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Orbactiv (ORITAVANCIN)
Orbactiv works by binding to the bacterial cell wall, disrupting its synthesis and ultimately leading to cell death.
Orbactiv (Oritavancin) is a lipoglycopeptide antibacterial drug developed by The Medicines Co and currently owned by Melinta Therapeutics. It is a small molecule that targets bacterial infections of the skin, including those caused by Staphylococcus and Streptococcus species. Orbactiv was FDA-approved in 2014 and has a long half-life of 96.2 hours. It is not yet available as a generic medication. Key safety considerations include its potential to cause infusion-related reactions and QT interval prolongation.
At a glance
| Generic name | ORITAVANCIN |
|---|---|
| Sponsor | Melinta Therap |
| Drug class | Lipoglycopeptide Antibacterial |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2014 |
Mechanism of action
Oritavancin is an antibacterial drug [see Microbiology (12.4)].
Approved indications
- Bacterial infection of skin
- Staphylococcal infection of skin
- Streptococcal infection of skin
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Headache
- Abscess (limb and subcutaneous)
- Infusion site phlebitis
- Infusion site reaction
- Alanine aminotransferase increased
- Aspartate aminotransferase increased
- Tachycardia
- Cellulitis
- Osteomyelitis
Key clinical trials
- Open Label, Dose-finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Participants With Suspected or Confirmed Bacterial Infections (PHASE1)
- Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections (PHASE2)
- Pathogenicity Factors of Staphylococcus Pettenkoferi in Foot Wounds and Osteitis in Diabetic Patients
- Comparing Oral Versus Parenteral Antimicrobial Therapy (PHASE4)
- Oritavancin for CIED Infections With MDR Gram-positive Cocci (NA)
- Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use (PHASE4)
- Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection (PHASE4)
- A Study to Assess the Cardiac Safety of Oritavancin in Healthy Participants (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Orbactiv CI brief — competitive landscape report
- Orbactiv updates RSS · CI watch RSS
- Melinta Therap portfolio CI