PeptideTrace
ApprovedGlycopeptide Antibiotic

Vancomycin

Vancocin, Firvanq

A

Evidence Grade A — Regulatory approved. 39588 published studies. 599 registered clinical trials.

599 trials39,588 studiesUSEUCA

Licensed Indications

  • Bone Infections
  • Infective Endocarditis
  • Lower Respiratory Tract Infections
  • Septicemia
  • Serious Gram-Positive Infections
  • Skin and Skin Structure Infections

User Experience Reports

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Overview

Vancomycin is one of medicine's most important antibiotics — the go-to treatment for serious MRSA infections and severe C. difficile gut infections. Available as an intravenous infusion for bloodstream and deep-tissue infections and as an oral formulation for intestinal infections, it has been a cornerstone of hospital medicine since the 1950s and remains on the WHO's List of Essential Medicines.

Research Activity

39,588studies
Human 24515
Animal 3109
In-vitro 5235
Reviews 4142

39,588 published studies: 24515 human, 3109 animal, 5235 in-vitro, 4142 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
Not authorised by EMA(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUNot applicable (not authorised)
CAPrescription drug

Summary

Vancomycin is marketed as Vancocin and Firvanq (approved 1958, with oral solution Firvanq approved 2018). It is the standard treatment for serious MRSA infections (bloodstream infections, endocarditis, pneumonia, bone infections) and is first-line for severe C. difficile colitis.

Vancomycin requires therapeutic drug monitoring — blood levels must be checked regularly to ensure the dose is effective without causing kidney damage or hearing loss. The rise of vancomycin-resistant enterococci (VRE) and occasional vancomycin-intermediate S. aureus (VISA) strains represent ongoing challenges. Despite being nearly 70 years old, vancomycin remains irreplaceable for many serious infections, though newer alternatives like daptomycin and the lipoglycopeptides offer advantages in specific settings.

Mechanism of Action

Vancomycin works by binding to a specific chemical structure (D-Ala-D-Ala) on the building blocks that bacteria use to construct their cell walls. By physically blocking this target with five precise hydrogen bonds, vancomycin prevents the enzymes that cross-link the cell wall from doing their job. Without a properly constructed cell wall, the bacterium cannot maintain its structural integrity and dies. This mechanism targets a fundamental bacterial process that human cells do not use.

Research Summary

With over 60 years of clinical experience, vancomycin is one of the most thoroughly understood antibiotics. It requires regular blood level monitoring to ensure doses are effective without causing kidney damage or hearing loss. Administration must be slow to avoid "Red Man Syndrome" — a flushing reaction caused by rapid infusion. The rise of vancomycin-resistant bacteria (particularly enterococci) is an ongoing concern, and occasional vancomycin-intermediate S. aureus strains have been identified. Despite being nearly 70 years old and despite the availability of newer alternatives like daptomycin and the lipoglycopeptides, vancomycin remains irreplaceable for many serious gram-positive infections. Research continues into optimal dosing strategies, particularly in obese patients and children.

Clinical Trials

NCT06383611N/AUnknown

Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty

Osteal Therapeutics, Inc.
NCT00005667N/AUnknown

Vancomycin Resistant Enterococci in Patients Awaiting Liver Transplantation at the University of Michigan: Prevalence, Risk Factors, Natural History and Outcome of Colonization

National Center for Research Resources (NCRR)
NCT04878718N/AUnknown

Vancomycin and Fecal Microbiota Transplant in a Single Patient With Autism Spectrum Disorder

ProgenaBiome
NCT06794944Phase IVNot Yet Recruiting

Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease

Brigham and Women's HospitalEndpoint: C. difficile decolonizationCompletion: 2031-09-01
NCT07339215N/ANot Yet Recruiting

Local Antibiotic Concentrations With Tissue Expanders in Breast Reconstruction

University of California, DavisEndpoint: Local antibiotic exposure (log-transformed AUC₀-₄ weeks)Completion: 2027-12-01
View all 599 trials on ClinicalTrials.gov →

Regulatory Timeline

1983
Regulatory

FDA ORIG 1

1989
Regulatory

Health Canada Market Authorisation

1991
Regulatory

FDA SUPPL 14

1991
Regulatory

FDA SUPPL 17

1993
Regulatory

FDA SUPPL 20

1996
Regulatory

FDA SUPPL 21

1997
Regulatory

FDA SUPPL 23

2008
Regulatory

FDA ORIG 1

2008
Regulatory

FDA ORIG 1

2008
Regulatory

FDA ORIG 1

2009
Regulatory

FDA SUPPL 1

2009
Regulatory

FDA SUPPL 2

2009
Regulatory

FDA SUPPL 2

2009
Regulatory

FDA SUPPL 3

2009
Regulatory

FDA SUPPL 2

2010
Regulatory

FDA SUPPL 3

2013
Regulatory

FDA SUPPL 4

2015
Regulatory

FDA ORIG 1

2018
Regulatory

FDA ORIG 1

2019
Regulatory

FDA SUPPL 26

2020
Regulatory

FDA SUPPL 27

2020
Regulatory

FDA SUPPL 19

2020
Regulatory

FDA SUPPL 25

2020
Regulatory

FDA SUPPL 17

2020
Regulatory

FDA SUPPL 28

2020
Regulatory

FDA SUPPL 16

2020
Regulatory

FDA SUPPL 20

2020
Regulatory

FDA SUPPL 16

2020
Regulatory

FDA SUPPL 20

2020
Regulatory

FDA SUPPL 23

2020
Regulatory

FDA SUPPL 21

2020
Regulatory

FDA SUPPL 1

2020
Regulatory

FDA SUPPL 14

2020
Regulatory

FDA SUPPL 12

2020
Regulatory

FDA SUPPL 15

2021
Regulatory

FDA SUPPL 27

2021
Regulatory

FDA SUPPL 28

2021
Regulatory

FDA SUPPL 16

2021
Regulatory

FDA SUPPL 9

2021
Regulatory

FDA SUPPL 32

2021
Regulatory

FDA SUPPL 28

2022
Regulatory

FDA ORIG 1

2022
Regulatory

FDA ORIG 1

2022
Regulatory

FDA ORIG 1

2023
Regulatory

FDA ORIG 1

2023
Regulatory

FDA SUPPL 6

2023
Regulatory

FDA SUPPL 4

2023
Regulatory

FDA SUPPL 2

2023
Regulatory

FDA SUPPL 5

2023
Regulatory

FDA SUPPL 1

Related Compounds

Corticotropin

Approved
Repository ACTH Preparation

Corticotropin is marketed as H.P. Acthar Gel (currently ANI Pharmaceuticals). It carries approximately 19 FDA-labelled indications including infantile spasms (its strongest evidence base), nephrotic syndrome, multiple sclerosis relapses, and rheumatic disorders. Acthar Gel has been at the centre of major pricing and legal controversies. The price rose from approximately $40 per vial in 2001 to over $40,000, driven by successive acquisitions and orphan-like positioning despite broad labelling. The former manufacturer Mallinckrodt agreed to a $260 million settlement over antitrust concerns. Clinically, the strongest evidence supports its use in infantile spasms, where it is considered a first-line treatment. For most other indications, debate continues over whether it offers meaningful advantages over far less expensive oral corticosteroids.

Enfuvirtide

Approved
HIV Fusion Inhibitor (Peptide)

Enfuvirtide is marketed as Fuzeon (approved March 2003). It requires twice-daily subcutaneous injections, and injection-site reactions occur in nearly all patients (98%). In clinical trials (TORO-1 and TORO-2), enfuvirtide combined with an optimised background regimen achieved significantly greater viral suppression than background regimen alone in treatment-experienced patients. Enfuvirtide represented a major advance when HIV drug resistance was a more pressing clinical challenge, but its use has declined substantially with the arrival of more convenient oral antiretrovirals. The twice-daily injection burden, injection-site reactions, high cost, and complex manufacturing (it is one of the largest synthetic peptides manufactured at scale) have limited its role to a last-resort option for patients with highly resistant HIV.

Dalbavancin

Approved
Lipoglycopeptide Antibiotic

Dalbavancin is marketed as Dalvance (approved May 2014). Originally approved as a two-dose regimen (Day 1 and Day 8), a single-dose regimen was approved in January 2016, and paediatric approval followed in 2021. Indicated for ABSSSI caused by susceptible gram-positive organisms. Dalbavancin's 346-hour half-life is the longest of any approved antibiotic, and there is growing off-label interest in its use for conditions requiring prolonged antibiotic courses, such as osteomyelitis and prosthetic joint infections — conditions where patients would otherwise need weeks of daily intravenous antibiotics. The DOTS trial (2025) showed non-inferiority to standard-of-care antibiotics for bone and joint infections, potentially expanding its clinical role significantly.