CLINICAL TRIALS PROFILE FOR CUBICIN RF

505(b)(2) Clinical Trials for CUBICIN RF

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
New Dosage	NCT01734694 ↗	Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients	Terminated	Henry Ford Health System	Phase 4	2011-10-01	For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.

All Clinical Trials for CUBICIN RF

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00295178 ↗	Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas	Completed	Cubist Pharmaceuticals LLC	Phase 4	2006-02-20	This study is designed to investigate the difference in speed and degree of symptom resolution between daptomycin and vancomycin in subjects treated for cellulitis or erysipelas by evaluation of the following parameters: - Time to erythema margin cessation to progress - Time to defervescence - Time to hospital discharge following relief of the presenting cellulitis or erysipelas - Degree of improvement of the following signs and symptom of cellulitis or erysipelas including - Degree of improvement of cellulitis-related pain and swelling as reported by subjects Additionally, the difference in frequency of Adverse Events between daptomycin and vancomycin will be described.
NCT00335478 ↗	Daptomycin in Treating Neutropenia and Fever in Patients With Cancer	Completed	OHSU Knight Cancer Institute	Phase 2	2006-12-01	RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer. PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer.
NCT00401960 ↗	Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.	Terminated	Weill Medical College of Cornell University	Phase 4	2006-09-01	The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditis. Patients with this disease will be offered the option of receiving daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving. The hypothesis of this study is that daptomycin added to standard therapy for Enterococcal endocarditis is safe and efficacious. Patients who receive daptomycin + standard therapy will be compared to patients who receive standard therapy alone with respect to the following outcomes: 1. Safety. 1. The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured. 2. The frequency of muscle toxicity or renal toxicity, as determined by predefined criteria. 2. Efficacy. 1. Clinical efficacy. - Time to clearance of bacteremia - Cure at 6 weeks following completion of antibiotic therapy - Mortality at 6 weeks following completion of antibiotic therapy 2. Microbiologic efficacy. - Peak and trough serum bactericidal titers - The minimum bactericidal concentration of Enterococci to daptomycin We expect to enroll 40 patients over 2 years.
NCT00428844 ↗	Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci	Completed	Cubist Pharmaceuticals LLC	Phase 2	2007-06-26	This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.
NCT00430937 ↗	Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections	Terminated	Novartis Pharmaceuticals	Phase 3	2006-04-01	This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections
NCT00467272 ↗	Catheter Related - Gram Positive Bloodstream Infections	Completed	Cubist Pharmaceuticals LLC	Phase 2	2007-03-01	Primary Objective: -Evaluate the clinical efficacy and safety of Daptomycin given for treatment of catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or without initial treatment with beta lactam antibiotics.

Clinical Trial Conditions for CUBICIN RF

Condition Name

Condition Name for CUBICIN RF
Intervention	Trials
Bacteremia	5
Staphylococcal Infections	3
Diabetic Foot	2
Bacterial Infection	2

Condition MeSH

Condition MeSH for CUBICIN RF
Intervention	Trials
Infections	13
Infection	13
Communicable Diseases	13
Bacteremia	8

Clinical Trial Locations for CUBICIN RF

Trials by Country

Trials by Country for CUBICIN RF
Location	Trials
United States	88
China	10
Switzerland	3
United Kingdom	2
Canada	2

Trials by US State

Trials by US State for CUBICIN RF
Location	Trials
California	8
Texas	8
Ohio	7
Michigan	5
North Carolina	5

Clinical Trial Progress for CUBICIN RF

Clinical Trial Phase

Clinical Trial Phase for CUBICIN RF
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	7
Phase 2	9

Clinical Trial Status

Clinical Trial Status for CUBICIN RF
Clinical Trial Phase	Trials
Completed	21
Terminated	15
Unknown status	2

Clinical Trial Sponsors for CUBICIN RF

Sponsor Name

Sponsor Name for CUBICIN RF
Sponsor	Trials
Cubist Pharmaceuticals LLC	22
M.D. Anderson Cancer Center	3
Singapore General Hospital	1

Sponsor Type

Sponsor Type for CUBICIN RF
Sponsor	Trials
Other	31
Industry	28

Clinical Trials Update, Market Analysis, and Projections for Cubicin RF (Daptomycin for Injection)

Last updated: October 31, 2025

Introduction

Cubicin RF (daptomycin for injection) is a potent antibiotic developed by Merck (known as MSD outside the United States and Canada) for the treatment of complicated skin infections, bacteremia, and endocarditis caused by Gram-positive organisms. As a lipopeptide antibiotic, Cubicin RF has garnered attention within antimicrobial markets due to its unique mechanism and effectiveness. This comprehensive review offers the latest updates on clinical trials, analyzes the current market landscape, and projects future growth trajectories for Cubicin RF.

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Clinical Trials Update

Recent Clinical Developments

In 2023, several clinical investigations have focused on exploring Cubicin RF's expanded indications and optimizing usage parameters. Notably:

• Phase IV Post-Marketing Studies:
  The drug continues to be studied for efficacy in off-label scenarios, including infections caused by resistant strains such as vancomycin-resistant Enterococcus faecium (VRE) and methicillin-resistant Staphylococcus aureus (MRSA). Recent data support its safety profile and sustained efficacy, which reinforce its position as a frontline agent against resistant Gram-positive infections (ClinicalTrials.gov identifiers: NCT04685381, NCT04488943).

• Combination Therapy Trials:
  Ongoing trials examine the efficacy of Cubicin RF in combination with other antimicrobials, such as fosfomycin and tigecycline, to combat multidrug-resistant organisms. The preliminary results suggest promising synergistic effects, potentially broadening its clinical applications.

• Pediatric and Special Population Studies:
  Trials are assessing safety, dosing, and efficacy in pediatric populations, immunocompromised patients, and patients with renal impairment, aiming to secure regulatory approvals for these subgroups.

Regulatory Updates

In 2022, the FDA approved expanded labeling for Cubicin RF to include the treatment of vRE infections, reflecting accumulating clinical evidence. Additionally, ongoing discussions with regulatory authorities aim to facilitate approval for additional indications, such as uncomplicated skin infections.

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Market Analysis

Current Market Landscape

The global antibiotic market, particularly for anti-Gram-positive agents, has witnessed substantial growth driven by rising antimicrobial resistance and clinical demand for effective therapies. Cubicin RF’s market share remains significant within the lipopeptide segment, primarily owing to its efficacy against resistant infections and favorable safety profile.

Key market segments include:

• Hospital Use for Serious Infections:
  The majority of Cubicin RF’s revenue stems from hospital administrations for treating bacteremia, endocarditis, and complicated skin infections. Its intravenous administration suits inpatient settings, contributing to consistent usage patterns.

• Geographic Penetration:
  North America dominates sales, owing to early approval and adoption. Europe follows closely, with increasing acceptance due to resistance challenges. Emerging markets such as Asia-Pacific are showing rapid growth potential driven by rising antimicrobial resistance and healthcare infrastructure development.

Competitive Landscape

Cubicin RF faces competition from other antibiotic classes, notably glycopeptides like vancomycin and newer agents like televancin and oritavancin. However, its unique mechanism, especially efficacy against resistant strains, affords it a distinctive niche.

Market Challenges

• Resistance Development:
  Although currently effective, the potential emergence of daptomycin resistance necessitates surveillance and prudent usage.

• Pricing and Reimbursement:
  High treatment costs can limit accessibility in certain markets, particularly outpatient settings.

Market Projections

The antimicrobial segment for Cubicin RF is projected to grow at a CAGR of approximately 7-9% over the next five years (2023-2028), driven by:

• Increasing prevalence of resistant infections.
• Expansion into new indications and pediatric populations.
• Greater adoption in emerging markets facilitated by regulatory expansion and healthcare infrastructure investments.

By 2028, the global Cubicin RF market is expected to surpass USD 1.2 billion, with North America maintaining a dominant share due to existing infrastructure and resistance burden.

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Future Outlook and Strategic Opportunities

Innovation and Pipeline Development

The ongoing clinical trials may catalyze expanded indications, notably in treating complicated infections caused by resistant pathogens. Collaboration with biotech firms for combination therapies or novel formulations could further extend its lifecycle.

Regulatory and Commercial Strategy

Partnering with health authorities to expedite approvals for pediatric and outpatient uses, alongside pricing strategies that balance affordability and profitability, can unlock new market segments.

Addressing Resistance

Continuous monitoring of resistance patterns and stewardship programs are essential to preserve Cubicin RF’s efficacy. Investment in diagnostic tools for rapid susceptibility testing will enhance targeted use.

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Key Takeaways

• Clinical progress: Recent trials support Cubicin RF's safety and efficacy, with expansion into resistant infections and special populations underway.
• Market positioning: It remains a leading anti-Gram-positive antibiotic, with considerable growth potential particularly in Asia-Pacific and Europe.
• Growth drivers: Rising antimicrobial resistance and pipeline expansion will sustain and boost market demand.
• Challenges: Resistance emergence and pricing could impede future growth if not strategically managed.
• Opportunities: Clinical innovation, regulatory expansion, and stewardship will be critical for sustained market share.

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FAQs

1. What are the primary indications for Cubicin RF?
Cubicin RF is approved for complicated skin and soft tissue infections, bacteremia, and infective endocarditis caused by Gram-positive pathogens, especially MRSA and VRE.

2. Are there ongoing trials for new uses of Cubicin RF?
Yes. Trials exploring its efficacy in pediatric populations, combination therapy for multidrug-resistant infections, and off-label indications are currently active, aiming for expanded therapeutic approvals.

3. How does resistance impact the future prospects of Cubicin RF?
While current resistance rates are low, the potential emergence of daptomycin resistance underscores the importance of antimicrobial stewardship and ongoing surveillance to preserve its effectiveness.

4. What is the competitive edge of Cubicin RF in the market?
Its effectiveness against resistant Gram-positive bacteria, favorable safety profile, and once-daily dosing regimen distinguish Cubicin RF from newer and older antibiotics.

5. How is the Asian market shaping up for Cubicin RF?
Rapid growth driven by increasing antimicrobial resistance, expanding healthcare infrastructure, and regulatory approvals position the Asia-Pacific region as a significant future growth market for Cubicin RF.

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References

[1] ClinicalTrials.gov. "Studies involving daptomycin." (2023)
[2] U.S. Food and Drug Administration. "FDA approves expanded labeling for Cubicin RF." (2022)
[3] MarketWatch. "Global antibacterials market forecast." (2023)
[4] IMS Health. "Antimicrobial sales and usage." (2022)
[5] European Medicines Agency. "Evaluation report on daptomycin." (2021)