oritavancin

Trade name: orbactiv

Small moleculeapproved

Approved

Aug 6, 2014

Oritavancin is an glycopeptide antibiotic with bactericidal activity effective in treating infections caused by Gram-positive organisms. It treats complicated skin and skin structure infections. This drug demonstrates similar activity to vancomycin, but it has stronger activity against Staphylococcus and Enterococcus. The pharmacokinetics and pharmacodynamics of oritavancin appear to be favourable and once-daily dosing is likely. The incidence of multi-drug resistant bacteria is increasing and explorations into additional treatment options are essential. Oritavancin is marketed under the brand name Orbactiv. Orbactiv is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms. Oritavancin has the following mechanism of action: 1) Inhibition of the transglycosylation (polymerisation) step of cell wall biosynthesis by binding to the stem peptide of peptidoglycan precursors 2) Inhibition of the transpeptidation (crosslinking) step of cell wall biosynthesis by binding to the peptide bridging segments of the cell wall 3) Disruption of bacterial membrane integrity, leading to depolarisation, increased permeability and rapid cell death. — NCATS

Clinical trial activity

17 trials · 10 clinical orgs · 1 marketing orgs

Phase 1
8
Phase 2
4
Phase 3
2
Phase 4
4

Earliest trial started Aug 1, 2007 (NCT00514527)

Timeline

2000s

  1. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

  3. Aug 6, 2014

    Melinta Therapeutics — Earliest FDA Approval

  4. Aug 6, 2014

    Melinta Therapeutics — NDA Organization

  5. Aug 6, 2014

    Melinta Therapeutics — NDA Secondary Org

Indications

Mechanism of action

Approval history

  • approvedPriority reviewAug 6, 2014

Chemistry & pharmacology

Loading structure…

SMILES

CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O[C@H]3C[C@](C)(N)[C@@H](O)[C@H](C)O3)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(NCc3ccc(-c4ccc(Cl)cc4)cc3)[C@@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O.O=P(O)(O)O.O=P(O)(O)O
Mol. weight
1989.11 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • chlorobiphenyl-chloroeremomycin
  • chlorobiphenyl-chloroeremomycin
  • ly333328
  • ly333328
  • ly 333328
  • ly-333328
  • ly-333328
  • ly-333328
  • orbactiv
  • orbactiv
  • orbactiv
  • orbactiv
  • oritavancin
  • oritavancin
  • oritavancin
  • oritavancin
  • oritavancin
  • oritavancin
  • oritavancin
  • oritavancin
  • oritavancin
  • oritavancin diphosphate
  • oritavancin diphosphate
  • oritavancin diphosphate
  • oritavancin diphosphate
  • oritavancin diphosphate
  • oritavancin diphosphate
  • oritavancin diphosphate
  • oritavancin diphosphate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07013552N/AJun 30, 2025Government of Poland, Silesian University of Medicine
NCT05521880Phase 4Oct 31, 2022University of Maryland
NCT05599295Phase 2Oct 31, 2022Melinta Therapeutics
NCT03873987Phase 1Jul 31, 2019Melinta Therapeutics
NCT03761953Phase 4Jan 1, 2019University of Pennsylvania
NCT02925416Phase 4Jan 1, 2017The Medicines Company
NCT02471690Phase 1Jul 1, 2015The Medicines Company
NCT02452918Phase 4Jun 1, 2015The Medicines Company
NCT02470702Phase 1Jun 1, 2015The Medicines Company
NCT02340988Phase 1Apr 1, 2015Spaulding Clinical Research Inc., The Medicines Company
NCT02357524Phase 1Jan 1, 2015The Medicines Company, University of Otago
NCT02134301Phase 1May 1, 2014The Medicines Company
NCT01762839Phase 1Jan 1, 2013Spaulding Clinical Research Inc., The Medicines Company
NCT01784536Phase 1Jan 1, 2013Spaulding Clinical Research Inc., The Medicines Company
NCT01252719Phase 3Dec 1, 2010Duke University, The Medicines Company
NCT01252732Phase 3Dec 1, 2010Duke University, The Medicines Company
NCT00514527Phase 2Aug 1, 2007Targanta
Showing 17 of 17 trials
Page 1 / 1

Organizations

Research & Development (10)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
The Medicines CompanyFor profit111132010
Spaulding Clinical Research Inc.For profit3012013
Duke UniversityAcademic/Hospital2012010
Melinta TherapeuticsFor profit2222019
Government of PolandGovernment1012025
Silesian University of MedicineAcademic/Hospital1112025
TargantaFor profit1112007
University of MarylandAcademic/Hospital1112022
University of OtagoAcademic/Hospital1012015
University of PennsylvaniaAcademic/Hospital1112019
10 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Melinta TherapeuticsFor profitNDAAug 6, 2014
Melinta TherapeuticsFor profitNDA2Aug 6, 2014