Xenleta(lefamulin)
Xenleta (lefamulin) is a small molecule pharmaceutical. Lefamulin was first approved as Xenleta on 2019-08-19. It is used to treat bacterial pneumonia in the USA. It has been approved in Europe to treat bacterial pneumonia and community-acquired infections.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| respiratory tract diseases | D012140 |
Trade Name
FDA
EMA
Xenleta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lefamulin acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XENLETA | Nabriva Therapeutics | N-211672 RX | 2019-08-19 | 1 products, RLD, RS |
| XENLETA | Nabriva Therapeutics | N-211673 RX | 2019-08-19 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| citric buffered normal saline xenleta | New Drug Application | 2024-10-11 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacterial pneumonia | EFO_1001272 | D018410 | J15.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LEFAMULIN ACETATE, XENLETA, NABRIVA | |||
| 2029-08-19 | GAIN | ||
| 2024-08-19 | NCE | ||
HCPCS
Code | Description |
|---|---|
| J0691 | Injection, lefamulin, 1 mg |
Clinical
Clinical Trials
7 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | 1 | — | — | — | 1 |
| Bacterial infections | D001424 | — | A49 | — | 1 | — | — | — | 1 |
| Bacterial skin diseases | D017192 | — | — | — | 1 | — | — | — | 1 |
| Mycoplasma infections | D009175 | — | — | 1 | 1 | — | — | — | 1 |
| Pleuropneumonia | D011001 | — | — | 1 | 1 | — | — | — | 1 |
| Mycoplasma genitalium | D045704 | NCBITaxon_2097 | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Fibrosis | D005355 | — | — | 1 | — | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lefamulin |
| INN | lefamulin |
| Description | Lefamulin, sold under the brand name Xenleta, is an antibiotic medication used it to treat adults with community-acquired bacterial pneumonia. It is taken by mouth or by injection into a vein.
|
| Classification | Small molecule |
| Drug class | antibacterials, pleuromulin derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=C[C@]1(C)C[C@@H](OC(=O)CS[C@@H]2CC[C@@H](N)C[C@H]2O)[C@]2(C)[C@H](C)CC[C@]3(CCC(=O)[C@H]32)[C@@H](C)[C@@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 1061337-51-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3291398 |
| ChEBI ID | — |
| PubChem CID | 25185057 |
| DrugBank | DB12825 |
| UNII ID | 21904A5386 (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 376 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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18 adverse events reported
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