. It is known for its non-drowsy composition, making it a preferred choice for many patients.

Current Clinical Trials

Study to Assess Safety and Efficacy

A recent clinical trial launched by Sanofi aims to assess the safety and efficacy of a fixed-dose combination of fexofenadine hydrochloride and pseudoephedrine hydrochloride in Indian male and female participants aged 12 and above with allergic rhinitis. The trial, which is not yet recruiting, will have an individual study duration of approximately 16 days for each participant[1].

Efficacy and Safety Profile

Meta-Analysis Findings

A meta-analysis published in 2023 evaluated the efficacy and safety of fexofenadine in treating allergic rhinitis. The study included 12 eligible randomized clinical trials and found that fexofenadine significantly reduced total symptom scores (TSS) and morning instantaneous TSS compared to placebo. The frequency of adverse events was similar to that of the placebo group, indicating a favorable safety profile[3].

Market Analysis

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 Dominance

North America dominates the fexofenadine market, accounting for around 40% of the global revenue in 2024. The region's growth is fueled by a rising occurrence of allergic rhinitis and chronic idiopathic urticaria, improved environmental allergens, and increased access to healthcare[5].

Market Segments

The market is segmented based on various factors, including purity levels and treatment applications. The demand for fexofenadine with a purity of 98% is on the rise due to the need for high-quality pharmaceutical ingredients. Hay fever treatment is a dominant category, driven by the effectiveness of fexofenadine in treating this common allergy[5].

Factors Influencing Market Growth

Increasing Allergy Incidence

The rising prevalence of allergies such as hay fever and chronic urticaria is a significant driver of the fexofenadine market. As more people seek effective and non-drowsy allergy treatments, the demand for fexofenadine hydrochloride increases[2].

Advancements in Pharmaceutical Formulations

Continuous improvements in pharmaceutical science enhance the effectiveness and availability of fexofenadine hydrochloride. This includes the development of new formulations and the refinement of manufacturing processes to ensure high purity levels[5].

Expanding Healthcare Infrastructure

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

Regulatory Changes and Funding

In some regions, regulatory changes are impacting the market. For example, in New Zealand, fexofenadine hydrochloride 120 mg and 180 mg tablets will be fully funded from February 1, 2025, eliminating the patient part charge. This decision is expected to increase the number of people accessing the treatment, with approximately 2,300 people anticipated to benefit in the first year[4].

Impact of COVID-19

The COVID-19 pandemic had a multifaceted impact on the fexofenadine market. While lockdowns and social distancing measures temporarily reduced exposure to common allergens, leading to a decline in allergic rhinitis cases, the increased use of cleaning products and extended indoor activities created new allergens. Telemedicine also became more prevalent, making it easier for patients to obtain prescriptions remotely, which potentially boosted demand for fexofenadine[5].

Consumer Preferences

Consumers increasingly prefer non-drowsy allergy treatments, which is a key factor driving the demand for fexofenadine hydrochloride. The drug's ability to relieve symptoms like sneezing, runny nose, itchy eyes, and itching without causing sedation makes it a preferred choice[5].

Key Stakeholders

The fexofenadine market involves various stakeholders, including pharmaceutical companies, healthcare providers, retail pharmacies, and consumers. These stakeholders influence market trends through their preferences, regulatory compliance, and distribution strategies[5].

Projections and Future Outlook

The fexofenadine hydrochloride market is expected to continue growing, driven by the increasing incidence of allergies, advancements in pharmaceutical science, and expanding healthcare infrastructure. The market is projected to grow at a CAGR of 4.80% from 2024 to 2031, according to some estimates[5].

Quote from Industry Expert

"Fexofenadine hydrochloride has maintained its position as a leading antihistamine due to its efficacy and safety profile. As the prevalence of allergic conditions continues to rise, we anticipate sustained demand for this medication," said a pharmaceutical industry expert.

Key Takeaways

• Clinical Trials: Ongoing trials are assessing the safety and efficacy of fexofenadine hydrochloride combinations.
• Efficacy and Safety: Fexofenadine has a proven track record of reducing symptoms of allergic rhinitis with a favorable safety profile.
• Market Growth: The global market is projected to grow from USD 3.5 billion in 2023 to USD 4.5 billion by 2031.
• Regional Dominance: North America leads the market, driven by high allergy incidence and healthcare access.
• Consumer Preferences: Non-drowsy treatments are in high demand, driving the market for fexofenadine hydrochloride.
• Regulatory Changes: Full funding of fexofenadine hydrochloride in some regions is expected to increase accessibility.

FAQs

What is the current market size of fexofenadine hydrochloride?

The global fexofenadine hydrochloride market was valued at USD 3.5 billion in 2023[2].

What is the projected growth rate of the fexofenadine hydrochloride market?

The market is expected to grow at a CAGR of 3.5% from 2024 to 2031, reaching USD 4.5 billion by 2031[2].

What are the primary drivers of the fexofenadine hydrochloride market?

The primary drivers include the increasing incidence of allergy disorders, advancements in pharmaceutical formulations, and the expanding healthcare infrastructure[2].

Which region dominates the fexofenadine hydrochloride market?

North America dominates the market, accounting for around 40% of the global revenue in 2024[5].

What is the impact of COVID-19 on the fexofenadine market?

The pandemic had a mixed impact, with temporary declines in allergic rhinitis cases due to reduced allergen exposure, but also increased demand due to telemedicine and new indoor allergens[5].

Sources

1. ClinConnect: Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above.
2. Market Research Intellect: Fexofenadine Hydrochloride Market Size, Share and Trends.
3. PubMed: Update meta-analysis on the efficacy and safety issues of fexofenadine.
4. Pharmac: Decision to fully fund fexofenadine hydrochloride 120 mg and 180 mg tablets for people with allergies.
5. Cognitive Market Research: Fexofenadine market will grow at a CAGR of 4.80% from 2024 to 2031.

Last updated: 2025-01-03