Dalbavancin

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Dalbavancin
Dalbavancin B0.svg
Clinical data
Trade names Dalvance, Xydalba, others
AHFS/Drugs.com Monograph
MedlinePlus a614036
License data
Routes of
administration 		Intravenous
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life 14.4 d [5]
Identifiers
  • 2-deoxy-1-O-[(3S,15R,18R,34R,35S,38S,48R,50aR)-5,31-dichloro-38-{[3-(dimethylamino)propyl]carbamoyl}-6,11,34,40,44-pentahydroxy-42-(α-D-mannopyranosyloxy)-15-(methylamino)-2,16,36,50,51,59-hexaoxo-2,3,16,17,18,19,35,36,37,38,48,49,50,50a-tetradecahydro-1H,15H,34H-20,23:30,33-dietheno-3,18:35,48-bis(iminomethano) 4,8:10,14:25,28:43,47-tetrametheno[1,14,6,22]dioxadiazacyclooctacosino[4,5-m] [10,2,16]benzoxadiazacyclohexacosin-56-yl]-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronic acid [6]
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard 100.308.391 OOjs UI icon edit-ltr-progressive.svg
Chemical and physical data
Formula C88H100Cl2N10O28
Molar mass 1816.71 g·mol−1
3D model (JSmol)
  • CC(C)CCCCCCCCC(=O)N[C@@H]1[C@H]([C@@H]([C@H](O[C@H]1Oc2c3cc4cc2Oc5ccc(cc5Cl)[C@H]([C@H]6C(=O)N[C@@H](c7cc(cc(c7-c8cc(ccc8O)[C@H](C(=O)N6)NC(=O)[C@@H]4NC(=O)[C@@H]9c1cc(cc(c1Cl)O)Oc1ccc(cc1O)[C@H](C(=O)N[C@H](Cc1ccc(cc1)O3)C(=O)N9)NC)O[C@@H]1[C@H]([C@H]([C@@H]([C@H](O1)CO)O)O)O)O)C(=O)NCCCN(C)C)O)C(=O)O)O)O
  • InChI=1S/C88H100Cl2N10O28/c1-38(2)13-10-8-6-7-9-11-14-61(106)94-70-73(109)75(111)78(86(120)121)128-87(70)127-77-58-31-43-32-59(77)124-55-23-19-42(29-50(55)89)71(107)69-85(119)98-67(80(114)92-25-12-26-100(4)5)48-33-44(102)34-57(125-88-76(112)74(110)72(108)60(37-101)126-88)62(48)47-28-40(17-22-52(47)103)65(82(116)99-69)95-83(117)66(43)96-84(118)68-49-35-46(36-54(105)63(49)90)123-56-24-18-41(30-53(56)104)64(91-3)81(115)93-51(79(113)97-68)27-39-15-20-45(122-58)21-16-39/h15-24,28-36,38,51,60,64-76,78,87-88,91,101-105,107-112H,6-14,25-27,37H2,1-5H3,(H,92,114)(H,93,115)(H,94,106)(H,95,117)(H,96,118)(H,97,113)(H,98,119)(H,99,116)(H,120,121)/t51-,60-,64-,65-,66-,67+,68+,69+,70-,71-,72-,73-,74+,75+,76+,78+,87-,88+/m1/s1 X mark.svgN
  • Key:IZJRUXNZMRDQJI-SZUNQUCBSA-N X mark.svgN
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Dalbavancin, sold under the brand names Dalvance in the US and Xydalba in the EU among others, is a second-generation lipoglycopeptide antibiotic medication. It belongs to the same class as vancomycin, the most widely used and one of the treatments available to people infected with methicillin-resistant Staphylococcus aureus (MRSA). [7]

Contents

Dalbavancin is a semisynthetic lipoglycopeptide that was designed to improve upon the natural glycopeptides vancomycin and teicoplanin. [8] It is derived from a complex of glycopeptide antibiotics, referred to as A-40926, that is produced by a new strain of Actinomadura. Dalbavancin has been referred to in the scientific literature by a series of names: MDL-63397, A-!-1, BI-397, VER-001.[ medical citation needed ] These different labels reflected where the research had been carried out: MDL representing Merrell-Dow-Lepetit, where the initial complex was discovered; BI referring to BioSearch Italia where Dalbavancin itself was first synthesized; VER referring to Versicor (which Biosearch Italia merged with to create Vicuron Pharmaceuticals).[ citation needed ] The phase I, II and III clinical trials were carried out of by Vicuron and the initial NDA filed.[ citation needed ] Vicuron was acquired by Pfizer in 2005, which decided to not further develop Dalbavancin at that time, subsequently selling the rights to Durata Therapeutics in 2009.[ citation needed ]

It possesses in vitro activity against a variety of Gram-positive pathogens [9] [10] including MRSA and methicillin-resistant Staphylococcus epidermidis (MRSE). [11] It is a once-weekly, two-dose antibiotic, the rights to which Actavis acquired when it bought Durata Therapeutics in 2014. [12]

The U.S. Food and Drug Administration (FDA) approved dalbavancin in May 2014, for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by certain susceptible bacteria such as Staphylococcus aureus including methicillin-susceptible and methicillin-resistant strains of Streptococcus pyogenes , in intravenous dosage form. [13] [14] [15]

Medical uses

Dalbavancin is considered a long-lasting antibiotic due to its prolonged half-life (14.4 d), high protein binding capacity, and intense tissue penetration. It binds reversibly to plasma proteins at approximately 93%, allowing for sustained drug concentrations over time. Dalbavancin demonstrates good tissue distribution, reaching therapeutic levels in skin structures, synovial fluid (found in joints), and bone tissue within 24 hours after administration. The benefits of this long-lasting nature are less frequent dosing requirements while maintaining efficacy. [5]

Dalbavancin is an antibiotic used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults caused by susceptible Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA). MRSA infections have become problematic in the community and in healthcare settings due to resistance to many available antibiotics. [16] Because dalbavancin has demonstrated efficacy against MRSA and other microorganisms to treat serious or life-threatening infections, it was the first drug approved as a Qualified Infectious Disease Product under the Generating Antibiotic Incentives Now (GAIN) act, which is part of the FDA Safety and Innovation Act. [17]

It has strong activity against many Gram-positive bacteria, including methicillin-sensitive and methicillin-resistant Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus. [3] Based on MIC data and other studies, dalbavancin is more potent and bactericidal and therefore requires lower concentrations than vancomycin against these organisms. [18] Dalbavancin also shows in vitro activity against vancomycin-susceptible Enterococcus faecium and Enterococcus faecalis. [3] Other Gram-positive organisms belonging to the Bacillus spp., Listeria spp., and Corynebacterium spp. may show in vitro susceptibility, and dalbavancin may exhibit activity against enterococci expressing the VanB or VanC phenotype of acquired resistance against vancomycin. [18] [19] There is no clinically significant activity against Gram-negative bacteria. [18]

Contraindications

Hypersensitivity to dalbavancin can occur, causing issues such as skin reactions or anaphylaxis. Caution is advised for patients with known hypersensitivity to other glycopeptides. There is currently no data on cross-reactivity between dalbavancin and vancomycin. [3]

Side effects

The most common adverse reactions encountered in Phase II and Phase III trials were nausea (5.5%), headache (4.7%), and diarrhea (4.4%), as well as rash (2.7%) and itchiness (2.1%). Other less frequent but serious adverse reactions included hematologic disorders, hepatotoxicity, Clostridium difficile colitis, bronchospasm, infusion-related reactions including Red Man Syndrome, and anaphylactic shock. [3] In trials, dalbavancin was associated with higher rates of hemorrhagic events compared to comparator groups and should be a precaution in patients undergoing surgery or taking anticoagulants. [18] Patients on dalbavancin also had post-baseline alanine aminotransferase (ALT) levels that were 3 times the upper normal limit, some even having elevations 10 times the upper normal limit; however, eight of the twelve dalbavancin-treated patients had comorbid conditions that could affect their ALT, compared to only one patient in the comparator group. [3] There is no evidence of ototoxicity associated with dalbavancin. [19]

Drug interactions

Clinical drug-drug interactions with dalbavancin have not been studied, and dalbavancin does not appear to interact with cytochrome P450 substrates, inhibitors, or inducers. It was found to have an in vitro synergistic interaction with the antimicrobial oxacillin, but the clinical significance of this interaction has yet to be established. [3]

Pregnancy and lactation

Use of dalbavancin in pregnant women has not been studied sufficiently and should only occur when the potential benefit outweighs the potential risk to the fetus. Animal studies did not show embryo or fetal toxicity at doses that were 1.2 and 0.7 times the human dose. However, delayed fetal maturation was observed at a dose that was 3.5 times the human dose. While dalbavancin is excreted in rat milk, it is unknown if it is excreted in human milk. It should be used in nursing mothers only when the potential benefit exceeds the potential risk. [3] There is no evidence in animals of teratogenicity. [19]

Production and composition

Dalbavancin is manufactured by fermentation of a selected Nonomuraea strain to generate the natural glycopeptide complex A-40926. This precursor is then selectively esterified at the carboxyl group of its sugar moiety, its peptidyl carboxyl group is amidated and the ester of the N-acylaminoglucuronic acid carboxyl group is saponified. [20] The outcome is a compound mixture of two closely related structural families — A and B — that can be further subdivided into a total of five subtypes (see table below). [6] At least ten different dalbavancin components have been described, of which the B0 component makes up around 80–98 wt%. [20]

Dalbavancin homologs
Core structure of dalbavancin Dalbavancin core.svg
Core structure of dalbavancin
HomologAlkyl sidechain of N-acylaminoglucuronic acid (R1)Amino-terminal substituent (R2)
A0CH(CH3)2H
A1CH2CH2CH3H
B0CH2CH(CH3)2H
B1CH2CH2CH2CH3H
B2CH2CH(CH3)2CH3

Mechanism of action

Dalbavancin is a lipoglycopeptide belonging in the same glycopeptide class as vancomycin. Similar to other glycopeptides, dalbavancin exerts its bactericidal effect by disrupting cell wall biosynthesis. It binds to the D-alanyl-D-alanyl residue on growing peptidoglycan chains and prevents transpeptidation from occurring, preventing peptidoglycan elongation and cell wall formation. Dalbavancin also dimerizes and anchors itself in the lipophilic bacterial membrane, thereby increasing its stability in the target environment and its affinity for peptidoglycan. [18]

Antimicrobial activity correlates with the ratio of area under the concentration-time curve to minimum inhibitory concentration for Staphylococcus aureus. [3]

Metabolism

When evaluated by in vitro studies, the metabolism of dalbavancin was minimally impacted by the human hepatic CYP450 system. [21] Further investigations with either inducers or inhibitors of this enzyme system demonstrated no changes in the elimination or clearance of dalbavancin, and the metabolism of model compounds of these CYP systems was not altered by the dalbavancin. Hydroxy-dalbavancin, a minor metabolite that has only been identified in urine, was also not changed in its formation or elimination with these enzyme models. [21] [22]

History

Dalbavancin has undergone a phase-III clinical trial for adults with complicated skin infections, but in December 2007, the US Food and Drug Administration (FDA) said more data were needed before approval. [12] Pfizer withdrew its marketing applications to conduct another phase-III clinical trial in September 2008. [23] Durata Therapeutics acquired the rights to dalbavancin in December 2009, and has initiated two new phase-III clinical trials for treatment of ABSSSIs. [24] Preliminary results in 2012 were promising. [25]

About 1,289 adults with ABSSSI were given dalbavancin or vancomycin randomly, and dalbavancin was found to exhibit efficacy comparable to vancomycin. [13]

In May 2014, dalbavancin was approved for medical use in the United States for ABSSSIs, including MRSA and Streptococcus pyogenes infections. [13] [14]

Related Research Articles

<i>Staphylococcus aureus</i> Species of Gram-positive bacterium

Staphylococcus aureus is a Gram-positive spherically shaped bacterium, a member of the Bacillota, and is a usual member of the microbiota of the body, frequently found in the upper respiratory tract and on the skin. It is often positive for catalase and nitrate reduction and is a facultative anaerobe that can grow without the need for oxygen. Although S. aureus usually acts as a commensal of the human microbiota, it can also become an opportunistic pathogen, being a common cause of skin infections including abscesses, respiratory infections such as sinusitis, and food poisoning. Pathogenic strains often promote infections by producing virulence factors such as potent protein toxins, and the expression of a cell-surface protein that binds and inactivates antibodies. S. aureus is one of the leading pathogens for deaths associated with antimicrobial resistance and the emergence of antibiotic-resistant strains, such as methicillin-resistant S. aureus (MRSA), is a worldwide problem in clinical medicine. Despite much research and development, no vaccine for S. aureus has been approved.

<span class="mw-page-title-main">Linezolid</span> Antibiotic medication

Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics. Linezolid is active against most Gram-positive bacteria that cause disease, including streptococci, vancomycin-resistant enterococci (VRE), and methicillin-resistant Staphylococcus aureus (MRSA). The main uses are infections of the skin and pneumonia although it may be used for a variety of other infections including drug-resistant tuberculosis. It is used either by injection into a vein or by mouth.

<span class="mw-page-title-main">Methicillin</span> Antibiotic medication

Methicillin (USAN), also known as meticillin (INN), is a narrow-spectrum β-lactam antibiotic of the penicillin class.

<span class="mw-page-title-main">Fusidic acid</span> Antibiotic

Fusidic acid, sold under the brand names Fucidin among others, is a steroid antibiotic that is often used topically in creams or ointments and eyedrops but may also be given systemically as tablets or injections.
As of October 2008, the global problem of advancing antimicrobial resistance has led to a renewed interest in its use.

Vancomycin-resistant <i>Staphylococcus aureus</i> Antibiotica resistant bacteria

Vancomycin-resistant Staphylococcus aureus (VRSA) are strains of Staphylococcus aureus that have acquired resistance to the glycopeptide antibiotic vancomycin. Bacteria can acquire resistant genes either by random mutation or through the transfer of DNA from one bacterium to another. Resistance genes interfere with the normal antibiotic function and allow a bacteria to grow in the presence of the antibiotic. Resistance in VRSA is conferred by the plasmid-mediated vanA gene and operon. Although VRSA infections are uncommon, VRSA is often resistant to other types of antibiotics and a potential threat to public health because treatment options are limited. VRSA is resistant to many of the standard drugs used to treat S. aureus infections. Furthermore, resistance can be transferred from one bacterium to another.

<span class="mw-page-title-main">Glycopeptide antibiotic</span> Class of antibiotic drugs

Glycopeptide antibiotics are a class of drugs of microbial origin that are composed of glycosylated cyclic or polycyclic nonribosomal peptides. Significant glycopeptide antibiotics include the anti-infective antibiotics vancomycin, teicoplanin, telavancin, ramoplanin and decaplanin, corbomycin, complestatin and the antitumor antibiotic bleomycin. Vancomycin is used if infection with methicillin-resistant Staphylococcus aureus (MRSA) is suspected.

<span class="mw-page-title-main">Tigecycline</span> Chemical compound

Tigecycline, sold under the brand name Tygacil, is a tetracycline antibiotic medication for a number of bacterial infections. It is a glycylcycline class drug that is administered intravenously. It was developed in response to the growing rate of antibiotic resistant bacteria such as Staphylococcus aureus, Acinetobacter baumannii, and E. coli. As a tetracycline derivative antibiotic, its structural modifications has expanded its therapeutic activity to include Gram-positive and Gram-negative organisms, including those of multi-drug resistance.

<span class="mw-page-title-main">Oritavancin</span> Pharmaceutical drug

Oritavancin, sold under the brand name Orbactiv among others, is a semisynthetic glycopeptide antibiotic medication for the treatment of serious Gram-positive bacterial infections. Its chemical structure as a lipoglycopeptide is similar to vancomycin.

<span class="mw-page-title-main">Cefoxitin</span> Chemical compound

Cefoxitin is a second-generation cephamycin antibiotic developed by Merck & Co., Inc. from Cephamycin C in the year following its discovery, 1972. It was synthesized in order to create an antibiotic with a broader spectrum. It is often grouped with the second-generation cephalosporins. Cefoxitin requires a prescription and as of 2010 is sold under the brand name Mefoxin by Bioniche Pharma, LLC. The generic version of cefoxitin is known as cefoxitin sodium.

<span class="mw-page-title-main">Ceftobiprole</span> Chemical compound

Ceftobiprole, sold under the brand name Zevtera among others, is a fifth-generation cephalosporin antibacterial used for the treatment of hospital-acquired pneumonia and community-acquired pneumonia. It is marketed by Basilea Pharmaceutica under the brand names Zevtera and Mabelio. Like other cephalosporins, ceftobiprole exerts its antibacterial activity by binding to important penicillin-binding proteins and inhibiting their transpeptidase activity which is essential for the synthesis of bacterial cell walls. Ceftobiprole has high affinity for penicillin-binding protein 2a of methicillin-resistant Staphylococcus aureus strains and retains its activity against strains that express divergent mecA gene homologues. Ceftobiprole also binds to penicillin-binding protein 2b in Streptococcus pneumoniae (penicillin-intermediate), to penicillin-binding protein 2x in Streptococcus pneumoniae (penicillin-resistant), and to penicillin-binding protein 5 in Enterococcus faecalis.

Targanta Therapeutics Corporation was a biopharmaceutical company headquartered in Cambridge, Massachusetts. The company also had operations in Indianapolis, Montreal and Toronto. Targanta completed its initial public offering on October 9, 2007 and traded on the Nasdaq market under the symbol: TARG. Targanta was acquired by The Medicines Company in 2009.

<span class="mw-page-title-main">Telavancin</span> Pharmaceutical drug

Telavancin is a bactericidal lipoglycopeptide for use in MRSA or other Gram-positive infections. Telavancin is a semi-synthetic derivative of vancomycin.

<span class="mw-page-title-main">Iclaprim</span> Chemical compound

Iclaprim is an antibiotic drug candidate that is active against Gram positive organisms. It is administered intravenously.

<span class="mw-page-title-main">Delafloxacin</span> Chemical compound

Delafloxacin sold under the brand name Baxdela among others, is a fluoroquinolone antibiotic used to treat acute bacterial skin and skin structure infections.

<span class="mw-page-title-main">Tedizolid</span> Oxazolidinone-class antibiotic

Tedizolid, sold under the brand name Sivextro is an oxazolidinone-class antibiotic. Tedizolid phosphate is a phosphate ester prodrug of the active compound tedizolid. It was developed by Cubist Pharmaceuticals, following acquisition of Trius Therapeutics, and is marketed for the treatment of acute bacterial skin and skin structure infections.

<span class="mw-page-title-main">Ceftaroline fosamil</span> Chemical compound

Ceftaroline fosamil (INN), brand name Teflaro in the US and Zinforo in Europe, is a cephalosporin antibiotic with anti-MRSA activity. Ceftaroline fosamil is a prodrug of ceftaroline. It is active against methicillin-resistant Staphylococcus aureus (MRSA) and other Gram-positive bacteria. It retains some activity of later-generation cephalosporins having broad-spectrum activity against Gram-negative bacteria, but its effectiveness is relatively much weaker. It is currently being investigated for community-acquired pneumonia and complicated skin and skin structure infection.

<span class="mw-page-title-main">Lipoglycopeptide</span> Class of chemical compounds

Lipoglycopeptides are a class of antibiotic that have lipophilic side-chains linked to glycopeptides. The class includes oritavancin, telavancin and dalbavancin.

<span class="mw-page-title-main">Omadacycline</span> Chemical compound

Omadacycline, sold under the brand name Nuzyra, is a broad spectrum antibiotic medication belonging to the aminomethylcycline subclass of tetracycline antibiotics. In the United States, it was approved in October 2018, for the treatment of community-acquired bacterial pneumonia and acute skin and skin structure infections.

<span class="mw-page-title-main">Lefamulin</span> Chemical compound

Lefamulin, sold under the brand name Xenleta, is an antibiotic medication used it to treat adults with community-acquired bacterial pneumonia. It is taken by mouth or by injection into a vein.

Kerry L. LaPlante is an American pharmacist, academic and researcher. She is the Dean at the University of Rhode Island College of Pharmacy. She is a Professor of Pharmacy and former department Chair of the Department of Pharmacy Practice at the University of Rhode Island, an Adjunct Professor of Medicine at Brown University, an Infectious Diseases Pharmacotherapy Specialist, and the Director of the Rhode Island Infectious Diseases Fellowship and Research Programs at the Veterans Affairs Medical Center in Providence, Rhode Island.

References

  1. ↑ "Summary Basis of Decision (SBD) for Xydalba". Health Canada . 23 October 2014. Retrieved 29 May 2022.
  2. ↑ "Drug and medical device highlights 2018: Helping you maintain and improve your health". Health Canada . 14 October 2020. Retrieved 17 April 2024.
  3. 1 2 3 4 5 6 7 8 9 "Dalvance- dalbavancin injection, powder, for solution". DailyMed. Retrieved 12 February 2022.
  4. ↑ "Xydalba EPAR". European Medicines Agency. 17 September 2018. Retrieved 12 February 2022.
  5. 1 2 Micheli G, Chiuchiarelli M, Taccari F, Fantoni M (2023). "The role of long-acting antibiotics in the clinical practice: a narrative review". Infez Med. 31 (4): 449–465. doi:10.53854/liim-3104-4. PMC   10705857 . PMID   38075413.
  6. 1 2 European Medicines Agency (EMA) assessment of dalbavancin
  7. ↑ "Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration". Drugs.com.
  8. ↑ Scheinfeld N (May 2006). "Dalbavancin: a review for dermatologists". Dermatology Online Journal. 12 (4): 6. doi:10.5070/D30WN7D4Q9. PMID   17083861.
  9. ↑ Chen AY, Zervos MJ, Vazquez JA (May 2007). "Dalbavancin: a novel antimicrobial". International Journal of Clinical Practice. 61 (5): 853–63. doi:10.1111/j.1742-1241.2007.01318.x. PMC   1890846 . PMID   17362476.
  10. ↑ Das B, Sarkar C, Biswas R, Pandey S (January 2008). "Review: dalbavancin--a novel lipoglycopeptide antimicrobial for gram positive pathogens". Pakistan Journal of Pharmaceutical Sciences . 21 (1): 78–87. PMID   18166524.
  11. ↑ "Dalbavancin: A Novel Lipoglycopeptide Antibacterial". Medscape.
  12. 1 2 UPDATE 1-Pfizer says US FDA wants more data on antibiotic. December 2007
  13. 1 2 3 "FDA approves Dalvance to treat skin infections". U.S. Food and Drug Administration (FDA). 23 May 2014. Archived from the original on 25 May 2014. Retrieved 12 February 2022.
  14. 1 2 "Drug Approval Package: Dalvance (dalbavancin hydrochloride) Lyophilized Powder for Injection NDA #021883". U.S. Food and Drug Administration (FDA). 24 June 2014. Retrieved 21 May 2022.
  15. ↑ Summary evaluation
  16. ↑ "MRSA | CDC". www.cdc.gov. 5 February 2019.
  17. ↑ "Dalbavancin: First I.V. antibiotic for acute bacterial skin infections". Archived from the original on 14 February 2018. Retrieved 3 November 2014.
  18. 1 2 3 4 5 Bennett JW, Lewis JS, Ellis MW (February 2008). "Dalbavancin in the treatment of complicated skin and soft-tissue infections: a review". Ther Clin Risk Manag. 4 (1): 31–40. doi: 10.2147/tcrm.s46 . PMC   2503664 . PMID   18728718.
  19. 1 2 3 "FDA Briefing Document: Anti-Infective Drugs Advisory Committee Meeting. NDA 21-883: Dalvance (Dalbavancin) for Injection" (PDF). Food and Drug Administration . Archived from the original (PDF) on 23 June 2017. Retrieved 16 December 2019.
  20. 1 2 USpatent 7119061
  21. 1 2 Leuthner KD, Buechler KA, Kogan D, Saguros A, Lee HS (June 2016). "Clinical efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSI)". Therapeutics and Clinical Risk Management. 12: 931–40. doi: 10.2147/TCRM.S86330 . PMC   4907732 . PMID   27354809.
  22. ↑ Buckwalter M, Dowell JA (November 2005). "Population pharmacokinetic analysis of dalbavancin, a novel lipoglycopeptide". Journal of Clinical Pharmacology. 45 (11): 1279–87. doi:10.1177/0091270005280378. PMID   16239361. S2CID   42875399.
  23. ↑ "Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial" (Press release). Pfizer Inc. 9 September 2008. Archived from the original on 1 August 2019. Retrieved 11 September 2008.
  24. ↑ Durata Begins Dalbavancin Study Enrollment. Drug Discovery & Development - 5 October 2011.
  25. ↑ Durata Therapeutics Announces Phase 3 Clinical Trial Results for Dalbavancin in the Treatment of ABSSSI
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