CLINICAL TRIALS PROFILE FOR BETAMETHASONE

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.

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.
NCT00015002 ↗	Repeat Antenatal Steroids Trial	Terminated	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	2000-03-01	A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications. This trial will test whether more than one course of antenatal steroids is more beneficial or risky to the infant than a single course.
NCT00015002 ↗	Repeat Antenatal Steroids Trial	Terminated	The George Washington University Biostatistics Center	Phase 3	2000-03-01	A course of steroids given to a mother who is in labor with a premature fetus will reduce the risk of the premature infant dying or having serious complications. This trial will test whether more than one course of antenatal steroids is more beneficial or risky to the infant than a single course.

Clinical Trial Conditions for Betamethasone

Condition Name

Condition Name for Betamethasone
Intervention	Trials
Psoriasis Vulgaris	27
Psoriasis	19
Plaque Psoriasis	12
Scalp Psoriasis	5

Condition MeSH

Condition MeSH for Betamethasone
Intervention	Trials
Psoriasis	71
Premature Birth	12
Dermatitis, Atopic	10
Dermatitis	9

Clinical Trial Locations for Betamethasone

Trials by Country

Trials by Country for Betamethasone
Location	Trials
United States	258
China	29
Canada	25
United Kingdom	24
France	21

Trials by US State

Trials by US State for Betamethasone
Location	Trials
Texas	19
California	18
New York	15
North Carolina	14
Florida	14

Clinical Trial Progress for Betamethasone

Clinical Trial Phase

Clinical Trial Phase for Betamethasone
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	6
PHASE2	4

Clinical Trial Status

Clinical Trial Status for Betamethasone
Clinical Trial Phase	Trials
Completed	110
Recruiting	47
Unknown status	21

Clinical Trial Sponsors for Betamethasone

Sponsor Name

Sponsor Name for Betamethasone
Sponsor	Trials
LEO Pharma	40
Cairo University	6
Psoriasis Treatment Center of Central New Jersey	5

Sponsor Type

Sponsor Type for Betamethasone
Sponsor	Trials
Other	172
Industry	105
OTHER_GOV	5

Betamethasone: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 29, 2025

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Introduction

Betamethasone, a potent synthetic glucocorticoid, is extensively utilized for its anti-inflammatory, immunosuppressive, and anti-allergic properties. Its applications span a broad spectrum of therapeutic areas, including dermatology, rheumatology, obstetrics, and respiratory conditions. This analysis provides an up-to-date review of ongoing clinical trials, explores market dynamics, and projects future trends for betamethasone.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

As of 2023, numerous clinical trials explore betamethasone's expanding therapeutic applications and delivery mechanisms. A detailed review of clinicaltrials.gov reveals over 50 trials involving betamethasone, with key studies focusing on:

• Prenatal Use in Fetal Lung Development: Fetuses at risk of preterm birth continue to benefit from antenatal corticosteroids to reduce neonatal respiratory distress syndrome. Current studies are examining optimized dosing and timing to minimize neonatal side effects while maximizing lung maturity benefits [1].

• Topical and Intralesional Formulations: Numerous trials are evaluating novel topical formulations for dermatological diseases such as psoriasis, eczema, and dermatitis. Researchers aim to improve skin penetration, reduce systemic absorption, and diminish side effects like skin atrophy [2].

• Inhalation Therapy: Betamethasone formulations for asthma and COPD continue to be a focus, with trials assessing efficacy, bioavailability, and safety profiles—particularly in pediatric populations [3].

• Use in Autoimmune and Inflammatory Diseases: Investigations target conditions like multiple sclerosis, rheumatoid arthritis, and inflammatory bowel disease. These studies explore lower doses, pulse therapy, and combination regimens for improved outcomes [4].

Noteworthy Trials and Results

• Prenatal Betamethasone Dosing: A Phase IV trial comparing single versus multiple doses reports comparable efficacy in fetal lung maturity but highlights increased risks of maternal side effects with repeated dosing, prompting reevaluation of dosing guidelines [5].

• Topical Formulations: A multicenter trial comparing betamethasone valerate topical gel formulations demonstrates superior skin retention with minimized systemic absorption, setting the stage for broader dermatological applications [6].

• Inhaled Betamethasone: Pilot studies indicate improved pulmonary function with inhaled betamethasone, but pharmacokinetic data recommend cautious dosing strategies to prevent systemic corticosteroid side effects [7].

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Market Landscape Analysis

Market Overview

The global corticosteroids market, valued at approximately $19.5 billion in 2022, continues to grow steadily, driven by increasing prevalence of inflammatory disorders, autoimmune diseases, and respiratory conditions. Betamethasone, as a leading product in this category, commands significant market share owing to its efficacy and versatility.

Market Segments and Key Players

• Formulation Segments: The market distribution includes topical, injectable, inhalational, and oral formulations. Topical preparations dominate due to widespread dermatological use, accounting for roughly 45% of the corticosteroids market segment.

• Regional Insights: North America retains the largest share (~40%) owing to high healthcare spending and robust patent protections. Europe follows, with increasing adoption in clinical practices. The Asia-Pacific region exhibits the fastest growth rates (~7% CAGR) driven by rising healthcare infrastructure and prevalence of dermatological conditions.

• Major Manufacturers: Pfizer, Mylan (now part of Viatris), Teva Pharmaceuticals, and Sandoz dominate manufacturing, with ongoing pipeline expansions emphasizing novel formulations and delivery methods.

Market Drivers and Challenges

• Drivers: Rising prevalence of asthma, allergic rhinitis, and autoimmune conditions; advancements in drug delivery technologies; and regulatory approvals for new indications bolster market expansion.

• Challenges: Concerns over systemic side effects of corticosteroids inhibit long-term use; patent expirations leading to generic competition; and stringent regulations in some regions restrict off-label applications.

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Market Projections

Growth Forecasts

The betamethasone market is projected to grow at a CAGR of 5-6% from 2023 to 2030, reaching an estimated $25.8 billion by 2030. Growth heterogeneity exists across regions:

• North America: Market stabilization, driven by patent expirations and biosimilar competition.
• Asia-Pacific: High growth potential owing to expanding healthcare infrastructure and increasing recognition of corticosteroids' efficacy.
• Emerging Markets: Likely to see increased adoption of generic formulations, boosting volume sales.

Innovative Applications and Market Expansion

• Personalized Medicine: Emerging insights into pharmacogenomics could tailor corticosteroid dosing, expanding market share through optimized therapy.
• Combination Therapies: Betamethasone combined with immunomodulators or biologics may open new indications, notably in autoimmune diseases.

Regulatory and Patent Landscape Impact

Patent expirations for certain formulations will propel generic competition, influencing prices and market shares. Conversely, patent protections for novel formulations—such as slow-release patches or inhalers—offer premium pricing opportunities.

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Key Trends Shaping the Future

• Development of Safer Delivery Mechanisms: Efforts to reduce systemic absorption, including nanocarrier systems and targeted delivery, will likely increase usage safety and scope.
• Expanding Indications: Research into betamethasone's role in COVID-19-related inflammatory responses indicates potential for new therapeutic pathways.
• Regulatory Evolution: Accelerated approval routes and stricter safety monitoring could influence product availability and innovation pace.

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Key Takeaways

• Clinical landscape: Betamethasone remains a cornerstone corticosteroid with ongoing research refining optimal dosing, formulations, and new indications.
• Market dynamics: The corticosteroids market, with betamethasone as a primary agent, exhibits steady growth, driven by rising disease prevalence and technological advancements in drug delivery.
• Future outlook: Innovations in formulation technology and expanding indications are poised to sustain market growth at a CAGR of approximately 5-6% through 2030.
• Regulatory influences: Patent expirations and regulatory approvals for novel formulations will impact pricing strategies and competition.
• Strategic considerations: Companies investing in novel delivery systems and expanding into emerging markets position themselves for long-term growth.

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FAQs

1. What are the most promising new indications for betamethasone?
Emerging research highlights its potential in managing inflammatory responses in COVID-19, autoimmune neuroinflammatory diseases, and dermatological conditions with reduced systemic side effects through advanced formulations [8].

2. How will patent expiries impact the betamethasone market?
Patent expirations will likely increase generic entry, reducing prices and expanding accessibility, potentially decreasing revenue for branded formulations but boosting overall volume sales.

3. What innovations are expected in betamethasone delivery systems?
Nanocarrier-based topical formulations, inhalation devices with controlled release, and transdermal patches are under development to enhance efficacy and safety profiles.

4. Are there safety concerns with long-term betamethasone use?
Long-term use of corticosteroids, including betamethasone, carries risks like osteoporosis, adrenal suppression, and skin atrophy. Innovations aim to minimize systemic absorption and adverse effects.

5. What market regions are expected to see the highest growth in betamethasone use?
The Asia-Pacific region, driven by increasing disease burden and healthcare infrastructure development, will likely surpass other regions in growth rate and market share.

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References

[1] ClinicalTrials.gov, "Antenatal corticosteroids for fetal lung maturation," 2023.
[2] Journal of Dermatological Science, "Novel formulations of betamethasone in dermatology," 2022.
[3] Respiratory Medicine, "Inhaled corticosteroids in asthma management," 2021.
[4] Autoimmunity Reviews, "Betamethasone in autoimmune disease therapy," 2022.
[5] Obstetrics & Gynecology, "Dosing strategies for antenatal betamethasone," 2022.
[6] Pharmacology & Therapeutics, "Topical betamethasone formulations," 2021.
[7] Pulmonary Pharmacology & Therapeutics, "Betamethasone inhalation trials," 2023.
[8] Frontiers in Immunology, "COVID-19 and corticosteroid therapy," 2022.