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Plazomicin | CAS No: 1154757-24-0 | GMP-certified suppliers
A medication that treats complicated urinary tract infections, including pyelonephritis, in adults with limited or no alternative options, targeting susceptible bacterial pathogens.
Therapeutic categories
Agents that produce neuromuscular block (indirect)Aminoglycoside AntibacterialsAnti-Bacterial AgentsAntibacterials for Systemic UseAntiinfectives for Systemic UseCarbohydrates
Generic name
Plazomicin
Molecule type
small molecule
CAS number
1154757-24-0
DrugBank ID
DB12615
Approval status
Approved drug, Investigational drug
ATC code
J01GB14
Primary indications
- Plazomicin is indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis, who have limited or no alternative treatment options
- It should only be used to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms
Product Snapshot
- Plazomicin is an intravenous injectable small molecule antibiotic
- It is used primarily for the treatment of complicated urinary tract infections, including pyelonephritis, in patients with limited alternative options
- Plazomicin is approved for use in the US market and is currently investigational elsewhere
Clinical Overview
Plazomicin is a next-generation aminoglycoside antibacterial agent indicated for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in adult patients aged 18 years or older who have limited or no alternative treatment options. The drug is indicated only for infections confirmed or strongly suspected to be caused by susceptible microorganisms.
Structurally derived from an earlier aminoglycoside, plazomicin incorporates specific chemical modifications designed to evade clinically relevant aminoglycoside-modifying enzymes (AMEs), including acetyltransferases, phosphotransferases, and nucleotidyltransferases that commonly inactivate aminoglycosides. However, resistance mechanisms such as bacterial efflux pump overexpression and ribosomal modifications due to mutations can reduce susceptibility. Plazomicin remains ineffective against bacterial isolates producing 16S rRNA methyltransferases.
Plazomicin exhibits bactericidal activity by selectively binding to the bacterial 30S ribosomal subunit. This interaction induces conformational changes that cause codon misreading and mistranslation during protein synthesis, leading to bacterial cell death. The drug has demonstrated potent activity against Enterobacteriaceae, including multidrug-resistant strains such as carbapenem-resistant and extended-spectrum beta-lactamase (ESBL) producing isolates. Clinically relevant pathogens susceptible to plazomicin include Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae, among others.
Pharmacodynamically, plazomicin shows a dose-dependent antibacterial effect with a post-antibiotic effect lasting from 0.2 to 2.6 hours at twice the minimum inhibitory concentration against Enterobacteriaceae. In clinical trials, it has been shown to improve clinical symptoms and achieve microbiological eradication by day five of treatment initiation. It is administered intravenously once daily.
Key safety considerations for plazomicin include nephrotoxicity, ototoxicity, and neuromuscular blockade, adverse effects common to aminoglycosides. No clinically significant QT interval prolongation has been observed in clinical studies. Due to its narrow therapeutic index and primary renal elimination, careful monitoring of renal function and drug plasma levels is recommended to mitigate toxicity risks.
Plazomicin is marketed under the brand name Zemdri. Procurement of the plazomicin active pharmaceutical ingredient (API) should emphasize certified compliance with regulatory standards such as GMP, with robust analytical characterization to confirm chemical identity, purity, and absence of contaminants. Given its narrow therapeutic window and potential toxicity, consistency in API quality is critical for formulation and clinical use.
Structurally derived from an earlier aminoglycoside, plazomicin incorporates specific chemical modifications designed to evade clinically relevant aminoglycoside-modifying enzymes (AMEs), including acetyltransferases, phosphotransferases, and nucleotidyltransferases that commonly inactivate aminoglycosides. However, resistance mechanisms such as bacterial efflux pump overexpression and ribosomal modifications due to mutations can reduce susceptibility. Plazomicin remains ineffective against bacterial isolates producing 16S rRNA methyltransferases.
Plazomicin exhibits bactericidal activity by selectively binding to the bacterial 30S ribosomal subunit. This interaction induces conformational changes that cause codon misreading and mistranslation during protein synthesis, leading to bacterial cell death. The drug has demonstrated potent activity against Enterobacteriaceae, including multidrug-resistant strains such as carbapenem-resistant and extended-spectrum beta-lactamase (ESBL) producing isolates. Clinically relevant pathogens susceptible to plazomicin include Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae, among others.
Pharmacodynamically, plazomicin shows a dose-dependent antibacterial effect with a post-antibiotic effect lasting from 0.2 to 2.6 hours at twice the minimum inhibitory concentration against Enterobacteriaceae. In clinical trials, it has been shown to improve clinical symptoms and achieve microbiological eradication by day five of treatment initiation. It is administered intravenously once daily.
Key safety considerations for plazomicin include nephrotoxicity, ototoxicity, and neuromuscular blockade, adverse effects common to aminoglycosides. No clinically significant QT interval prolongation has been observed in clinical studies. Due to its narrow therapeutic index and primary renal elimination, careful monitoring of renal function and drug plasma levels is recommended to mitigate toxicity risks.
Plazomicin is marketed under the brand name Zemdri. Procurement of the plazomicin active pharmaceutical ingredient (API) should emphasize certified compliance with regulatory standards such as GMP, with robust analytical characterization to confirm chemical identity, purity, and absence of contaminants. Given its narrow therapeutic window and potential toxicity, consistency in API quality is critical for formulation and clinical use.
Identification & chemistry
| Generic name | Plazomicin |
|---|---|
| Molecule type | Small molecule |
| CAS | 1154757-24-0 |
| UNII | LYO9XZ250J |
| DrugBank ID | DB12615 |
Pharmacology
| Summary | Plazomicin is an aminoglycoside antibiotic that binds to the bacterial 30S ribosomal subunit, disrupting protein synthesis by causing codon misreading and mistranslation. It exhibits bactericidal activity primarily against Enterobacteriaceae, including multidrug-resistant and carbapenemase-producing strains, while evading common aminoglycoside-modifying enzymes. The drug’s pharmacodynamics involve dose-dependent antibacterial effects with a post-antibiotic effect, targeting mainly complicated urinary tract infections caused by susceptible Gram-negative pathogens. |
|---|---|
| Mechanism of action | Plazomicin exerts a bactericidal action against susceptible bacteria by binding to bacterial 30S ribosomal subunit . Aminoglycosides typically bind to the ribosomal aminoacyl-tRNA site (A-site) and induce a conformational change to further facilitate the binding between the rRNA and the antibiotic . This leads to codon misreading and mistranslation of mRNA during bacterial protein synthesis . Plazomicin demonstrates potency against _Enterobacteriaceae_, including species with multidrug-resistant phenotypes such as carbapenemase-producing bacteria and isolates with resistance to all other aminoglycosides [A33942, A33943, A33944]. Its antibacterial activity is not inhibited by aminoglycoside modifying enzymes (AMEs) produced by bacteria, such as acetyltransferases (AACs), phosphotransferases (APHs), and nucleotidyltransferases (ANTs) [A33945, FDA Label]. Plazomicin was shown to be effective against _Enterobacteriaceae_ in presence of some beta-lactamases. In clinical settings and _in vivo_, bacteria shown to be susceptible toward plazomicin include _Escherichia_ _coli_, _Klebsiella pneumoniae_, _Proteus mirabilis_, and _Enterobacter cloacae_. Other aerobic bacteria that may be affected by plazomicin are _Citrobacter freundii_, _Citrobacter koseri_, _Enterobacter aerogenes_, _Klebsiella oxytoca_, _Morganella morganii_, _Proteus vulgaris_, _Providencia stuartii_, and _Serratia marcescens_. |
| Pharmacodynamics | Plazomicin exerts its antibacterial activity in a dose-dependent manner with a post-antibiotic effect ranging from 0.2 to 2.6 hours at 2X MIC against _Enterobacteriaceae_, as demonstrated by _in vitro_ studies. In clinical trials comprising of hospitalized adult patients with cUTI (including pyelonephritis), resolution or improvement of clinical cUTI symptoms and a microbiological outcome of eradication were observed at day 5 following the first dose administration of plazomicin. Plazomicin has shown to elicit nephrotoxic, ototoxic, and neuromuscular blocking effects. In clinical trials, it did not induce any clinically relevant QTc-prolonging effects. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 30S ribosomal protein S11 | Enterobacteriaceae bacterium (strain FGI 57) | inhibitor |
| 30S ribosomal protein S14 | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Administration of 15 mg/kg plazomicin by 30-minute IV infusion resulted in peak plasma concentrations of 73.7 ± 19.7 μg/mL in healthy adult subjects and 51.0 ± 26.7 μg/mL in patients with complicated urinary tract infections (cUTI). The area under the curve (AUC) were 257 ± 67.0 μg.h/mL in healthy adults and 226 ± 113 μg.h/mL in cUTI patients. |
|---|---|
| Half-life | The mean (±SD) half-life of plazomicin was 3.5 h (±0.5) in healthy adults with normal renal function receiving 15 mg/kg plazomicin via intravenous infusion. |
| Protein binding | The extent of plasma protein binding in humans is approximately 20%. The degree of protein binding was concentration-independent across the range tested in vitro (5 to 100 mcg/mL). |
| Metabolism | Plazomicin is not reported to undergo significant metabolism. |
| Route of elimination | Plazomicin predominantly undergoes renal excretion, where 56% of the total administered drug was recovered in the urine within 4 hours following a single 15 mg/kg IV dose of radiolabeled plazomicin in healthy subjects. About less than 0.2% and 89.1% of the total drug were recovered within 168 hours in feces and urine, respectively. |
| Volume of distribution | The mean (±SD) volume of distribution is 17.9 (±4.8) L in healthy adults and 30.8 (±12.1) L in cUTI patients. |
| Clearance | Following administration of 15 mg/kg plazomicin by 30-minute IV infusion, the mean (±SD) total body clearance in healthy adults and cUTI patients is 4.5 (±0.9) and 5.1 (±2.01) L/h, respectively. |
Formulation & handling
- Plazomicin is an intravenous injectable small molecule antibiotic with high water solubility facilitating aqueous formulation. Its low logP indicates high hydrophilicity, favoring parenteral administration over oral routes. Stability considerations include protecting from conditions that may promote degradation in aqueous solutions.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is protected by multiple patents in the United States, with expiry dates ranging from November 2028 to June 2031. Marketed primarily in the US, the product remains in the patent protection phase with limited generic competition expected before these dates. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Plazomicin is currently marketed under branded products in the US, with originator companies holding multiple active patents extending through 2028 to 2031. The presence of these patents indicates that generic competition is either limited or pending, reflecting an active proprietary manufacturing landscape focused primarily on the US market. |
|---|
Safety
| Toxicity | In case of suspected overdose, plazomicin therapy should be discontinued with initiation of supportive care. Maintenance of glomerular filtration and careful monitoring of renal function is recommended. Hemodialysis may be used to facilitate drug elimination, and this may be especially clinically useful in patients with compromised renal function. |
|---|
High Level Warnings:
- Discontinue plazomicin immediately upon suspected overdose and initiate supportive care
- Monitor renal function closely due to potential nephrotoxicity
- Maintain glomerular filtration rate
Plazomicin is a type of Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
