plazomicin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
aminoglycosides, antibiotics obtained from various Micromonospora 5287 1154757-24-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • plazomicin
  • plazomicin sulfate
  • ACHN-490
Plazomicin is an aminoglycoside that acts by binding to bacterial 30S ribosomal subunit, thereby inhibiting protein synthesis. Plazomicin has concentration-dependent bactericidal activity as measured by time kill studies. In vitro studies demonstrated a plazomicin post-antibiotic effect ranging from 0.2 to 2.6 hours at 2X MIC against Enterobacteriaceae.
  • Molecular weight: 592.69
  • Formula: C25H48N6O10
  • CLOGP: -2.37
  • LIPINSKI: 3
  • HAC: 16
  • HDO: 11
  • TPSA: 269.29
  • ALOGS: -1.68
  • ROTB: 13

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.14 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.84 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 25, 2018 FDA ACHAOGEN INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01GB14 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
AMINOGLYCOSIDE ANTIBACTERIALS
Other aminoglycosides

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Urinary tract infectious disease indication 68566005




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.04 acidic
pKa2 13.21 acidic
pKa3 13.84 acidic
pKa4 9.4 Basic
pKa5 9.12 Basic
pKa6 8.51 Basic
pKa7 7.43 Basic
pKa8 6.73 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 500MG BASE/10ML (EQ 50MG BASE/ML) ZEMDRI CIPLA USA N210303 June 25, 2018 RX SOLUTION INTRAVENOUS 9266919 Nov. 21, 2028 METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS
EQ 500MG BASE/10ML (EQ 50MG BASE/ML) ZEMDRI CIPLA USA N210303 June 25, 2018 RX SOLUTION INTRAVENOUS 9688711 Nov. 21, 2028 METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS
EQ 500MG BASE/10ML (EQ 50MG BASE/ML) ZEMDRI CIPLA USA N210303 June 25, 2018 RX SOLUTION INTRAVENOUS 8383596 June 2, 2031 METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 500MG BASE/10ML (EQ 50MG BASE/ML) ZEMDRI CIPLA USA N210303 June 25, 2018 RX SOLUTION INTRAVENOUS June 25, 2023 NEW CHEMICAL ENTITY
EQ 500MG BASE/10ML (EQ 50MG BASE/ML) ZEMDRI CIPLA USA N210303 June 25, 2018 RX SOLUTION INTRAVENOUS June 25, 2028 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

None

External reference:

IDSource
LYO9XZ250J UNII
C3502652 UMLSCUI
EDS PDB_CHEM_ID
CHEMBL1650559 ChEMBL_ID
42613186 PUBCHEM_CID
DB12615 DRUGBANK_ID
CHEMBL2364623 ChEMBL_ID
D10151 KEGG_DRUG
10847 IUPHAR_LIGAND_ID
2049549 RXNORM
d08816 MMSL
1193790007 SNOMEDCT_US
725719004 SNOMEDCT_US
772052009 SNOMEDCT_US
4037688 VANDF
017613 NDDF
017619 NDDF
C550938 MESH_SUPPLEMENTAL_RECORD_UI
9522 INN_ID
1380078-95-4 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Zemdri (plazomicin) HUMAN PRESCRIPTION DRUG LABEL 1 69097-820 INJECTION 500 mg INTRAVENOUS NDA 29 sections
Zemdri (plazomicin) HUMAN PRESCRIPTION DRUG LABEL 1 71045-010 INJECTION 500 mg INTRAVENOUS NDA 29 sections
Zemdri (plazomicin) HUMAN PRESCRIPTION DRUG LABEL 1 80735-820 INJECTION 500 mg INTRAVENOUS NDA 29 sections