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.
NCT00137501 ↗	Two Dose Regimens of Nifedipine for the Management of Preterm Labor	Terminated	American University of Beirut Medical Center	Phase 3	2003-05-01	Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most widely used tocolytic at the American University of Beirut Medical Center despite the fact that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm labor to the extent that some authorities are recommending abandoning it for routine use as a tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe alternative tocolytic agent for the management of preterm labor after several studies have shown that the use of nifedipine in comparison with other tocolytics is associated with a more frequent successful prolongation of pregnancy, resulting in significantly fewer admissions of newborns to the neonatal intensive care unit, and is associated with a lower incidence of respiratory distress syndrome. The unequivocal impact of this method of tocolysis on short term postponement of delivery and the opportunity that this provides for affecting in-utero transfer and steroid administration has prompted many investigators to recommend focusing future trials on testing different dose regimens of nifedipine. To the best of the investigators' knowledge, no study comparing two different dose regimens of nifedipine has been previously published in the literature. The objective of their study is to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In addition, the investigators' study will try to assess the safety profile of the 2 dose regimens on the mother and the neonate by assessing a selected number of outcome variables. The data generated will be used to change their protocol for managing patients presenting with threatened preterm delivery and will fill the existing gap regarding the most effective and safest dose regimen of nifedipine in such patients.
NCT00139256 ↗	Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section	Terminated	Emory University	Phase 2/Phase 3	2005-08-01	This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone versus a placebo given prior to the mothers at term and near term gestation (>34 and 30 minutes from 4.5% to 2.5%.

Clinical Trial Conditions for betamethasone

Condition Name

Condition Name for betamethasone
Intervention	Trials
Psoriasis Vulgaris	27
Psoriasis	19
Plaque Psoriasis	13
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	52
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	7
PHASE3	9
PHASE2	4

Clinical Trial Status

Clinical Trial Status for betamethasone
Clinical Trial Phase	Trials
Completed	111
Recruiting	48
Unknown status	21

Clinical Trial Sponsors for betamethasone

Sponsor Name

Sponsor Name for betamethasone
Sponsor	Trials
LEO Pharma	40
Cairo University	7
Psoriasis Treatment Center of Central New Jersey	5

Sponsor Type

Sponsor Type for betamethasone
Sponsor	Trials
Other	176
Industry	108
NIH	5

Betamethasone Market Analysis and Financial Projection

Last updated: May 1, 2026

Betamethasone: Clinical Trials Update, Market Analysis, and Projection

What does “betamethasone” cover in the market and trials?

Betamethasone is a corticosteroid used across dermatology, ophthalmology, respiratory disease, rheumatology/autoimmune indications, and obstetrics (notably fetal lung maturation). Commercially, it appears as multiple branded and generic products and multiple salt/ester forms, with different regulatory footprints by route (oral, topical, inhaled, ophthalmic, injectable). The clinical-trials landscape is therefore indication-specific and route-specific, and trial counts can vary materially depending on whether databases classify “betamethasone” as a single active substance versus specific forms (e.g., betamethasone sodium phosphate, betamethasone acetate, combinations with antibiotics/antiseptics).

Clinical Trials Update: what is actively tracked?

Betamethasone trials are typically concentrated in:

• Inflammatory dermatoses (topical steroid potency comparisons; vehicle formulation; steroid-sparing regimens)
• Ophthalmic inflammation (post-operative inflammation control; uveitis or blepharitis programs; combination products)
• Respiratory and allergenic inflammation (inhaled corticosteroid regimens; rescue strategies; short-course comparisons)
• Autoimmune/inflammatory systemic indications (adjunct strategies with immunomodulators; flare management protocols)
• Obstetrics (fetal lung maturation regimens, often in obstetric and perinatal critical-care protocols)

Constraint on completeness: A fully complete, count-level “up to date” clinical-trials update requires a live sweep of trial registries and paywalled sponsor databases. With no live query capability and no specific database export attached, the only safe, non-speculative statement is that betamethasone remains a mature, widely trialed active with ongoing post-marketing and indication-optimization studies. The request for a “clinical trials update” with current status, phase mix, and top-sponsor pipeline cannot be produced accurately without a source snapshot.

What is the betamethasone market structure by route?

Betamethasone is a mature, off-patent steroid in most jurisdictions, so the market is dominated by:

• Generic topical and ophthalmic products (multiple strength/vehicle variants)
• Branded hospital/obstetric injectable in some geographies and tender cycles
• Multi-ingredient combination products (where betamethasone is paired with antibiotics/antifungals or anesthetics for dermatology and ophthalmology)

Implication for analysis: market share is driven less by “innovation pipeline” and more by:

• Regulatory approvals for new formulations
• Tender procurement and hospital formulary inclusion
• Combination-product positioning and pharmacist/prescriber preference
• Bioequivalence and switching cycles for generics

How big is the betamethasone opportunity and where does growth come from?

A defensible market projection for “betamethasone” depends on defining the TAM by:

• Route (topical vs ophthalmic vs injectable vs inhaled)
• Formulation (single active vs combinations)
• Geography and reimbursement design

Without a cited baseline market size and explicit TAM definition, producing a numerical projection would introduce unverifiable claims. A clean projection can only be produced from a specific market report dataset (or an explicit model with supplied baselines). No such dataset is provided or citable from the prompt.

What would an actionable projection look like (framework tied to betamethasone’s economics)?

Even for mature steroids, projection work can be made decision-grade if it separates three drivers:

1. Volume stability and conversion dynamics

• Topical corticosteroids often show stable chronic-use demand.
• Switching happens with formulary changes and generic launch waves.
• Growth is usually modest in mature markets, faster in expanding healthcare access regions.

2. Mix shift toward higher-value presentations

• Combination products can command higher net prices than single-ingredient products.
• Ophthalmic perioperative segments can show better reimbursement resilience versus OTC topical.

3. Regulatory and procurement effects

• Injectable and obstetric programs are procurement-driven; tender cycles can create short-term discontinuities in revenue.
• Local GMP and supply chain execution often decide winner outcomes more than molecule IP.

Regulatory and competitive positioning

For betamethasone, commercial differentiation is typically realized through:

• New dosage forms and fixed-dose combinations
• Improved safety profiles via formulation (vehicle, particle size, penetration tuning for topical)
• Route expansion via clinical substantiation (label expansion rather than de novo patent protection)

In practical terms, any “market projection” for betamethasone products should be modeled as a portfolio of formulations rather than a single product line, each with different pricing and lifecycle events.

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Key Takeaways

• Betamethasone is a mature corticosteroid with clinical activity that remains route and indication specific rather than driven by a new-molecule pipeline.
• Market economics are dominated by generics and formulation-level differentiation; growth depends on mix shift (combination products and route-specific reimbursement) and procurement dynamics (injectable/obstetrics).
• A numeric “clinical trials update” and a quantified “market projection” cannot be produced to decision-grade standards without a citable live trial registry snapshot and a defined baseline market dataset.

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FAQs

1) Is betamethasone still the subject of new clinical trials?
Yes, but most programs focus on formulation optimization, route-specific indications, and comparative regimens rather than new mechanism-of-action development.

2) What indications matter most for betamethasone revenue?
Revenue is typically concentrated in dermatology/topical anti-inflammatory use, ophthalmic anti-inflammatory and post-operative settings, and injectable/obstetric hospital procurement, depending on geography.

3) Why does betamethasone market growth look modest versus newer biologics?
Because the molecule is mature and largely off-patent, competing products are primarily generics and combinations, making price and share outcomes sensitive to tendering and switching.

4) What drives product differentiation for betamethasone?
Dosage form, vehicle, concentration, and combination partnering (e.g., fixed-dose combinations) are the dominant commercial levers.

5) How should projections be modeled for betamethasone?
Model by route and formulation class, then overlay geography-specific tender and reimbursement dynamics rather than treating “betamethasone” as one homogeneous product.

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References

[1] APA citation list not available because no sources were provided in the prompt and no external sources were retrieved in this session.