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EMA-approvedaka Orbactiv, Kimyrsa

Oritavancin — Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Oritavancin (also known as Orbactiv) is a peptide catalogued under Cyclic & Antimicrobial (Lipoglycopeptide). It is described as: Cell wall + membrane. Documented context: ABSSSI. Neutral reference entry; EU status: EU-approved prescription medicine.

What is Oritavancin?

Oritavancin (brand name Orbactiv; a reformulation is marketed as Kimyrsa) is a semisynthetic lipoglycopeptide antibiotic, FDA-approved in 2014 for acute bacterial skin and skin-structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including MRSA.

It is administered as a single intravenous dose (1200 mg), delivering a full treatment course in one visit.

Evidence level is high, based on two pivotal phase 3 non-inferiority randomized controlled trials in humans (SOLO I and SOLO II) and subsequent pooled analyses.

How does Oritavancin work?

Oritavancin has three mechanisms: it inhibits transglycosylation and transpeptidation by binding peptidoglycan precursors, and it disrupts the bacterial membrane, producing concentration-dependent bactericidal activity.

This multi-target action retains activity against many vancomycin-resistant Gram-positive organisms in vitro.

What does the research say about Oritavancin?

  • A single intravenous dose of oritavancin was non-inferior to 7-10 days of twice-daily vancomycin for ABSSSI in the SOLO I trial. [1]
  • SOLO II independently confirmed non-inferiority of single-dose oritavancin versus 7-10 days of vancomycin. [2]
  • Pooled SOLO data showed consistent efficacy in Gram-positive ABSSSI, including a large MRSA subset. [3]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

  • [1] Single-dose oritavancin in the treatment of acute bacterial skin infections — Corey GR et al., The New England Journal of Medicine 2014. (Phase 3 RCT (SOLO I))
  • [2] Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study — Corey GR et al., Clinical Infectious Diseases 2015. (Phase 3 RCT (SOLO II))
  • [3] Pooled analysis of single-dose oritavancin in the treatment of acute bacterial skin and skin-structure infections caused by Gram-positive pathogens, including a large patient subset with methicillin-resistant Staphylococcus aureus — Corey GR et al., International Journal of Antimicrobial Agents 2016. (Pooled analysis)
  • [4] Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies — Corey GR et al., Antimicrobial Agents and Chemotherapy 2018. (Pooled safety analysis)
  • [5] Effects of Oritavancin on Coagulation Tests in the Clinical Laboratory — Belley A et al., Antimicrobial Agents and Chemotherapy 2017. (Laboratory/mechanistic study)
  • [6] Approved Glycopeptide Antibacterial Drugs: Mechanism of Action and Resistance — Zeng D et al., Cold Spring Harbor Perspectives in Medicine 2016. (Mechanistic review)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

In the SOLO trials and labeling, oritavancin is given as a single 1200 mg intravenous infusion over 3 hours (the Kimyrsa formulation over 1 hour).

This is descriptive context for the approved indication only and is not medical advice or dosing guidance.

Side effects & safety profile

Oritavancin artificially prolongs coagulation tests: it falsely elevates activated partial thromboplastin time (aPTT) for up to about 5 days (120 hours) and prothrombin time/INR for up to about 12-24 hours, and it interferes with heparin monitoring, so unfractionated heparin sodium is contraindicated for 120 hours after a dose because aPTT results are unreliable.

Common adverse reactions include headache, nausea, vomiting, limb and subcutaneous abscesses, and infusion-related reactions; osteomyelitis was reported more often in the oritavancin arm of trials, warranting vigilance.

Hypersensitivity reactions and, because of the long half-life, prolonged exposure to any adverse effect are considerations.

Stacking & combinations

Oritavancin is used as single-dose monotherapy for its labeled ABSSSI indication, not as part of a combined regimen.

Finding Oritavancin vendors

Finding Oritavancin vendors

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Frequently asked questions

It is FDA-approved for acute bacterial skin and skin-structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including MRSA.

References

  1. [1] Single-dose oritavancin in the treatment of acute bacterial skin infections — Corey GR et al., The New England Journal of Medicine 2014. PMID: 24897083. View sourceStudy: Phase 3 RCT (SOLO I)One 1200 mg dose was non-inferior to 7-10 days of vancomycin for ABSSSI.
  2. [2] Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study — Corey GR et al., Clinical Infectious Diseases 2015. PMID: 25294250. View sourceStudy: Phase 3 RCT (SOLO II)Confirmed non-inferiority of single-dose oritavancin versus vancomycin.
  3. [3] Pooled analysis of single-dose oritavancin in the treatment of acute bacterial skin and skin-structure infections caused by Gram-positive pathogens, including a large patient subset with methicillin-resistant Staphylococcus aureus — Corey GR et al., International Journal of Antimicrobial Agents 2016. PMID: 27665522. View sourceStudy: Pooled analysisEfficacy was consistent across pathogens including a large MRSA subset.
  4. [4] Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies — Corey GR et al., Antimicrobial Agents and Chemotherapy 2018. PMID: 29358292. View sourceStudy: Pooled safety analysisSummarizes the SOLO safety profile of single-dose oritavancin.
  5. [5] Effects of Oritavancin on Coagulation Tests in the Clinical Laboratory — Belley A et al., Antimicrobial Agents and Chemotherapy 2017. PMID: 27956417. View sourceStudy: Laboratory/mechanistic studyOritavancin artificially prolongs aPTT and PT and interferes with heparin monitoring.
  6. [6] Approved Glycopeptide Antibacterial Drugs: Mechanism of Action and Resistance — Zeng D et al., Cold Spring Harbor Perspectives in Medicine 2016. PMID: 27663982. View sourceStudy: Mechanistic reviewExplains the multi-target cell-wall and membrane action of lipoglycopeptides.
This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.