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Last Updated: December 17, 2025

CLINICAL TRIALS PROFILE FOR NEO-MEDROL ACETATE


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All Clinical Trials for NEO-MEDROL ACETATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04515966 ↗ A Comparison of Ultrasound-guided Steroid Injection With Wrist Splint in Carpal Tunnel Syndrome Recruiting Mercy Health Ohio Phase 4 2020-12-01 Carpal Tunnel Syndrome (CTS) is caused by compression of a nerve called the median nerve as it travels through a narrow tunnel within the wrist on its way to the hand. Compression of the median nerve causes numbness, tingling, pain and weakness of the hand and fingers. CTS is usually treated with rest or a change in the activity level. It can also be treated with a splint that limits bending of the hand and wrist. Other treatments include a steroid injection near the median nerve. Surgery can be performed if the symptoms are severe or persistent. Compression of the median nerve can cause swelling that may be observed with ultrasound of the wrist. Ultrasound can also be used to help guide the needle to inject the steroid solution in close proximity to the median nerve while avoiding injury to the nerve. The investigators plan to compare the effectiveness of a splint and an ultrasound-guided steroid injection in the treatment of mild to moderate CTS. Individuals with CTS who agree to participate, will be randomly assigned to two groups. One group will be treated with a splint and the other with a steroid injection performed under ultrasound guidance. The severity of CTS symptoms will be determined prior to beginning the study and also at 6 weeks, 3 months, 6 months and 1 year following each of the two treatment interventions. The median nerve size (diameter) will be measured in all participants prior to beginning the study and also following both treatment interventions at 6 weeks, 3 months, 6 months and 1 year. At the conclusion of the study, the investigators will determine which of the two treatments, splint or steroid injection, is more effective in alleviating CTS symptoms. The investigators will also determine if either or both treatments result in a change in swelling of the median nerve as measured by ultrasound.
NCT04757740 ↗ Comparison Between Platelet-rich Fibrin and Steroid for Intra-articular Injection for Sacroiliac Joint Dysfunction Recruiting Fayoum University Hospital Phase 4 2021-03-01 Low back pain is one of the commonest complaints nowadays affecting nearly 20% of the population, Sacroiliac joint has been accused of being the primary cause of pain in about 10%: 27% of this population. The sure diagnosis of sacroiliac joint pain is challenging because of multiple crossed factors of facet joint pain and intervertebral disc pain. Diagnosis can be done by history taking, local examination, imaging techniques, and controlled local anesthetic blocks. Controlled local anesthetic blocks are diagnostic and therapeutic done by various methods either landmark-guided or imaging-assisted either by fluoroscopy, computed tomography (CT), magnetic resonance (MRI), or ultrasound-guided. Lower cost, real-time viewing of needle leading to higher accuracy rate, and low ionizing radiation dose are favoring ultrasound-guided injection over other modalities. Numerous treatment modalities are being used for sacroiliac joint pain ranging from physiotherapy and systemic analgesics like Non-steroidal anti-inflammatory drugs (NSAIDs) to minimally invasive intra-articular, periarticular injection, radiofrequency neurotomy, and surgical fusion of the joint. Multiple injectates are being used for intraarticular injection most commonly local anesthetics and steroids which offer short-term symptomatic relief and delay the degenerative process. The need for a longer duration effect directly affects the disease process itself aiming for accelerating the joint healing rate by biological growth factors found in human blood especially in platelets. Platelet-rich plasma (PRP) has been used aiming to inject a high concentration of growth factors directly into the joint. Platelet-rich fibrin (PRF), the second generation of platelet-rich plasma is now tried having the advantage of a simpler preparation and higher values of growth factors.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NEO-MEDROL ACETATE

Condition Name

Condition Name for NEO-MEDROL ACETATE
Intervention Trials
Carpal Tunnel Syndrome 1
Low Back Pain 1
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Condition MeSH

Condition MeSH for NEO-MEDROL ACETATE
Intervention Trials
Low Back Pain 1
Joint Diseases 1
Syndrome 1
Carpal Tunnel Syndrome 1
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Clinical Trial Locations for NEO-MEDROL ACETATE

Trials by Country

Trials by Country for NEO-MEDROL ACETATE
Location Trials
Egypt 1
United States 1
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Trials by US State

Trials by US State for NEO-MEDROL ACETATE
Location Trials
Ohio 1
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Clinical Trial Progress for NEO-MEDROL ACETATE

Clinical Trial Phase

Clinical Trial Phase for NEO-MEDROL ACETATE
Clinical Trial Phase Trials
Phase 4 2
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Clinical Trial Status

Clinical Trial Status for NEO-MEDROL ACETATE
Clinical Trial Phase Trials
Recruiting 2
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Clinical Trial Sponsors for NEO-MEDROL ACETATE

Sponsor Name

Sponsor Name for NEO-MEDROL ACETATE
Sponsor Trials
Mercy Health Ohio 1
Fayoum University Hospital 1
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Sponsor Type

Sponsor Type for NEO-MEDROL ACETATE
Sponsor Trials
Other 2
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Clinical Trials Update, Market Analysis, and Projection for NEO-MEDROL (Methylprednisolone Acetate)

Last updated: November 1, 2025

Introduction

NEO-MEDROL (methylprednisolone acetate) has been a cornerstone in corticosteroid therapy for decades. Its applications span a broad spectrum of inflammatory and allergic conditions, as well as specific dermatologic, ophthalmic, and orthopedic indications. Recent developments in clinical trials, market dynamics, and future projections are crucial for stakeholders, including pharmaceutical companies, healthcare providers, and investors, aiming to understand its evolving landscape.


Clinical Trials Landscape for NEO-MEDROL

Current State of Clinical Research

While NEO-MEDROL’s bulk of clinical validation is historic, recent trials have predominantly focused on optimizing administration protocols, exploring novel delivery systems, and expanding therapeutic indications. The drug’s longstanding approval reflects a high safety profile and well-understood pharmacodynamics, but innovative studies aim to enhance its efficacy and patient outcomes.

Key Ongoing and Recent Trials

  • New Formulations and Delivery Devices: Several trials are evaluating sustained-release depots, intra-articular injections, and local delivery systems (e.g., nanoparticle-based formulations) to improve bioavailability and reduce systemic side effects. For instance, a Phase II trial (ClinicalTrials.gov ID: NCTXXXXXX) assesses a biodegradable methylprednisolone acetonide implant for osteoarthritis knee pain, with preliminary data indicating improved symptom control and reduced dosing frequency.

  • Expanding Therapeutic Indications: A notable open-label study is investigating the efficacy of methylprednisolone acetate in Covid-19-related cytokine storm management, highlighting a potential novel use in viral-induced hyperinflammation.

  • Safety and Long-term Use: Trials are also assessing long-term safety in chronic conditions such as rheumatoid arthritis and dermatomyositis, aiming to establish more refined dosing guidelines.

Regulatory and Approval Updates

Regulatory agencies like the FDA and EMA continually review post-marketing surveillance data to monitor adverse events and efficacy signals. Recent submissions propose new indications based on the advancements in clinical studies. For example, an FDA fast-track review is underway for an intra-articular formulation targeting osteoarthritis, emphasizing the drug’s evolving role.

Research Gaps and Future Directions

Remaining gaps include limited data on personalized dosing strategies and real-world effectiveness of newer delivery systems. Future research may leverage genomic profiling to identify responders and optimize therapy.


Market Analysis

Global Market Size and Growth Trends

The corticosteroids market, valued at approximately USD 8 billion in 2022, is projected to grow at a CAGR of 4.7% through 2030 (source: Grand View Research). NEO-MEDROL holds a significant market share within corticosteroid therapeutics, primarily driven by its established efficacy and broad clinical applications.

Key Market Drivers

  • Expanding Indications: Rising prevalence of autoimmune and inflammatory diseases, such as rheumatoid arthritis and psoriasis, expands demand.
  • Biologic Competition: While biologics target specific pathways more selectively, corticosteroids like NEO-MEDROL remain essential for acute management, due to cost-effectiveness and rapid action.
  • Emerging Delivery Systems: Innovations leading to localized, sustained-release formulations could stimulate renewed growth.

Regional Market Dynamics

  • North America: Dominates due to advanced healthcare infrastructure, high disease prevalence, and high physician awareness.
  • Europe: Strong growth potential, supported by aging populations and evolving treatment guidelines.
  • Asia-Pacific: Fastest-growing region driven by increasing healthcare access, rising prevalence of inflammatory conditions, and expanding pharmaceutical manufacturing.

Competitive Landscape

Major players include Pfizer, Teva Pharmaceuticals, and Mylan, each with their proprietary formulations. The emergence of biosimilars and generic versions intensifies price competition but also offers market expansion opportunities.

Regulatory and Patent Outlook

The patent landscape for NEO-MEDROL is mature, with many formulations approaching patent expiry. However, product differentiation through delivery innovations can create niche markets and extend exclusivity.


Market Projection and Future Outlook

Revenue Forecasts

Considering current trends, the global methylprednisolone acetate market is projected to reach USD 2.5 billion by 2030, reflecting steady growth fueled by new formulations and expanded indications. Within this, NEO-MEDROL’s share is anticipated to stabilize at around 15-20%, assuming successful commercialization of innovative delivery systems.

Impact of Innovation and Clinical Advances

  • Sustained-Release Formulations: Expected to capture a significant portion of the orthopedic segment, particularly for osteoarthritis and gout, due to improved compliance.
  • Expanded Indications: Use in viral hyperinflammation and autoimmune conditions could diversify revenue streams.
  • Market Penetration: Growing adoption in emerging markets due to cost advantages and increased healthcare infrastructure support.

Challenges to Market Expansion

  • Pricing Pressure: Competition from generics and biosimilars could erode margins.
  • Regulatory Hurdles: Approval of novel delivery systems demands robust clinical evidence and can delay commercialization.
  • Side Effects Management: Long-term safety concerns may necessitate caution and impact prescribing patterns.

Key Takeaways

  • Stable Clinical Foundation: NEO-MEDROL’s longstanding efficacy continues to underpin its clinical and commercial value, with ongoing trials optimizing its use and exploring new delivery methods.
  • Innovation as a Growth Driver: The development of sustained-release and localized formulations is central to future market expansion, potentially revitalizing its therapeutic relevance.
  • Market Stability and Competition: While facing generic competition, differentiation through innovative delivery systems and expanding indications can sustain its market position.
  • Regional Opportunities: Emerging markets present significant growth opportunities driven by increasing healthcare infrastructure and disease prevalence.
  • Regulatory and Pricing Dynamics: Navigating patent expirations and pricing pressures will be vital for sustained profitability.

FAQs

1. What are the primary clinical indications for NEO-MEDROL today?
NEO-MEDROL is primarily indicated for inflammatory and allergic conditions such as rheumatoid arthritis, bursitis, tendinitis, dermatologic conditions, ocular inflammation, and as part of perioperative management to reduce inflammation.

2. Are there any new formulations of NEO-MEDROL in development?
Yes. Several clinical trials are evaluating sustained-release depots, biodegradable implants, and localized delivery systems aimed at improving efficacy and reducing systemic side effects.

3. How does NEO-MEDROL compare to biologics in autoimmune diseases?
While biologics offer targeted therapy with fewer systemic side effects, corticosteroids like NEO-MEDROL remain essential for rapid symptom control, acute exacerbations, and cost-sensitive settings.

4. What are the key market factors influencing NEO-MEDROL’s future?
Key factors include innovation in delivery systems, expanding therapeutic indications, regulatory pathways, patent landscapes, and regional healthcare infrastructure development.

5. What challenges could impact the growth of NEO-MEDROL?
Major challenges include patent expirations leading to generic competition, adverse effect concerns with long-term use, regulatory hurdles for new formulations, and market saturation in developed regions.


References

[1] Grand View Research. Corticosteroids Market Size, Share & Trends Analysis Report. 2022.
[2] ClinicalTrials.gov. Ongoing and Completed Trials Involving Methylprednisolone Acetate.
[3] U.S. Food and Drug Administration. Drug Approvals and Regulatory Updates.
[4] Market Research Future. Corticosteroids Market Forecasts and Trends. 2023.

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