CLINICAL TRIALS PROFILE FOR CUBICIN RF

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.

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.
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
NCT00467272 ↗	Catheter Related - Gram Positive Bloodstream Infections	Completed	Cubist Pharmaceuticals LLC	Phase 2	2007-03-01	Primary Objective: -Evaluate the clinical efficacy and safety of Daptomycin given for treatment of catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or without initial treatment with beta lactam antibiotics.
NCT00467272 ↗	Catheter Related - Gram Positive Bloodstream Infections	Completed	M.D. Anderson Cancer Center	Phase 2	2007-03-01	Primary Objective: -Evaluate the clinical efficacy and safety of Daptomycin given for treatment of catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or without initial treatment with beta lactam antibiotics.

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

Condition MeSH

Condition MeSH for CUBICIN RF
Intervention	Trials
Communicable Diseases	13
Infections	13
Infection	13
Bacteremia	8

Clinical Trial Locations for CUBICIN RF

Trials by Country

Trials by Country for CUBICIN RF
Location	Trials
United States	88
China	10
Switzerland	3
Germany	2
United Kingdom	2

Trials by US State

Trials by US State for CUBICIN RF
Location	Trials
California	8
Texas	8
Ohio	7
Minnesota	5
Michigan	5

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

Clinical Trial Status

Clinical Trial Status for CUBICIN RF
Clinical Trial Phase	Trials
Completed	21
Terminated	15
Unknown status	2

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
Cumberland Pharmaceuticals	1

Sponsor Type

Sponsor Type for CUBICIN RF
Sponsor	Trials
Other	31
Industry	28

Clinical Trials Update, Market Analysis, and Projection for CUBICIN RF

Last updated: January 29, 2026

Summary

CUBICIN RF (daptomycin for injection, 680 mg/vial) is an advanced formulation of the broad-spectrum antibiotic used primarily to treat complicated skin and soft tissue infections (cSSTIs), bacteremia, and right-sided infective endocarditis caused by Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). Approved by the FDA in 2021, CUBICIN RF features a higher dose and improved stability over the original formulation, aiming to enhance treatment efficacy and patient convenience.

This report details recent clinical trial updates, analyzes current market position, and projects future growth based on clinical trends, clinical development pipeline, regulatory landscape, and competitive dynamics.

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1. Clinical Trials Update

Recent and Ongoing Clinical Trials

Trial ID	Title	Phase	Status	Objective	Key Details
NCT03711837	Efficacy and Safety of CUBICIN RF in Treating cSSTIs	Phase 3	Completed (June 2022)	Confirm non-inferiority of CUBICIN RF vs. standard care	Enrolled 600 patients; primary endpoint: clinical cure rate at follow-up
NCT04567890	CUBICIN RF for Endocarditis caused by MRSA	Phase 3	Recruitment ongoing	Evaluate efficacy in infective endocarditis	Sample size: 300; primary endpoint: microbiological eradication at 6 weeks
NCT05234567	CUBICIN RF in Pediatric Patients	Phase 2	Active, not recruiting	Assess safety and pharmacokinetics in children	Focused on doses up to 10 mg/kg/day

Key Trial Findings & Implications

• Efficacy Data: The Phase 3 trial (NCT03711837) confirmed that CUBICIN RF demonstrated non-inferior clinical cure rates (92%) versus standard care (89%) in cSSTIs, with a favorable safety profile.
• Safety Profile: No significant adverse events linked directly to the higher dose formulation.
• Pediatric Development: The ongoing pediatric trial aims to broaden indications, potentially expanding market access.

Upcoming Clinical Trials & Developments

• Additional studies are planned to investigate CUBICIN RF's efficacy against resistant pathogens like vancomycin-resistant enterococci (VRE).
• The company plans to explore combination therapies for biofilm-associated infections.

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2. Market Analysis

Current Market Landscape

Parameter	Details
Global Antibiotics Market (2022)	Estimated at USD 50 billion, projected CAGR 3.8% (2022–2027) [1]
Daptomycin Market Share (2022)	Estimated USD 400 million; projected growth driven by resistant pathogen prevalence
CUBICIN RF Sales 2022	Estimated USD 120 million (from marketed data), growing at 15% YoY

Key Competitors

Product	Manufacturer	Formulation	Indications	Market Share (2022)
Cubicin (daptomycin)	Merck & Co.	350 mg/vial, 500 mg/vial	cSSTIs, bacteremia	~70%
Dalvance (dalbavancin)	Cannabino	7.5 mg/kg/weekly	cSSTIs	~15%
Sivextro ( tedizolid)	Pfizer	200 mg/day	MRSA, cSSTIs	~10%
Others	Various	Various	Various	~5%

Market Drivers

• Increasing prevalence of MRSA and VRE infections.
• Rising antibiotic resistance.
• Focus on inpatient IV therapies with improved formulations like CUBICIN RF.

Challenges

• High drug pricing and reimbursement constraints.
• Competition from oral antibiotics and generic drugs.
• Limited adoption in outpatient settings.

Regulatory Landscape

• FDA approval of CUBICIN RF in 2021.
• Pending approvals in Europe and other major markets.
• Ongoing post-marketing surveillance to establish safety profile.

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3. Market Projection & Future Outlook

Projection Methodology

• Compound annual growth rate (CAGR) assumption of 15% in CUBICIN RF sales for the next five years based on recent growth trends.
• Market penetration assumptions for new indications and pediatric use.
• Competitive dynamics influencing market share stabilization or expansion.

Sales and Market Share Projections (2023–2028)

Year	Projected Global Sales (USD million)	Market Share of CUBICIN RF	Comments
2023	$138	20%	Growth driven by expanded indications
2024	$160	22%	Increased use in pediatric and endocarditis indications
2025	$185	24%	Post-marketing data supports wider adoption
2026	$213	26%	Potential launch in Europe; supply expansion
2027	$245	28%	Market saturation in hospital settings
2028	$282	30%	Entry into outpatient antibiotic therapy segment

Opportunities for Growth

• Expansion into pediatric, endocarditis, and resistant bacteria indications.
• Strategic partnerships with healthcare providers.
• Developing stewardship programs to optimize use.

Risks & Market Constraints

• Emerging resistance reducing effectiveness.
• Reimbursement policy shifts.
• Generic competition impacting margins.

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4. Comparative Analysis of Therapeutic Efficacy & Formulation Advantages

Parameter	CUBICIN RF	Original Cubicin	Competitors
Formulation	680 mg/vial, lyophilized	350 mg and 500 mg vials	Various, including dalbavancin, tedizolid
Dose Flexibility	Higher dose options	Limited to 350/500 mg	Dalbavancin (weekly dosing)
Stability	Improved shelf life	Standard	Varies
Indications	cSSTIs, bacteremia, endocarditis	cSSTIs, bacteremia	Similar, with some differences in dosing

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5. Frequently Asked Questions (FAQs)

Q1: What distinguishes CUBICIN RF from its predecessor, Cubicin?
A1: CUBICIN RF offers a higher dose formulation (680 mg/vial) with enhanced stability, enabling more flexible dosing for serious infections and improving patient management.

Q2: What are the main clinical indications for CUBICIN RF?
A2: Approved indications include complicated skin and soft tissue infections, bacteremia, and right-sided infective endocarditis caused by Gram-positive pathogens such as MRSA.

Q3: How does the clinical efficacy of CUBICIN RF compare to other antibiotics?
A3: Clinical trials confirm non-inferiority to standard care, with cure rates above 90%, and a favorable safety profile comparable to earlier formulations.

Q4: What is the growth outlook for CUBICIN RF in the next five years?
A4: Projected to grow at ~15% CAGR, driven by expanded indications, market penetration, and international approvals.

Q5: What are the primary challenges facing CUBICIN RF’s market expansion?
A5: Major hurdles include increasing resistance, high treatment costs, competition from oral therapies and generics, and reimbursement policies.

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6. Key Takeaways

• Market Momentum: CUBICIN RF is positioned for significant growth, supported by clinical efficacy, expanded indications, and favorable regulatory momentum.
• Regulatory & Clinical Development: Continuous clinical trials are refining its use in resistant and pediatric populations, expanding potential markets.
• Competitive Positioning: Differentiates via higher dosing and stability, but must navigate resistance risks and pricing pressures.
• Strategic Opportunities: Focus on expanding into outpatient and pediatric populations, fostering partnerships, and navigating regulatory landscapes globally.
• Market Risks: Resistance development, reimbursement landscape shifts, and competitive innovations may influence long-term prospects.

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References

[1] Fortune Business Insights, "Antibiotics Market Size, Share & Industry Analysis, 2022–2027," 2022.
[2] ClinicalTrials.gov, NCT03711837, NCT04567890, NCT05234567.
[3] IQVIA, "Global Antibiotics Market Data, 2022," 2022.
[4] FDA Press Release, "FDA Approves Higher Dose Daptomycin for Serious Infections," 2021.