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Drug ReportsPlazomicin
Plazomicin
Zemdri (plazomicin) is a small molecule pharmaceutical. Plazomicin was first approved as Zemdri on 2018-06-25. It is used to treat escherichia coli infections, pyelonephritis, and urinary tract infections in the USA.
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Financial
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5D
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YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
Trade Name
FDA
EMA
Zemdri
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Plazomicin sulfate
Tradename
Company
Number
Date
Products
ZEMDRICiplaN-210303 RX2018-06-25
1 products, RLD, RS
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
escherichia coli infectionsEFO_1001318D004927B96.20
pyelonephritisEFO_1001141D011704N10-N16
urinary tract infectionsEFO_0003103D014552N39.0
Agency Specific
FDA
EMA
Expiration
Code
PLAZOMICIN SULFATE, ZEMDRI, CIPLA USA
2028-06-25GAIN
2023-06-25NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Plazomicin Sulfate, Zemdri, Cipla Usa
83835962031-06-02DPU-2328
88224242028-11-21DP
92669192028-11-21U-2328
96887112028-11-21DPU-2328
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01G: Aminoglycoside antibacterials
— J01GB: Other aminoglycosides in atc
— J01GB14: Plazomicin
HCPCS
Code
Description
J0291
Injection, plazomicin, 5 mg
Clinical
Clinical Trials
10 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
Urinary tract infectionsD014552EFO_0003103N39.0—12——3
PyelonephritisD011704EFO_1001141N10-N16—12——3
Ventilator-associated pneumoniaD053717EFO_1001865J95.851——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
Chronic kidney failureD007676EFO_0003884N18.61————1
Renal insufficiencyD051437HP_0000083N191————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePlazomicin
INNplazomicin
Description
Plazomicin, sold under the brand name Zemdri, is an aminoglycoside antibiotic used to treat complicated urinary tract infections. As of 2019 it is recommended only for those in whom alternatives are not an option. It is given by injection into a vein.
Classification
Small molecule
Drug classantibiotics (Micromonospora strains)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN[C@@H]1[C@@H](O)[C@@H](O[C@@H]2[C@@H](O)[C@H](O[C@H]3OC(CNCCO)=CC[C@H]3N)[C@@H](N)C[C@H]2NC(=O)[C@@H](O)CCN)OC[C@]1(C)O
Identifiers
PDB—
CAS-ID1154757-24-0
RxCUI—
ChEMBL IDCHEMBL1650559
ChEBI ID—
PubChem CID42613186
DrugBankDB12615
UNII IDLYO9XZ250J (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 901 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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9 adverse events reported
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