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

Clinical Trial Conditions for CUBICIN

Condition Name

Condition Name for CUBICIN
Intervention	Trials
Bacteremia	5
Staphylococcal Infections	3
Bacterial Infection	2
Skin Diseases, Infectious	2

Condition MeSH

Condition MeSH for CUBICIN
Intervention	Trials
Infections	13
Infection	13
Communicable Diseases	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
Michigan	5
North Carolina	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
OHSU Knight Cancer Institute	1

Sponsor Type

Sponsor Type for CUBICIN
Sponsor	Trials
Other	31
Industry	28

Cubicin (daptomycin) Clinical Trials Update, Market Analysis, and Projection

Last updated: April 30, 2026

What is Cubicin and what does it treat?

Cubicin is the brand name for daptomycin, a cyclic lipopeptide antibiotic used for serious Gram-positive infections. In-market indications vary by geography and label updates, but the core clinical use set is stable: complicated skin and skin structure infections (cSSSI) and bacteremia/infective endocarditis due to susceptible Gram-positive pathogens, with use guided by susceptibility and treatment setting.

What is the current clinical-trials footprint?

A full “current active trials” census depends on a live registry pull. This response therefore limits to verifiable, stable trial and post-approval program themes that define the clinical use trajectory of daptomycin and that typically drive new-label or new-combination uptake. Those themes are:

• Dose and regimen optimization to improve efficacy against difficult-to-treat Gram-positive infections.
• Combination strategies in challenging scenarios, including persistent bacteremia or higher MIC organisms.
• De-escalation and susceptibility/MIC-guided use to control resistance risk and sustain clinical outcomes.
• Special populations (renal impairment, obesity, pediatrics where applicable) through PK/PD and pragmatic safety programs.

Clinical development signal: daptomycin’s market position has been maintained by a steady stream of comparative effectiveness, PK/PD refinement, and combination/management studies rather than disruptive new mechanism trials.

Which trial outcomes matter for uptake?

Daptomycin’s clinical value is anchored to two durable outcome pillars in serious Gram-positive disease:

1. Bacteremia and endocarditis efficacy against susceptible organisms, including treatment success rates in controlled trials and subsequent real-world cohorts.
2. Resistance management through MIC monitoring, regimen selection, and avoidance of subtherapeutic exposure.

These are the decision points hospitals use for formulary placement: regimen reliability, stewardship fit, and constraints around renal dosing.

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How is the market structured for Cubicin?

Where Cubicin is competed

Daptomycin’s label scope overlaps with multiple antibiotic classes used for Gram-positive infections:

• Glycopeptides (vancomycin)
• Oxazolidinones (linezolid, with different safety tradeoffs)
• Cephalosporins and beta-lactams (when organism susceptibility allows)
• Newer Gram-positive options in specific segments where stewardship protocols favor narrower-spectrum or different safety profiles

What drives demand

Demand for Cubicin is driven by:

• Incidence of hospital-acquired and healthcare-associated Gram-positive infections
• Proportion of cases requiring IV therapy
• Hospital formulary and stewardship policies, especially where MIC-guided daptomycin use is incorporated
• Seasonality and outbreak patterns that change Gram-positive case mix

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What is the pricing and access reality?

Cubicin is a premium brand in hospital antibiotic budgets, but real-world net pricing is shaped by:

• Manufacturer contracting and group purchasing organization (GPO) dynamics
• Inclusion or exclusion in institutional formularies
• Use restrictions for specific patient subgroups or organism MIC thresholds
• Competitive switching when alternative IV options are priced or stocked more favorably

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Market analysis: baseline view

Current demand drivers (2023-2026 horizon)

• Steady inpatient demand for serious Gram-positive infections
• Ongoing clinical preference for daptomycin in patients where alternatives are constrained by safety (renal toxicity with other agents, hematologic toxicity with linezolid) or where organism profile supports daptomycin
• Continued stewardship adoption of PK/PD-optimized regimens to preserve effectiveness and limit resistance selection

Key risks

• Loss of share from low-cost generics of daptomycin in the US and EU, depending on regulatory timelines and pricing pressure
• Resistance dynamics if daptomycin MIC creep increases failure rates in specific niches
• Formulary tightening in some systems that limit use to narrow criteria

Net market behavior you should expect

• Volume stability with pricing erosion risk as generic penetration increases in major markets.
• Segment bifurcation: daptomycin use remains entrenched in complex cases, while simpler cases may be routed to cheaper alternatives.

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What is the projection for Cubicin revenue and demand?

A precise revenue projection requires live forecasts for Cubicin net sales by geography and current payer/contract terms. This response therefore provides a projection framework tied to observable market forces rather than presenting unsupported point forecasts.

Projection logic

Cubicin’s forward market path is typically governed by a three-variable equation:

1. Generic share gain (net sales pressure)
2. Stewardship and outcomes retention (volume resilience)
3. Competitive intensity in high-acuity Gram-positive segments

Forward scenarios (directional)

• Base case: daptomycin volume holds in serious Gram-positive disease; revenue trends down as net price declines with competitive pressures.
• Downside case: faster substitution to generics and broader restriction criteria reduce eligible utilization; net sales fall more sharply.
• Upside case: stewardship expands optimized regimens and MIC-guided use, sustaining higher-than-expected utilization in complicated bacteremia/endocarditis cohorts; price erosion partially offsets volume resilience.

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How do clinical-trial and evidence themes affect market forecast?

Clinical evidence is not just academic; it changes protocol behavior. The themes most likely to support durable utilization are:

• MIC-guided therapy protocols that keep daptomycin in the “correct organism” bucket
• Data supporting dose optimization in difficult-to-treat cases that can be translated into order sets and stewardship guidance
• Evidence that supports manageable safety monitoring (CK monitoring practices, renal dosing discipline)

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What is the competitive outlook for daptomycin?

Competitive set

• Vancomycin remains the structural comparator because it anchors many hospital guidelines.
• Linezolid and other options compete based on safety/tolerance and site-of-infection fit.
• Newer anti-Gram-positive therapies (varies by year and geography) can siphon off small but high-margin cohorts, especially where hospital formularies favor alternative stewardship pathways.

What matters most

• Hospitals optimize antibiotic choice with a balance of outcomes, safety, and total cost. If daptomycin net cost declines faster than efficacy concerns, uptake can persist even as branded revenue compresses.

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Key Takeaways

• Cubicin is daptomycin, a core inpatient IV option for serious Gram-positive infections; its uptake is driven by bacteremia/endocarditis outcomes and stewardship-compatible dosing.
• Clinical development is characterized by regimen optimization and MIC/PK-guided use rather than a disruptive mechanism shift, supporting sustained clinical reliance.
• Market outlook is shaped more by generic penetration and net pricing than by breakthrough clinical efficacy. Expect volume resilience in complex cases with pricing-driven revenue pressure.
• Forward performance should be modeled with three levers: generic share gain, stewardship retention of eligible utilization, and competitive intensity in high-acuity segments.

FAQs

1) Is Cubicin still used in endocarditis and bacteremia?
Yes. Daptomycin’s established role in serious Gram-positive bloodstream infections and infective endocarditis continues to anchor its clinical and formulary presence.

2) What patient factors most influence daptomycin prescribing?
Susceptibility patterns (including MIC considerations), renal function, and infection severity drive regimen selection and monitoring intensity.

3) Does resistance risk affect market demand?
Yes. MIC creep and stewardship controls influence when clinicians choose daptomycin and how long therapy continues, affecting utilization rates.

4) What is the biggest commercial risk for branded Cubicin?
Net sales pressure from generic competition and contracting dynamics that reduce branded pricing.

5) What clinical-evidence themes support ongoing use?
PK/PD optimization, MIC-guided therapy protocols, and regimen refinement for difficult-to-treat Gram-positive infections support sustained protocol inclusion.

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References

[1] U.S. Food and Drug Administration. Cubicin (daptomycin) prescribing information. FDA label.
[2] European Medicines Agency. Cubicin (daptomycin) product information. EMA label.
[3] PubMed. Daptomycin clinical trials in cSSSI, bacteremia, and endocarditis (source articles and comparative studies).
[4] IDSA guidelines for skin and soft tissue infections and guidelines for hospital-acquired infections (daptomycin role in recommendations).