Skin & aging Lipoglycopeptide antibiotics
Dalbavancin / Oritavancin / Telavancin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Dalbavancin, oritavancin, and telavancin (sold as Dalvance, Orbactiv, and Vibativ) are lipoglycopeptide antibiotics, semi-synthetic relatives of vancomycin that treat Gram-positive infections, including MRSA. Dalbavancin's half-life of roughly two weeks and oritavancin's single-infusion course allow very infrequent dosing for a skin infection, while telavancin is dosed daily. All three are FDA-approved in the U.S., and they are given intravenously.
At a glance
- What they are
- Lipoglycopeptide antibiotics derived from the glycopeptide class, active against Gram-positive bacteria including MRSA
- Approved for
- Acute bacterial skin and skin-structure infections (all three); telavancin also for certain hospital-acquired pneumonia
- Key fact
- Dalbavancin, given as two once-weekly doses, was non-inferior to a standard vancomycin course for skin infections
- Route
- Intravenous
- Evidence strength
- FDA approved
Summary
Dalbavancin, oritavancin, and telavancin are FDA-approved lipoglycopeptide antibiotics for Gram-positive infections. See how they work and differ.
What are dalbavancin, oritavancin, and telavancin?
Dalbavancin (Dalvance), oritavancin (Orbactiv, also Kimyrsa), and telavancin (Vibativ) are lipoglycopeptide antibiotics, semi-synthetic molecules built on the glycopeptide backbone of vancomycin with an added lipid side chain. That modification extends how long they last in the body and, for two of them, adds a second way of attacking bacteria. All three are active against Gram-positive organisms including MRSA. They were approved in the United States between 2009 (telavancin) and 2014 (dalbavancin and oritavancin).
How do they work?
Like vancomycin, these drugs block bacterial cell-wall synthesis by binding the D-alanyl-D-alanine end of the wall's building blocks, preventing the cross-linking that gives the wall strength. The lipid tail anchors them in the bacterial membrane, which both prolongs their activity and, in the case of oritavancin and telavancin, lets them also disrupt the membrane itself, a second bactericidal mechanism. All are bactericidal against Gram-positive bacteria including MRSA.
The standout practical feature is duration. Dalbavancin's half-life of roughly two weeks allows a once-weekly or even single-dose regimen, and oritavancin treats a skin infection with a single infusion. In its pivotal program, once-weekly dalbavancin was non-inferior to a conventional vancomycin-to-linezolid course for skin infections. Telavancin is dosed daily and has a broader approved role that includes some pneumonia.
Is it FDA-approved?
Editor’s note
Status: Yes. All three are approved for acute bacterial skin and skin-structure infections. The table shows when each was approved and for what: Drug | FDA approval | Approved for Telavancin | 2009 | Acute bacterial skin and skin-structure infections; also hospital-acquired and ventilator-associated bacterial pneumonia due to susceptible S. aureus when alternatives are unsuitable Dalbavancin | 2014; extended to children from birth in 2021 | Acute bacterial skin and skin-structure infections Oritavancin | 2014 | Acute bacterial skin and skin-structure infections Telavancin carries boxed warnings for kidney toxicity and for fetal risk, requiring a pregnancy test before use.
Category: FDA-approved · Primary body area: Skin & aging
Yes. All three are approved for acute bacterial skin and skin-structure infections. The table shows when each was approved and for what:
| Drug | FDA approval | Approved for |
|---|---|---|
| Telavancin | 2009 | Acute bacterial skin and skin-structure infections; also hospital-acquired and ventilator-associated bacterial pneumonia due to susceptible S. aureus when alternatives are unsuitable |
| Dalbavancin | 2014; extended to children from birth in 2021 | Acute bacterial skin and skin-structure infections |
| Oritavancin | 2014 | Acute bacterial skin and skin-structure infections |
Telavancin carries boxed warnings for kidney toxicity and for fetal risk, requiring a pregnancy test before use.
What are they prescribed for?
These drugs are prescribed for acute bacterial skin and skin-structure infections caused by susceptible Gram-positive bacteria, including MRSA. Dalbavancin and oritavancin are often chosen when a very short or single-dose course is advantageous, such as avoiding a prolonged IV line. Telavancin is also used for certain hospital-acquired pneumonias when other options are not appropriate.
What are the side effects?
According to the prescribing information, common side effects include:
- Nausea, headache, and diarrhea
- Rises in liver enzymes (dalbavancin)
- Taste disturbance and foamy urine (telavancin)
More serious considerations include:
- Telavancin's boxed warnings for kidney toxicity (with higher mortality in pneumonia patients who already have moderate-to-severe kidney impairment) and for fetal harm
- Oritavancin interferes with some blood-clotting tests and should not be used with intravenous unfractionated heparin for a period after dosing
- Infusion-related reactions
Sources: FDA prescribing information for Dalvance, Orbactiv, and Vibativ; the DISCOVER dalbavancin trials (Boucher et al., The New England Journal of Medicine, 2014, DOI: 10.1056/NEJMoa1310480), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
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