Drugs / Dalbavancin

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) DALVANCE 2016-01-20 – 2021-07-22 fda.gov
Approved EU (EMA) Xydalba 2015-02-19 europa.eu
Approved US (FDA) DALVANCE 2014-05-23 fda.gov

Trials 21 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT06810583 May 2025 → Sep 2030 expected acute myeloid leukemia, childhood acute lymphoblastic leukemia St. Jude Children's Research Hospital Recruiting No outcome recorded
Phase 1 NCT02688790 Apr 2016 → Apr 2019 bacterial infectious disease AbbVie Terminated No outcome recorded
Phase 1 NCT01946568 Jun 2013 → Apr 2015 bacterial infectious disease Durata Therapeutics Inc., an affiliate of Allergan plc Completed No outcome recorded
Phase 1 NCT00678106 Sep 2008 → Jul 2009 bacterial infectious disease Pfizer Completed No outcome recorded
Phase 25 trials
Phase 2 NCT04775953 Apr 2021 → Oct 2023 staphylococcal infection National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT03091439 May → Aug 2017 osteomyelitis Allergan Terminated No outcome recorded
Phase 2 NCT03148756 May → Aug 2017 bacterial infectious disease, infective endocarditis AbbVie Terminated No outcome recorded
Phase 2 NCT02685033 Mar 2016 → Dec 2017 osteomyelitis Durata Therapeutics Inc., an affiliate of Allergan plc Completed No outcome recorded
Phase 2 NCT00057369 Feb 2001 → Jun 2003 bacterial infectious disease Vicuron Pharmaceuticals Unknown No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04847921 Apr 2021 → Oct 2023 gram-positive bacterial infections, substance abuse University of Colorado, Denver Terminated No outcome recorded
Phase 37 trials
Phase 3 NCT05117398 Jun 2023 → Sep 2025 overdue bacterial infectious disease with sepsis, staphylococcus aureus infection Assistance Publique - Hôpitaux de Paris Recruiting No outcome recorded
Phase 3 NCT02814916 Mar 2017 → Jan 2024 methicillin-resistant staphylococcus aureus infectious disease AbbVie Completed No outcome recorded
Phase 3 NCT02344511 Mar 2016 → Oct 2018 osteomyelitis Durata Therapeutics International BV (an Affiliate of Actavis, Inc.) Withdrawn No outcome recorded
Phase 3 NCT02269644 Nov 2015 → Nov 2016 Durata Therapeutics Inc., an affiliate of Allergan plc Withdrawn No outcome recorded
Phase 3 NCT02127970 Apr 2014 → Mar 2015 abscess, cellulitis, skin infection Durata Therapeutics Inc., an affiliate of Allergan plc Completed No outcome recorded
Phase 3 NCT01431339 Jul 2011 → Nov 2012 abscess, cellulitis, skin infection Durata Therapeutics Inc., an affiliate of Allergan plc Completed No outcome recorded
Phase 3 NCT01339091 Mar 2011 → Sep 2012 abscess, cellulitis, skin infection Durata Therapeutics Inc., an affiliate of Allergan plc Completed No outcome recorded
Phase 43 trials
Phase 4 NCT06266494 Mar 2024 → May 2026 overdue University of Colorado, Denver Recruiting No outcome recorded
Phase 4 NCT03982030 Apr 2023 → Apr 2025 gram-positive bacterial infections Wake Forest University Health Sciences Withdrawn No outcome recorded
Phase 4 NCT03426761 Jan 2018 → Dec 2022 osteomyelitis, periprosthetic joint infection Infectious Diseases Physicians, Inc. Completed No outcome recorded
Phase not applicable1 trial
NCT05046860 Mar 2022 → Aug 2026 overdue periprosthetic joint infection Centre Hospitalier Universitaire de Nice Active not recruiting No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 31 trial
Phase 3 NCT07699211 Comparator Dec 2026 → Sep 2028 expected bacterial endocarditis Stefan Hagel Not yet recruiting No outcome recorded
Phase 45 trials
Phase 4 NCT05977868 Comparator Aug 2023 → Feb 2025 digestive system infectious disorder West Virginia University Terminated No outcome recorded
Phase 4 NCT03372941 Comparator Mar 2019 → Oct 2021 skin infection Washington University School of Medicine Terminated No outcome recorded
Phase 4 NCT03233438 Comparator Jul 2017 → Oct 2018 bacterial infectious disease Allergan Completed No outcome recorded
Phase 4 NCT02940730 Comparator May 2017 → Jun 2018 infectious peritonitis University of Colorado, Denver Completed No outcome recorded
Phase 4 NCT02961764 Comparator Nov 2016 → Mar 2019 Allergan Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2021-07-23 AbbVie DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients abbvie.com

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 29 sources stand behind the page.

FieldValueCited text
Known as Dalbavancin ClinicalTrials.gov intervention name — accepted as the source's own label NCT05046860
26

NCT05117398

NCT00678106

NCT05977868

NCT03982030

NCT01339091

NCT04847921

NCT02961764

NCT06810583

NCT02344511

NCT01431339

NCT03426761

NCT03233438

NCT03148756

NCT03372941

NCT01946568

NCT02685033

NCT02940730

NCT02269644

NCT02814916

NCT07699211

NCT00057369

NCT06266494

NCT02688790

NCT02127970

NCT04775953

NCT03091439

Known as BI-397 ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Known as DALBAVANCIN HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Known as Dalbavancin hydrochloride (1:1.6) ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Known as Dalbavancin hydrochloride (5:8) ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Known as Dalbavancina ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Known as Dalbavancine ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Known as Dalvance ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Known as MDL 64,397 ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Known as VER-001 ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Known as VERO001 ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Known as Xydalba “Dalbavancin (Xydalba®) 1500 mg - One unique dose” NCT05117398
Known as Zeven ChEMBL registry synonym — accepted as the source's own label CHEMBL3301669
Modality Other / unclassified “Dalbavancin is a long-acting, bactericidal, lipoglycopeptide antibiotic” PMID 34905144 Dec 2021
Route Intravenous “Dalbavancin was administered as a single-dose (1500 mg intravenous [IV])” PMID 34905144 Dec 2021