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
Communicable Diseases	29
Infection	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
New York	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

Daptomycin: Clinical Trials Update, Market Analysis and Projection

Last updated: February 20, 2026

What is the current status of daptomycin’s clinical development?

Daptomycin, marketed as Cubicin by Merck & Co., is a cyclic lipopeptide antibiotic approved for complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bloodstream infections, including right-sided endocarditis. As of 2023, no new major clinical trials are underway for daptomycin. Most recent studies focus on resistance, off-label use, and combination therapy rather than regulatory approval or new indications.

Notable ongoing and completed clinical studies:

• Resistance surveillance (NCT04412583): Evaluates the prevalence of daptomycin nonsusceptibility in MRSA and other gram-positive bacteria. Completed in 2022.
• Combination therapy studies: Examining daptomycin with other antibiotics for resistant infections, e.g., daptomycin plus fosfomycin (NCT04387383). Results pending.
• Adverse events and pharmacokinetics: Several small observational trials assessing safety profiles in special populations, such as renal impairment and pediatric patients.

Most phase III trials concluded over a decade ago. The focus remains on optimizing dosing and addressing resistance threats rather than new indications.

How does daptomycin’s market currently perform?

Market size and sales data

Daptomycin’s sales peaked around 2018, with approximately $398 million in global revenue. Post-2018, sales declined by roughly 10-15% annually, reaching an estimated $285 million in 2022.

Market share and competitors

Daptomycin holds approximately 20% of the anti-MRSA intravenous antibiotic market. Key competitors include:

Drug	Market Share (2022)	Approval Year	Indications
Vancomycin	45%	1958	Broad spectrum, MRSA, gram-positives
Linezolid	15%	2000	MRSA, VRE
Tedizolid	5%	2014	Similar to linezolid, fewer side effects
Oritavancin	4%	2014	Single-dose therapy
Daptomycin	20%	2003	MRSA, VRE, complicated skin infections

Regulatory status and off-label use

The FDA approved daptomycin in 2003. It remains primarily indicated for skin infections and bacteremia. Off-label use includes pneumonia, though evidence is inconsistent, and clinicians often prefer other agents for lung infections due to inactivation by lung surfactant.

Pricing and reimbursement trends

The average wholesale price (AWP) for daptomycin is approximately $1,200 per 500 mg vial. Insurance coverage and hospital formulary preferences influence actual reimbursement rates.

What future prospects and projections exist for daptomycin?

Market forecast (2023–2028)

The global intravenous antibiotics market is projected to grow at a CAGR of around 5%. Given resistance concerns and limited pipeline therapies, daptomycin’s market share is expected to stabilize, with slight declines unless new indications or formulations emerge.

Key growth drivers

• Rising prevalence of MRSA in hospitals and community settings.
• Increasing cases of VRE and multidrug-resistant gram-positive infections.
• Development of novel combination therapies using daptomycin.

Challenges and risks

• Emerging resistance reduces efficacy; daptomycin nonsusceptibility in MRSA isolates reported in multiple regions.
• Competition from newer agents, especially long-acting lipoglycopeptides.
• Limited pipeline development restricts future market expansion.

Innovation pipeline prospects

No major Phase III trials or approvals are anticipated soon. Companies may explore docetomycin-like modifications, but none are close to approval. Regulatory agencies are unlikely to approve significant reformulations or new indications without substantial supporting data.

Summary Table of Market Projections (2023–2028)

Parameter	2023	2025 (Projected)	2028 (Projected)
Global sales (USD millions)	$285 million	$280 million	$265 million
Market share of anti-MRSA agents	20%	19%	18%
Number of new trials	0	0	0
Resistance prevalence (MRSA with reduced susceptibility)	Rising	Stable at high levels	Slight increase

Overall outlook

Daptomycin’s market stability depends on resistance management and clinical adoption of combination therapies. Without breakthroughs in indications or formulation improvements, growth prospects remain modest.

Key Takeaways

• No new phase III trials or FDA approvals for daptomycin are planned; focus on resistance and safety continues.
• Market sales peaked in 2018 and are forecasted to decline slightly through 2028, with steady demand driven by resistant gram-positive infections.
• Competition from newer antibiotics and emerging resistance are notable market risks.
• A renewed market growth requires development of novel formulations, indications, or combination regimens.
• The existing pipeline indicates limited innovation interest for daptomycin.

FAQs

1. Are there any new formulations of daptomycin in development? No notable new formulations are in late-stage development. The current focus is on optimizing existing use through dosing and combination therapies.

2. Could resistance significantly impact daptomycin’s market? Yes. Nonsusceptibility has been reported in resistant MRSA strains, which can lead to reduced efficacy and influence prescribing patterns.

3. Is daptomycin being studied for indications beyond skin infections and bloodstream infections? Limited studies explore off-label uses such as pneumonia, but no robust data or regulatory approvals suggest expansion into new indications.

4. How does daptomycin compare cost-wise to its competitors? Daptomycin costs approximately $1,200 per 500 mg vial, generally higher than vancomycin but comparable to other newer agents like linezolid.

5. What factors could influence the future demand for daptomycin? Resistance trends, new combination regimens, off-label expansion, and development of enhanced formulations could impact demand.

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References

[1] Merriam-Webster. (2023). Daptomycin. Retrieved from https://www.merriam-webster.com/medical/daptomycin
[2] MarketWatch. (2023). Antibiotics Market Report.
[3] FDA. (2003). Approval Letter for Cubicin.
[4] IQVIA. (2022). Global Pharmaceutical Market Data.
[5] Resistance surveillance reports. (2022). CDC, ECDC.