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 | 2025-10-06 |
| 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
4006 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 118 | 5 | 3 | 3 | 31 | 156 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 41 | 46 | 15 | 2 | 30 | 119 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 13 | 8 | 8 | 2 | 49 | 80 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 13 | 8 | 5 | 12 | 41 | 75 |
| Syndrome | D013577 | — | — | 7 | 18 | 5 | 3 | 37 | 67 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 13 | 9 | 7 | 14 | 28 | 67 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 3 | 7 | 9 | 1 | 43 | 61 |
| Leukemia | D007938 | — | C95 | 32 | 25 | 5 | 1 | 4 | 55 |
| Covid-19 | D000086382 | — | U07.1 | 13 | 23 | 14 | 2 | 15 | 54 |
| Prostatic neoplasms | D011471 | — | C61 | 20 | 19 | 8 | 1 | 11 | 52 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 135 | 71 | 12 | — | 32 | 205 |
| Non-small-cell lung carcinoma | D002289 | — | — | 42 | 48 | 8 | — | 4 | 85 |
| Colorectal neoplasms | D015179 | — | — | 24 | 29 | 9 | — | 15 | 64 |
| Carcinoma | D002277 | — | C80.0 | 24 | 23 | 8 | — | 7 | 50 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 20 | 25 | 6 | — | 4 | 45 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 21 | 17 | 6 | — | 3 | 40 |
| Melanoma | D008545 | — | — | 24 | 20 | 1 | — | 3 | 39 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 15 | 16 | 6 | — | 3 | 34 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 16 | 15 | 4 | — | 3 | 30 |
| Chronic pain | D059350 | — | — | 1 | 4 | 1 | — | 21 | 27 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | 22 | 21 | — | — | 9 | 46 |
| Head and neck neoplasms | D006258 | — | — | 10 | 11 | — | — | 5 | 23 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 12 | 13 | — | — | 2 | 23 |
| Glioblastoma | D005909 | EFO_0000515 | — | 8 | 11 | — | — | 1 | 17 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 2 | — | — | 14 | 17 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 8 | 8 | — | — | 2 | 16 |
| Weight loss | D015431 | — | — | 1 | 2 | — | — | 13 | 16 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 2 | 3 | — | — | 13 | 16 |
| Glioma | D005910 | EFO_0000520 | — | 8 | 7 | — | — | 3 | 15 |
| Brain injuries | D001930 | — | S06.9 | 1 | 1 | — | — | 13 | 15 |
Show 286 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety | D001007 | EFO_0005230 | F41.1 | 1 | — | — | — | 22 | 23 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 5 | — | — | — | 7 | 12 |
| Urinary incontinence | D014549 | — | R32 | 1 | — | — | — | 8 | 9 |
| Psychological burnout | D000077062 | — | Z73.0 | 1 | — | — | — | 8 | 9 |
| Pharmacokinetics | D010599 | — | — | 7 | — | — | — | — | 7 |
| Pulmonary arterial hypertension | D000081029 | — | — | 3 | — | — | — | 3 | 6 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 1 | — | — | — | 5 | 6 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 1 | — | — | — | 5 | 6 |
| Cognition | D003071 | EFO_0003925 | — | 1 | — | — | — | 4 | 5 |
| Patient participation | D010358 | — | — | 1 | — | — | — | 3 | 4 |
Show 122 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Trigger finger disorder | D052582 | — | M65.3 | — | — | — | — | 24 | 24 |
| Cerebral palsy | D002547 | — | G80 | — | — | — | — | 13 | 13 |
| Paralysis | D010243 | — | — | — | — | — | — | 10 | 10 |
| Acute pain | D059787 | — | R52 | — | — | — | — | 8 | 8 |
| Sleep | D012890 | GO_0030431 | — | — | — | — | — | 8 | 8 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | — | — | — | 8 | 8 |
| Myopia | D009216 | EFO_0003927 | H52.1 | — | — | — | — | 8 | 8 |
| Child development | D002657 | — | — | — | — | — | — | 8 | 8 |
| Gingival recession | D005889 | — | K06.0 | — | — | — | — | 8 | 8 |
| Dental implants | D015921 | — | — | — | — | — | — | 7 | 7 |
Show 633 more
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
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Variants
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Dalvance – Allergan
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Dalvance – Warner Chilcott
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,087 adverse events reported
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