Numerous clinical trials have evaluated dalbavancin across a broad spectrum of Gram-positive bacterial infections, primarily focusing on acute bacterial skin and skin structure infections, osteoarticular and prosthetic joint infections, diabetic complications, and endovascular infections. These studies span Phase 1 through Phase 4 alongside observational registries and real-world utilization studies, encompassing completed, actively recruiting, and select terminated or withdrawn protocols. Trial sponsors range from pharmaceutical entities like Angelini and Allergan to major hospital centers such as Centre Hospitalier Universitaire de Nice.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06810583 | RECRUITING | Leukemia; Acute Myeloid Leukemia; Lymphoblastic Leukemia in Children |
St. Jude Children's Research Hospital |
2025-05-22 | PHASE1 |
| NCT07699211 | NOT_YET_RECRUITING | Endocarditis Infective; Endocarditis, Bacterial |
Stefan Hagel |
2026-12 | PHASE3 |
| NCT05046860 | ACTIVE_NOT_RECRUITING | Osteoarticular Infection |
Centre Hospitalier Universitaire de Nice |
2022-03-07 | |
| NCT06266494 | UNKNOWN | Frostbite |
University of Colorado, Denver |
2024-03-01 | PHASE4 |
| NCT05117398 | RECRUITING | Catheter Bacteremia; Staphylococcus Aureus Infection |
Assistance Publique - Hôpitaux de Paris |
2023-06-23 | PHASE3 |
| NCT03982030 | WITHDRAWN | Gram-Positive Bacterial Infections; Soft Tissue Infections |
Wake Forest University Health Sciences |
2023-04 | PHASE4 |
| NCT05977868 | TERMINATED | Endovascular Infection; Bone and Joint Infection; Skin and Soft Tissue Infection; Pulmonary Infection; Gastrointestinal Infection; Genitourinary Infection |
West Virginia University |
2023-08-04 | PHASE4 |
| NCT02814916 | COMPLETED | Methicillin-Resistant Staphylococcus Aureus; Bacterial Infections; Staphylococcal Skin Infections |
AbbVie |
2017-03-30 | PHASE3 |
| NCT04775953 | COMPLETED | Staphylococcal Bacteraemia |
National Institute of Allergy and Infectious Diseases (NIAID) |
2021-04-22 | PHASE2 |
| NCT04847921 | TERMINATED | Gram-Positive Bacterial Infections; Gram-Positive Bacteraemia; Substance Use Disorders; Intravenous Substance Abuse |
University of Colorado, Denver |
2021-04-30 | PHASE2; PHASE3 |
| NCT03426761 | COMPLETED | Bone Infection; Osteomyelitis; Septic Arthritis; Joint Infection; Prosthetic Joint Infection |
Infectious Diseases Physicians, Inc. |
2018-01-25 | PHASE4 |
| NCT05046860 | Recruiting | Osteoarticular Infection |
Centre Hospitalier Universitaire de Nice |
2022-03-07 | Not Applicable |
| NCT04959799 | Completed | Diabetes|Infection |
Aziende Chimiche Riunite Angelini Francesco S.p.A|Iqvia Pty Ltd |
2022-01-02 | -- |
| NCT03372941 | TERMINATED | Skin Infection |
Washington University School of Medicine |
2019-03-04 | PHASE4 |
| NCT04485676 | Completed | Skin Diseases Bacterial|Skin Diseases Infectious |
Angelini Farmacéutica|Effice Servicios Para la Investigacion S.L. |
2020-07-15 | -- |
| NCT06089044 | Completed | Prosthesis-related Infections |
Tourcoing Hospital |
2020-01-01 | -- |
| NCT02688790 | TERMINATED | Bacterial Infections |
AbbVie |
2016-04-01 | PHASE1 |
| NCT02961764 | COMPLETED | Acute Bacterial Skin and Skin Structure Infections |
Allergan |
2016-11-29 | PHASE4 |
| NCT03696901 | Terminated | Bacterial Infections |
Correvio International Sarl|AMS Advanced Medical Services GmbH|PrimeVigilance|Advanz Pharma |
2018-11-21 | -- |
| NCT03233438 | COMPLETED | Bacterial Infections; Acute Bacterial Skin and Skin Structure Infection |
Allergan |
2017-07-24 | PHASE4 |
| NCT02344511 | WITHDRAWN | Osteomyelitis |
Durata Therapeutics International BV (an Affiliate of Actavis, Inc.) |
2016-03 | PHASE3 |
| NCT02940730 | COMPLETED | Infectious Peritonitis |
University of Colorado, Denver |
2017-05-01 | PHASE4 |
| NCT02685033 | COMPLETED | Osteomyelitis |
Durata Therapeutics Inc., an affiliate of Allergan plc |
2016-03-15 | PHASE2 |
| NCT03091439 | TERMINATED | Osteomyelitis |
Allergan |
2017-05-15 | PHASE2 |
| NCT03148756 | TERMINATED | Endocarditis; Bacteremia |
AbbVie |
2017-05-12 | PHASE2 |
| NCT02269644 | WITHDRAWN | Community Acquired Pneumonia |
Durata Therapeutics Inc., an affiliate of Allergan plc |
2015-11 | PHASE3 |
| NCT01946568 | COMPLETED | Bacterial Infections. |
Durata Therapeutics Inc., an affiliate of Allergan plc |
2013-06 | PHASE1 |
| NCT02127970 | COMPLETED | Abscess; Wound Infection; Surgical Site Infection; Cellulitis |
Durata Therapeutics Inc., an affiliate of Allergan plc |
2014-04-18 | PHASE3 |
| NCT01431339 | COMPLETED | Abscess; Wound Infection; Surgical Site Infection; Cellulitis |
Durata Therapeutics Inc., an affiliate of Allergan plc |
2011-07 | PHASE3 |
| NCT01339091 | COMPLETED | Abscess; Wound Infection; Surgical Site Infection; Cellulitis |
Durata Therapeutics Inc., an affiliate of Allergan plc |
2011-03 | PHASE3 |
| NCT00678106 | COMPLETED | Bacterial Infections |
Pfizer |
2008-09 | PHASE1 |
| NCT00057369 | UNKNOWN | Bacteremia |
Vicuron Pharmaceuticals |
2001-02 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-02-03)
Check the
Dalbavancin
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.