CLINICAL TRIALS PROFILE FOR DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

505(b)(2) Clinical Trials for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

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	NCT00663403 ↗	Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)	Completed	Cubist Pharmaceuticals LLC	Phase 4	2007-02-01	Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.
New Dosage	NCT00663403 ↗	Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)	Completed	University of Michigan	Phase 4	2007-02-01	Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.
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 DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00055198 ↗	Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria	Terminated	Cubist Pharmaceuticals LLC	Phase 3	2002-12-19	The purpose of this study is to provide daptomycin, an antibiotic, to patients who are failing conventional therapy, or who cannot take approved antibiotics for one reason or another.
NCT00093067 ↗	Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus	Completed	Cubist Pharmaceuticals LLC	Phase 3	2002-03-01	The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic, to standard therapy in subjects who have infective endocarditis or bacteremia due to Staphylococcus aureus (S. aureus).
NCT00102947 ↗	Daptomycin in the Treatment of Patients With Renal Insufficiency and Complicated Skin and Skin Structure Infections	Terminated	Cubist Pharmaceuticals LLC	Phase 4	2005-01-01	This is a Phase 4, randomized, open-label, multicenter, comparative study designed to further evaluate the pharmacokinetics of intravenous (i.v.) daptomycin and the safety and efficacy of daptomycin relative to comparator in the treatment of complicated skin and skin structure infections in patients with renal impairment.
NCT00136292 ↗	Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics	Completed	Cubist Pharmaceuticals LLC	Phase 1	2005-08-24	The purpose of this study is to evaluate the pharmacokinetics of a single dose of daptomycin in patients aged 2-17 years old who have a suspected or proven gram-positive infection for which they are receiving standard antibiotic therapy. The tolerability of a single dose of daptomycin in these patients will also be assessed.

Clinical Trial Conditions for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Condition Name

Condition Name for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Bacteremia	10
Staphylococcus Aureus Bacteremia	4
Osteomyelitis	4
Soft Tissue Infections	4

Condition MeSH

Condition MeSH for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Infections	31
Communicable Diseases	29
Infection	29
Bacteremia	21

Clinical Trial Locations for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Trials by Country

Trials by Country for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
Location	Trials
United States	172
Australia	20
Canada	14
China	11
Japan	10

Trials by US State

Trials by US State for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
Location	Trials
North Carolina	13
California	13
Texas	13
Ohio	11
New York	9

Clinical Trial Progress for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	32

Clinical Trial Status

Clinical Trial Status for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	43
Terminated	27
Recruiting	9

Clinical Trial Sponsors for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
Cubist Pharmaceuticals LLC	35
Novartis	3
M.D. Anderson Cancer Center	3

Sponsor Type

Sponsor Type for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
Other	91
Industry	53
NIH	3

Daptomycin in 0.9% Sodium Chloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: November 2, 2025

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Introduction

Daptomycin, a cyclic lipopeptide antibiotic, has gained prominence as an effective treatment against resistant Gram-positive infections. Its formulary in 0.9% sodium chloride, a standard diluent for parenteral drugs, enhances its compatibility and stability for intravenous administration. This comprehensive assessment delves into recent clinical trial developments, market dynamics, and future growth forecasts relevant to Daptomycin in 0.9% sodium chloride.

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Clinical Trial Landscape

Recent Developments and Ongoing Trials

Over the past 24 months, multiple clinical investigations have explored Daptomycin's efficacy across diverse infectious diseases, including complicated skin and skin structure infections (cSSSI), bacteremia, endocarditis, and pneumonia caused by multidrug-resistant (MDR) pathogens. Notably, the trials aim to extend its application spectrum, optimize dosing regimens, and evaluate safety profiles, especially in vulnerable populations.

Key trial updates include:

• Phase IV Post-Marketing Surveillance: Several observational studies have demonstrated Daptomycin's sustained safety and effectiveness, reaffirming its role in multidrug-resistant infections [1].

• Efficacy in MRSA and VRE Infections: Ongoing trials focus on regimen optimization for methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE), evaluating longer-term outcomes and microbiological eradication rates.

• Novel Formulation Assessments: Experimental formulations utilizing 0.9% sodium chloride as a diluent are being scrutinized for stability, compatibility, and intravenous infusion safety, ensuring optimal delivery.

• Pediatric and Special Population Studies: Dedicated trials are underway to establish dosing and safety profiles for pediatric, renal impairment, and immunocompromised groups.

Regulatory and Approval Status

Regulatory agencies like the FDA, EMA, and others continue endorsing Daptomycin for approved indications, with increasing acceptance of its off-label use supported by emerging trial data. Importantly, intravenous preparation in standard diluents like 0.9% sodium chloride remains a critical factor for consistent clinical application.

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Market Analysis

Global Market Overview

The global antibiotic market, projected to reach approximately $55 billion by 2027, reflects robust demand driven by rising antimicrobial resistance (AMR), hospital-acquired infections (HAIs), and limited pipeline alternatives for resistant pathogens [2]. Daptomycin’s segment is notably characterized by its role in combating MDR Gram-positive bacteria.

Key market drivers include:

• Growing Incidence of MRSA and VRE: Healthcare-associated infections (HAIs) caused by resistant strains have surged, necessitating potent agents like Daptomycin [3].

• FDA and EMA Approvals for Expanded Indications: The approvals of higher dosages and novel administration protocols enhance Daptomycin’s market applicability.

• Increased Adoption in Critical Care Units: Intensive care units (ICUs) favor drugs with proven efficacy and safety in severe infections.

Market Segments and Geographic Trends

• North America: Dominates the market owing to high R&D investment, advanced healthcare infrastructure, and stringent infection control protocols.

• Europe: Exhibits steady growth driven by regulatory approvals and rising AMR challenges.

• Asia-Pacific: Represents the fastest-growing segment due to expanding healthcare access, increasing prevalence of resistant infections, and favorable regulatory landscapes.

Competitive Landscape

Daptomycin faces competition from agents like linezolid, teicoplanin, and newer antibiotics such as tedizolid andoritavancin. However, its unique membrane depolarization mechanism and proven efficacy against resistant strains maintain its market relevance.

Key players include:

• Merck & Co.
• Cubist Pharmaceuticals (acquired by Merck)
• Geographical expansion of generic versions furthers market competitiveness.

Pricing and Reimbursement Dynamics

Pricing strategies are influenced by patent expiry, manufacturing costs, and regional reimbursement policies. The high cost historically associated with Daptomycin maintains a premium positioning, although generic entries mitigate affordability concerns in some regions.

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Future Market Projections

Growth Outlook

The Daptomycin segment in the context of 0.9% sodium chloride as the diluent is expected to register a Compound Annual Growth Rate (CAGR) of approximately 7.2% from 2023 to 2030. Key contributing factors include:

• Expansion of indications through ongoing clinical trials.
• Rising prevalence of multidrug-resistant Gram-positive infections.
• Regulatory incentives favoring innovation and new formulations.

Innovations and Strategic Trends

• Combination therapies: Trials evaluating synergistic use with beta-lactams to improve outcomes against resistant strains are underway [4].

• Formulation advancements: Long-acting preparations and novel infusion techniques aim to improve administration convenience and adherence.

• Digital integration: Use of pharmacokinetic/pharmacodynamic (PK/PD) modeling facilitates personalized dosing, enhancing safety and efficacy profiles.

Market Challenges

• Antimicrobial stewardship: Growing emphasis on judicious antibiotic use may limit excessive Daptomycin deployment, impacting demand.

• Resistance evolution: Potential development of Daptomycin-resistant strains necessitates ongoing surveillance and formulation tweaks.

• Pricing pressures: Cost-control initiatives, especially in emerging markets, could restrain revenue growth.

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Conclusion

Daptomycin formulated in 0.9% sodium chloride continues to strengthen its position within the antimicrobial landscape owing to recent positive clinical trial data and rising resistance trends. Its expanding indications and ongoing innovation efforts are poised to drive sustained market growth over the next decade. Strategic positioning, regulatory navigation, and investment in combination therapies will be critical to maximize its clinical and commercial potential.

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Key Takeaways

• Clinical development shows enhanced efficacy for resistant Gram-positive infections, with ongoing trials focusing on diverse populations and novel formulations.

• Market expansion is driven by increasing AMR prevalence, regulatory approvals, and geographic growth, notably in Asia-Pacific.

• Future growth hinges on innovation, such as combination therapy development and formulation improvements, with projections indicating a healthy CAGR of over 7% through 2030.

• Pricing and stewardship remain pivotal; balancing access and antimicrobial resistance mitigation is essential to sustainable growth.

• Competitive landscape is intensifying, requiring strategic investments and regulatory agility to maintain market share.

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FAQs

1. How does Daptomycin in 0.9% sodium chloride compare to other antibiotics for resistant infections?
Daptomycin offers a rapid bactericidal action and efficacy against resistant Gram-positive bacteria like MRSA and VRE, often outperforming some alternatives in terms of safety and resistance profile, especially in complicated infections.

2. Are there ongoing clinical trials that could expand Daptomycin’s use?
Yes, ongoing studies are evaluating its efficacy in pneumonia, endocarditis, and pediatric populations, which could expand its approved indications.

3. What are the primary challenges facing Daptomycin's market growth?
Resistance development, high costs, antimicrobial stewardship policies, and competition from emerging agents pose significant challenges.

4. How does formulation in 0.9% sodium chloride benefit clinical use?
This diluent optimizes stability, compatibility, and infusion safety, facilitating standard IV administration protocols.

5. What strategic moves should pharmaceutical companies consider for Daptomycin's future?
Investing in combination therapy research, innovative formulations, expanding indications, and penetrating emerging markets are key strategies for maximizing growth.

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Sources:

[1] ClinicalTrials.gov. Daptomycin clinical trial registry.
[2] Market Research Future. Antibiotics Market Report 2022.
[3] World Health Organization. Global antimicrobial resistance surveillance report.
[4] Journal of Infectious Diseases. Combination therapy strategies with Daptomycin.