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Last Updated: May 16, 2025

CLINICAL TRIALS PROFILE FOR BETAMETHASONE


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505(b)(2) Clinical Trials for Betamethasone

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

All Clinical Trials for Betamethasone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004778 ↗ Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery Completed Children's Hospital of Philadelphia Phase 3 1993-08-01 OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004778 ↗ Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 3 1993-08-01 OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
NCT00004778 ↗ Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery Completed National Center for Research Resources (NCRR) Phase 3 1993-08-01 OBJECTIVES: I. Evaluate the effect of thyrotropin-releasing hormone (TRH) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. II. Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease. III. Investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Betamethasone

Condition Name

Condition Name for Betamethasone
Intervention Trials
Psoriasis Vulgaris 27
Psoriasis 18
Plaque Psoriasis 11
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Condition MeSH

Condition MeSH for Betamethasone
Intervention Trials
Psoriasis 70
Premature Birth 12
Respiratory Distress Syndrome, Newborn 9
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Clinical Trial Locations for Betamethasone

Trials by Country

Trials by Country for Betamethasone
Location Trials
United States 256
Canada 25
United Kingdom 24
China 22
France 21
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Trials by US State

Trials by US State for Betamethasone
Location Trials
Texas 19
California 18
New York 15
Florida 14
Pennsylvania 13
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Clinical Trial Progress for Betamethasone

Clinical Trial Phase

Clinical Trial Phase for Betamethasone
Clinical Trial Phase Trials
Phase 4 55
Phase 3 47
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Betamethasone
Clinical Trial Phase Trials
Completed 105
Recruiting 34
Unknown status 21
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Clinical Trial Sponsors for Betamethasone

Sponsor Name

Sponsor Name for Betamethasone
Sponsor Trials
LEO Pharma 40
Cairo University 5
Shahid Beheshti University of Medical Sciences 4
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Sponsor Type

Sponsor Type for Betamethasone
Sponsor Trials
Other 158
Industry 97
NIH 5
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Betamethasone: Clinical Trials Update, Market Analysis, and Projections

Introduction to Betamethasone

Betamethasone is a synthetic corticosteroid with potent anti-inflammatory and immunosuppressive properties. It is widely used in the treatment of various health conditions, including arthritis, allergies, inflammatory diseases, and skin disorders. Here, we will delve into the current clinical trials, market analysis, and future projections for betamethasone.

Current Clinical Trials

Several clinical trials are ongoing or recently completed to evaluate the efficacy and safety of betamethasone in different applications:

Evaluation of Topical Rebamipide Versus Topical Betamethasone

A Phase 1/2 trial sponsored by Cairo University is comparing the efficacy of topical rebamipide versus topical betamethasone for the management of oral ulcers in Behcet's disease. This trial is not yet recruiting and involves 40 participants[1].

Antenatal Corticosteroid Therapy

A completed trial sponsored by Central Hospital, Nancy, France, investigated the impact of antenatal corticosteroid therapy on birth parameters. This study involved 363 participants and was completed in December 2022[1].

Preemptive Infiltration for Postoperative Pain

A Phase 4 trial conducted by Beijing Tiantan Hospital evaluated the efficacy of preemptive infiltration with betamethasone and ropivacaine for postoperative pain in laminoplasty or laminectomy. The trial involved 116 participants and was active but not recruiting as of December 2021[1].

BETANINO: Betamethasone Dose Reduction

The BETANINO trial, sponsored by Assistance Publique - Hôpitaux de Paris, is a non-inferiority study evaluating the neurocognitive outcomes of children born before 32 weeks of gestation with reduced doses of betamethasone. This trial involves 643 participants and is expected to complete by October 2025[1].

Market Analysis

Market Size and Growth Projections

The global betamethasone sodium phosphate market is poised for significant growth. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.51% from 2024 to 2031, increasing from USD 607.2 million in 2023 to USD 1005.67 million by 2031[2].

Key Drivers of Market Growth

  • Increasing Prevalence of Health Conditions: The rising incidence of arthritis, allergies, and other inflammatory diseases is a major driver. For instance, the increasing cases of asthma and arthritis globally are boosting the demand for betamethasone sodium phosphate[2].
  • Expansion of the Pharmaceutical Industry: The rapid expansion of the pharmaceutical industry, particularly in North America and Europe, is another significant factor. North America, with its strong presence of leading market players and research institutions, is expected to dominate the market[2].
  • Research and Development: Ongoing research and clinical trials are driving the market. Studies evaluating the efficacy of betamethasone sodium phosphate for various conditions will further augment demand[2].

Regional Analysis

  • North America: Expected to dominate the market due to the strong presence of leading market players and research institutions.
  • Europe: Accounts for a significant share of the global pharmaceutical market, with Europe accounting for 23.4% of global pharmaceutical sales in 2021[2].
  • Asia-Pacific: Projected to have the fastest CAGR during the forecast period, driven by an increase in cases of asthma and other chronic diseases[2].

Market Segmentation

By Type

The betamethasone market is segmented into different forms, including:

  • Betamethasone Dipropionate: Used in ointments and creams for skin conditions.
  • Betamethasone Sodium Phosphate: Commonly used in injectable and oral forms for systemic conditions.
  • Betamethasone Valerate: Used in topical preparations for skin diseases[5].

By Distribution Channel

Hospital pharmacies are a dominant distribution channel, particularly in North America, due to the preference for these channels for pharmaceutical products[2].

Competitive Landscape

The market is characterized by the presence of several leading players, including:

  • Merck & Co., Inc.
  • American Regent, Inc.
  • GlaxoSmithKline plc.
  • East West Pharma
  • Omega Remedies Pvt Ltd.
  • Moraceae Pharmaceuticals Pvt. Ltd.
  • Emson Medichem Pvt. Ltd.
  • Dermocare Laboratories (Guj.) Pvt Ltd
  • Cipla Inc.
  • Micro Labs Ltd
  • Pharmtak Ophtalmics Pvt. Ltd.
  • Psyco Remedies[2][5].

These companies are investing heavily in research and development, driving innovation and competition in the market.

Market Challenges

Side Effects

Despite the growth drivers, the market faces challenges such as side effects associated with betamethasone sodium phosphate, including soaring blood pressure, itching, muscle weakness, and osteoporosis. These side effects can hamper market growth[2][5].

Regulatory Restrictions

Government regulations regarding the safety and efficacy of betamethasone sodium phosphate can also impact market growth. Strict regulatory environments may limit the market's expansion[2][5].

Future Market Scenario

The future of the betamethasone sodium phosphate market looks promising, with ongoing research and clinical trials expected to evaluate the effects of the drug for various conditions. This will provide lucrative growth opportunities and further boost the demand for betamethasone sodium phosphate.

"The global betamethasone sodium phosphate market is projected to grow at a CAGR of 6.51% from 2024 to 2031, driven by the increasing prevalence of arthritis, allergies, and the expansion of the pharmaceutical industry"[2].

Key Takeaways

  • Market Growth: The global betamethasone sodium phosphate market is projected to grow at a CAGR of 6.51% from 2024 to 2031.
  • Key Drivers: Increasing prevalence of health conditions and the expansion of the pharmaceutical industry.
  • Regional Dominance: North America is expected to dominate the market, followed by Europe and the Asia-Pacific region.
  • Market Segmentation: The market is segmented by type into betamethasone dipropionate, sodium phosphate, and valerate.
  • Challenges: Side effects and regulatory restrictions are key challenges facing the market.

Frequently Asked Questions (FAQs)

1. What is the projected CAGR of the betamethasone sodium phosphate market from 2024 to 2031?

The market is projected to grow at a CAGR of 6.51% from 2024 to 2031[2].

2. What are the primary drivers of the betamethasone sodium phosphate market?

The primary drivers include the increasing prevalence of arthritis and allergies, and the rapid expansion of the pharmaceutical industry[2].

3. Which region is expected to dominate the betamethasone sodium phosphate market?

North America is expected to dominate the market due to the strong presence of leading market players and research institutions[2].

4. What are the benefits of the solid form of betamethasone sodium phosphate?

The solid form is preferred due to its ease of handling, cost efficiency in transportation and distribution, and its suitability for formulating injections and tablets[2].

5. What are the potential challenges facing the betamethasone sodium phosphate market?

The market faces challenges such as side effects associated with the drug and regulatory restrictions regarding its safety and efficacy[2][5].

Sources

  1. LARVOL Sigma: Betamethasone News - LARVOL Sigma.
  2. DrugPatentWatch: Betamethasone Sodium Phosphate Market Analysis and Price Projections.
  3. Cognitive Market Research: Betamethasone Market Report 2024 (Global Edition).
  4. EU Clinical Trials: Double-blind randomized controlled study versus placebo to evaluate the efficacy of mono-administration of betamethasone in children with symptomatic conditions.
  5. Allied Market Research: Betamethasone Ointment Market Size, Share & Industry Analysis 2026.
Last updated: 2025-01-07

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