Dalbavancin

Summary

Dalbavancin (CHEMBL3301669) is an approved protein antibacterial drug (ATC J01XA04); indicated across 8 conditions including bacterial infectious disease and osteomyelitis.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: J01XA04
• Indications: 8 conditions
• Clinical trials: 27
• Chemistry: 1816.7 Da · C88H100Cl2N10O28

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3301669
Name	Dalbavancin
Type	Protein
Max phase	4
FDA approved	yes
PubChem CID	16134627
ChEBI	CHEBI:82721
ATC	J01XA04
Molecular formula	C88H100Cl2N10O28
Molecular weight	1816.7
InChIKey	KGPGQDLTDHGEGT-SZUNQUCBSA-N

SMILES: CC(C)CCCCCCCCC(=O)N[C@@H]1[C@H]([C@@H]([C@H](O[C@H]1OC2=C3C=C4C=C2OC5=C(C=C(C=C5)[C@H]([C@H]6C(=O)N[C@@H](C7=C(C(=CC(=C7)O)O[C@@H]8[C@H]([C@H]([C@@H]([C@H](O8)CO)O)O)O)C9=C(C=CC(=C9)[C@H](C(=O)N6)NC(=O)[C@@H]4NC(=O)[C@@H]1C2=C(C(=CC(=C2)OC2=C(C=CC(=C2)[C@H](C(=O)N[C@H](CC2=CC=C(O3)C=C2)C(=O)N1)NC)O)O)Cl)O)C(=O)NCCCN(C)C)O)Cl)C(=O)O)O)O

IUPAC name: (2S,3S,4R,5R,6S)-6-[[(1S,2R,19R,22R,34S,37R,40R,52S)-5,32-dichloro-52-[3-(dimethylamino)propylcarbamoyl]-2,26,31,44,49-pentahydroxy-22-(methylamino)-21,35,38,54,56,59-hexaoxo-47-[(2R,3S,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-7,13,28-trioxa-20,36,39,53,55,58-hexazaundecacyclo[38.14.2.23,6.214,17.219,34.18,12.123,27.129,33.141,45.010,37.046,51]hexahexaconta-3,5,8,10,12(64),14(63),15,17(62),23(61),24,26,29(60),30,32,41(57),42,44,46(51),47,49,65-henicosaen-64-yl]oxy]-3,4-dihydroxy-5-(10-methylundecanoylamino)oxane-2-carboxylic acid

ChEBI definition: A semisynthetic glycopeptide used for the treatment of acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms including MRSA.

Pharmacological roles (ChEBI): antibacterial drug, antimicrobial agent.

Also known as: A-A-1, BI-397, BI397, Dalbavancin, Dalbavancina, Dalbavancine, MDL 64,397, MDL-64397, VER-001, VER001, VERO001, Zeven

Parent form; salt/anhydrous children: CHEMBL3301650

Patent coverage: 1,101 distinct patent families (2,357 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 2,353 (100%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

8 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
bacterial infectious disease	4	MONDO:0005113	EFO:0000771
osteomyelitis	3	MONDO:0005246	EFO:0003102
pneumonia	3	MONDO:0005249	EFO:0003106
abscess	3	MONDO:0005227	EFO:0003030
cellulitis	3	MONDO:0005230	EFO:0003035
staphylococcus aureus infection	3	MONDO:0005545	EFO:0005681
bacterial infectious disease with sepsis	2	MONDO:0005229	EFO:0003033

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 27.

Phase distribution

Phase	Trials
PHASE4	7
PHASE3	6
PHASE2	5
PHASE1	4
Not specified	4
PHASE2/PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06266494	PHASE4	RECRUITING	Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
NCT02961764	PHASE4	COMPLETED	Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
NCT03233438	PHASE4	COMPLETED	Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
NCT03372941	PHASE4	TERMINATED	Hospital Avoidance Strategies for ABSSSI
NCT03426761	PHASE4	COMPLETED	Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections
NCT03982030	PHASE4	WITHDRAWN	Dalbavancin Outpatient Pilot
NCT05977868	PHASE4	TERMINATED	Comparing Oral Versus Parenteral Antimicrobial Therapy
NCT05117398	PHASE3	RECRUITING	Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
NCT01339091	PHASE3	COMPLETED	Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT02127970	PHASE3	COMPLETED	Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT02269644	PHASE3	WITHDRAWN	A P3 Comparator Trial in Community Acquired Bacterial Pneumonia
NCT02344511	PHASE3	WITHDRAWN	Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis
NCT02814916	PHASE3	COMPLETED	Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
NCT04847921	PHASE2/PHASE3	TERMINATED	Substance Use Disorder (SUD)-Associated Infections’ Treatment With Dalbavancin ENabling OUtpatient Transition
NCT00057369	PHASE2	UNKNOWN	Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
NCT02685033	PHASE2	COMPLETED	Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis
NCT03091439	PHASE2	TERMINATED	Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis
NCT03148756	PHASE2	TERMINATED	Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis
NCT04775953	PHASE2	COMPLETED	DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
NCT06810583	PHASE1	RECRUITING	A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia
NCT00678106	PHASE1	COMPLETED	Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
NCT01946568	PHASE1	COMPLETED	A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.
NCT02688790	PHASE1	TERMINATED	Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection
NCT04624451	Not specified	TERMINATED	Evaluation of Intravenous Dalbavancin for Peritonitis
NCT04959799	Not specified	COMPLETED	Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections (DALBADIA)
NCT05046860	Not specified	UNKNOWN	Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements
NCT06089044	Not specified	COMPLETED	Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).