CLINICAL TRIALS PROFILE FOR DAPTOMYCIN

505(b)(2) Clinical Trials for DAPTOMYCIN

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

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

Condition Name

Condition Name for DAPTOMYCIN
Intervention	Trials
Bacteremia	10
Staphylococcus Aureus Bacteremia	4
Osteomyelitis	4
Soft Tissue Infections	4

Condition MeSH

Condition MeSH for DAPTOMYCIN
Intervention	Trials
Infections	31
Infection	29
Communicable Diseases	29
Bacteremia	21

Clinical Trial Locations for DAPTOMYCIN

Trials by Country

Trials by Country for DAPTOMYCIN
Location	Trials
United States	172
Australia	20
Canada	14
China	11
Japan	10

Trials by US State

Trials by US State for DAPTOMYCIN
Location	Trials
Texas	13
North Carolina	13
California	13
Ohio	11
Michigan	9

Clinical Trial Progress for DAPTOMYCIN

Clinical Trial Phase

Clinical Trial Phase for DAPTOMYCIN
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	32

Clinical Trial Status

Clinical Trial Status for DAPTOMYCIN
Clinical Trial Phase	Trials
Completed	43
Terminated	27
Recruiting	9

Clinical Trial Sponsors for DAPTOMYCIN

Sponsor Name

Sponsor Name for DAPTOMYCIN
Sponsor	Trials
Cubist Pharmaceuticals LLC	35
University of Zurich	3
Novartis	3

Sponsor Type

Sponsor Type for DAPTOMYCIN
Sponsor	Trials
Other	91
Industry	53
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Daptomycin

Last updated: September 19, 2025

Introduction

Daptomycin, a lipopeptide antibiotic developed by Cubist Pharmaceuticals (acquired by Merck & Co.), is a potent bactericidal agent targeting Gram-positive pathogens, including Methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and other multidrug-resistant strains. Approved by the FDA in 2003, Daptomycin has established itself as a critical option in combating complicated skin infections, bacteremia, and endocarditis. As antimicrobial resistance escalates and the pipeline of novel antibiotics remains limited, understanding Daptomycin's clinical trial landscape, market dynamics, and growth projections is vital for stakeholders across healthcare, biotech, and investment sectors.

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Clinical Trials Landscape and Recent Updates

Current Clinical Trial Status

Daptomycin's clinical research has largely transitioned from initial safety and efficacy evaluations to optimizing dosing, combination therapies, and tackling resistant bacterial strains. According to clinical trial databases like ClinicalTrials.gov, over 20 studies have been registered or completed, reflecting ongoing interest in expanding its therapeutic indications.

Recent and Ongoing Clinical Studies

• Combination Therapy Studies: Recent trials explore Daptomycin combined with other antibiotics such as fosfomycin or ceftaroline to combat difficult-to-treat infections, particularly MRSA bacteremia complicated by implantable device infections. Results indicate improved microbiological clearance and reduced treatment durations, supporting its synergistic potential.

• Dosing Optimization: Trials assessing higher doses of Daptomycin (10-12 mg/kg) suggest enhanced efficacy without significant toxicity, especially for endocarditis and complex infections. These studies aim to refine dosing guidelines aligning with bacterial load and infection severity.

• New Indications: Investigations into Daptomycin's role in ventilator-associated pneumonia (VAP) or intra-abdominal infections are ongoing, though results are mixed, with current approvals not extending beyond approved indications.

Unmet Needs and Challenges in Clinical Research

Despite its proven efficacy, limitations such as increasing resistance, potential myopathy, and pulmonary accumulation pose challenges. Clinical trials are focusing on mitigating these issues via novel formulations or combination strategies to sustain Daptomycin's clinical utility.

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Market Analysis

Market Overview

The global antibiotics market was valued at approximately USD 46 billion in 2021, with the segment for Gram-positive active agents like Daptomycin estimated at USD 4-6 billion, driven by the rising prevalence of resistant infections and the limited pipeline of new antibiotics.

Key Competitive Landscape

Daptomycin's primary competitors include vancomycin, linezolid, tedizolid, and newer agents like dalbavancin and oritavancin. Its unique mechanism of disrupting bacterial membrane potential confers advantages over some rivals, especially for resistant strains.

Market Drivers

• Antibiotic Resistance Crisis: The surge in MRSA, VRE, and other resistant pathogens fuels demand for potent, reliably effective drugs like Daptomycin.

• Regulatory Approvals & Label Expansion: Expanded indications, including off-label uses, bolster sales. Recent FDA approvals for higher dosing facilitate stronger market positioning.

• Hospital-Acquired Infection Burden: The increasing incidence of hospital-acquired bloodstream infections sustains demand in inpatient settings.

Market Challenges

• Pricing and Reimbursement: High costs associated with Daptomycin limit adoption, notably in health systems with strict budget constraints.

• Resistance Development: Emerging resistance threatens long-term efficacy, necessitating continual clinical research and formulation innovations.

• Generics and Patent Expiry: Patent expiration in the mid-2010s led to generic versions, increasing competition and pressure on pricing.

Regional Insights

• North America: Dominant market due to high prevalence of resistant infections and advanced healthcare infrastructure.

• Europe: Growing adoption aligned with antimicrobial stewardship programs.

• Asia-Pacific: Rapidly expanding market driven by increasing healthcare expenditure and burgeoning infection rates.

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Market Projection and Future Outlook

Growth Forecast (2023-2030)

Based on current trends, the Daptomycin market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 6-8% over the next decade. Factors underpinning this estimate include:

• Increasing antimicrobial resistance: Enhances reliance on existing antibiotics like Daptomycin, especially in hospital settings.

• Innovations in formulation: Development of less resistance-prone formulations or delivery methods could extend market lifespan.

• Regulatory momentum: Potential approval for additional indications such as pneumonia or device-related infections may expand market share.

Potential Disruptors

• Emerging Resistance: Resistance against Daptomycin, although currently limited, could diminish its market share unless mitigated.

• New Antibiotics: Introduction of next-generation agents with superior efficacy, safety, or convenient dosing could challenge Daptomycin's dominance.

• Alternative Therapies: Advances in immunotherapies or phage-based treatments pose long-term threats.

Strategic Opportunities

• Combination Therapies: Co-formulations with other antibiotics to prevent resistance.

• Personalized Dosing Regimens: Tailoring doses based on pharmacogenomics to optimize efficacy and minimize toxicity.

• Expansion into New Indications: Focused trials for pneumonia, diabetic foot infections, or biofilm-associated infections.

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Conclusion

Daptomycin maintains a crucial position within the antimicrobial arsenal, with a robust clinical trial portfolio supporting its versatility and efficacy. The market outlook remains promising, driven by the escalating burden of resistant Gram-positive infections and ongoing innovations to optimize its use. However, the sustainability of Daptomycin's market share hinges on addressing resistance challenges, optimizing dosing strategies, and expanding indications through targeted clinical research.

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Key Takeaways

• Clinical research continues to refine Daptomycin's dosing and combination strategies, promising enhanced efficacy against resistant infections.

• Market growth is underpinned by the rising global burden of Gram-positive resistant bacteria, with high demand in hospital settings.

• Potential expansion into new indications and formulations could bolster long-term market viability.

• Resistance development remains a critical threat, necessitating ongoing surveillance and innovative clinical trials.

• Competitive pressures include emergence of newer antibiotics and generics, emphasizing the importance of strategic R&D investments.

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FAQs

Q1: What are the primary approved indications for Daptomycin?
A: Daptomycin is FDA-approved for complicated skin and skin structure infections, including diabetic foot infections (when combined with agents for anaerobic coverage), bacteremia, and right-sided infective endocarditis caused by susceptible Gram-positive pathogens.

Q2: Are there ongoing efforts to expand Daptomycin’s clinical use?
A: Yes, current trials explore higher dosing regimens, combination therapies, and potential new indications such as pneumonia and device-related infections, aiming to broaden its therapeutic applications.

Q3: What are the main resistance concerns associated with Daptomycin?
A: Resistance, though currently limited, has been documented, particularly among VRE strains, with mechanisms involving modifications to bacterial cell membrane charge and composition, potentially leading to decreased binding efficacy.

Q4: How does Daptomycin compare to other Gram-positive antibiotics?
A: Daptomycin offers bactericidal activity with a unique mechanism targeting bacterial membranes, often retaining efficacy against resistant strains where vancomycin or linezolid may fail. However, its use is limited by resistance risk, myopathy potential, and dosing considerations.

Q5: What is the outlook for Daptomycin in the face of emerging antibiotic developments?
A: While newer agents are emerging, Daptomycin’s established efficacy and ongoing clinical adaptations position it as a vital component within the antimicrobial landscape, provided resistance and safety profiles are carefully managed.

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References:

[1] ClinicalTrials.gov. (2023). Daptomycin studies.

[2] MarketWatch. (2022). Antibiotics Market Size, Share & Trends.

[3] FDA. (2023). Daptomycin FDA approval and labeling information.

[4] Infectious Disease Society of America. (2021). Antimicrobial Resistance Reports.