PeptideTrace
ApprovedLipoglycopeptide AntibioticImmune & Anti-inflammatory

Oritavancin (Orbactiv, Kimyrsa)

A

Evidence Grade A — Regulatory approved. 492 published studies. 21 registered clinical trials.

21 trials492 studiesUSEUCA

Medically reviewed by a licensed medical professional

Licensed Indications

  • Bacterial Skin Infections
  • Soft Tissue Infections
  • Acute Bacterial Skin and Skin Structure Infections

User Experience Reports

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Overview

Oritavancin (sold as Orbactiv and Kimyrsa) is an intravenous antibiotic that can cure a serious bacterial skin infection with a single hospital visit. Its remarkably long duration of action means one dose provides a full course of treatment that would otherwise require 7–10 days of twice-daily vancomycin infusions. This is particularly valuable for patients who face barriers to completing multi-day treatment courses.

Also Known As

Oritavancin is also known by these brand and alternate names:

Research Activity

492studies
Human 309
Animal 12
In-vitro 138
Reviews 188

492 published studies: 309 human, 12 animal, 138 in-vitro, 188 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
EMA-authorised(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUPrescription medicine (EU centralised authorisation)
CAPrescription drug

Summary

Oritavancin is marketed as Orbactiv (approved August 2014) and Kimyrsa (approved March 2021 as a faster 1-hour infusion). Indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA.

The single-dose regimen is oritavancin's key differentiator. In clinical trials (SOLO I and II), a single dose was non-inferior to 7–10 days of twice-daily vancomycin. This is particularly valuable in emergency department settings and for patients with unstable housing, active substance use, or other barriers to completing multi-day antibiotic courses. However, oritavancin interferes with coagulation laboratory tests for up to 120 hours after dosing, complicating monitoring in patients who also need anticoagulation.

Mechanism of Action

Oritavancin kills bacteria through three simultaneous mechanisms, making it exceptionally potent. Like vancomycin, it binds the D-Ala-D-Ala target on cell wall building blocks. But it also directly disrupts the bacterial cell membrane through its fatty acid side chain, and uniquely, it blocks a second cell wall construction step (transpeptidation) that vancomycin cannot reach. This triple attack gives it activity against some bacteria that are resistant to vancomycin.

Research Summary

In two Phase III trials involving nearly 2,000 patients, a single dose of oritavancin was non-inferior to 7–10 days of twice-daily vancomycin for acute bacterial skin infections, including MRSA. The single-dose approach is especially useful in emergency department settings and for patients with unstable housing or other circumstances that make return visits difficult. The main clinical concern is interference with blood clotting laboratory tests — oritavancin can falsely elevate aPTT readings for up to five days after dosing, which complicates monitoring for patients who also need blood-thinning medications. Heparin is contraindicated for five days after a dose. There is no trial data supporting its use in bloodstream infections, endocarditis, or bone infections, though its long duration makes off-label use in these settings an area of clinical interest.

Clinical Trials

PeptideTrace tracks 21 registered clinical trials for Oritavancin sourced from ClinicalTrials.gov.

NCT07550595Phase IINot Yet Recruiting

Oritavancin for Treatment of Serious Cardiac Infections

Kirby InstituteEndpoint: Desirability of Outcome Ranking (DOOR) at Day 70Completion: 2028-09-30
NCT07013552N/ANot Yet Recruiting

Oritavancin for CIED Infections With MDR Gram-positive Cocci

Medical University of SilesiaEndpoint: Co-primary efficacy endpoint - treatment success rateCompletion: 2026-10-01
NCT05521880Phase IVTerminated

Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use

University of Maryland, BaltimoreEndpoint: Frequency of clinically assessed cure, completion (no need for further parenteral antimicrobial therapy) or transition to suppressive antimicrobial therapy at 12 weeks for patients discharged to home with long acting agents and MOUDCompletion: 2025-05-23
NCT06688084N/AActive, Not Recruiting

Pathogenicity Factors of Staphylococcus Pettenkoferi in Foot Wounds and Osteitis in Diabetic Patients

Centre Hospitalier Universitaire de NīmesEndpoint: Genetic diversity of Staphyloccocus pettenkoferi strains isolated from osteitis and non-diabetic wounds, blood cultures and nasal carriage.Completion: 2026-05-01
NCT05977868Phase IVTerminated

Comparing Oral Versus Parenteral Antimicrobial Therapy

West Virginia UniversityEndpoint: Cure/Control at 3 MonthsCompletion: 2025-02-14
View all 21 trials on ClinicalTrials.gov →

Regulatory Timeline

2014
Regulatory

FDA ORIG 1

2015
Regulatory

EMA Marketing Authorisation

2015
Regulatory

FDA SUPPL 1

2016
Regulatory

FDA SUPPL 2

2016
Regulatory

FDA SUPPL 3

2018
Regulatory

FDA SUPPL 4

2019
Regulatory

FDA SUPPL 5

2021
Regulatory

FDA ORIG 1

2021
Regulatory

FDA SUPPL 6

2021
Regulatory

FDA SUPPL 1

2022
Regulatory

FDA SUPPL 7

2025
Regulatory

FDA SUPPL 5

Scientific Detail

Overview (Scientific)

Oritavancin is a semisynthetic lipoglycopeptide from chloroeremomycin, with heptapeptide core, MW ~1,793 Da. Features N-4-(4-chlorophenyl)benzyl lipophilic side chain, 4-epi-vancosamine, and three chlorine atoms. Three complementary mechanisms: D-Ala-D-Ala binding, pentaglycyl bridge binding, and membrane disruption. Single 1,200 mg IV dose (Orbactiv 3h; Kimyrsa 1h). Terminal half-life ~245-393 hours (10-16 days).

Mechanism of Action (Scientific)

Three complementary mechanisms. First: binds D-Ala-D-Ala termini blocking transglycosylation; homodimerizes before binding for higher affinity than vancomycin. Second: uniquely binds pentaglycyl bridging segments inhibiting transpeptidation - enables activity against vanA/vanB VRE. Third: hydrophobic side chain anchors into phospholipid bilayer causing membrane disruption - active against biofilm and stationary-phase bacteria.

Summary (Scientific)

Marketed as Orbactiv (approved August 6, 2014) and Kimyrsa (1h infusion, March 12, 2021). SOLO I (N=954): 82.3% vs. 78.9% composite response (non-inferior). SOLO II (N=1,005): 80.1% vs. 82.9% (non-inferior). Pooled safety (N=1,959): comparable AE rates. Indication: ABSSSI in adults caused by susceptible gram-positive organisms including MRSA.

Related Compounds

Vancomycin

Approved
Glycopeptide Antibiotic

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.

Zilucoplan

Approved
Complement C5 Inhibitor (Peptide)

Zilucoplan is marketed as Zilbrysq (approved October 2023) for anti-acetylcholine receptor antibody-positive generalised myasthenia gravis in adults. Administered as a daily subcutaneous self-injection. In the RAISE trial, zilucoplan showed statistically significant improvements in both activities of daily living and quantitative muscle strength scores compared to placebo, with improvements evident from week one. Its key differentiator from existing complement inhibitors (eculizumab, ravulizumab) is the self-injectable format — those alternatives require hospital-based intravenous infusions. As with all complement inhibitors, patients require meningococcal vaccination before starting treatment due to increased susceptibility to meningococcal infection.

Daptomycin

Approved
Lipopeptide Antibiotic

Daptomycin is marketed as Cubicin (approved September 2003). It is indicated for complicated skin and soft tissue infections and S. aureus bloodstream infections including right-sided endocarditis. Administered as a once-daily intravenous infusion. A key limitation is that daptomycin cannot be used for pneumonia — lung surfactant inactivates the drug. In the bacteraemia trial, daptomycin was non-inferior to vancomycin with significantly lower rates of kidney problems (11% versus 26%). Creatine kinase (CK) levels must be monitored during treatment, as daptomycin can cause muscle toxicity. Generics became available after patent expiry, significantly reducing cost.

Related Research

This content is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional before making decisions about your health.