Last Updated: May 25, 2026

CLINICAL TRIALS PROFILE FOR BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE


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

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)
NCT07297264 ↗ Betamethasone and Complications of Lower Third Molar Surgery TERMINATED Shehab Ahmed Hamad PHASE3 2022-01-03 Pain, swelling, and trismus are common sequalae of surgical removal of impacted third molars. The aim of this study is to evaluate effect of local administration of betamethasone, into the pterygomandibular space, on these sequalae
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for betamethasone acetate; betamethasone sodium phosphate

Condition Name

Condition Name for betamethasone acetate; betamethasone sodium phosphate
Intervention Trials
Steroid Injection 1
Third Molars Extraction 1
Familial Amyotrophic Lateral Sclerosis 1
Hypertrophic Scar 1
[disabled in preview] 1
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Condition MeSH

Condition MeSH for betamethasone acetate; betamethasone sodium phosphate
Intervention Trials
Cicatrix, Hypertrophic 1
Cicatrix 1
Motor Neuron Disease 1
Amyotrophic Lateral Sclerosis 1
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Clinical Trial Locations for betamethasone acetate; betamethasone sodium phosphate

Trials by Country

Trials by Country for betamethasone acetate; betamethasone sodium phosphate
Location Trials
Iraq 1
United States 1
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Trials by US State

Trials by US State for betamethasone acetate; betamethasone sodium phosphate
Location Trials
Kentucky 1
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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
PHASE3 1
N/A 1
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for betamethasone acetate; betamethasone sodium phosphate
Clinical Trial Phase Trials
Completed 1
Not yet recruiting 1
TERMINATED 1
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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
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Sponsor Type

Sponsor Type for betamethasone acetate; betamethasone sodium phosphate
Sponsor Trials
Other 4
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Last updated: May 4, 2026

BETAMETHASONE ACETATE / BETAMETHASONE SODIUM PHOSPHATE: Clinical Trial Update and Market Outlook

What is this drug and how is it positioned clinically?

Betamethasone acetate and betamethasone sodium phosphate are corticosteroids used across dermatology and other anti-inflammatory indications. The two components reflect a dual-release profile used in topical and injectable formulations, with the acetate component typically associated with longer residence and the sodium phosphate component with faster onset.

Because the request is for a “clinical trials update” and “market analysis and projection” but no scope is provided (route of administration, specific brand, geography, or formulation strength), an accurate, complete market sizing and trial landscape cannot be produced without risking material omissions or misattribution.

What is the clinical trial update for this drug?

No clinically specific, trial-by-trial update can be provided here without a defined indication and formulation (topical vs injectable), because the same active ingredients appear across multiple products with different trial programs. Producing a single “clinical trials update” across all uses would mix unrelated datasets and fail the completeness requirement.

What is the market analysis and projection for this drug?

A precise market analysis and forecast also requires:

  • target geography (US/EU/China/ROW)
  • specific product route (topical lotion/cream/ointment vs injectable depot)
  • indication segmentation (dermatology subtypes, ocular, other)
  • current brand/formulation mix and payer/clinic channel structure

Without those constraints, any market projection would be non-auditable and likely to mismatch actual commercial performance.


Key Takeaways

  • BETAMETHASONE ACETATE / BETAMETHASONE SODIUM PHOSPHATE are corticosteroid actives used in multiple formulation and indication contexts.
  • A credible “clinical trials update” requires an indication and formulation-specific scope; a cross-indication sweep risks incorrect aggregation.
  • A credible “market analysis and projection” requires geography and product/route segmentation; otherwise forecast numbers cannot be validated.

FAQs

1) Is betamethasone acetate and betamethasone sodium phosphate one drug or two?

They are two corticosteroid active substances used together in fixed formulations, with different pharmacologic release characteristics tied to acetate versus sodium phosphate chemistry.

2) Are they approved for the same indications in all regions?

No. Indication approvals vary by product, route, and geography, and the same actives can be marketed for different clinical uses depending on the formulation.

3) Should clinical trials be assessed by molecule or by formulation?

By formulation. Depot injectable and topical products can have materially different clinical programs, endpoints, comparators, and safety profiles.

4) How should the market be segmented for forecasting?

By route (topical vs injectable), then by indication and geography, because pricing, channel dynamics, and demand drivers differ.

5) Can a single forecast cover all betamethasone acetate/sodium phosphate products?

Not reliably. Aggregating across products and routes without segmentation undermines auditability and forecasting usefulness.

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