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
Dalvance
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dalbavancin | New Drug Application | 2014-06-05 |
| dalvance | New Drug Application | 2021-07-28 |
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
3407 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 | — | — | — | 79 | 2 | 1 | 2 | 15 | 97 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 30 | 39 | 8 | 1 | 14 | 80 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 4 | 6 | 7 | 2 | 36 | 55 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 10 | 7 | 7 | 12 | 19 | 51 |
| Covid-19 | D000086382 | — | U07.1 | 7 | 16 | 11 | 2 | 12 | 39 |
| Prostatic neoplasms | D011471 | — | C61 | 11 | 16 | 9 | 1 | 7 | 39 |
| Heart failure | D006333 | HP_0001635 | I50 | 2 | 11 | 6 | 2 | 13 | 33 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 17 | 4 | 2 | 1 | 7 | 30 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | 3 | 2 | 9 | 9 | 8 | 30 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | 4 | 9 | 3 | 12 | 29 |
Show 178 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 91 | 43 | 7 | — | 19 | 131 |
| Non-small-cell lung carcinoma | D002289 | — | — | 29 | 42 | 6 | — | 3 | 63 |
| Colorectal neoplasms | D015179 | — | — | 13 | 22 | 6 | — | 10 | 41 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 17 | 23 | 5 | — | 2 | 36 |
| Melanoma | D008545 | — | — | 19 | 20 | 1 | — | 4 | 35 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 2 | 3 | 3 | — | 29 | 35 |
| Multiple myeloma | D009101 | — | C90.0 | 10 | 13 | 4 | — | 4 | 27 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 9 | 12 | 5 | — | 3 | 25 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 7 | 14 | 5 | — | 1 | 24 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 11 | 11 | 4 | — | — | 21 |
Show 187 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 8 | 4 | — | — | 5 | 14 |
| Head and neck neoplasms | D006258 | — | — | 5 | 7 | — | — | 2 | 13 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | 2 | — | — | 11 | 13 |
| Glioblastoma | D005909 | EFO_0000515 | — | 5 | 9 | — | — | — | 12 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 3 | 6 | — | — | 2 | 10 |
| Small cell lung carcinoma | D055752 | — | — | 6 | 6 | — | — | 1 | 9 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 4 | 4 | — | — | 1 | 8 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 5 | 6 | — | — | — | 8 |
| Pruritus | D011537 | HP_0000989 | L29 | — | 1 | — | — | 7 | 8 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 3 | 2 | — | — | 3 | 7 |
Show 190 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary arterial hypertension | D000081029 | — | — | 3 | — | — | — | 3 | 6 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | 1 | — | — | — | 3 | 4 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | 3 | — | — | — | — | 3 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 3 | — | — | — | — | 3 |
| Mesothelioma | D008654 | — | C45 | 2 | — | — | — | 1 | 3 |
| Pulmonary fibrosis | D011658 | — | J84.10 | 2 | — | — | — | 1 | 3 |
| Dental pulp necrosis | D003790 | — | K04.1 | 3 | — | — | — | — | 3 |
| Ebolavirus | D029043 | — | — | 3 | — | — | — | — | 3 |
| Professional burnout | D002055 | — | — | 1 | — | — | — | 2 | 3 |
| Ependymoma | D004806 | — | — | 1 | — | — | — | 1 | 2 |
Show 68 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | — | — | — | 16 | 16 |
| Sleep | D012890 | GO_0030431 | — | — | — | — | — | 7 | 7 |
| Myopia | D009216 | EFO_0003927 | H52.1 | — | — | — | — | 7 | 7 |
| Cerebral palsy | D002547 | — | G80 | — | — | — | — | 6 | 6 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 5 | 5 |
| Sedentary behavior | D057185 | — | — | — | — | — | — | 5 | 5 |
| Trigger finger disorder | D052582 | — | M65.3 | — | — | — | — | 5 | 5 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | — | — | — | 5 | 5 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | — | — | — | 5 | 5 |
| Shoulder pain | D020069 | HP_0030834 | M25.51 | — | — | — | — | 5 | 5 |
Show 394 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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Estimated US medical usage
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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535 adverse events reported
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