CLINICAL TRIALS PROFILE FOR BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

505(b)(2) Clinical Trials for BETAMETHASONE ACETATE; 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 ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04593706 ↗	Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars)	Not yet recruiting	Tel-Aviv Sourasky Medical Center	N/A	2020-11-01	Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids and hypertrophic Scars)
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.
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.

Clinical Trial Conditions for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Condition Name

Condition Name for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Familial Amyotrophic Lateral Sclerosis	1
Hypertrophic Scar	1
Keloid	1
Scarring	1

Condition MeSH

Condition MeSH for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Keloid	1
Hypertrophy	1
Cicatrix, Hypertrophic	1
Cicatrix	1

Clinical Trial Locations for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Trials by Country

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Trials by Country for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Location	Trials
United States	1

Trials by US State

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−

Trials by US State for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Location	Trials
Kentucky	1

Clinical Trial Progress for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Clinical Trial Phase

Clinical Trial Phase for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase	Trials
N/A	1
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase	Trials
Completed	1
Not yet recruiting	1

Clinical Trial Sponsors for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Sponsor Name

Sponsor Name for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Sponsor	Trials
Tel-Aviv Sourasky Medical Center	1
Edward Kasaraskis	1
University of Kentucky	1

Sponsor Type

Sponsor Type for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Sponsor	Trials
Other	3

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

Introduction

Betamethasone acetate and betamethasone sodium phosphate are two formulations of the corticosteroid betamethasone, widely used in various medical conditions. This article provides an update on ongoing clinical trials, market analysis, and future projections for these drugs.

Clinical Uses of Betamethasone Acetate and Betamethasone Sodium Phosphate

Betamethasone Acetate

Betamethasone acetate is used to treat a broad range of conditions, including allergic disorders, bursitis, cerebral edema, and various inflammatory diseases such as rheumatoid arthritis, osteoarthritis, and gouty arthritis. It is commonly administered via intramuscular, intravenous, intra-articular, and soft tissue injections[4].

Betamethasone Sodium Phosphate

Betamethasone sodium phosphate is often used in combination with betamethasone acetate, providing immediate activity due to its short half-life of 36 to 72 hours. It is used for similar indications as betamethasone acetate, including acute gouty arthritis, rheumatoid arthritis, and other inflammatory conditions. It is also administered intramuscularly and intra-articularly[4].

Ongoing Clinical Trials

Studies on Betamethasone Sodium Phosphate

Several ongoing clinical trials are evaluating the efficacy and safety of betamethasone sodium phosphate. For instance, a study by Thammasat University in Thailand is comparing 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].

Another significant study by the OrthoCarolina Research Institute in the United States is investigating whether betamethasone corticosteroid injection modifies the course of De Quervain’s Tenosynovitis compared to a toradol injection (Ketorolac). This study is estimated to conclude in December 2024[2].

Studies on Betamethasone Acetate

Betamethasone acetate is also being studied in various clinical settings. While specific ongoing trials are not detailed, it is often used in combination with betamethasone sodium phosphate in clinical practice. The combination, known as Celestone® Soluspan®, is approved for multiple injection routes and is widely used for its sustained activity[4].

Market Analysis

Betamethasone Sodium Phosphate Market

The global betamethasone sodium phosphate market is projected to grow significantly, with a Compound Annual Growth Rate (CAGR) of 6.51% from 2024 to 2031. The market is expected to increase from USD 607.2 million in 2023 to USD 1005.67 million by 2031. This growth is driven by the increasing prevalence of arthritis and allergic disorders, as well as the rapid expansion of the pharmaceutical industry[2].

Betamethasone Acetate Market

The global betamethasone acetate market is valued at approximately USD 421.4 million in 2022 and is expected to exhibit a CAGR of 4.8% during the forecast period. North America dominates this market, holding a 37.8% market share, primarily due to the increased use of intramuscular suspensions for treating various diseases, including ophthalmic and dermatological conditions[5].

Regional Market Dynamics

North America

North America is expected to dominate both the betamethasone sodium phosphate and betamethasone acetate markets. The region's strong presence of leading market players, rising investments in research, and the increasing prevalence of health conditions such as arthritis and allergic disorders contribute to this dominance[2][5].

Europe

Europe is the second-largest market for betamethasone acetate, driven by the increasing prevalence of dermatological diseases. For instance, in 2021, approximately 185 million individuals in Europe were affected by dermatological conditions, which has led to an increased demand for betamethasone acetate[5].

Market Segmentation

By Application

The betamethasone acetate market is segmented into various applications, including respiratory disease, renal disease, gastrointestinal disease, ophthalmic disease, and dermatological disease. The dermatological disease segment is expected to dominate the market due to the high usage of betamethasone acetate for treating skin conditions such as inflammation[5].

By Age Group

The geriatric segment is expected to dominate the betamethasone acetate market, driven by the increased usage of the drug to treat various diseases in adults, such as renal and respiratory diseases[5].

By Distribution Channel

Hospital pharmacies are expected to dominate the distribution channel segment for betamethasone acetate, due to the increasing number of hospital pharmacies and the preference for these settings for administering corticosteroid injections[5].

Future Market Scenario

Growing Demand

The demand for both betamethasone sodium phosphate and betamethasone acetate is expected to rise due to the increasing prevalence of arthritis, allergic disorders, and other inflammatory conditions. The expansion of the pharmaceutical industry and ongoing research activities will further propel the market growth[2][5].

Emerging Trends

There is a growing trend towards the use of combination therapies, such as the combination of betamethasone acetate and betamethasone sodium phosphate, which provides both immediate and sustained activity. This trend is expected to continue, driving innovation and growth in the market[4].

Key Takeaways

• Clinical Trials: Ongoing trials are evaluating the efficacy and safety of betamethasone sodium phosphate and its combinations, particularly in treating osteoarthritis and other inflammatory conditions.
• Market Growth: Both betamethasone sodium phosphate and betamethasone acetate markets are projected to grow significantly, driven by increasing health condition prevalence and pharmaceutical industry expansion.
• Regional Dynamics: North America and Europe are key markets, with North America dominating due to strong market players and research investments.
• Market Segmentation: Dermatological and geriatric segments are expected to drive the betamethasone acetate market, while hospital pharmacies will remain a major distribution channel.

FAQs

What are the primary uses of betamethasone acetate and betamethasone sodium phosphate?

Betamethasone acetate and betamethasone sodium phosphate are used to treat various inflammatory conditions, including arthritis, bursitis, and allergic disorders. They are administered via different routes, including intramuscular, intra-articular, and soft tissue injections.

Which regions dominate the market for these drugs?

North America dominates both the betamethasone sodium phosphate and betamethasone acetate markets, followed by Europe, due to the strong presence of market players, research investments, and the prevalence of relevant health conditions.

What is the projected growth rate for the betamethasone sodium phosphate market?

The global betamethasone sodium phosphate market is projected to grow at a CAGR of 6.51% from 2024 to 2031.

What are the key drivers of the market growth for these drugs?

The increasing prevalence of arthritis and allergic disorders, along with the rapid expansion of the pharmaceutical industry, are key drivers of the market growth for both betamethasone sodium phosphate and betamethasone acetate.

Are there any ongoing clinical trials for these drugs?

Yes, there are ongoing clinical trials evaluating the efficacy and safety of betamethasone sodium phosphate, particularly in treating knee osteoarthritis and De Quervain’s Tenosynovitis.

Sources

1. Immediate and delayed effects of antenatal corticosteroids on fetal heart rate - PubMed
2. Betamethasone Sodium Phosphate Market Size, Growth, Report 2031 - Markets and Data
3. Betamethasone sodium phosphate - University of Maryland, Baltimore
4. Betamethasone acetate - University of Maryland, Baltimore
5. Betamethasone Acetate Market Size, Trends and Forecast to 2030 - Coherent Market Insights