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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR CUBICIN RF


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505(b)(2) Clinical Trials for Cubicin Rf

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cubicin Rf

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cubicin Rf

Condition Name

Condition Name for Cubicin Rf
Intervention Trials
Bacteremia 5
Staphylococcal Infections 3
Diabetic Foot 2
Bacterial Infection 2
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Condition MeSH

Condition MeSH for Cubicin Rf
Intervention Trials
Infection 13
Communicable Diseases 13
Infections 13
Bacteremia 8
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Clinical Trial Locations for Cubicin Rf

Trials by Country

Trials by Country for Cubicin Rf
Location Trials
United States 88
China 10
Switzerland 3
Canada 2
Germany 2
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Trials by US State

Trials by US State for Cubicin Rf
Location Trials
Texas 8
California 8
Ohio 7
North Carolina 5
Minnesota 5
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Clinical Trial Progress for Cubicin Rf

Clinical Trial Phase

Clinical Trial Phase for Cubicin Rf
Clinical Trial Phase Trials
Phase 4 16
Phase 3 7
Phase 2 9
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Clinical Trial Status

Clinical Trial Status for Cubicin Rf
Clinical Trial Phase Trials
Completed 21
Terminated 15
Unknown status 2
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Clinical Trial Sponsors for Cubicin Rf

Sponsor Name

Sponsor Name for Cubicin Rf
Sponsor Trials
Cubist Pharmaceuticals LLC 22
M.D. Anderson Cancer Center 3
Hartford Hospital 1
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Sponsor Type

Sponsor Type for Cubicin Rf
Sponsor Trials
Other 31
Industry 28
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CUBICIN RF: Clinical Trials, Market Analysis, and Projections

Introduction to CUBICIN RF

CUBICIN RF, also known as daptomycin for injection, is a lipopeptide antibiotic developed by Merck & Co., Inc. It is used to treat complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bloodstream infections, including those caused by methicillin-resistant strains.

Clinical Trials and Efficacy

Adult Population

CUBICIN RF has a well-established safety and efficacy profile in adult populations since its initial approval in 2007. Clinical trials have shown high success rates, with an 88% clinical success rate compared to 77% for the comparator in treating cSSSI and S. aureus bloodstream infections[1][3].

Pediatric Population

The drug has also been approved for pediatric use in patients aged 1 to 17 years. The approval was based on pharmacokinetic (PK) modelling studies and two phase-4 clinical studies. These studies demonstrated that daptomycin is well tolerated and efficacious in pediatric patients with cSSSI and S. aureus bloodstream infections. The recommended dosages vary by age group:

  • 12-17 years: 7 mg/kg once every 24 hours
  • 7-11 years: 9 mg/kg once every 24 hours
  • 1-6 years: 12 mg/kg once every 24 hours[1][3].

Adverse Reactions

Common adverse reactions in pediatric patients include vomiting and elevated creatinine phosphokinase. In adults, significant adverse reactions include abnormal liver function tests, elevated CPK, and dyspnea[1][5].

Market Analysis

Current Market Size

The peptide antibiotics market, which includes CUBICIN RF, was valued at USD 4.4 billion in 2021. This market segment is dominated by the treatment of skin infections, with CUBICIN RF being a key product used for this purpose[2].

Growth Projections

The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.06% from 2022 to 2030, reaching a value of USD 6.86 billion by 2030. The growth is driven by increasing research and development activities and the rising prevalence of skin infections such as cellulitis, impetigo, and others[2].

Market Segmentation

The market is segmented by product type, disease, route of administration, distribution channel, and region. The skin infection segment, which accounts for 30.4% of the market share, is expected to continue dominating the market during the forecast period[2].

Key Players and Competition

CUBICIN RF is manufactured by Merck & Co., Inc., which is one of the major players in the peptide antibiotics market. Other key players include Pfizer Inc., AbbVie Inc., GSK Group of Companies, Sandoz International GmbH, and Xellia Pharmaceuticals. The competitive landscape is driven by innovation in product formulations and expanding indications for existing products[2].

Regulatory Approvals

Health Canada Approval

CUBICIN RF received approval from Health Canada for pediatric indications in 2017. The approval was based on the safety and efficacy data from PK studies and clinical trials in pediatric patients. The decision highlighted the favorable benefit-harm-uncertainty balance of daptomycin in the pediatric population[3].

FDA Approval

In the United States, CUBICIN RF is approved by the FDA for the treatment of cSSSI and S. aureus bloodstream infections. The FDA prescribing information includes detailed guidelines on dosage, administration, and potential adverse reactions[5].

Usage and Administration

Dosage and Administration

CUBICIN RF is administered intravenously once every 24 hours. The dosage varies by age and type of infection. For patients with renal impairment, the dosage regimen is adjusted to 4 mg/kg or 6 mg/kg once every 48 hours[5].

Precautions and Warnings

The drug should be used cautiously in patients with potential nervous system and/or muscular system effects, especially in pediatric patients younger than 12 months. It is also important to monitor for Clostridium difficile–associated diarrhea and perform susceptibility testing in cases of persisting or relapsing S. aureus bacteremia/endocarditis[5].

Market Trends and Opportunities

Increasing Prevalence of Skin Infections

The rising prevalence of skin infections such as cellulitis, impetigo, and furuncles is driving the demand for effective treatments like CUBICIN RF. This trend is expected to continue, contributing to the growth of the peptide antibiotics market[2].

Advancements in Formulations

The approval of reformulated products like CUBICIN RF in 2017 highlights the ongoing efforts to improve the efficacy and safety of peptide antibiotics. Such advancements are likely to attract more patients and healthcare providers, further expanding the market[3].

Challenges and Limitations

Resistance and Side Effects

One of the challenges faced by CUBICIN RF is the potential for antibiotic resistance. Additionally, the drug can cause significant side effects, such as elevated CPK and abnormal liver function tests, which need to be carefully monitored[1][5].

Limited Data in Certain Patient Groups

There is limited data on the use of CUBICIN RF in patients with left-sided infective endocarditis and those with prosthetic valve endocarditis. This limits its application in these patient groups[5].

Key Takeaways

  • Clinical Efficacy: CUBICIN RF has demonstrated high clinical success rates in treating cSSSI and S. aureus bloodstream infections in both adult and pediatric populations.
  • Market Growth: The peptide antibiotics market, driven by the skin infection segment, is projected to grow at a CAGR of 5.06% from 2022 to 2030.
  • Regulatory Approvals: CUBICIN RF has received approvals from Health Canada and the FDA for its use in pediatric and adult populations.
  • Usage and Administration: The drug is administered intravenously with varying dosages based on age and type of infection.
  • Challenges: The potential for antibiotic resistance and significant side effects are key challenges that need to be addressed.

FAQs

What is CUBICIN RF used for?

CUBICIN RF is used for the treatment of complicated skin and skin structure infections (cSSSI) and Staphylococcus aureus bloodstream infections, including those caused by methicillin-resistant strains.

What are the common adverse reactions associated with CUBICIN RF in pediatric patients?

Common adverse reactions in pediatric patients include vomiting and elevated creatinine phosphokinase[1].

How is CUBICIN RF administered?

CUBICIN RF is administered intravenously once every 24 hours, with dosages varying by age and type of infection[5].

What is the projected market size of the peptide antibiotics market by 2030?

The peptide antibiotics market is projected to reach USD 6.86 billion by 2030, growing at a CAGR of 5.06% from 2022 to 2030[2].

Is CUBICIN RF approved for use in pediatric patients?

Yes, CUBICIN RF is approved for use in pediatric patients aged 1 to 17 years for the treatment of cSSSI and S. aureus bloodstream infections[1][3].

Sources

  1. OptumRx: Cubicin - RF (daptomycin) – Expanded indication.
  2. BioSpace: Peptide Antibiotics Market Size USD 6.86 Billion by 2030.
  3. Health Canada: Regulatory Decision Summary for Cubicin, Cubicin RF.
  4. UFLIB: Leveraging Real World Data and Machine Learning to Improve ...
  5. FDA: Cubicin RF (daptomycin for injection), 500 mg/vial.

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