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.
NCT00261807 ↗	Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections	Completed	Cubist Pharmaceuticals LLC	N/A	2005-06-01	Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.
NCT00261807 ↗	Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections	Completed	University of Maryland	N/A	2005-06-01	Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.
NCT00261807 ↗	Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections	Completed	University of Maryland, Baltimore	N/A	2005-06-01	Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.

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
Osteomyelitis	4
Soft Tissue Infections	4
Staphylococcus Aureus Bacteremia	4

Condition MeSH

Condition MeSH for DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Infections	31
Infection	29
Communicable Diseases	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
Texas	13
North Carolina	13
California	13
Ohio	11
Michigan	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
Duke University	3
University of Zurich	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-Development Update and Market Outlook

Last updated: May 5, 2026

What is the product and where does it fit in the daptomycin landscape?

“Daptomycin in 0.9% sodium chloride” refers to daptomycin supplied in isotonic saline (0.9% NaCl) as the diluent or preparation medium for administration. In practice, commercial and clinical positioning tracks the same active ingredient: daptomycin (cyclic lipopeptide antibacterial), an FDA-approved option for complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bacteremia (SAB), including right-sided endocarditis (RIE), and used in additional off-label and guideline-driven settings.

The market for “daptomycin in 0.9% NaCl” is typically analyzed together with the daptomycin injectable franchise because:

• the active ingredient is unchanged (daptomycin),
• saline is the standard reconstitution/infusion vehicle,
• formulation-specific supply channels matter, but reimbursement and utilization are driven primarily by labeled indications and clinical positioning of daptomycin.

What are the latest clinical-trial signals relevant to daptomycin formulations?

No specific, formulation-indexed “daptomycin in 0.9% sodium chloride” trial program is identifiable from the sources available in this run. Clinical-trial updates for daptomycin are normally registered under the active ingredient and then described with formulation details (vehicle, infusion time, concentration). Without trial-by-trial linkage to the exact “0.9% NaCl” presentation, a formulation-specific update cannot be produced without risking accuracy.

Which indications and patient populations are driving daptomycin use?

For decision-grade market projection, the actionable anchor is daptomycin’s labeled use patterns and the clinical niches where it competes effectively:

• cSSSI (including infections due to susceptible Gram-positive organisms)
• SAB and RIE caused by methicillin-susceptible and methicillin-resistant Staphylococcus aureus
• off-label and guideline-aligned use in complex Gram-positive infections and bacteremia end points, where clinicians seek alternatives to beta-lactams or vancomycin when resistance, tolerability, or dosing practicality is a barrier.

The clinical value proposition that sustains demand is strongest in:

• SAB/RIE treatment algorithms where daptomycin can reduce reliance on vancomycin monitoring and manage renal constraints through standard dosing adjustments
• cSSSI episodes with high likelihood of Gram-positive pathogens, where rapid coverage and predictable IV administration matter

How does safety monitoring affect adoption and market volume?

Daptomycin’s market trajectory is strongly shaped by safety practices that influence prescriber behavior and hospital formularies:

• Creatine phosphokinase (CPK) monitoring for myopathy risk
• Risk mitigation in higher-dose or prolonged therapy
• consideration of comorbidities (renal function and baseline muscle risk)
• management of drug-drug and electrolyte considerations in hospital settings

These factors affect:

• the “switchability” from vancomycin and beta-lactams
• duration-of-therapy patterns
• the proportion of courses that remain on formulary once institutional protocols are established

What is the current market structure for daptomycin?

The daptomycin market is characterized by:

• Originator and generic competition in injectable antibiotics
• procurement-driven behavior (group purchasing organization tenders, hospital antibiotic stewardship)
• patient-outcome-driven use in SAB/RIE where efficacy and safety protocols are known
• switching dynamics based on local antibiograms, cost-per-course, and availability

Because “daptomycin in 0.9% sodium chloride” is a vehicle presentation, market share is typically governed by:

• total daptomycin utilization (all presentations)
• tender pricing and stocking preferences for the exact packaged/ready-to-use form
• administration workflow fit (reconstitution complexity, infusion time, preparation steps)

What market projection can be made for daptomycin in 0.9% NaCl using available evidence?

A formulation-level forecast requires:

• a baseline market size split by presentation,
• pricing and reimbursement differences by vehicle,
• and trial- or regulatory-linked volume shifts.

No presentation-specific split is available from the sources accessed in this run. Producing a numeric projection for “daptomycin in 0.9% sodium chloride” would require assumptions that would not meet the accuracy standard for a patent- and investment-grade analysis.

Market projection approach that stays accurate

A defensible projection can be produced only at the daptomycin active-ingredient level, and then mapped to vehicle share based on disclosed procurement practices. In this run, those procurement and split-share data are not available for formulation-specific mapping.

Accordingly, this report provides:

• a clinical and market drivers framework for forecasting daptomycin demand, and
• a risk and catalyst checklist that determines whether a formulation-linked product gains volume.

What are the near-term demand drivers for daptomycin courses?

Forecast leverage points for daptomycin demand typically come from the following measurable levers:

1. Hospital antibiotic stewardship protocols

   • If protocols emphasize AUC-like stewardship and constrain vancomycin duration, daptomycin can take share in SAB/RIE pathways.
   • Institutions that already run CPK monitoring workflows can scale use.

2. Resistance and empiric coverage patterns

   • MRSA prevalence and local Gram-positive epidemiology determine empiric switch thresholds.

3. Cost per course and tender cycles

   • Daptomycin share is sensitive to generic price erosion and tender competitiveness.
   • Formulation presentations that reduce pharmacy workload or preparation variability can win repeat tenders.

4. Complicated infection admission rates

   • cSSSI admissions and bacteremia incidence drive underlying volume.
   • The mix shift toward ICU and higher-acuity settings tends to support IV anti-MRSA utilization.

What are the headwinds to volume growth?

1. Substitution by other Gram-positive agents
   • hospital formularies can shift to alternatives based on susceptibility patterns and adverse-event profiles.
2. Operational friction
   • longer infusion requirements, CPK monitoring burden, or nursing workflow fit can slow adoption in some institutions.
3. Safety concerns in prolonged courses
   • higher-dose or longer duration regimens increase monitoring and may reduce prescriber willingness.

What clinical endpoints matter for future uptake and differentiation?

For a daptomycin product to increase utilization, the endpoints that move formularies are:

• microbiologic clearance rates and relapse metrics in SAB/RIE
• composite cure endpoints in cSSSI
• treatment duration reductions
• safety endpoints tied to creatine phosphokinase elevations and myopathy risk

If future studies in daptomycin demonstrate improved outcomes or simplified monitoring, those signals can shift adoption and tender position.

What does this mean for R&D and IP positioning around daptomycin-in-saline presentations?

A formulation-specific IP strategy tied to “daptomycin in 0.9% sodium chloride” must clear three practical gates:

1. Clinical relevance
   • Proof that the vehicle/presentation materially impacts stability, handling, or reduced preparation error without compromising efficacy and safety.
2. Manufacturability and supply reliability
   • Pharmacy workflow alignment and shelf-life/stability advantages that drive tender wins.
3. Regulatory defensibility
   • clear labeling impact or process advantage that supports differentiation beyond identical active ingredient.

Key Takeaways

• Daptomycin in 0.9% sodium chloride is best treated as a vehicle/presentation variant of daptomycin injectable, with clinical and market demand driven mainly by labeled indications and stewardship-driven adoption.
• A formulation-specific clinical trials update and numeric market projection cannot be produced accurately from the accessible evidence in this run; trial and procurement data typically do not isolate the exact “0.9% NaCl” presentation in a way that supports clean partitioning.
• Near-term demand is controlled by SAB/RIE protocol fit, CPK monitoring workflow, local resistance patterns, and tender pricing more than by vehicle wording.
• For a vehicle-linked product to grow, the winning differentiation is operational and stability value that translates into tender share and reduced pharmacy handling burden.

FAQs

1) Is “daptomycin in 0.9% sodium chloride” a different drug from daptomycin?
No. It is a presentation/vehicle description for the same active ingredient, daptomycin.

2) Which daptomycin indications most influence hospital utilization?
cSSSI and Staphylococcus aureus bacteremia (including right-sided endocarditis) drive much of the routine IV utilization and formulary placement.

3) What safety factor most affects prescribing and demand?
CPK monitoring and myopathy risk management influence prescriber comfort, especially for higher-dose or longer courses.

4) What determines whether a specific presentation wins tenders?
Total cost per course plus pharmacy workflow fit (reconstitution/handling burden), stability/shelf-life, and reliability of supply.

5) Can clinical-trial updates be used to forecast this specific formulation’s volume?
Only if trials explicitly isolate the formulation/presentation. When trials report results by active ingredient without presentation-level partitioning, the forecast must be built at the active ingredient level.

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References (APA)

[1] FDA. (n.d.). Daptomycin prescribing information and product labeling (as available on FDA’s website). U.S. Food and Drug Administration. https://www.fda.gov/