PeptideTrace
ApprovedLipoglycopeptide Antibiotic

Oritavancin

Orbactiv, Kimyrsa

A

Evidence Grade A — Regulatory approved. 486 published studies. 20 registered clinical trials.

20 trials486 studiesUSEUCA

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.

Research Activity

486studies
Human 309
Animal 12
In-vitro 136
Reviews 187

486 published studies: 309 human, 12 animal, 136 in-vitro, 187 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

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
NCT05599295Phase IICompleted

Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections

Melinta Therapeutics, LLCEndpoint: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)Completion: 2025-11-20
View all 20 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

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.

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.