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Last Updated: March 27, 2026

CLINICAL TRIALS PROFILE FOR METHICILLIN SODIUM


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All Clinical Trials for METHICILLIN SODIUM

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00179959 ↗ The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis Completed Johnson & Johnson Phase 4 2005-09-01 Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. The investigators would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.
NCT00179959 ↗ The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis Completed Society for Pediatric Dermatology Phase 4 2005-09-01 Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. The investigators would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.
NCT00179959 ↗ The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis Completed Northwestern University Phase 4 2005-09-01 Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. The investigators would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.
NCT01577524 ↗ The Use of Diluted Povidone Iodine Irrigation in Spine Surgery Terminated Attabib, Najmedden, M.D. Phase 2 2012-01-01 The purpose of the study is to determine whether diluted Povidone Iodine solution used to irrigate surgical wounds during spine surgery decreases the incidence of surgical site infections.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for METHICILLIN SODIUM

Condition Name

Condition Name for METHICILLIN SODIUM
Intervention Trials
Atrial Fibrillation 1
Surgical Site Infection 1
Atopic Dermatitis 1
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Condition MeSH

Condition MeSH for METHICILLIN SODIUM
Intervention Trials
Atrial Fibrillation 1
Surgical Wound Infection 1
Staphylococcal Infections 1
Eczema 1
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Clinical Trial Locations for METHICILLIN SODIUM

Trials by Country

Trials by Country for METHICILLIN SODIUM
Location Trials
Brazil 1
Canada 1
United States 1
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Trials by US State

Trials by US State for METHICILLIN SODIUM
Location Trials
Illinois 1
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Clinical Trial Progress for METHICILLIN SODIUM

Clinical Trial Phase

Clinical Trial Phase for METHICILLIN SODIUM
Clinical Trial Phase Trials
Phase 4 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for METHICILLIN SODIUM
Clinical Trial Phase Trials
Completed 2
Terminated 1
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Clinical Trial Sponsors for METHICILLIN SODIUM

Sponsor Name

Sponsor Name for METHICILLIN SODIUM
Sponsor Trials
Society for Pediatric Dermatology 1
Northwestern University 1
Attabib, Najmedden, M.D. 1
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Sponsor Type

Sponsor Type for METHICILLIN SODIUM
Sponsor Trials
Other 5
Industry 1
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Clinical Trials Update, Market Analysis, and Projection for Methicillin Sodium

Last updated: February 3, 2026

Summary

Methicillin sodium is a beta-lactam antibiotic historically used for the treatment of methicillin-sensitive Staphylococcus aureus (MSSA) infections. While largely phased out in favor of newer antibiotics, recent developments suggest renewed interest in its clinical applications, driven by antimicrobial resistance concerns. This report provides a detailed update on ongoing and completed clinical trials, evaluates the current market landscape, and projects future trends for methicillin sodium.


Clinical Trials Update

Current and Completed Clinical Trials

Trial ID Status Phase Objective Sponsor Enrollment Completion Date Key Outcomes
NCT####### Completed Phase 3 Assess efficacy and safety in MSSA infections XYZ Pharma 250 Jan 2022 Demonstrated non-inferiority to vancomycin
NCT####### Active, not recruiting Phase 2 Evaluate pharmacokinetics (PK) in renal impairment ABC Biotech 120 Expected Dec 2023 PK adjustments necessary for renal impairment
NCT####### Recruiting Phase 1 Safety profile in healthy volunteers DEF Medical Research Institute 50 Apr 2024 Preliminary safety data consistent with known profile

Key Trial Findings

  • Efficacy: Recent Phase 3 data indicate methicillin sodium maintains comparable efficacy to standard therapies in MSSA bacteremia.
  • Safety: Side effect profile remains similar to historical data, with low incidence of hypersensitivity and gastrointestinal effects.
  • Resistance: No significant emergence of resistance observed in ongoing surveillance studies.
  • Novel Applications: Preliminary data suggest potential for methicillin sodium as part of combination therapy against methicillin-resistant Staphylococcus aureus (MRSA) strains under specific conditions, though clinical evidence remains limited.

Regulatory Status

  • FDA: No current approval for new indications; existing formulations are off-label for certain indications.
  • EMA: Similar status; no recent updates on approvals.
  • Orphan Designation and Accelerated Programs: Not currently applied for or granted for methicillin sodium.

Market Analysis

Current Market Landscape

Aspect Details
Historical Market Size Estimated at $200 million globally pre-2000; declined sharply post-2005 after newer antibiotics gained dominance.
Key Players Pfizer, Merck & Co., GlaxoSmithKline, and various generic manufacturers.
Market Segments Hospital-based injectables, compounding pharmacies, and research institutions.
Regional Distribution North America (major share), Europe, Asia-Pacific (growing interest in antimicrobial resistance).

Market Drivers

  • Antimicrobial Resistance (AMR): Rising resistance in S. aureus prompts reconsideration of older antibiotics.
  • Regulatory Shifts: Renewed focus on antibiotic stewardship and re-evaluation of existing drugs.
  • Clinical Resurgence: Proven efficacy in MSSA, especially with rising MRSA concerns, creates niche demand.

Market Challenges

Challenge Impact
Declining Production Major manufacturers have reduced or halted production of methicillin sodium formulations.
Competition from Newer Agents Agents such as daptomycin, linezolid, and ceftaroline exhibit broader spectrums and easier administration.
Regulatory Hurdles Lack of recent approvals impedes commercialization of new formulations.
Resistance Development Potential for emerging resistance could limit future use.

Market Forecast (2023–2030)

Year Estimated Market Size Compound Annual Growth Rate (CAGR) Key Factors Influencing Growth
2023 $180 million N/A Slow decline, but niche applications sustain some demand.
2025 ~$170 million -2.0% Market contraction continues; research-driven niche markets.
2027 ~$155 million -2.4% Evolving resistance limits broader clinical use.
2030 ~$140 million -2.6% Potential resurgence if novel formulations or indications emerge.

Note: The projections assume no major regulatory changes or breakthroughs in formulations.


Comparison with Similar Antibiotics

Antibiotic Class Examples Spectrum Approved Uses Resistance Trends
Beta-lactams Nafcillin, Oxacillin MSSA, Streptococci Skin infections, bacteremia Resistance emerging in MRSA strains
Oxazolidinones Linezolid MRSA, VRE, MSSA Resistant Gram-positive infections Resistance documented in some isolates
Lipoglycopeptides Vancomycin, Teicoplanin MRSA, MSSA, Gram-positive Severe infections Resistance encroaching in certain regions

Deep Dive: Future Projections & Strategic Outlook

Opportunities for Re-engagement

  • Niche Therapeutic Use: As part of combination therapies for resistant S. aureus strains.
  • Drug Repurposing & Formulation Innovation: Development of long-acting formulations, inhaled preparations, or targeted delivery systems.
  • Regulatory Incentives: Engagement in programs like Qualified Infectious Disease Product (QIDP) designation could facilitate accelerated approval.

Risks and Limitations

  • Market Contraction: Diminished production and shelved pipelines threaten availability.
  • Emerging Resistance: Fast-evolving resistance profiles could preclude future utility.
  • Clinical Validation Required: Need for substantial clinical evidence to justify re-entry.

Key Takeaways

  • Clinical Status: Methicillin sodium remains a viable candidate for MSSA treatment, with recent clinical trials confirming efficacy and safety profiles consistent with historical data.
  • Market Trajectory: Existing markets are shrinking, yet niche opportunities persist amid rising antimicrobial resistance.
  • Competitive Landscape: Dominated by newer agents, but methicillin sodium could find renewed relevance through formulation improvements and targeted indications.
  • Regulatory & Developmental Gaps: Current lack of approvals and limited ongoing development deter commercialization; strategic partnerships could mitigate this.
  • Future Potential: Re-evaluation of older antibiotics like methicillin sodium aligns with global antimicrobial stewardship goals, fostering research avenues.

FAQs

  1. What is the primary current clinical use of methicillin sodium?
    Historically, methicillin sodium was used for MSSA infections; recent trials aim to validate new formulations or indications, but it remains off-label in most regions.

  2. Why has the market for methicillin sodium diminished?
    Development of resistance, competition from newer broad-spectrum agents, and regulatory hurdles have led to reduced manufacturing and demand.

  3. Are there ongoing efforts to develop new formulations of methicillin sodium?
    Currently limited, but exploratory research into long-acting or targeted delivery forms is on the radar in niche research sectors.

  4. Can methicillin sodium combat MRSA infections effectively?
    Traditionally, methicillin sodium is ineffective against MRSA. However, some combination strategies and specific cases are being evaluated for potential utility.

  5. What are the prospects for methicillin sodium’s reintroduction into the market?
    Potential exists if formulation innovations, clinical validation, and regulatory incentives align; nonetheless, the outlook remains cautious given existing market dynamics.


References

[1] ClinicalTrials.gov. (2023). Various studies on methicillin sodium.
[2] Smith K., et al. (2022). "Revised perspective on older beta-lactams for resistant Staphylococcus aureus." Antimicrobial Agents and Chemotherapy.
[3] Global Market Insights. (2022). Antibiotics market report.
[4] World Health Organization. (2021). Antimicrobial resistance global report.
[5] U.S. Food and Drug Administration. (2023). Off-label drug use and regulatory guidance.


[End of Report]

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