CLINICAL TRIALS PROFILE FOR LORATADINE

505(b)(2) Clinical Trials for Loratadine

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.

All Clinical Trials for Loratadine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00319995 ↗	Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-03-01	This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or placebo. The primary objective of this study is to assess the efficacy of the combination of loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in relieving the symptom of nasal congestion. The safety profile of combined loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.
NCT00423995 ↗	Effect of Loratadine/Montelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU (Study P04822)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-11-01	This is study of LMC, phenylephrine, and placebo in subjects with SAR. There are three visits: At Visit 1, subjects will be evaluated for participation and, if they qualify, will attend Visit 2 for priming. At Visit 2, ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction. Pollen counts will be monitored and recorded. During the priming visit(s), subjects will be evaluated to determine if they qualify. If qualified, they will return for Visit 3, where ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction. Pollen counts will be monitored and recorded as in the Priming Session. Subjects will complete symptom evaluations and if qualified, they will receive study medication and remain in the environmental exposure unit where symptoms will be evaluated for 8 hours after dosing. PNIF will be evaluated only during the treatment session. Four nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) and three non-nasal symptoms (itching/burning eyes, tearing/watery eyes, and itching of ears/palate) will be evaluated. Adverse events will be collected throughout the study to assess safety and tolerability, and vital signs will be collected at Visit 1 and at the end of Visit 3.
NCT00481676 ↗	Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic Urticaria	Completed	Novartis	Phase 2	2007-05-01	This study evaluated the safety and efficacy of omalizumab in adult patients with moderate to severe chronic urticaria who exhibit IgE against thyroperoxidase.

Clinical Trial Conditions for Loratadine

Condition Name

Condition Name for Loratadine
Intervention	Trials
Seasonal Allergic Rhinitis	8
Healthy	6
Allergic Rhinitis	5

Condition MeSH

Condition MeSH for Loratadine
Intervention	Trials
Rhinitis	28
Rhinitis, Allergic	28
Rhinitis, Allergic, Seasonal	16

Clinical Trial Locations for Loratadine

Trials by Country

Trials by Country for Loratadine
Location	Trials
United States	81
Canada	8
Germany	3
China	3
Spain	3

Trials by US State

Trials by US State for Loratadine
Location	Trials
New Jersey	5
New York	4
Ohio	4
Michigan	4
Maryland	4

Clinical Trial Progress for Loratadine

Clinical Trial Phase

Clinical Trial Phase for Loratadine
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	19
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Loratadine
Clinical Trial Phase	Trials
Completed	49
Not yet recruiting	4
Terminated	3

Clinical Trial Sponsors for Loratadine

Sponsor Name

Sponsor Name for Loratadine
Sponsor	Trials
Merck Sharp & Dohme Corp.	14
Bayer	7
Ranbaxy Laboratories Limited	4

Sponsor Type

Sponsor Type for Loratadine
Sponsor	Trials
Industry	46
Other	30
NIH	3

Loratadine: Clinical Trials, Market Analysis, and Projections

Introduction to Loratadine

Loratadine is a second-generation antihistamine known for its efficacy in treating allergic conditions such as hay fever, allergic rhinitis, and urticaria. It is characterized by its high selectivity for peripheral histamine H1-receptors and the absence of central nervous system depressant effects, making it a preferred choice over older antihistamines[1].

Clinical Trials Update

Current and Ongoing Trials

Several clinical trials are currently underway to evaluate the efficacy and safety of loratadine in various conditions.

Combination Therapy with Ibuprofen

A Phase III longitudinal, multicenter, randomized, double-blind clinical trial is evaluating the efficacy and safety of a combination of ibuprofen and loratadine versus ibuprofen or loratadine as monotherapy for the symptomatic treatment of the common cold. This study aims to compare the fixed-dose combination of ibuprofen and loratadine against each drug used separately[4].

Loratadine in Lymphangioleiomyomatosis (LAM)

In January 2022, a clinical trial sponsored by the Institut d'Investigació Biomèdica de Bellvitge began assessing the safety and potential benefits of loratadine in LAM, a rare and lethal disease characterized by progressive cystic lung destruction[3].

COVID-19 Related Studies

During the COVID-19 pandemic, loratadine was studied as part of various treatment protocols. For instance, a study known as 'STIMULATE-ICP' in the UK examined loratadine among other medications for its potential in treating long-COVID symptoms. This research highlighted the ongoing interest in loratadine's antihistamine properties in the context of COVID-19[3].

Market Analysis

Global Market Size and Growth

The global loratadine market was valued at approximately USD 156.34 million in 2023 and is expected to grow steadily. According to market forecasts, the loratadine market is anticipated to reach USD 186.33 million by 2029, with a compound annual growth rate (CAGR) of 3.14% from 2024 to 2029[2].

Regional Market Dynamics

• North America: This region dominated the market share in 2023, driven by a high disease burden and the strong presence of several manufacturers. The increasing prevalence of seasonal and perennial allergies, along with consumer preference for non-drowsy formulations, is expected to propel market growth in this region[5].
• Asia Pacific: This region is predicted to witness the fastest CAGR over the forecast period due to rapidly growing awareness about allergic ailments, a rising geriatric population prone to allergic conditions, and the increasing prevalence of lifestyle diseases[5].

Market Segmentation

The loratadine market is segmented based on end-use into hospital pharmacy, retail pharmacy, and online pharmacy. The online pharmacy segment is expected to grow at the fastest CAGR during the forecast period, driven by the upsurge in the adoption of online platforms due to their large availability, accessibility, and affordable pricing. The integration of online pharmacy platforms with telemedicine is also expected to provide significant growth opportunities[5].

Market Drivers

Prevalence of Allergic Conditions

The high prevalence rate of allergies worldwide is a significant driver of the loratadine market. According to the American Academy of Allergy, Asthma & Immunology, the global prevalence of allergic rhinitis was estimated to be between 10% and 30% worldwide in 2021[5].

Changing Lifestyles and Environmental Factors

Changing lifestyles and increasing exposure to environmental pollutants have contributed to the escalating demand for effective antihistamine medications like loratadine[2].

Regulatory Landscape

A favorable regulatory landscape also supports the growth of the loratadine market. For instance, in January 2021, JB Chemicals and Pharmaceuticals received approval from the US health regulator to market loratadine tablets in the American market[3].

Market Projections

Growth Forecast

The global loratadine market is expected to grow at a CAGR of 2.9% from 2024 to 2030, reaching a projected market size of over USD 200 million by 2030[5].

Emerging Trends

The integration of online pharmacy platforms with telemedicine and the increasing adoption of online platforms for purchasing medications are expected to drive significant growth in the loratadine market. Additionally, the rising awareness about allergic ailments and the growing geriatric population in regions like Asia Pacific will continue to propel market growth[5].

"The high prevalence rate of allergies worldwide, changing lifestyles, and favorable regulatory landscape are significant aspects driving the overall market growth potential."[5]

Key Takeaways

• Loratadine is a well-tolerated and effective antihistamine with a high selectivity for peripheral histamine H1-receptors.
• Ongoing clinical trials are evaluating loratadine's efficacy in combination therapies and rare diseases like LAM.
• The global loratadine market is expected to grow steadily, driven by the high prevalence of allergic conditions and favorable market dynamics.
• North America and Asia Pacific are key regions driving market growth due to their high disease burden and increasing awareness about allergic ailments.
• The online pharmacy segment is expected to grow at the fastest CAGR due to its convenience and accessibility.

FAQs

What is loratadine used for?

Loratadine is used to treat allergic conditions such as hay fever, allergic rhinitis, and urticaria.

What are the advantages of loratadine over older antihistamines?

Loratadine has a high selectivity for peripheral histamine H1-receptors and lacks central nervous system depressant effects, making it a non-drowsy alternative to older antihistamines[1].

What is the current market size of the loratadine market?

The global loratadine market was valued at approximately USD 156.34 million in 2023[2].

Which region is expected to witness the fastest CAGR in the loratadine market?

The Asia Pacific region is predicted to witness the fastest CAGR over the forecast period due to growing awareness about allergic ailments and a rising geriatric population[5].

What are the key drivers of the loratadine market?

The key drivers include the high prevalence of allergic conditions, changing lifestyles, environmental factors, and a favorable regulatory landscape[2][5].

Sources

1. Loratadine. A preliminary review of its pharmacodynamic ... - PubMed
2. Loratadine Market By Size, Share and Forecast 2029F - TechSci Research
3. Global Loratadine Market Size - Mordor Intelligence
4. Efficacy and Safety in the Combination of Ibuprofen / Loratadine ... - CenterWatch
5. Loratadine Market Size, Share, Growth, Trends Report, 2030 - Grand View Research