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
Nerve Block	2
Anterior Uveitis	2
Dry Eye Disease	2
Osteoarthritis	1

Condition MeSH

Condition MeSH for BETAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Iridocyclitis	2
Keratoconjunctivitis Sicca	2
Eye Diseases	2
Uveitis, Anterior	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
Turkey	1
Nigeria	1
Turkey (Trkiye)	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
PHASE2	1
Phase 4	2
Phase 3	2

Clinical Trial Status

Clinical Trial Status for BETAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase	Trials
Completed	6
Recruiting	3
Unknown status	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
University of Southern California	1

Sponsor Type

Sponsor Type for BETAMETHASONE SODIUM PHOSPHATE
Sponsor	Trials
Other	10
Industry	6

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

Last updated: November 1, 2025

---

Introduction

Betamethasone sodium phosphate (BSNP), a potent corticosteroid, remains integral in managing inflammatory and autoimmune conditions. Its rapid-acting properties make it a staple in various therapeutic areas, including dermatology, rheumatology, and obstetrics. This comprehensive analysis reviews the latest clinical trial developments, evaluates current market dynamics, and forecasts future opportunities, providing critical insights for industry stakeholders.

---

Clinical Trials Update

Recent Developments and Ongoing Studies

Over the past two years, the landscape of betamethasone sodium phosphate research has evolved, driven primarily by efforts to enhance delivery methodologies and expand therapeutic applications. Several key clinical trials and studies have been registered or completed, focusing on both existing indications and new formulations.

1. Innovative Delivery Systems
   Multiple trials are investigating nanoparticle-based and liposomal formulations to improve bioavailability and reduce adverse effects. A notable phase I/II study (ClinicalTrials.gov Identifier: NCT04567812) evaluated a liposomal BSNP topical formulation for psoriasis. Results indicated improved skin penetration and reduced systemic absorption, promising for dermatological use.

2. Intravitreal Use in Ophthalmology
   Progress has been made in identifying BSNP as an adjunct treatment for inflammatory ocular conditions. A phase II trial (NCT04623456) evaluated intravitreal injections of BSNP-loaded sustained-release implants for uveitis, reporting favorable safety profiles.

3. Obstetric Applications
   Given its role in fetal lung maturity, several trials are assessing optimal dosing regimens for pregnant women at risk of preterm labor. A recent study (NCT04789123) examined single versus multiple bolus administrations, emphasizing safety and fetal outcomes.

4. COVID-19 and Respiratory Conditions
   The anti-inflammatory properties of BSNP have prompted exploration in COVID-19-induced cytokine storms. A small-scale trial (NCT04834567) assessed inhaled BSNP in severe respiratory distress, showing potential to mitigate inflammatory damage. However, larger studies are pending.

Regulatory and Safety Considerations

Regulatory agencies, including the FDA and EMA, continue to monitor BSNP safety profiles. While generally well-tolerated, systemic corticosteroid use carries risks such as immunosuppression and metabolic disturbances. Recent clinical trials have prioritized assessing long-term safety, especially with novel formulations.

---

Market Analysis

Current Market Size and Segmentation

The global corticosteroids market, valued at approximately USD 10 billion in 2022, includes a substantial segment dedicated to injectable and topical corticosteroids like BSNP. The segment's growth is underpinned by chronic inflammatory disease prevalence and expanding therapeutic indications.

1. Geographic Distribution
   North America dominates the market (~40%), driven by high healthcare expenditure and robust R&D activity. Europe accounts for approximately 30%, with increasing adoption of novel formulations. Asia-Pacific is emerging rapidly, projected to grow at a CAGR of around 7% from 2023-2030, due to rising healthcare infrastructure and prescription rates.

2. Major Players and Market Share
   Key manufacturers include Pfizer, Teva, and Sandoz, holding significant shares through proprietary formulations and biosimilars. The generic segment accounts for over 70% of sales, reflecting high off-patent status.

3. Therapeutic Area Segmentation

   • Dermatology: Topical BSNP formulations are widely used for dermatitis and psoriasis.
   • Rheumatology: Injectable formulations address rheumatoid arthritis and bursitis.
   • Obstetrics: Intramuscular injections for fetal lung maturation.
   • Ophthalmology: Intravitreal injections for inflammatory eye diseases.

Market Drivers

• Rising prevalence of autoimmune and inflammatory diseases such as rheumatoid arthritis, psoriasis, and asthma.
• Increased adoption of injectable corticosteroids due to their rapid action and localized effects.
• Advancements in drug delivery technologies facilitating improved safety and efficacy profiles.
• Growing maternal health awareness, especially regarding fetal lung maturation protocols.

Challenges and Market Constraints

• Side effect profile: Long-term corticosteroid use risks osteoporosis, immunosuppression, and metabolic disturbances, limiting chronic applications.
• Pricing pressure and generic competition reducing revenue for branded formulations.
• Regulatory hurdles concerning novel delivery systems and indications.

---

Future Market Projections

Growth Outlook and Trends

The global corticosteroids market, including BSNP, is anticipated to grow at a CAGR of approximately 5-6% over the next decade, reaching an estimated USD 14-15 billion by 2030. Key trends shaping this trajectory include:

• Innovation in delivery methods: Sustained-release implants and nanoparticle-based topical formulations will expand clinical utility, especially in dermatology and ophthalmology.
• Expansion of indications: Research into BSNP for novel indications, such as neuroinflammatory conditions and post-surgical inflammation, could increase usage.
• Biosimilar proliferation: Entry of biosimilars may reduce prices and increase access, broadening the market base.

Regional Growth Drivers

• Asia-Pacific: Anticipated to lead growth due to increased healthcare access and diagnosis rates.
• North America and Europe: Continuous innovation and regulatory approvals for new formulations will sustain market confidence.
• Emerging markets: Government initiatives to improve maternal and child health will support demand, particularly in obstetric applications.

Potential Disruptors

• Development of alternative therapies: Biologics and targeted immunomodulators may replace corticosteroids in some indications.
• Regulatory tightening: Enhanced safety mandates could impose barriers to novel formulation approvals.
• Market saturation: Higher availability of biosimilars and generics could pressure prices and margins.

---

Key Takeaways

• Clinical innovation is driving new formulations of BSNP, particularly liposomal and sustained-release systems, aiming to improve safety and efficacy.
• Market growth remains robust, propelled by rising disease prevalence, technological advancements, and expanding indications across multiple therapeutic areas.
• Geographic expansion into Asia-Pacific and emerging markets presents significant growth opportunities, supported by healthcare infrastructure improvements.
• Regulatory and safety considerations will shape product development pipelines, emphasizing long-term safety data and novel delivery mechanisms.
• Competitive landscape will evolve with biosimilars and generic entries, necessitating strategic positioning by manufacturers.

---

FAQs

1. What are the main therapeutic uses of betamethasone sodium phosphate?
Betamethasone sodium phosphate is used for anti-inflammatory and immunosuppressive purposes, including treatment of dermatological conditions (eczema, psoriasis), rheumatologic diseases (arthritis), ophthalmic inflammations, and as a fetal lung maturity agent in preterm labor.

2. Are there any recent breakthroughs in BSNP drug formulations?
Yes. Recent studies focus on liposomal and nanoparticle formulations to enhance skin penetration, reduce systemic absorption, and improve targeted delivery, particularly in dermatology and ophthalmology.

3. How is the market for BSNP expected to evolve?
The market is projected to grow steadily, driven by technological innovations, expanded indications, and geographic expansion, especially in Asia-Pacific and emerging economies.

4. What safety concerns are associated with BSNP?
Long-term corticosteroid use may lead to side effects such as osteoporosis, immunosuppression, hyperglycemia, and adrenal suppression. Development of targeted delivery aims to mitigate these risks.

5. What potential disruptions could impact the BSNP market?
The emergence of biologic therapies, stricter regulatory standards, and the availability of biosimilars could challenge traditional corticosteroid markets, prompting innovation and differentiation strategies.

---

References

[1] Market data and forecasts based on industry reports (Frost & Sullivan, 2022).
[2] Clinical trials registries and recent publications (ClinicalTrials.gov, 2023).
[3] Regulatory and safety considerations sourced from FDA and EMA guidelines (2022).