Are dalbavancin, oritavancin and telavancin FDA-approved, and what does the research show?

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What are dalbavancin, oritavancin and telavancin?

Dalbavancin, oritavancin and telavancin are three antibiotics, sold in the United States as Dalvance, as Orbactiv and Kimyrsa, and as Vibativ ⁴, ⁵, ⁶, ⁷. Each label calls its drug a "lipoglycopeptide antibacterial" ¹, ², ³. The word joins three parts: lipo- for fat, glyco- for sugar, and peptide, a short chain of amino acids. A glycopeptide is the same word without the fat part, a peptide that carries sugars.

They are antibiotics for serious bacterial infections, and each label gives the route as an infusion into a vein ¹, ², ³. They are not wellness, weight-loss, skin-care, hair, immune-boosting or performance peptides. The skin in their labels is infected skin: the approved uses are bacterial infections of the skin and, for telavancin, a pneumonia as well ¹, ², ³.

Each label describes its drug as semisynthetic, a natural substance altered in the laboratory ¹, ², ³. The Dalvance label says dalbavancin is "synthesized from a fermentation product" of a microorganism ¹. The Vibativ label calls telavancin "a synthetic derivative of vancomycin," an older antibiotic that has its own page in this library ³. The Orbactiv label lists vancomycin, telavancin and dalbavancin together as "other glycopeptides" ².

Are dalbavancin, oritavancin and telavancin FDA-approved?

Dalbavancin (Dalvance) ⁴, oritavancin (Orbactiv ⁵ and Kimyrsa ⁶) and telavancin (Vibativ) ⁷ are each FDA-approved and listed as prescription drugs in Drugs@FDA, and one Vibativ record lists one vial size as discontinued ⁷. As of November 9, 2026, the date of its data, Drugs@FDA lists Dalvance ⁴, Orbactiv ⁵, Kimyrsa ⁶ and Vibativ ⁷ each with a product of marketing status "Prescription". The Dalvance, Orbactiv and Vibativ cartons are each marked Rx only, meaning by prescription only, and each label gives the route as intravenous, into a vein ¹, ², ³.

Dalbavancin. Dalvance was approved on May 23, 2014, under NDA 021883 ⁴. An NDA is a new drug application, the filing on which FDA approves a drug. Its current label says it "is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin susceptible isolates)" ¹. As of November 9, 2026, the date of its data, Drugs@FDA also lists five applications for generic dalbavancin, each with marketing status "Prescription" ⁹. They were approved between October 23, 2025 and June 4, 2026 ⁹.

An acute bacterial skin and skin structure infection, ABSSSI, is a bacterial infection of the skin and the tissue under it. In the Dalvance trials the infections were cellulitis, major abscesses and wound infections ¹. Gram-positive bacteria are a broad group, named for a laboratory stain, that includes the staphylococci and streptococci the labels list. Methicillin-resistant Staphylococcus aureus, known as MRSA, is a staph strain that resists a standard family of antibiotics.

Oritavancin. Orbactiv was approved on August 6, 2014, under NDA 206334 ⁵. Its label says it "is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only)" ². The label adds that safety and effectiveness in patients younger than 18 "have not been established" ².

Kimyrsa is a second oritavancin product from the same sponsor, approved on March 12, 2021, under NDA 214155 ⁶. Drugs@FDA classes that application as a "New Formulation or New Manufacturer" ⁶. The Orbactiv label says the two products "have differences in dose strength, duration of infusion and preparation instructions" ². The Kimyrsa label says it "is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only)" ⁸.

Telavancin. Vibativ was approved on September 11, 2009, under NDA 022110 ⁷. Its label gives two indications, both for adults ³. For skin, it "is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or Enterococcus faecalis (vancomycin[-]susceptible isolates only)" ³. A complicated skin and skin structure infection, cSSSI, is a bacterial infection of the skin and the tissue under it. The Vibativ label uses that term where the Dalvance and Orbactiv labels use ABSSSI ¹, ², ³.

For the lungs, Vibativ "is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (both methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable" ³. Those are pneumonias that begin in a hospital or in a patient on a breathing machine.

As of November 9, 2026, the date of its data, Drugs@FDA lists two Vibativ vial strengths under NDA 022110, the larger as "Prescription" and the smaller as "Discontinued" ⁷. "Discontinued" there is the marketing status of one vial size; the application stands, with the larger vial marketed ⁷.

A second application, NDA 022407, was approved on June 21, 2013 ¹⁰. The record classes it as a "New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval," and it lists both strengths as "Prescription" ¹⁰. The current Vibativ label lists the larger vial only ³. NDA 022407's record, "Consolidated with Original NDA after Approval," still lists the smaller vial as "Prescription"; the current label supplies the larger vial only ³, ¹⁰.

Each label also limits use: its drug should be used only for "infections that are proven or strongly suspected to be caused by susceptible bacteria" ¹, ², ³. The stated purpose is to slow the development of drug-resistant bacteria ¹, ², ³.

How do dalbavancin, oritavancin and telavancin work?

Each of the three labels describes an attack on the bacterial cell wall, the rigid coat around a bacterium, and the three accounts differ in detail ¹, ², ³. Dalbavancin "interferes with cell wall synthesis" by binding to the tip of a short peptide in peptidoglycan, the wall's mesh-like building material, "thus preventing cross-linking" ¹.

The Orbactiv label lists three mechanisms for oritavancin ². It blocks two separate steps of cell wall construction, and it causes "disruption of bacterial membrane integrity, leading to depolarization, permeabilization, and cell death" ². Depolarization is the loss of the membrane's electrical charge, and permeabilization means the membrane becomes leaky. Telavancin "inhibits cell wall biosynthesis by binding to late-stage peptidoglycan precursors, including lipid II," and it "also binds to the bacterial membrane and disrupts membrane barrier function" ³. Late-stage peptidoglycan precursors, lipid II among them, are the wall's building blocks just before they are joined into it.

Each label describes its drug as bactericidal in laboratory tests, meaning it kills bacteria instead of only stopping their growth ¹, ², ³. The bacteria named in each label's skin-infection indication are Gram-positive: Staphylococcus aureus including MRSA, several streptococci, and vancomycin-susceptible Enterococcus faecalis ¹, ², ³. Vibativ's pneumonia indication names Staphylococcus aureus only ³. The Vibativ label adds: "Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative organisms" ³. Gram-negative bacteria are the other broad group under the same laboratory stain.

The three labels report very different half-lives, a half-life being the time the body takes to clear half of a drug from the blood. The Dalvance label gives dalbavancin a terminal half-life of 346 hours in healthy subjects, about two weeks ¹. In patients, the same label estimates an effective half-life of about 8.5 days ¹. A terminal half-life describes the last and slowest phase of clearance, and an effective half-life is an estimate of how fast drug levels fall overall.

The Orbactiv label gives oritavancin a terminal half-life of about 245 hours, roughly ten days ². The Vibativ label gives telavancin's as about 8 hours in healthy adults ³. A 2014 trial report describes dalbavancin as having "a long plasma half-life, allowing for once-weekly dosing" ¹¹.

What does the research show?

Each of the three drugs is approved by FDA for a use ¹, ², ³. None of the sources cited here compares dalbavancin, oritavancin and telavancin with one another ¹¹, ¹, ², ³, ⁸. A noninferiority trial is built to show that a new drug is not worse than a standard one by more than a set margin. Dalbavancin's two DISCOVER trials and the two Orbactiv trials of oritavancin were of that kind ¹¹, ². In a randomized, double-blind trial, chance decides each patient's treatment, and neither patients nor doctors know who receives which drug.

Dalbavancin. Dalbavancin was studied in people in DISCOVER 1 and DISCOVER 2, two identically designed randomized trials in patients with acute bacterial skin and skin-structure infection ¹¹. The report is in the journal issue dated June 5, 2014 ¹¹. Patients received dalbavancin into a vein on days 1 and 8, or vancomycin into a vein for at least 3 days ¹¹. The vancomycin group could then switch to linezolid, an antibiotic taken by mouth, to complete 10 to 14 days ¹¹. The main measure was early clinical response at 48 to 72 hours: the redness had stopped spreading and the patient had no fever ¹¹.

In the pooled analysis, 525 of 659 patients (79.7 percent) given dalbavancin responded, as did 521 of 653 (79.8 percent) given vancomycin-linezolid ¹¹. The weighted difference was -0.1 percentage point, with a 95 percent confidence interval of -4.5 to 4.2 ¹¹. A confidence interval is the range in which the true difference plausibly lies. Dalbavancin met the noninferiority test in each trial, and Durata Therapeutics funded both ¹¹. In the label's pooled trials, early response with Staphylococcus aureus was 206 of 257 (80.2 percent) on Dalvance and 219 of 256 (85.5 percent) on comparator ¹.

The Dalvance label's Clinical Studies section reports two double-blind trials in 1,312 randomized adults ¹. Early response was reached by 240 of 288 patients (83.3 percent) on Dalvance and 233 of 285 (81.8 percent) on vancomycin-linezolid in Trial 1 ¹. In Trial 2 the figures were 285 of 371 (76.8 percent) and 288 of 368 (78.3 percent) ¹.

At a later visit, on days 26 to 30, clinical success was 83.7 percent (241 of 288) against 88.1 percent (251 of 285) in Trial 1 ¹. In Trial 2 it was 88.1 percent (327 of 371) against 84.5 percent (311 of 368) ¹. The label cautions that these later rates "cannot be utilized to establish non-inferiority" ¹.

A third trial in the Dalvance label randomized 698 adults to a single Dalvance infusion or to two infusions a week apart ¹. A response there meant the infected area had shrunk by at least 20 percent at 48 to 72 hours, without rescue antibiotics ¹. It was seen in 284 of 349 patients (81.4 percent) after one infusion and 294 of 349 (84.2 percent) after two ¹. The label says the infections and patients in this trial "were similar to those described above for previous ABSSSI trials" ¹.

In children, an open-label trial, in which everyone knew the treatment given, enrolled patients from birth to under 18 years, and 191 received a study drug ¹. The label describes the trial as "conducted in pediatric patients 3 months of age to less than 18 years with ABSSSI, not known or expected to be caused exclusively by Gram-negative organisms" ¹. Early response was 97.3 percent (73 of 75) with one Dalvance infusion, 93.6 percent (73 of 78) with two, and 86.7 percent (26 of 30) with a comparator antibiotic ¹. The trial's primary objective was safety, and the label says it "was not powered for a comparative inferential efficacy analysis" ¹. The pediatric counts are the label's modified intent-to-treat population of 183, which excluded the five infants under 3 months ¹.

Oritavancin. The Orbactiv label reports two identically designed, double-blind noninferiority trials in which 1,987 adults were randomized ². They compared a single Orbactiv infusion with vancomycin into a vein for 7 to 10 days ². Early clinical response at 48 to 72 hours meant the lesion had stopped spreading or had shrunk, with no fever and no rescue antibiotic ².

Among patients who received a study drug, 391 of 475 (82.3 percent) on Orbactiv and 378 of 479 (78.9 percent) on vancomycin responded in Trial 1 ². The difference was 3.4 percentage points, with a 95 percent confidence interval of -1.6 to 8.4 ². In Trial 2 the figures were 403 of 503 (80.1 percent) and 416 of 502 (82.9 percent), a difference of -2.7 points (-7.5 to 2.0) ². Pooled across both trials in the microbiological intent-to-treat population, early response with MRSA was 166 of 204 (81.4 percent) on Orbactiv and 162 of 201 (80.6 percent) on vancomycin ². These are the Orbactiv label's results ².

Telavancin. The Vibativ label reports two double-blind trials in adults with complicated skin infections in which MRSA was the suspected or confirmed main cause ³. Patients received Vibativ or vancomycin for 7 to 14 days ³. The main measure was clinical cure at a follow-up visit ³.

The label's all-treated efficacy population was 1,794 patients, 884 on Vibativ and 910 on vancomycin; one later sentence prints 1,784 ³. The label does not give these trials' follow-up visit timing ³.

In Trial 1 clinical cure was 72.5 percent (309 of 426) with Vibativ and 71.6 percent (307 of 429) with vancomycin ³. In Trial 2 it was 74.7 percent (342 of 458) and 74.0 percent (356 of 481) ³.

The label also reports cure rates by how well patients' kidneys worked at the start ³. Kidney function is measured as creatinine clearance, and the label's dividing line is 50 mL/min ³. Among evaluable patients at or below that line, 58 of 86 (67.4 percent) on Vibativ were cured, against 67 of 81 (82.7 percent) on vancomycin ³. Above it, the rates were 87.0 percent (520 of 598) on Vibativ and 85.9 percent (524 of 610) on vancomycin ³. These counts pool the two skin-infection trials' clinically evaluable patients ³.

For pneumonia, the label reports two double-blind trials of Vibativ against vancomycin, given for 7 to 21 days, in adults with hospital-acquired or ventilator-associated pneumonia ³. The analysis the label shows covers patients with at least one Gram-positive bacterium found in a respiratory sample at the start ³. Among them, estimated death from any cause by day 28 was 28.7 percent with Vibativ (187 patients) and 24.3 percent with vancomycin (180) in Trial 1 ³. In Trial 2 it was 24.3 percent (224 patients) and 22.3 percent (206) ³. These percentages are Kaplan-Meier estimates, which allow for patients whose day-28 outcome is unknown, and the label's warning section counts deaths in a different analysis ³.

Clinical cure among all treated patients in Trial 1 was 57.5 percent (214 of 372) with Vibativ and 59.1 percent (221 of 374) with vancomycin ³. In Trial 2 it was 60.2 percent (227 of 377) and 60.0 percent (228 of 380) ³.

What are the side effects?

Each label reports its own trials, and each says its rates "cannot be directly compared to rates in the clinical trials of another drug" ¹, ², ³. A boxed warning appears on the Vibativ label alone among the three ³.

Dalbavancin (Dalvance). In trials against other antibiotics, serious adverse reactions occurred in 109 of 1,778 patients (6.1 percent) on Dalvance and 80 of 1,224 (6.5 percent) on a comparator ¹. The most common reactions were nausea (5.5 percent against 6.4 percent), headache (4.7 against 4.8) and diarrhea (4.4 against 5.9) ¹. Across the label's Phase 2 and 3 trials, among patients whose ALT was normal at the start, 17 on Dalvance (0.8 percent) later had levels above three times normal ¹. So did 2 on comparators (0.2 percent), and the label says the rises "were reversible in all subjects with follow-up assessments" ¹.

In the children's trial, the most common reaction was fever, in 2 of 161 patients given Dalvance ¹. The label gives no comparator-arm fever rate for that trial ¹.

The label warns: "Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with DALVANCE" ¹. Anaphylaxis is a severe, sudden allergic reaction. It also warns: "Rapid intravenous infusions of DALVANCE can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain" ¹. Urticaria is hives, and pruritus is itching.

Dalvance "is contraindicated in patients with known hypersensitivity to dalbavancin" ¹. The label reports "no adequate and well-controlled studies" of use in pregnant women ¹.

Oritavancin (Orbactiv). In two trials, serious adverse reactions were reported in 57 of 976 patients (5.8 percent) given Orbactiv and 58 of 983 (5.9 percent) given vancomycin ². Nausea affected 9.9 percent against 10.5 percent, headache 7.1 against 6.7, and vomiting 4.6 against 4.7 ². Abscesses of a limb or under the skin were reported in 3.8 percent against 2.3 percent ². The label warns that "more cases of osteomyelitis were reported in the ORBACTIV treated arm than in the vancomycin-treated arm" ². Osteomyelitis is an infection of bone.

The Orbactiv label says it can "artificially prolong" the results of some blood-clotting tests, while it "has no effect on the coagulation system in vivo," that is, in the body ². Unfractionated heparin, the standard form of the blood thinner heparin, is monitored with one of those tests. So use of "intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV administration" ².

Orbactiv is also "contraindicated in patients with known hypersensitivity to oritavancin products" ². The label warns: "Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products, including ORBACTIV" ². It reports "no available data" on use in pregnant women ².

Telavancin (Vibativ). The boxed warning has three parts ³. The first: "Patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) had increased mortality observed versus vancomycin" ³. Renal impairment is reduced kidney function, and CrCl is creatinine clearance.

The label's warning section counts all pneumonia-trial patients by the treatment they received ³. Among those with CrCl of 50 mL/min or below, 95 of 241 (39 percent) on Vibativ died within 28 days, against 72 of 243 (30 percent) on vancomycin ³. Among those with CrCl above 50 mL/min, the figures were 86 of 510 (17 percent) on Vibativ and 92 of 510 (18 percent) on vancomycin ³.

The second part: "Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients" ³. In the skin-infection trials, kidney-related adverse events occurred in 30 of 929 patients (3 percent) on Vibativ and 10 of 938 (1 percent) on vancomycin ³. In the pneumonia trials the rates were 10 percent on Vibativ and 8 percent on vancomycin ³. The label gives these as percentages of 751 Vibativ and 752 vancomycin patients, without counts ³.

The third part: "VIBATIV may cause fetal harm. In animal reproduction studies, adverse developmental outcomes were observed in 3 animal species at clinically relevant doses" ³.

In the skin-infection trials, the most common reaction was taste disturbance, in 33 percent on Vibativ against 7 percent on vancomycin ³. Nausea (27 percent against 15), vomiting (14 against 7) and foamy urine (13 against 3) followed ³.

Vibativ prolonged the QTc interval, a measure of the heart's electrical recovery between beats, in a study of healthy volunteers ³. The label says use "should be avoided" in patients with congenital long QT syndrome, known QTc prolongation, uncompensated heart failure or severe left ventricular hypertrophy ³. Such patients were not included in its trials ³. Congenital long QT syndrome is an inherited heart-rhythm disorder, and uncompensated heart failure is heart failure whose symptoms are not controlled. Left ventricular hypertrophy is a thickening of the wall of the heart's main pumping chamber.

Telavancin interferes with some clotting tests, and use of "intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration" ³. Vibativ is also "contraindicated in patients with known hypersensitivity to telavancin" ³. The label warns: "Serious and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses" ³.

All three labels. Each warns of Clostridioides difficile-associated diarrhea, a bowel infection that can follow antibiotic treatment, with a severity "from mild diarrhea to fatal colitis" ¹, ², ³. The Dalvance and Orbactiv labels tell prescribers to ask about earlier allergic reactions to glycopeptides ¹, ². The Vibativ label says it "should be used with caution in patients with known hypersensitivity to vancomycin" ³.

In sport

Dalbavancin, oritavancin and telavancin are not named on the 2026 Prohibited List of WADA, the World Anti-Doping Agency ¹². All three are given by intravenous infusion, so the list's rule on that method, M2.2, bears on the route ¹, ², ³, ¹². It prohibits "Intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations" ¹².

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JumpstartMD does not prescribe dalbavancin, oritavancin or telavancin. Our peptide library covers them so you have the facts on their FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.