CLINICAL TRIALS PROFILE FOR BETAMETHASONE SODIUM PHOSPHATE

505(b)(2) Clinical Trials for betamethasone sodium phosphate

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	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	Edward Kasaraskis	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	University of Kentucky	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.

All Clinical Trials for betamethasone sodium phosphate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00542139 ↗	Evaluation of Diprospan Injection to the Knee on Rehabilitation of Patients After TKR of the Contralateral Knee	Completed	Hadassah Medical Organization	Phase 4	2007-12-01	This study is performed to assess the influence of intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate) into osteoarthritic knee in patients who undergo a total knee replacement of their contralateral knee. The study population will include 50 patients with bilateral knee osteoarthritis, admitted for their first knee replacement surgery. Only patients with older than 50 years with primary osteoarthritis will be included. The patients will be randomized into 2 groups. Intervention group will receive an injection of 2ml Diprospan diluted in 10 ml Bupivocaine. The control group will receive an injection of 10ml of Bupivocaine. All patients will be followed after 6 weeks and three functional rehabilitation and pain scores will be assessed (VAS pain score, Timed Up and Go Score and Functional Ambulatory Category Scale).
NCT00406887 ↗	Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis	Completed	Sirion Therapeutics, Inc.	Phase 3	2002-08-01	The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.
NCT00405496 ↗	Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis	Completed	Sirion Therapeutics, Inc.	Phase 2	2000-03-01	The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.

Clinical Trial Conditions for betamethasone sodium phosphate

Condition Name

Condition Name for betamethasone sodium phosphate
Intervention	Trials
Anterior Uveitis	2
Dry Eye Disease	2
Neonatal Respiratory Distress Syndrome	1

Condition MeSH

Condition MeSH for betamethasone sodium phosphate
Intervention	Trials
Keratoconjunctivitis Sicca	2
Eye Diseases	2
Uveitis, Anterior	2

Clinical Trial Locations for betamethasone sodium phosphate

Trials by Country

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−

Trials by Country for betamethasone sodium phosphate
Location	Trials
United States	33
Israel	3
Nigeria	1
China	1
Turkey	1

Trials by US State

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−

Trials by US State for betamethasone sodium phosphate
Location	Trials
California	3
Kentucky	3
New York	3
Texas	2
Tennessee	2

Clinical Trial Progress for betamethasone sodium phosphate

Clinical Trial Phase

Clinical Trial Phase for betamethasone sodium phosphate
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	4

Clinical Trial Status

Clinical Trial Status for betamethasone sodium phosphate
Clinical Trial Phase	Trials
Completed	6
Recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for betamethasone sodium phosphate

Sponsor Name

Sponsor Name for betamethasone sodium phosphate
Sponsor	Trials
Surface Pharmaceuticals, Inc.	2
Sirion Therapeutics, Inc.	2
Ahmadu Bello University Teaching Hospital	1

Sponsor Type

Sponsor Type for betamethasone sodium phosphate
Sponsor	Trials
Other	10
Industry	5

Betamethasone Sodium Phosphate: Clinical Trials, Market Analysis, and Projections

Introduction

Betamethasone sodium phosphate is a corticosteroid widely used in the treatment of various inflammatory and allergic conditions. This article provides an update on the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Completed Trials

Several clinical trials are currently underway or have recently been completed to evaluate the safety and efficacy of betamethasone sodium phosphate in different medical conditions.

• KIDS-STEP_Betamethasone Therapy in Hospitalised Children With CAP: This Phase 3 trial, sponsored by Julia Bielicki, is evaluating the safety of betamethasone hydrochloride tablets in hospitalized children with community-acquired pneumonia (CAP). The trial, which involves 510 participants, is expected to be completed by June 2025[1].

• Antenatal Corticosteroid Therapy: A trial conducted by Central Hospital, Nancy, France, has been completed and focused on the impact of antenatal corticosteroid therapy on birth parameters. This study involved 363 participants and was concluded in December 2022[1].

• Betamethasone Sodium Phosphate for Dry Eye Disease: A Phase 2 trial by Harrow Health is investigating the efficacy and safety of an eye drop (SURF-200) containing betamethasone sodium phosphate for treating episodic flare-ups of dry eye disease. The trial was completed in March 2022[1].

• Intra-articular Corticosteroid Injection for Knee Osteoarthritis: Thammasat University, Thailand, is conducting a study to compare the efficacy of intra-articular corticosteroid injections of Triamcinolone acetonide and Betamethasone (Diprospan) for treating knee osteoarthritis. This study is expected to conclude in June 2024[2][5].

Safety and Efficacy Studies

A multicenter, randomized, double-masked study published in Dove Medical Press evaluated the ocular safety, tolerability, and efficacy of 0.2% betamethasone sodium phosphate in cataract surgery subjects. The study found that betamethasone sodium phosphate was safe and effective in reducing inflammation post-surgery[4].

Market Analysis

Market Size and Growth

The global betamethasone sodium phosphate market is projected to experience significant growth over the forecast period from 2024 to 2031. Here are some key market metrics:

• Market Size: The market is expected to grow from USD 607.2 million in 2023 to USD 1005.67 million in 2031, with a Compound Annual Growth Rate (CAGR) of 6.51%[2][5].

• Driving Factors: The increasing prevalence of arthritis, allergies, and other inflammatory conditions is a major driver of this growth. For instance, the Centre for Disease Control and Prevention estimates that approximately 5.4% of adults aged 18-44 and 26% of adults aged 45-64 in the United States have reported arthritis, which significantly boosts the demand for betamethasone sodium phosphate[2].

Regional Market Dynamics

The market is dominated by North America due to the strong presence of leading pharmaceutical companies and research institutions. For example, the OrthoCarolina Research Institute is conducting a study to determine if corticosteroid injections (betamethasone) modify the course of De Quervain’s Tenosynovitis, further contributing to the market's growth[2].

Product Forms and Benefits

The solid form of betamethasone sodium phosphate is particularly popular due to its ease of handling, cost efficiency, and preference in the pharmaceutical industry for formulating injections and tablets. This form is also favored for its ease of transportation and distribution[5].

Market Projections

Future Growth Opportunities

The market is expected to see lucrative growth opportunities driven by several factors:

• Increasing Prevalence of Diseases: The rise in cases of arthritis, allergies, and other inflammatory conditions globally will continue to drive the demand for betamethasone sodium phosphate[2][5].

• Research and Development: Ongoing and future clinical trials, such as those conducted by Thammasat University and the OrthoCarolina Research Institute, will further evaluate the efficacy and safety of betamethasone sodium phosphate, potentially expanding its applications[2][5].

• Pharmaceutical Industry Expansion: The rapid expansion of the pharmaceutical industry, particularly in regions like North America and Europe, will support the growth of the betamethasone sodium phosphate market. For instance, Europe accounted for 23.4% of global pharmaceutical sales in 2021, while North America accounted for 49.1%[5].

Key Players and Competitive Landscape

The global betamethasone sodium phosphate market includes several key players and research institutions that are actively involved in clinical trials and product development. Companies like Harrow Health and leading research institutions such as Thammasat University and the OrthoCarolina Research Institute are driving innovation and growth in this market[2][5].

Conclusion

Betamethasone sodium phosphate is poised for significant growth driven by its increasing use in treating various inflammatory and allergic conditions. Ongoing and future clinical trials will continue to evaluate its safety and efficacy, further expanding its applications. The market's projected CAGR of 6.51% from 2024 to 2031 underscores the strong potential for this drug in the pharmaceutical industry.

Key Takeaways

• The global betamethasone sodium phosphate market is projected to grow from USD 607.2 million in 2023 to USD 1005.67 million in 2031.
• The market is driven by the increasing prevalence of arthritis, allergies, and other inflammatory conditions.
• Ongoing clinical trials are evaluating the safety and efficacy of betamethasone sodium phosphate in various medical conditions.
• The solid form of betamethasone sodium phosphate is preferred due to its ease of handling and cost efficiency.
• North America dominates the market due to the strong presence of leading pharmaceutical companies and research institutions.

FAQs

What is the current market size of betamethasone sodium phosphate?

The current market size of betamethasone sodium phosphate is approximately USD 607.2 million in 2023[2][5].

What is the projected CAGR for the betamethasone sodium phosphate market from 2024 to 2031?

The projected CAGR for the betamethasone sodium phosphate market from 2024 to 2031 is 6.51%[2][5].

What are the primary drivers of the betamethasone sodium phosphate market growth?

The primary drivers include the increasing prevalence of arthritis, allergies, and other inflammatory conditions, as well as the rapid expansion of the pharmaceutical industry[2][5].

Which regions dominate the betamethasone sodium phosphate market?

North America and Europe are the dominant regions in the betamethasone sodium phosphate market, with North America accounting for a significant share due to the presence of leading pharmaceutical companies and research institutions[2][5].

What are some of the ongoing clinical trials involving betamethasone sodium phosphate?

Ongoing trials include studies on its use in treating knee osteoarthritis, dry eye disease, and community-acquired pneumonia in children, among others[1][2][5].

Why is the solid form of betamethasone sodium phosphate preferred?

The solid form is preferred due to its ease of handling, cost efficiency, and ease of transportation and distribution[5].