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
Osteomyelitis	4
Soft Tissue Infections	4
Skin Diseases, Infectious	3

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	15
China	11
Canada	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
Phase 4	32
Phase 3	19
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Daptomycin
Clinical Trial Phase	Trials
Completed	43
Terminated	27
Unknown status	8

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	87
Industry	53
NIH	3

Daptomycin: Clinical Trials, Market Analysis, and Projections

Introduction to Daptomycin

Daptomycin is a groundbreaking antibiotic belonging to the class of cyclic lipopeptides, known for its efficacy against a broad range of gram-positive pathogens, including those resistant to methicillin, vancomycin, and other conventional antibiotics. Here, we delve into the clinical trials, market analysis, and future projections of this critical drug.

Clinical Trials and Efficacy

Daptomycin has undergone extensive clinical trials to establish its safety and efficacy. In two randomized, international trials involving 1092 patients with complicated skin and skin-structure infections, daptomycin was compared to conventional antibiotics such as penicillinase-resistant penicillins and vancomycin. The results showed clinical success rates of 83.4% for the daptomycin-treated group and 84.2% for the comparator-treated group, indicating comparable efficacy[1].

Another significant finding was that 63% of patients treated with intravenous daptomycin required only 4-7 days of therapy, compared to 33% of patients treated with comparator antibiotics. This shorter treatment duration highlights the potential for daptomycin to reduce the length of hospital stays and improve patient outcomes[1].

Market Analysis

The daptomycin market is experiencing significant growth driven by several key factors:

Market Size and Growth Rate

As of 2023, the daptomycin market was valued at USD 3.2 billion and is projected to grow to USD 4.3 billion by 2032, with a compound annual growth rate (CAGR) of 3.27% during the forecast period (2024-2032)[2].

Key Drivers

• Increasing Prevalence of Infections: The rise in skin and skin structure infections, bloodstream infections, and right-sided infective endocarditis is a major driver. These conditions are often caused by bacteria resistant to traditional antibiotics, making daptomycin a vital treatment option[2][3].
• Antibiotic Resistance: The growing issue of antibiotic resistance has increased the demand for daptomycin, as it remains effective against resistant strains[3].
• Healthcare Infrastructure: Improved healthcare infrastructure and the availability of pharmaceuticals in various regions are also driving market growth[2].

Geographical Distribution

• North America: This region, particularly the United States, plays a crucial role in the daptomycin market due to the high adoption of advanced technology and the presence of large pharmaceutical companies[5].
• Europe: Europe holds the second-largest market share, with Germany and the UK being key markets. The UK is noted for its fast growth in this sector[2].
• Asia-Pacific: This region is expected to grow at the fastest CAGR from 2024 to 2032, driven by the development of pharmaceutical and healthcare facilities, especially in China and India[2].

Competitive Landscape

The daptomycin market is characterized by intense competition and recent significant developments:

• Generic Versions: In May 2024, Dr. Reddy’s Laboratories launched a generic version of daptomycin for injection in the U.S. market, which is expected to increase market competition and improve accessibility[3].
• Quality Control Issues: Merck initiated a recall of their Cubicin (daptomycin) product in May 2024 due to contamination with particulate matter, highlighting the importance of stringent quality control measures[3].
• Research and Development: Leading pharmaceutical companies such as Teva Pharmaceuticals, Merck, Pfizer, and Cipla are investing heavily in research and development to expand their product lines and address emerging challenges in antibiotic resistance[3].

Challenges and Opportunities

Challenges

• High Cost and Adverse Effects: The high cost of daptomycin and potential adverse effects are significant challenges that hamper market growth. However, the benefits of the drug often outweigh these drawbacks, especially in severe infections[3].
• Regulatory Hurdles: Stringent regulatory requirements and the need for continuous quality control can pose challenges for manufacturers[3].

Opportunities

• Growing Awareness: Increasing awareness among patients and healthcare providers about the effectiveness of daptomycin in treating resistant bacterial infections is creating new opportunities for market growth[3][5].
• Government Initiatives: Government programs aimed at preventing antibiotic resistance and promoting the development of new antibiotics are also driving the market forward[3].

Future Projections

The daptomycin market is anticipated to continue its growth trajectory due to several factors:

• Rising Demand: The increasing prevalence of infections and the growing need for effective antibiotics will drive demand for daptomycin[2][3].
• Ongoing Research: Ongoing clinical trials and research aimed at exploring new uses and improving treatment outcomes will further bolster the market[3].
• Geographical Expansion: The market is expected to expand in regions like Asia-Pacific, driven by the development of healthcare infrastructure and increasing awareness about the drug[2].

"Daptomycin has been approved and successfully launched for the treatment of complicated skin and skin-structure infections caused by gram-positive pathogens and bacteremia and right-sided endocarditis due to *Staphylococcus aureus*, including strains that are resistant to methicillin or other antibiotics"[4].

Key Takeaways

• Clinical Efficacy: Daptomycin has demonstrated comparable efficacy to conventional antibiotics in treating complicated skin and skin-structure infections.
• Market Growth: The daptomycin market is projected to grow from USD 3.32 billion in 2024 to USD 4.3 billion by 2032, driven by increasing infections and antibiotic resistance.
• Geographical Distribution: North America, Europe, and the Asia-Pacific region are key markets, with the latter expected to grow at the fastest CAGR.
• Challenges and Opportunities: High costs and adverse effects are challenges, but growing awareness and government initiatives present significant opportunities.
• Future Projections: The market is expected to continue growing due to rising demand, ongoing research, and geographical expansion.

FAQs

What is daptomycin used for?

Daptomycin is used for the treatment of complicated skin and skin-structure infections, bacteremia, and right-sided infective endocarditis caused by gram-positive pathogens, including those resistant to methicillin and vancomycin.

What are the key drivers of the daptomycin market?

The key drivers include the increasing prevalence of infections, growing antibiotic resistance, improved healthcare infrastructure, and the availability of pharmaceuticals.

Which regions are expected to drive the growth of the daptomycin market?

North America, especially the United States, Europe, and the Asia-Pacific region are expected to drive market growth, with the Asia-Pacific region anticipated to grow at the fastest CAGR.

What are the challenges facing the daptomycin market?

High costs and potential adverse effects are significant challenges, along with stringent regulatory requirements and the need for continuous quality control.

How is the competitive landscape of the daptomycin market evolving?

The market is seeing the launch of generic versions, significant investments in research and development by major pharmaceutical companies, and recalls due to quality control issues, which are shaping the competitive landscape.

What are the future projections for the daptomycin market?

The market is projected to grow from USD 3.32 billion in 2024 to USD 4.3 billion by 2032, driven by rising demand, ongoing research, and geographical expansion.

Sources

1. Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections - Clinical Infectious Diseases, Volume 38, Issue 12, 15 June 2004.
2. Daptomycin Market Analysis - Market Research Future.
3. Daptomycin Market: Industry Analysis 2030 - Stellar Market Research.
4. Daptomycin: From the Mountain to the Clinic, with Essential Help from Dr. Francis Tally - Clinical Infectious Diseases, Volume 50, Supplement 1.
5. Daptomycin Market Scope and Analysis (2024-2031): Key Drivers, Challenges, and Opportunities - OpenPR.