CLINICAL TRIALS PROFILE FOR TEFLARO

505(b)(2) Clinical Trials for TEFLARO

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 TEFLARO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01400867 ↗	Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections	Completed	AstraZeneca	Phase 2/Phase 3	2011-12-01	This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
NCT01400867 ↗	Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections	Completed	Forest Laboratories	Phase 2/Phase 3	2011-12-01	This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
NCT01524302 ↗	Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia	Completed	Forest Laboratories	Phase 4	2012-02-01	This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of ceftaroline compared to levofloxacin may be further highlighted from this investigation.
NCT01524302 ↗	Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia	Completed	Gary E. Stein, Pharm.D.	Phase 4	2012-02-01	This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of ceftaroline compared to levofloxacin may be further highlighted from this investigation.
NCT01530763 ↗	Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)	Completed	AstraZeneca	Phase 2/Phase 3	2012-09-01	This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
NCT01530763 ↗	Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)	Completed	Forest Laboratories	Phase 2/Phase 3	2012-09-01	This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.
NCT01645735 ↗	Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus	Completed	AstraZeneca	Phase 4	2012-10-01	The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

Clinical Trial Conditions for TEFLARO

Condition Name

Condition Name for TEFLARO
Intervention	Trials
Infections	3
Bacteremia	2
Joint Infections	1
Acute Bacterial Skin and Skin Structure Infections	1

Condition MeSH

Condition MeSH for TEFLARO
Intervention	Trials
Pneumonia	5
Infections	4
Infection	4
Pneumonia, Bacterial	3

Clinical Trial Locations for TEFLARO

Trials by Country

Trials by Country for TEFLARO
Location	Trials
United States	55
Greece	4
Georgia	4
Argentina	3
Romania	3

Trials by US State

Trials by US State for TEFLARO
Location	Trials
California	5
Ohio	5
Michigan	5
Florida	4
West Virginia	3

Clinical Trial Progress for TEFLARO

Clinical Trial Phase

Clinical Trial Phase for TEFLARO
Clinical Trial Phase	Trials
Phase 4	8
Phase 2/Phase 3	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for TEFLARO
Clinical Trial Phase	Trials
Completed	7
Unknown status	3
Terminated	1

Clinical Trial Sponsors for TEFLARO

Sponsor Name

Sponsor Name for TEFLARO
Sponsor	Trials
Forest Laboratories	10
AstraZeneca	3
Gary E. Stein, Pharm.D.	1

Sponsor Type

Sponsor Type for TEFLARO
Sponsor	Trials
Industry	13
Other	8

Clinical Trials Update, Market Analysis, and Projection for Teflaro (Ceftaroline Fosamil)

Last updated: October 28, 2025

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Introduction

Teflaro (ceftaroline fosamil) is a broad-spectrum cephalosporin antibiotic with notable activity against methicillin-resistant Staphylococcus aureus (MRSA) and other resistant pathogens. Approved by the U.S. Food and Drug Administration (FDA) in 2010, Teflaro has garnered attention as an essential agent in combating complicated skin and soft tissue infections (cSSTI) and community-acquired bacterial pneumonia (CABP). This report provides an updated review of ongoing clinical trials, evaluates recent market dynamics, and projects the future trajectory of Teflaro's commercial prospects.

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Clinical Trials Update

Current Clinical Investigations

Since its approval, Teflaro has undergone minimal publicly disclosed clinical trials, primarily focusing on expanded indications, dose optimization, and resistance management.

• Expanded Indication Trials:
  The most recent notable clinical activity involves studies aimed at broadening its use in less common but severe infections, such as osteomyelitis and diabetic foot infections. For example, a Phase IV trial (ClinicalTrials.gov Identifier: NCT04577835) initiated in 2021 assesses efficacy and safety in diabetic foot infections, but results are pending.

• Comparative Effectiveness Studies:
  Head-to-head trials comparing Teflaro with newer antibiotics, such as telavancin or delafloxacin, are ongoing to substantiate its positioning within antibiotics stewardship protocols. These include Phase III investigations seeking to reinforce its role in resistant infections.

• Resistance Mechanism Monitoring:
  Several surveillance studies are in progress, evaluating the potential emergence of resistance to ceftaroline in S. aureus and other pathogens. These are observational in nature and do not embody interventional trials.

Regulatory Feedback and Future Trials

The FDA has not mandated new phase trials for Teflaro's expanded use. However, ongoing post-marketing surveillance and real-world evidence collection are ongoing to monitor safety and efficacy. The European Medicines Agency (EMA) is reviewing a similar application for expanded indications, and results from these assessments could influence future clinical strategies.

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Market Analysis

Market Segment and Current Adoption

Teflaro occupies a niche in the antibiotic landscape, primarily prescribed for resistant Gram-positive infections. Its sales peaked in 2017 at approximately $200 million, driven mainly by hospital formularies. Post-2018, growth stagnated due to increased competition, generics in the pipeline, and shifting treatment guidelines.

In 2022, the drug registered gross sales of approximately $180 million, reflecting modest decline attributed to:

• Competitive Pressure:
  The introduction of alternative agents such as dalbavancin, oritavancin, and newer beta-lactams, has fragmented the market share.

• Antimicrobial Stewardship:
  Rising emphasis on judicious antibiotic use has restrained broad-use antibiotics, favoring narrow-spectrum or oral agents where possible.

• COVID-19 Pandemic Impact:
  Hospital resource reallocation and reduced elective procedures have temporarily hindered certain indications’ volume.

Geographical and Demographic Trends

• United States:
  Dominant market, commanding approximately 85% of global sales. Usage concentrated in hospital settings, especially in tertiary care centers with high MRSA prevalence.

• Europe:
  Slightly lower penetration due to different formulary preferences and resistance patterns. EMA-based approvals for some new indications could boost future adoption.

• Emerging Markets:
  Limited penetration due to pricing and infrastructure barriers, but growing demand driven by rising resistant infections.

Competitive Landscape

Teflaro faces competition from:

• Vancomycin and Linezolid:
  Long-established, with generic options lowering costs.

• Newer Agents:
  Such as ceftazidime-avibactam and meropenem-vaborbactam, though primarily targeting gram-negative organisms.

• Other Cephalosporins:
  Ceftazidime/avibactam and ceftaroline itself are part of an increasingly crowded catheter of novel cephalosporins.

Regulatory and Reimbursement Factors

Reimbursement remains favorable within hospital-based settings under CMS (Centers for Medicare & Medicaid Services), but outpatient use is limited by institutional formulary policies. Ongoing negotiations and health economic data could influence payers’ willingness to reimburse for broader use.

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Market Projection

Short-term Outlook (2023–2025)

The immediate outlook suggests stagnation with a potential marginal increase in sales driven by:

• Expanded use in specific resistant infections, particularly osteomyelitis and diabetic foot infections.

• Inclusion in hospital formularies globally due to resistance issues.

However, sales are unlikely to surpass the 2017 peak without significant label expansion or new indications.

Medium to Long-term Outlook (2026–2030)

Potential growth catalysts include:

• Indication Expansion:
  Successful completion and positive outcomes from ongoing trials could enable supplementary approvals for conditions such as complicated intra-abdominal infections and bacteremia.

• Pricing and Market Penetration in Emerging Economies:
  Strategic licensing and local manufacturing could expand global footprint.

• Development of Oral Formulations:
  Currently unavailable, but oral equivalents could drastically boost outpatient prescribing and overall sales.

• Resistance Trends:
  Increasing resistance to competing antibiotics, especially vancomycin-resistant pathogens, may favor ceftaroline-based therapies, bolstering market demand.

Challenges and Risks

• The entry of generics could erode margins and sales potential.

• Regulatory delays or setbacks in clinical trials may impede expansion plans.

• Antimicrobial stewardship initiatives may restrict use, limiting sales growth.

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Conclusion and Key Takeaways

• Clinical trials for Teflaro are primarily focused on expanding indications and resistance monitoring, with no major new approval pathways imminent unless unresolved resistance concerns or significant efficacy advantages emerge.

• Market dynamics reflect stagnation in recent years with modest decline, mainly attributable to increased generic competition and stewardship measures.

• Future projection depends heavily on successful clinical trial outcomes, regulatory approvals for new indications, and strategic positioning within resistant infection treatment protocols.

• Key factors influencing Teflaro’s trajectory include the evolution of resistance profiles, hospital formularies’ preferences, and developments in alternative antibiotics.

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Key Takeaways

1. Limited Clinical Expansion:
   Teflaro’s development pipeline is inactive; ongoing trials are predominantly observational or for label extensions with uncertain outcomes impacting its future.

2. Market Stability with Growth Potential:
   The antibiotic faces market saturation but can benefit from resistance-driven demand and regional expansion, particularly in emerging markets.

3. Competitive Landscape:
   The rise of generic antibiotics and new agents necessitates differentiation strategies, including exploring oral formulations or combination therapies.

4. Regulatory and Payer Influences:
   Success hinges on favorable regulatory decisions regarding expanded indications and payer acceptance of new value propositions.

5. Strategic Opportunities:
   Long-term growth will likely depend on innovation in formulation and strategic alliances, particularly in regions with high unmet needs.

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References

[1] U.S. FDA. Teflaro (ceftaroline fosamil) prescribing information. 2010.
[2] ClinicalTrials.gov. Search results for Teflaro-related studies. 2023.
[3] IQVIA. Antibiotic Market Insight Reports. 2022.
[4] EvaluatePharma. 2023 Global Drug Market Forecast.
[5] CDC. Antibiotic Resistance Surveillance and Reports. 2022.