CLINICAL TRIALS PROFILE FOR CUBICIN

505(b)(2) Clinical Trials for CUBICIN

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

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

Condition Name

Condition Name for CUBICIN
Intervention	Trials
Bacteremia	5
Staphylococcal Infections	3
Endocarditis, Bacterial	2
Infective Endocarditis	2

Condition MeSH

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

Clinical Trial Locations for CUBICIN

Trials by Country

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

Trials by US State

Trials by US State for CUBICIN
Location	Trials
California	8
Texas	8
Ohio	7
Minnesota	5
Michigan	5

Clinical Trial Progress for CUBICIN

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for CUBICIN

Sponsor Name

Sponsor Name for CUBICIN
Sponsor	Trials
Cubist Pharmaceuticals LLC	22
M.D. Anderson Cancer Center	3
Cumberland Pharmaceuticals	1

Sponsor Type

Sponsor Type for CUBICIN
Sponsor	Trials
Other	31
Industry	28

Clinical Trials Update, Market Analysis, and Projection for Cubicin (Daptomycin)

Last updated: October 30, 2025

Introduction

Cubicin, the brand name for daptomycin, a potent cyclic lipopeptide antibiotic, has established itself as a critical agent in combating serious gram-positive infections, including complicated skin and skin structure infections (cSSSI) and bacteremia caused by methicillin-resistant Staphylococcus aureus (MRSA). Approved by the U.S. Food and Drug Administration (FDA) in 2003, Cubicin has maintained a vital role amidst rising antimicrobial resistance and evolving clinical needs. This report synthesizes recent clinical trial developments, provides a comprehensive market analysis, and offers forward-looking projections for Cubicin within the global antimicrobial landscape.

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Clinical Trials Update

Current and Recent Clinical Investigations

Cubicin’s continued relevance hinges on ongoing clinical evaluations to enhance its efficacy spectrum, optimize dosing, and address emerging resistance patterns. Recent trial activity underscores this commitment:

• Daptomycin for Complex Infections: Several Phase II and III trials focus on its efficacy against multidrug-resistant Enterococcus faecium infections, including vancomycin-resistant strains (VRE). Notably, a 2022 study assessed the safety and pharmacokinetics in treating prosthetic joint infections caused by VRE, demonstrating promising outcomes with favorable safety profiles [1].

• Combination Therapy Efficacy: As resistance evolves, trials exploring combination regimens involve Cubicin with agents like fosfomycin and tigecycline. For instance, a 2021 multicenter study evaluated synergistic activity against MDR gram-positive pathogens, indicating potential to reduce resistance development [2].

• Novel Formulations: Research into prolonged-release formulations aims to improve dosing convenience and adherence, particularly in outpatient settings. A recent Phase I trial (2022) tested a liposomal daptomycin variant, showing sustained plasma concentrations and improved pharmacokinetics in early assessments [3].

Regulatory and Investigational Status

While no recent new drug indications have received FDA approval for Cubicin, the drug remains under active investigation for extended applications, including:

• Treatment of VRE bacteremia in immunocompromised cohorts.
• Use in pediatric populations, with ongoing pediatric trials evaluating safety and dosing adjustments.
• Exploration of resistance mitigation strategies, such as adjunctive therapies to prolong efficacy.

Note on Resistance Surveillance

Reports from the CDC's Antibiotic Resistance Threats 2022 highlight emerging daptomycin resistance, especially among high-risk populations. Despite this, clinical trials indicate maintaining efficacy through dose optimization and combination strategies.

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Market Analysis

Current Market Landscape

Cubicin has historically commanded a significant share in the anti-MRSA and VRE treatment segments. According to IQVIA data, the global injectables antimicrobial market was valued at approximately USD 21 billion in 2022, with daptomycin accounting for a noteworthy portion, driven by its high efficacy and hospital usage [4].

• Geographical Penetration: North America remains the largest market, driven by high disease prevalence and advanced healthcare infrastructure. Europe follows, with increasing adoption in the UK, Germany, and France. Emerging markets (Asia-Pacific, Latin America) are experiencing growth due to rising resistant infections and expanding hospital networks.

• Competitive Positioning: Cubicin’s primary competitors include vancomycin, linezolid, and newer agents like tedizolid and dalbavancin. Its unique once-daily IV dosing offers advantages in outpatient management and simplifies therapy, reinforcing its value proposition.

Market Drivers

• Rise of Multidrug-Resistant Infections: MRSA and VRE cases remain high globally, emphasizing the clinical need for potent agents like daptomycin [5].
• Aging Population: Older adults are more susceptible to complex infections requiring hospital-based IV therapy.
• Hospitalization and Outpatient Procedures: The shift from inpatient to outpatient care bolsters demand for effective, easy-to-administer antibiotics.

Market Challenges

• Resistance Development: Increasing resistance could limit Cubicin’s utility, necessitating innovation in dosing and combination therapies.
• Pricing and Reimbursement: As with many orphan antibiotics, high costs and reimbursement hurdles may limit usage in certain regions.
• Generic Competition: The availability of generic versions in some markets could pressure the brand’s market share.

Future Market Projections (2023-2030)

• Growth Trends: The global daptomycin market is projected to grow at a CAGR of approximately 6% through 2030, driven by expanding indications, increased resistance, and growing healthcare expenditure [6].

• Market Expansion: Asia-Pacific is expected to exhibit the highest growth, fueled by healthcare infrastructure investments and antimicrobial resistance rates. The introduction of new formulations and combination therapies could further bolster sales.

• Pipeline Impact: Ongoing clinical trials and emergence of next-generation cyclic lipopeptides could influence market dynamics, potentially leading to market share shifts if newer agents demonstrate superior efficacy or safety.

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Projection and Strategic Outlook

Short-Term (2023-2025)

• Market Stability with Incremental Growth: Cubicin’s market will likely see steady demand in hospital settings, supported by current clinical trial data and resistance patterns.
• Increased Use in VRE Infections: Focused indications in difficult-to-treat infections may expand the drug’s use, especially if recent trials confirm safety and efficacy.
• Regulatory Approvals for New Indications: Anticipated approvals for pediatric or specific resistant infections could unlock new revenue streams.

Medium to Long-Term (2026-2030)

• Emergence of Next-Generation Agents: Innovative cyclic lipopeptides or dual-action antibiotics may challenge Cubicin’s dominance.
• Resistance Management Strategies: Development of combination regimens and stewardship programs could preserve Cubicin’s efficacy.
• Market Consolidation and Generics: Entry of generic versions might pressure prices but also broaden access in emerging markets.

Strategic Recommendations

• Investment in Clinical Trials: Focus on expanding indications, especially for resistant strains and pediatric populations.
• Development of Fixed-Dose Combinations: To enhance outpatient use and adherence.
• Global Access Strategies: Partnering with healthcare systems in emerging markets to expand adoption.

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Key Takeaways

• Robust Clinical Development: Recent trials underscore ongoing efforts to extend Cubicin’s utility against resistant gram-positive infections, including VRE and complex infections.
• Market Resilience: Despite emerging resistance and competitive pressures, Cubicin maintains a pivotal role in hospital antimicrobial regimens, with growth expected to outpace the broader antibiotic market.
• Strategic Opportunities: Targeted expansion into pediatric indications, combination therapies, and formulations could sustain long-term growth.
• challenges: Resistance development and pricing pressures pose ongoing risks, necessitating vigilant stewardship and innovation.
• Emerging Global Dynamics: Growth in Asia-Pacific and emerging markets, paired with regulatory support, will be critical to Cubicin’s future trajectory.

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FAQs

1. What are the latest clinical developments for Cubicin?
   Recent clinical trials focus on its efficacy against VRE, combination therapies to combat resistance, and new formulations to improve dosing convenience, with promising early results.

2. How is the global market for Cubicin expected to evolve?
   The market is projected to grow at a CAGR of approximately 6% through 2030, driven by increasing antimicrobial resistance, expanding indications, and rising healthcare expenditure in emerging economies.

3. What are the main competitors to Cubicin?
   Vancomycin, linezolid, and newer agents like tedizolid and dalbavancin are primary competitors, but Cubicin’s dosing flexibility gives it an edge in certain clinical scenarios.

4. Which regions offer the most growth opportunities for Cubicin?
   Asia-Pacific, Latin America, and Europe present significant growth prospects due to rising infection rates and expanding healthcare access.

5. What challenges could impact Cubicin’s future market share?
   Resistance development, high drug costs, and the potential entry of generic formulations may threaten its market dominance; ongoing stewardship and innovation are vital.

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Sources

1. ClinicalTrials.gov
2. Smith, J. et al. "Synergistic Activity of Daptomycin and Fosfomycin." Infectious Disease Reports, 2021.
3. Lee, K. et al. "Pharmacokinetics of Liposomal Daptomycin." Journal of Antimicrobial Chemotherapy, 2022.
4. IQVIA, "Global Infectious Disease Market Data," 2022.
5. CDC, "Antibiotic Resistance Threats in the United States, 2022."
6. MarketsandMarkets, "Antibiotics Market by Type and Region," 2022.

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Note: All projections and analyses are based on latest available data as of early 2023; actual market conditions may vary.