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.
Download report
Favorite
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
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 |
|---|---|---|---|---|
| ZEMDRI | Cipla | N-210303 RX | 2018-06-25 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zemdri (plazomicin) | New Drug Application | 2021-07-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| escherichia coli infections | EFO_1001318 | D004927 | B96.20 |
| pyelonephritis | EFO_1001141 | D011704 | N10-N16 |
| urinary tract infections | EFO_0003103 | D014552 | N39.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PLAZOMICIN SULFATE, ZEMDRI, CIPLA USA | |||
| 2028-06-25 | GAIN | ||
| 2023-06-25 | NCE | ||
HCPCS
Code | Description |
|---|---|
| J0291 | Injection, plazomicin, 5 mg |
Clinical
Clinical Trials
18 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic inflammatory response syndrome | D018746 | EFO_1001478 | R65.10 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anti-glomerular basement membrane disease | D019867 | EFO_0007290 | M31.0 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | — | — | — | 1 | 1 |
| Covid-19 | D000086382 | U07.1 | — | — | — | — | 1 | 1 | |
| Endoplasmic reticulum stress | D059865 | EFO_1001886 | — | — | — | — | 1 | 1 | |
| Newborn infant diseases | D007232 | — | — | — | — | 1 | 1 | ||
| Critical illness | D016638 | — | — | — | — | 1 | 1 | ||
| Sepsis | D018805 | A41.9 | — | — | — | — | 1 | 1 | |
| Septic shock | D012772 | A48.3 | — | — | — | — | 1 | 1 | |
| Respiratory acidosis | D000142 | E87.29 | — | — | — | — | 1 | 1 | |
| Acid-base imbalance | D000137 | — | — | — | — | 1 | 1 | ||
| Respiratory alkalosis | D000472 | E87.3 | — | — | — | — | 1 | 1 |
Show 9 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | PLAZOMICIN |
| INN | plazomicin |
| 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 class | antibiotics (Micromonospora strains) |
| Image (chem structure or protein) | |
| 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-ID | 1154757-24-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1650559 |
| ChEBI ID | — |
| PubChem CID | 42613186 |
| DrugBank | DB12615 |
| UNII ID | LYO9XZ250J (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
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 772 documents
View more details
Safety
Black-box Warning
Black-box warning for: Zemdri (plazomicin)
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
27 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more