Dalvance, Xydalba(dalbavancin)
Dalvance, Xydalba (dalbavancin) is an unknown pharmaceutical. Dalbavancin was first approved as Dalvance on 2014-05-23. It is used to treat bacterial infections, infectious skin diseases, staphylococcal infections, and streptococcal infections in the USA. It has been approved in Europe to treat bacterial skin diseases and soft tissue infections.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Dalbavancin, Dalvance
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dalbavancin | ANDA | 2025-12-03 |
| dalbavancin hydrochloride | ANDA | 2025-11-06 |
| dalvance | New Drug Application | 2025-01-13 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DALBAVANCIN HYDROCHLORIDE, DALVANCE, ABBVIE | |||
| 2024-07-22 | NPP | ||
| 2024-05-23 | GAIN | ||
| 2019-05-23 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Dalbavancin Hydrochloride, Dalvance, Abbvie | |||
| 6900175 | 2028-05-23 | U-3499 | |
HCPCS
Code | Description |
|---|---|
| J0875 | Injection, dalbavancin, 5 mg |
Clinical
Clinical Trials
4085 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | 1 | — | 1 |
| Fatigue | D005221 | — | R53.83 | — | — | — | 1 | — | 1 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | — | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | — | 1 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dalbavancin |
| INN | dalbavancin |
| Description | Dalbavancin is 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. It has a role as an antibacterial drug and an antimicrobial agent. It is a carbohydrate acid derivative, a monosaccharide derivative, a glycopeptide and a semisynthetic derivative. |
| Classification | Small molecule |
| Drug class | vancomycin-related compounds |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN[C@H]1C(=O)N[C@@H]2Cc3ccc(cc3)Oc3cc4cc(c3O[C@@H]3O[C@H](C(=O)O)[C@@H](O)[C@H](O)[C@H]3NC(=O)CCCCCCCCC(C)C)Oc3ccc(cc3Cl)[C@@H](O)[C@@H]3NC(=O)[C@H](NC(=O)[C@@H]4NC(=O)[C@@H](NC2=O)c2cc(cc(O)c2Cl)Oc2cc1ccc2O)c1ccc(O)c(c1)-c1c(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@@H]2O)cc(O)cc1[C@@H](C(=O)NCCCN(C)C)NC3=O |
Identifiers
| PDB | — |
| CAS-ID | 171500-79-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3301669 |
| ChEBI ID | 82721 |
| PubChem CID | 16134627 |
| DrugBank | DB06219 |
| UNII ID | 808UI9MS5K (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
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Dalvance – Allergan
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Dalvance – Warner Chilcott
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,652 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,117 adverse events reported
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