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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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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
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
XENLETANabriva TherapeuticsN-211672 RX2019-08-19
1 products, RLD, RS
XENLETANabriva TherapeuticsN-211673 RX2019-08-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
citric buffered normal saline xenletaNew Drug Application2021-03-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial pneumoniaEFO_1001272D018410J15.9
Agency Specific
FDA
EMA
Expiration
Code
LEFAMULIN ACETATE, XENLETA, NABRIVA
2029-08-19GAIN
2024-08-19NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Lefamulin Acetate, Xenleta, Nabriva
91207272031-05-23DS, DP
80716432029-01-16DS, DP
81536892028-03-19DS, DP
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01X: Other antibacterials in atc
— J01XX: Other antibacterials in atc
— J01XX12: Lefamulin
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
PneumoniaD011014EFO_0003106J18——2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—1———1
Bacterial infectionsD001424A49—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
Cystic fibrosisD003550EFO_0000390E841————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLEFAMULIN
INNlefamulin
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 classantibacterials, 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-ID1061337-51-6
RxCUI—
ChEMBL IDCHEMBL3291398
ChEBI ID—
PubChem CID25185057
DrugBankDB12825
UNII ID21904A5386 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 298 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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329 adverse events reported
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