Drugs / Dalbavancin
Dalbavancin
also known as
BI-397 · DALBAVANCIN HYDROCHLORIDE · Dalbavancin hydrochloride (1:1.6) · Dalbavancin hydrochloride (5:8) · Dalbavancina · Dalbavancine · Dalvance · MDL 64,397 · +4 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 · 1 missed | ||||||
| Phase 2 | NCT04775953 | Apr 2021 → Oct 2023 | staphylococcal infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT03091439 | May → Aug 2017 | osteomyelitis | Allergan | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03148756 | May → Aug 2017 | bacterial infectious disease, infective endocarditis | AbbVie | Terminated | No outcome recorded Stop: Business |
| 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 Stop: Enrollment |
| Phase 37 trials · 3 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT01431339 | Jul 2011 → Nov 2012 | abscess, cellulitis, skin infection | Durata Therapeutics Inc., an affiliate of Allergan plc | Completed | Met primary |
| Phase 3 | NCT01339091 | Mar 2011 → Sep 2012 | abscess, cellulitis, skin infection | Durata Therapeutics Inc., an affiliate of Allergan plc | Completed | Met primary |
| 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 Stop: Business |
| 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 |
| Comparator or background therapy6 trials | ||||||
| Phase 3 | NCT07699211 Comparator | Dec 2026 → Sep 2028 expected | bacterial endocarditis | Stefan Hagel | Not yet recruiting | No outcome recorded |
| 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 Stop: Enrollment |
| 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 |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-12-16 | Aziende Chimiche Riunite Angelini Francesco S.p.A | Regulatory EMA recommends extension of dalbavancin indication in children angelinipharma.com ↗
Angelini Pharma announced today that the European Commission (EC) has approved the extension of dalbavancin for the treatment of pediatric patients (3 months of age and older) with acute bacterial skin and soft tissue infections (ABSSSI). |
| 2021-07-23 | AbbVie | Regulatory DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients abbvie.com ↗
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-12-16 | Aziende Chimiche Riunite Angelini Francesco S.p.A | EMA recommends extension of dalbavancin indication in children angelinipharma.com ↗ |
| 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.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dalbavancin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07699211 ↗ |
| 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 |