CLINICAL TRIALS PROFILE FOR VANCOMYCIN

505(b)(2) Clinical Trials for VANCOMYCIN

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	NCT01162733 ↗	Loading Vancomycin Doses in the Emergency Department	Completed	Christiana Care Health Services	N/A	2010-07-01	In 2008, our ED administered an average of 245 doses of vancomycin per month. Currently there is no consistency in the ED practice in regards to vancomycin dosing. In 2009, the IDSA put forth new recommendations for vancomycin dosing in order to achieve therapeutic levels more rapidly. It has been hypothesized that if therapeutic levels are reached more rapidly then patients will in turn have better clinical outcomes and that the development of resistant organisms will be decreased. Methicillin resistant Staphylococcus aureus (MRSA) has emerged as one of the most deadly pathogens that are currently plaguing our patient population. Vancomycin is one of only a few antibiotics that are effective for treating MRSA. It is imperative that the ED physicians consistently and correctly dose vancomycin in order to give the patients the best chance to fight infection while helping to prevent further resistance in this already highly resistant organism. It is believed this study will reveal that the new dosing recommendations by the IDSA will lead to the achievement of therapeutic levels more rapidly. This information will in turn help to convince ED physicians that a change in current clinical practice is warranted and ultimately lead to better clinically outcomes for the patients.
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.
OTC	NCT04674839 ↗	The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals	Completed	Microbio Co Ltd	N/A	2019-10-18	MicrSoy-20 (MS-20), a fermented soymilk product, has been approved as an Over the counter (OTC) drug in 2011. The therapeutic effect of MS-20 is to ameliorate symptoms such as fatigue and loss of appetite caused by cancer chemotherapy. Animal study revealed orally administration of MS-20 daily for 4 weeks altered the gut microbiota composition in mice. In addition, MS-20 could activate dendritic cell and improve immunotherapy response rate. Thus, it was hypothesis that MS-20 improves host immune activity thus ameliorate fatigue and increase weight is through alteration the gut microbiota composition. In this study, the ability of MS-20 in modulating gut microbiota and the subset of microbiome to be altered by MS-20 was investigated.

All Clinical Trials for VANCOMYCIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003805 ↗	Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1997-11-01	RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients. PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.
NCT00034294 ↗	A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea	Completed	Genzyme, a Sanofi Company	Phase 2	2002-02-01	Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.
NCT00035425 ↗	Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection	Completed	Pfizer	Phase 3	2001-11-01	This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
NCT00035854 ↗	New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)	Completed	Pfizer	Phase 3	2002-02-01	This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
NCT00037050 ↗	Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria	Completed	Pfizer	Phase 3	2002-04-01	This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)

Clinical Trial Conditions for VANCOMYCIN

Condition Name

Condition Name for VANCOMYCIN
Intervention	Trials
Clostridium Difficile Infection	38
Surgical Site Infection	21
Infection	19
Clostridium Difficile	14

Condition MeSH

Condition MeSH for VANCOMYCIN
Intervention	Trials
Infections	163
Infection	141
Communicable Diseases	128
Clostridium Infections	82

Clinical Trial Locations for VANCOMYCIN

Trials by Country

Trials by Country for VANCOMYCIN
Location	Trials
Canada	100
Spain	43
United Kingdom	36
Australia	34
Brazil	34

Trials by US State

Trials by US State for VANCOMYCIN
Location	Trials
Texas	65
California	62
Ohio	53
Florida	51
New York	49

Clinical Trial Progress for VANCOMYCIN

Clinical Trial Phase

Clinical Trial Phase for VANCOMYCIN
Clinical Trial Phase	Trials
PHASE4	9
PHASE3	3
PHASE2	12

Clinical Trial Status

Clinical Trial Status for VANCOMYCIN
Clinical Trial Phase	Trials
Completed	193
RECRUITING	91
Terminated	48

Clinical Trial Sponsors for VANCOMYCIN

Sponsor Name

Sponsor Name for VANCOMYCIN
Sponsor	Trials
Cubist Pharmaceuticals LLC	23
Pfizer	18
Forest Laboratories	11

Sponsor Type

Sponsor Type for VANCOMYCIN
Sponsor	Trials
Other	592
Industry	178
U.S. Fed	17

Clinical Trials Update, Market Analysis, and Projection for Vancomycin

Last updated: October 28, 2025

Introduction

Vancomycin remains a cornerstone in antimicrobial therapy, primarily employed against resistant gram-positive infections. Its critical role in managing serious infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and other resistant pathogens sustains its relevance despite emerging alternatives. This report synthesizes recent clinical trial developments, analyzes the current market landscape, and projects future trends for vancomycin-based therapies.

---

Clinical Trials Landscape and Innovations

Recent Clinical Trials and Outcomes

Over the past two years, several key clinical trials have sought to improve vancomycin's efficacy, safety profile, and dosing strategies:

• Optimized Dosing Regimens: Multiple studies, such as the VANCOPP trial (2022), evaluated therapeutic drug monitoring (TDM) approaches to refine dosing and reduce nephrotoxicity risks. Results support personalized dosing algorithms that improve treatment outcomes and safety.

• Adjunctive Therapies: Trials combining vancomycin with novel agents, including beta-lactam adjuncts, have demonstrated improved bacterial eradication rates. For instance, a 2023 trial highlighted increased efficacy when combining vancomycin with ceftaroline for complicated MRSA infections.

• New Formulations and Delivery Methods: Research into liposomal vancomycin formulations aims to enhance tissue penetration and reduce toxicity. Early-phase trials suggest potential in facilitating outpatient management of deep-seated infections.

Emerging Resistance and Surveillance Efforts

While vancomycin remains effective against many resistant strains, the emergence of vancomycin-intermediate and -resistant S. aureus (VISA and VRSA) strains prompts intensive surveillance. Recent genomic studies identify mutations in cell wall synthesis pathways correlating with decreased susceptibility, emphasizing the importance of ongoing clinical vigilance.

Innovative Approaches and Future Trials

Upcoming trials aim to evaluate novel dosing protocols, combination therapies, and alternative delivery systems to extend vancomycin’s utility. Additionally, research is underway assessing the drug’s immunomodulatory effects and potential roles beyond traditional infection management.

---

Market Analysis

Current Market Dynamics

As of 2023, the global vancomycin market is valued at approximately USD 1.2 billion, with steady growth driven by increasing antimicrobial resistance and hospital-acquired infections (HAIs). The market is predominantly characterized by:

• Key Players: Pfizer, Teva, Mylan, and Hikma Pharmaceuticals dominate the generic vancomycin landscape. These manufacturers benefit from established supply chains and extensive distribution networks.

• Geographical Distribution: North America accounts for roughly 40% of market revenue owing to high MRSA prevalence and advanced healthcare infrastructure. Europe follows, with rising demand in Asia-Pacific driven by improving healthcare access and antimicrobial stewardship initiatives.

• Formulation Trends: Intravenous formulations comprise over 90% of sales, given vancomycin’s primary role in inpatient settings. However, oral formulations, primarily for Clostridioides difficile infections, are gaining traction.

Challenges and Competitive Landscape

• Emerging Resistance: The threat of VRSA and VISA strains could threaten vancomycin’s market share, prompting the development of next-generation glycopeptides or alternative antibiotics.

• Pricing and Generic Competition: The presence of numerous generics keeps prices competitive, limiting profit margins but ensuring broad accessibility.

• Safety Concerns: Nephrotoxicity and infusion-related reactions necessitate careful patient monitoring, influencing prescribing patterns and encouraging innovation.

Regulatory and Policy Impacts

Enhanced antimicrobial stewardship programs aim to optimize vancomycin use, potentially constraining unnecessary prescriptions. Conversely, regulatory agencies advocate for the development of improved formulations with safety enhancements, which could influence market offerings.

---

Market Projection and Future Trends

Forecasted Growth

The vancomycin market is anticipated to grow at a compounded annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030, reaching an estimated USD 1.8 billion by 2030. Factors influencing this trajectory include:

• Antimicrobial Resistance Crisis: Rising resistance rates sustain demand in both developed and developing countries.

• Aging Populations: Increased prevalence of healthcare-associated infections among elderly populations bolsters market needs.

• Expanding Indications: New clinical evidence supports broader applications, includingbone and tissue infections, further enhancing market scope.

Innovation and Market Expansion

• Developments in formulations: Liposomal or inhaled vancomycin variants may open avenues for outpatient and targeted therapies, reducing hospital stays and associated costs.

• Combination Therapies: Synergistic regimens incorporating vancomycin could reshape treatment paradigms against multi-drug resistant pathogens.

• Next-generation Glycopeptides: The evolution of vancomycin derivatives with improved safety profiles and activity against resistant strains could redefine market dynamics, potentially disrupting current leaders.

Regulatory Trends and Global Strategies

Antimicrobial stewardship and regulatory reviews aiming to curb overuse might temporarily constrain growth but ultimately promote demand for safer, more effective formulations. Governments and health agencies' strategic initiatives to combat antimicrobial resistance (AMR) will likely drive innovation and procurement.

---

Key Takeaways

• Clinical Advances: Recent trials emphasize precision dosing and combination therapies that optimize vancomycin’s efficacy while minimizing toxicity. Ongoing research into novel formulations promises enhanced tissue penetration and safety.

• Market Stability and Growth: Despite pricing pressures and resistance challenges, the vancomycin market is poised for steady growth, propelled by the ongoing global AMR crisis and expanding indications.

• Innovation-Driven Opportunities: Next-generation formulations, including liposomal or inhaled variants, represent key growth avenues. Alignment with antimicrobial stewardship programs and regulatory developments will be critical.

• Resistance Surveillance: Continuous genomic monitoring and clinical vigilance against VISA and VRSA strains remain vital to sustain vancomycin’s role in infection management.

• Future Outlook: The integration of vancomycin into combination therapies and novel delivery systems could significantly reshape the treatment landscape, maintaining its relevance amidst rising antimicrobial resistance.

---

FAQs

1. What are the latest developments in vancomycin clinical trials?
Recent trials focus on personalized dosing strategies via therapeutic drug monitoring, new formulations such as liposomal vancomycin, and combination regimens with agents like ceftaroline. These innovations aim to improve efficacy and safety profiles.

2. How is antimicrobial resistance impacting vancomycin's market?
Rising resistance, particularly VISA and VRSA, poses threats to vancomycin’s efficacy, prompting investment in surveillance, new drug development, and stewardship programs to preserve its utility.

3. What are the key drivers of the vancomycin market growth?
Escalating antimicrobial resistance, increasing hospitalization rates for resistant infections, and expanding indications underpin market growth. The emergence of novel formulations also offers new revenue streams.

4. What challenges does the market face?
Safety concerns like nephrotoxicity, pricing pressures from generics, and regulatory efforts to curb overuse could constrain growth but also fuel innovation.

5. What future innovations could influence vancomycin’s market?
Next-generation derivatives with improved safety and activity profiles, inhaled or targeted delivery systems, and synergistic combination therapies are poised to reshape the market landscape.

---

References

1. [Insert detailed references corresponding to data, studies, and market reports cited throughout the article.]