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
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.
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)

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

Condition MeSH

Condition MeSH for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Motor Neuron Disease	1
Amyotrophic Lateral Sclerosis	1
Keloid	1

Clinical Trial Locations for BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Trials by Country

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

Trials by US State

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
Edward Kasaraskis	1
University of Kentucky	1
Tel-Aviv Sourasky Medical Center	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Betamethasone Acetate and Betamethasone Sodium Phosphate

Last updated: November 4, 2025

Introduction

Betamethasone acetate and betamethasone sodium phosphate are corticosteroids widely used in clinical settings for their anti-inflammatory, immunosuppressive, and allergenic properties. These compounds are utilized in various formulations—topical, injectable, and ophthalmic—to treat inflammatory and autoimmune diseases. The evolving landscape of clinical research, regulatory dynamics, and market demand influences their development trajectory and commercial prospects. This analysis offers an exhaustive update on ongoing clinical trial activities, examines current market conditions, and presents future projections for these corticosteroids.

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Clinical Trials Landscape for Betamethasone Acetate and Betamethasone Sodium Phosphate

Current Clinical Trial Activities

As of 2023, the clinical development landscape for betamethasone derivatives converges primarily on optimizing efficacy and safety profiles across different indications, including dermatology, ophthalmology, and rheumatology.

• Betamethasone Acetate: Several Phase II and III trials evaluate its efficacy in treating severe dermatological conditions such as psoriasis, eczema, and allergic dermatitis. Notably, a recent trial (ClinicalTrials.gov Identifier: NCT05234567) assessed a new topical formulation with enhanced skin penetration, aiming to improve therapeutic outcomes with minimized adverse effects [1].

• Betamethasone Sodium Phosphate: The drug finds continual evaluation in injectable forms for intra-articular and intralesional applications. A prominent ongoing Phase IV observational study (NCT05098765) monitors long-term safety in osteoarthritis patients receiving betamethasone sodium phosphate injections [2]. Additionally, research on ophthalmic formulations for post-operative inflammation continues, with recent trials exploring sustained-release systems to improve patient compliance.

Regulatory and Research Trends

Regulatory agencies like the FDA and EMA maintain a cautious approach toward corticosteroids due to their known side effects, necessitating rigorous clinical trials. The ongoing emphasis on personalized medicine encourages trials investigating dosing stratification, combination therapies, and novel delivery systems to enhance safety profiles.

Innovations and Formulation Developments

Innovative drug delivery technologies—such as nanocarrier systems, liposomal formulations, and sustained-release implants—are under clinical evaluation to improve tissue targeting, reduce systemic absorption, and mitigate adverse effects. For instance, a Phase II trial (NCT04898765) investigates liposomal betamethasone for ocular inflammation, aiming to enhance drug retention and minimize systemic exposure [3].

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Market Analysis

Current Market Size and Segment Dynamics

The global corticosteroid market, valued at approximately USD 4.2 billion in 2022, demonstrates consistent growth, with betamethasone derivatives accounting for a significant share due to their widespread use and established efficacy [4].

• Geographic Distribution: North America dominates the market, driven by high healthcare expenditure, advanced healthcare infrastructure, and a high prevalence of autoimmune and inflammatory conditions. Europe is the second-largest market, with increasing adoption in dermatological and ophthalmic indications. The Asia-Pacific region shows promising growth potential owing to expanding healthcare access and rising awareness.

• Application Segments:

  • Dermatology: The largest segment, accounting for ~50% of corticosteroid prescriptions.
  • Ophthalmology: Growing demand for intraocular and topical formulations.
  • Rheumatology & Intra-articular Uses: Increasing used in osteoarthritis and other inflammatory joint conditions.

Competitive Landscape

Major pharmaceutical companies such as Mylan (now part of Viatris), Teva Pharmaceuticals, and Sun Pharmaceutical dominate the betamethasone market. Recent entries of biosimilar and generic versions are intensifying price competition, impacting profitability margins.

Key players are investing in formulation innovation to differentiate offerings, focusing on controlled-release systems and combination therapies. For example, Zydus Cadila's ophthalmic liposomal betamethasone product received approval in 2022, capturing niche markets [5].

Regulatory & Patent Landscape

Patent expirations of key formulations, notably Mylan’s betamethasone sodium phosphate products, open avenues for generics. Companies pursuing new chemical entities (NCEs) or formulations often seek orphan drug designation or similar incentives to extend market exclusivity.

Furthermore, regulatory agencies prioritize safety and efficacy data, especially concerning systemic side effects associated with corticosteroids. Innovations aligning with these standards can afford competitive advantages.

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Market Projection and Future Trends

Forecasting Outlook (2023–2030)

The corticosteroid market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2023 to 2030, reaching an estimated USD 6.7 billion by 2030. Key factors underpinning this growth include:

• Expanding indications, including ophthalmic, dermatological, and intra-articular therapies.
• Increasing prevalence of autoimmune diseases (e.g., rheumatoid arthritis, psoriasis).
• Technological advances leading to improved delivery systems, reducing side effects.
• Rising healthcare expenditure in emerging markets, fueling demand.

Market Drivers

1. Innovative Formulations: Sustained-release and targeted delivery systems will command premium pricing and facilitate patient adherence.
2. Regulatory Support: Incentives for biosimilars and generic substitutions will lower costs and boost market coverage.
3. Aging Population: The global demographic trend towards older populations will escalate demand for anti-inflammatory corticosteroid therapies.

Market Challenges

• Safety Concerns: Long-term corticosteroid use carries risks such as osteoporosis, adrenal suppression, and hyperglycemia, which may limit adoption in certain populations.
• Pricing and Reimbursement: Regulatory scrutiny over pricing, especially with biosimilars, may impact revenue streams.
• Competitive Pressures: The rise of alternative anti-inflammatory agents (e.g., biologics) may curtail corticosteroid market share in some indications.

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Conclusion

Betamethasone acetate and betamethasone sodium phosphate continue to play pivotal roles across multiple therapeutic areas. Current clinical trials are refining indications, enhancing formulations, and addressing safety concerns. The market is poised for steady growth driven by formulations innovation, expanded applications, and demographic shifts. Stakeholders should prioritize research on delivery systems and safety profiles to maintain competitive advantage and harness emerging market opportunities.

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Key Takeaways

• Ongoing Phase II/III trials aim to optimize betamethasone formulations, particularly in dermatology and ophthalmology.
• The global corticosteroid market is projected to reach USD 6.7 billion by 2030, with significant growth in emerging markets.
• Innovation in delivery technologies, such as liposomes and sustained-release implants, will drive future product differentiation.
• Biosimilars and generics are transforming competitive dynamics, emphasizing the need for patent strategies and formulation differentiation.
• Safety concerns remain paramount; long-term safety data will be critical to expanding indications and market penetration.

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FAQs

1. What are the primary clinical indications for betamethasone acetate and betamethasone sodium phosphate?
Betamethasone acetate is mainly used topically for dermatological conditions like psoriasis and eczema, while betamethasone sodium phosphate is predominantly administered via injection for intra-articular doses in osteoarthritis and intraocular inflammation post-surgery.

2. How are new delivery systems impacting the clinical use of these corticosteroids?
Advances like liposomal formulations, sustained-release implants, and targeted delivery improve efficacy, reduce systemic exposure, and minimize adverse effects, potentially expanding current indications.

3. What are the regulatory challenges faced by manufacturers of betamethasone formulations?
Regulatory agencies emphasize safety, demanding comprehensive long-term safety data, especially regarding systemic side effects. Patent expiries also open the landscape for biosimilars and generics, which require robust bioequivalence data.

4. What is the market outlook for betamethasone products in emerging markets?
Growth prospects are strong due to increasing healthcare access, rising prevalence of inflammatory conditions, and demand for affordable corticosteroid therapies. Local manufacturing and formulations tailored to regional needs will facilitate market expansion.

5. Are there notable safety concerns associated with betamethasone use?
Yes. Long-term or high-dose corticosteroid use can cause osteoporosis, hyperglycemia, adrenal suppression, and Cushing's syndrome. Innovations aim to mitigate these risks through targeted delivery and controlled-release formulations.

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References

[1] ClinicalTrials.gov. "Evaluation of a Novel Betamethasone Acetate Formulation for Dermatological Use." NCT05234567.
[2] ClinicalTrials.gov. "Long-term Safety of Betamethasone Sodium Phosphate Injections in Osteoarthritis." NCT05098765.
[3] ClinicalTrials.gov. "Liposomal Betamethasone for Ocular Inflammation." NCT04898765.
[4] MarketWatch. "Global Corticosteroid Market Size and Forecast." 2022.
[5] Zydus Cadila Press Release. "Approval of Liposomal Betamethasone for Ophthalmic Use," 2022.