Drugs / Oritavancin
Oritavancin
also known as
Orbactiv · Oritavancin Diphosphate · Kimyrsa · LY-333328 · LY-333328 DIPHOSPHATE · Nuvocid · Oritavancin Injection · Oritavancin phosphate · +4 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Tenkasi (previously Orbactiv) | — | 2015-03-19 | europa.eu ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT02470702 | Jun → Oct 2015 | — | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02340988 | Apr → Sep 2015 | — | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02357524 | Jan → Mar 2015 | — | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02134301 | May 2014 → Nov 2025 | gram-positive bacterial infections | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01784536 | Jan → Mar 2013 | — | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01762839 | Dec 2012 → Jan 2013 | — | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT07550595 | Jul 2026 → Jun 2028 expected | gram-positive bacterial infections, infective endocarditis, prosthesis-related infectious disease | Kirby Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05599295 | Jun 2023 → Nov 2025 | — | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00514527 | Aug 2007 → Apr 2008 | abscess, cellulitis, staphylococcal infection, streptococcal infection | Targanta Therapeutics Corporation | Completed | Met primary |
| Phase 32 trials · 2 met primary | ||||||
| Phase 3 | NCT01252719 | Dec 2010 → Oct 2012 | abscess, cellulitis, skin infection | Melinta Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT01252732 | Dec 2010 → Jun 2013 | abscess, cellulitis, skin infection | Melinta Therapeutics, Inc. | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT05521880 | Jul 2024 → May 2025 | bacterial infectious disease, infective arthritis, osteomyelitis, substance-related disorder | University of Maryland, Baltimore | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03761953 | Jul 2019 → Mar 2022 | infective endocarditis, staphylococcus aureus infection | University of Pennsylvania | Withdrawn | No outcome recorded |
| Phase 4 | NCT02925416 | Jan → Jun 2017 | skin disease caused by bacterial infection | The Medicines Company | Completed | No outcome recorded |
| Phase 4 | NCT02452918 | Sep 2015 → Jul 2016 | — | The Medicines Company | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07013552 | Jun 2025 → Jul 2026 overdue | gram-positive bacterial infections, infective endocarditis, nosocomial infection, prosthesis-related infectious disease | Medical University of Silesia | Not yet recruiting | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1 | NCT03873987 Comparator | Jul → Aug 2019 | — | Melinta Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02471690 Comparator | Jul 2015 → Apr 2016 | — | The Medicines Company | Completed | No outcome recorded |
| Phase 4 | NCT05977868 Comparator | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2018-10-11 | Menarini Group | The MENARINI GROUP Announces Commercial Agreement for Vabomere, Orbactiv and Minocin in 68 Countries menarini.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | oritavancin | “meropenem, oritavancin, oxacillin, penicillin, piperacillin-tazobactam, tigecycline, vancomycin” NCT05977868 ↗18“Oritavancin is the active drug substance in both Orbactiv and Kimyrsa.” NCT05599295 ↗ |
| Known as | Kimyrsa | “This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate...” NCT05599295 ↗1“This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and...” NCT03873987 ↗ |
| Known as | LY-333328 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1688530 ↗ |
| Known as | LY-333328 DIPHOSPHATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1688530 ↗ |
| Known as | Nuvocid | “Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)” NCT00514527 ↗ |
| Known as | Orbactiv | “This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate...” NCT05599295 ↗2“This protocol describes a double-blind study to evaluate the safety and pharmacokinetics of multiple IV doses of 1200 mg ORBACTIV (oritavancin) in healthy subjects.” NCT02470702 ↗ “Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects” NCT02340988 ↗ |
| Known as | Oritavancin Diphosphate | “This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate...” NCT05599295 ↗ |
| Known as | Oritavancin Injection | “Drug: Oritavancin Injection” NCT03761953 ↗ |
| Known as | Oritavancin phosphate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1688530 ↗ |
| Known as | Oritavancina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1688530 ↗ |
| Known as | Oritavancine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1688530 ↗ |
| Known as | Tenkasi | “Patients treated with a long half-life antibiotic - oritavancin (Tenkasi)” NCT07013552 ↗ |
| Known as | Tenkasi (previously orbactiv) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1688530 ↗ |
| Modality | Other / unclassified | “Oritavancin is a novel lipoglycopeptide with demonstrated effectiveness against complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens” PMID 21537018 ↗ May 2011 |
| Route | Intravenous | “single and infrequent dosing of intravenous (i.v.) oritavancin for the treatment of cSSSI caused by Gram-positive pathogens” PMID 21537018 ↗ May 2011 |