CLINICAL TRIALS PROFILE FOR BETAMETHASONE SODIUM PHOSPHATE

505(b)(2) Clinical Trials for 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 SODIUM PHOSPHATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00405496 ↗	Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis	Completed	Sirion Therapeutics, Inc.	Phase 2	2000-03-01	The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of uveitis.
NCT00406887 ↗	Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis	Completed	Sirion Therapeutics, Inc.	Phase 3	2002-08-01	The purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.
NCT00542139 ↗	Evaluation of Diprospan Injection to the Knee on Rehabilitation of Patients After TKR of the Contralateral Knee	Completed	Hadassah Medical Organization	Phase 4	2007-12-01	This study is performed to assess the influence of intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate) into osteoarthritic knee in patients who undergo a total knee replacement of their contralateral knee. The study population will include 50 patients with bilateral knee osteoarthritis, admitted for their first knee replacement surgery. Only patients with older than 50 years with primary osteoarthritis will be included. The patients will be randomized into 2 groups. Intervention group will receive an injection of 2ml Diprospan diluted in 10 ml Bupivocaine. The control group will receive an injection of 10ml of Bupivocaine. All patients will be followed after 6 weeks and three functional rehabilitation and pain scores will be assessed (VAS pain score, Timed Up and Go Score and Functional Ambulatory Category Scale).
NCT00914836 ↗	Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder	Withdrawn	HaEmek Medical Center, Israel	N/A	2009-06-01	The use of corticosteroid subacromial injections have been found to be effective for the treatment of shoulder pain. Higher doses may be better than lower doses for subacromial corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to compare 2 doses of corticosteroids.
NCT00982332 ↗	Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica	Unknown status	Bnai Zion Medical Center	N/A	2010-03-01	The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.
NCT02066844 ↗	Navigator vs Standard Needle Injection for Hip	Completed	Cartiva, Inc.	Phase 2	2014-02-01	The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a standard needle injection. In addition, delivery preparation will be compared between a Navigator injection and a standard hip injection. The data collected from this pilot study will serve as the basis to design a larger multi-center study.
NCT03446937 ↗	Effect of Antenatal Corticosteroids on Neonatal Morbidity.	Completed	Ahmadu Bello University Teaching Hospital	N/A	2017-12-01	It will be a randomized controlled trial. There will be two study groups. Study group 1 will be given dexamethasone while study group 2 will be given betamethasone. The control group will be given placebo.

Clinical Trial Conditions for BETAMETHASONE SODIUM PHOSPHATE

Condition Name

Condition Name for BETAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Anterior Uveitis	2
Nerve Block	2
Dry Eye Disease	2
Morbidity	1

Condition MeSH

Condition MeSH for BETAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Eye Diseases	2
Uveitis, Anterior	2
Dry Eye Syndromes	2
Uveitis	2

Clinical Trial Locations for BETAMETHASONE SODIUM PHOSPHATE

Trials by Country

Trials by Country for BETAMETHASONE SODIUM PHOSPHATE
Location	Trials
United States	33
Israel	3
China	1
Turkey	1
Iraq	1

Trials by US State

Trials by US State for BETAMETHASONE SODIUM PHOSPHATE
Location	Trials
California	3
Kentucky	3
New York	3
Texas	2
Tennessee	2

Clinical Trial Progress for BETAMETHASONE SODIUM PHOSPHATE

Clinical Trial Phase

Clinical Trial Phase for BETAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for BETAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase	Trials
Completed	6
Recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for BETAMETHASONE SODIUM PHOSPHATE

Sponsor Name

Sponsor Name for BETAMETHASONE SODIUM PHOSPHATE
Sponsor	Trials
Surface Pharmaceuticals, Inc.	2
Sirion Therapeutics, Inc.	2
Edward Kasaraskis	1

Sponsor Type

Sponsor Type for BETAMETHASONE SODIUM PHOSPHATE
Sponsor	Trials
Other	11
Industry	6

BETAMETHASONE SODIUM PHOSPHATE Market Analysis and Financial Projection

Last updated: April 23, 2026

Betamethasone Sodium Phosphate: Clinical Trials Update, Market Analysis, and Projection

Betamethasone sodium phosphate (BSP) is an injectable corticosteroid positioned across multiple inflammatory and allergic indications. Commercial availability is largely driven by generic and established-brand products rather than ongoing, single-entity innovation. Clinical-trial activity for BSP itself is sporadic in public registries; most contemporary development is incremental (formulation, local delivery, or comparative studies in established steroid indications) rather than new molecular entities.

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What clinical trials exist for betamethasone sodium phosphate right now?

Registry coverage and trial pattern

Public clinical-trial registries show a pattern typical for older, off-patent corticosteroids: low frequency of new trials that explicitly use betamethasone sodium phosphate as the active ingredient and higher frequency of trials that evaluate:

• Betamethasone-containing regimens (often including other betamethasone salts or combination dosing)
• Local administration approaches (e.g., intra-articular, ocular, or procedural use)
• Comparative safety/PK endpoints for formulations

Trial archetypes seen in BSP-linked studies

Across recent years, BSP-linked public studies typically fall into three buckets:

1) Obstetrics and preterm-related indications
Betamethasone is used to promote fetal lung maturation in preterm birth risk. Many BSP-related trials test dosing timing, schedule comparisons, or comparative corticosteroid regimens using betamethasone products broadly.

2) Inflammation and pain syndromes treated with corticosteroid injections
Trials frequently evaluate symptom relief and safety in orthopedic or inflammatory settings, with BSP used as the steroid agent. Endpoints often include pain scores and inflammatory biomarker changes.

3) Ocular inflammation and peri-procedural steroid protocols
Ocular-use trials exist for corticosteroid dosing strategies and complication profiles (e.g., postoperative inflammation), with BSP sometimes included depending on formulation.

Most recent observable signal

In practice, the highest “actionable” clinical signal for investors in BSP is less about breakthrough efficacy and more about:

• Formulation differentiation (solubility, onset, injection tolerability)
• Comparative clinical outcomes vs other corticosteroids
• Regulatory lifecycle events tied to manufacturing changes and generic competition

(Clinical-trial discovery for BSP is fragmented because many studies reference betamethasone products without consistently naming “betamethasone sodium phosphate” as a standalone active ingredient in trial metadata.)

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How big is the betamethasone sodium phosphate market and where does demand come from?

Demand drivers

BSP demand tracks three enduring sources:

• Generic injection consumption in acute and chronic inflammation
• Procedural and perioperative corticosteroid use
• Ongoing obstetrics use for fetal lung maturation regimens where betamethasone is standard of care

Market characterization

BSP sits within a broader corticosteroid injection market dominated by:

• Betamethasone and dexamethasone products
• Hydrocortisone derivatives
• Methylprednisolone analogs

BSP’s market shape is usually:

• High volume, low unit-value relative to specialty biologics
• Strong price competition from generics
• Tender and hospital formulary dependence
• Regulatory and manufacturing continuity as key risk factors

Competitive structure

BSP’s competitive landscape is characterized by:

• Multiple interchangeable generic injectables
• Brand heritage in obstetrics and established inflammatory use
• Local/regional variations in preferred steroid formulation and pricing

The commercial outcome is that BSP behaves like a mature product: revenue growth depends more on volume stability, substitution stability, and geographic tender dynamics than on innovation cycles.

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What is the likely market projection for betamethasone sodium phosphate?

Base-case projection framework

Because BSP is an older, off-patent steroid, market projections typically use three levers:

1) Unit volume stability
Driven by standard-of-care inclusion in obstetrics and routine injection use for inflammation.

2) Price erosion and tender dynamics
Generic corticosteroids face ongoing downward pricing pressure, especially where supply increases.

3) Formulation continuity and supply reliability
Manufacturing reliability and regulatory quality drive supply availability more than clinical differentiation.

Projection direction

For BSP specifically, the market trajectory is usually:

• Modest revenue growth in nominal terms due to population and healthcare utilization growth
• Flat to declining real pricing from generic competition
• Regional variability with tenders determining winners

A reasonable projection profile for an investment or procurement lens is:

• Revenue: low-single-digit CAGR (nominal)
• Margins: constrained unless a supplier holds procurement leverage or differentiated formulation approvals
• Volume: stable to slightly up in areas with growth in obstetric care access and chronic inflammatory treatment coverage

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Where are the commercial inflection points in clinical development for BSP?

Commercially meaningful clinical questions

Even when trials show “incremental” findings, commercial relevance concentrates on endpoints that affect:

• Hospital formulary selection
• Switching behavior among competing corticosteroids
• Reimbursement and procurement preferences
• Safety and administration tolerance

Most commercially relevant trial designs

For BSP, the trial types that tend to influence market uptake include:

• Comparative studies vs dexamethasone or methylprednisolone under similar dosing and administration protocols
• Formulation and bioavailability work that supports rapid onset or reduced administration burden
• Safety surveillance data that addresses known class risks (infection risk, glucose effects, ocular pressure considerations when used in eye contexts)

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What does regulatory and IP reality imply for strategy?

BSP is positioned inside a mature IP environment. Strategy typically shifts from “protection of a novel molecule” to:

• Manufacturing process quality
• Regulatory lifecycle management
• Line extension via formulation improvements
• Local market approvals and lifecycle submissions

The practical investment implication: growth comes from supply dominance and lifecycle execution, not from patent exclusivity.

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Market and clinical summary for decision-makers

Clinical

• BSP-linked trials concentrate on established steroid use cases (obstetrics, injection-based inflammation, procedural and ocular protocols).
• Novelty is typically incremental, with procurement-relevant endpoints more common than new disease targets.

Market

• Demand is stable and driven by standard-of-care and routine injection practice.
• Revenue growth is constrained by generic competition and price erosion.
• Supply reliability and tender dynamics shape commercial outcomes.

Projection

• Market is likely to grow nominally with healthcare utilization but remains price pressured.
• Winners capture share through supply continuity, quality track record, and formulary positioning.

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Key Takeaways

• Betamethasone sodium phosphate is a mature, off-patent corticosteroid with clinical demand anchored in established indications.
• Public clinical-trial activity is present but predominantly incremental, targeting formulation and comparative outcomes rather than new therapeutic breakthroughs.
• Market growth is expected to be modest and nominal, with flat-to-declining real pricing under sustained generic competition.
• Commercial advantage is most likely to come from manufacturing reliability, procurement leverage, and lifecycle execution.

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FAQs

1) Is betamethasone sodium phosphate still being actively studied in modern trials?

Yes, but trial activity is mainly incremental and concentrated in established steroid use contexts, often emphasizing comparative outcomes and formulation or administration parameters.

2) What indications drive the largest and most stable demand?

Obstetrics-related regimens for fetal lung maturation risk and routine injection-based management of inflammatory conditions typically provide the most durable demand.

3) How does generic competition affect pricing for BSP?

Generic penetration typically drives price erosion and compresses margins, with procurement tenders determining market share among suppliers.

4) What clinical endpoints matter most for commercial uptake?

Endpoints that influence hospital and formulary selection, including comparative effectiveness and safety under routine use, matter more than exploratory biomarkers.

5) What is the most likely revenue trajectory over the next few years?

Nominal revenue is likely to grow modestly with utilization, while real growth remains constrained by pricing pressure and supply competition.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. Accessed 2026-04-23. https://clinicaltrials.gov/
[2] World Health Organization. Corticosteroids (class) and essential medicine context. Accessed 2026-04-23. https://www.who.int/
[3] FDA. Drug Development and Clinical Trials information for corticosteroids and labeling context. Accessed 2026-04-23. https://www.fda.gov/