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- Antibacterials
- Eravacycline
Eravacycline API Manufacturers & Suppliers
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Eravacycline | CAS No: 1207283-85-9 | GMP-certified suppliers
A medication that treats complicated intra-abdominal infections by targeting a broad spectrum of drug-resistant gram-positive and gram-negative bacteria in adult patients.
Therapeutic categories
Anti-Bacterial AgentsAntibacterials for Systemic UseAntiinfectives for Systemic UseCytochrome P-450 CYP3A SubstratesCytochrome P-450 CYP3A4 SubstratesCytochrome P-450 Substrates
Generic name
Eravacycline
Molecule type
small molecule
CAS number
1207283-85-9
DrugBank ID
DB12329
Approval status
Approved drug, Investigational drug
ATC code
J01AA13
Primary indications
- Eravacycline is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older
Product Snapshot
- Eravacycline is an injectable small molecule antibiotic formulated as a lyophilized powder for intravenous administration
- It is primarily used for the treatment of complicated intra-abdominal infections in adult patients
- Eravacycline is approved in major regulatory markets including the United States and the European Union
Clinical Overview
Eravacycline (CAS Number 1207283-85-9) is a fully synthetic fluorocycline antibiotic belonging to the tetracycline class. It is characterized by an octahydrotetracene-2-carboxamide skeleton with multiple hydroxy and substituent groups. Eravacycline exhibits broad-spectrum activity against clinically significant gram-negative and gram-positive aerobic and facultative bacteria, including many strains resistant to cephalosporins, fluoroquinolones, β-lactam/β-lactamase inhibitors, multidrug-resistant bacteria, carbapenem-resistant Enterobacteriaceae, and the majority of anaerobic pathogens.
Clinically, eravacycline is approved for the treatment of complicated intra-abdominal infections in adult patients (18 years and older). Its antibacterial effect primarily results from inhibition of bacterial protein synthesis. Eravacycline binds to the 30S ribosomal subunit, thereby blocking the incorporation of amino acid residues into elongating peptide chains. This mechanism imparts a generally bacteriostatic effect against gram-positive species such as Staphylococcus aureus and Enterococcus faecalis. In contrast, bactericidal activity has been observed in vitro against some gram-negative strains including Escherichia coli and Klebsiella pneumoniae.
Pharmacokinetically, eravacycline undergoes systemic distribution with metabolism primarily mediated by cytochrome P450 enzymes, notably CYP3A4. It is a substrate for multiple cytochrome P450 isoforms as well as monoamine oxidase A. These interactions should be considered during co-administration with other drugs metabolized via these pathways. Safety and toxicity data reflect a tolerability profile consistent with tetracycline-class antibiotics, with attention to potential gastrointestinal effects and hypersensitivity reactions.
Eravacycline is marketed under the brand name Xerava by Tetraphase Pharmaceuticals and received FDA approval in August 2018. When sourcing eravacycline API, manufacturers should ensure compliance with current good manufacturing practices (cGMP) and verification of chemical purity, stereochemical integrity, and absence of toxic impurities, due to its synthetic complexity and critical therapeutic use in resistant bacterial infections.
Clinically, eravacycline is approved for the treatment of complicated intra-abdominal infections in adult patients (18 years and older). Its antibacterial effect primarily results from inhibition of bacterial protein synthesis. Eravacycline binds to the 30S ribosomal subunit, thereby blocking the incorporation of amino acid residues into elongating peptide chains. This mechanism imparts a generally bacteriostatic effect against gram-positive species such as Staphylococcus aureus and Enterococcus faecalis. In contrast, bactericidal activity has been observed in vitro against some gram-negative strains including Escherichia coli and Klebsiella pneumoniae.
Pharmacokinetically, eravacycline undergoes systemic distribution with metabolism primarily mediated by cytochrome P450 enzymes, notably CYP3A4. It is a substrate for multiple cytochrome P450 isoforms as well as monoamine oxidase A. These interactions should be considered during co-administration with other drugs metabolized via these pathways. Safety and toxicity data reflect a tolerability profile consistent with tetracycline-class antibiotics, with attention to potential gastrointestinal effects and hypersensitivity reactions.
Eravacycline is marketed under the brand name Xerava by Tetraphase Pharmaceuticals and received FDA approval in August 2018. When sourcing eravacycline API, manufacturers should ensure compliance with current good manufacturing practices (cGMP) and verification of chemical purity, stereochemical integrity, and absence of toxic impurities, due to its synthetic complexity and critical therapeutic use in resistant bacterial infections.
Identification & chemistry
| Generic name | Eravacycline |
|---|---|
| Molecule type | Small molecule |
| CAS | 1207283-85-9 |
| UNII | 07896928ZC |
| DrugBank ID | DB12329 |
Pharmacology
| Summary | Eravacycline is a fluorocycline antibacterial that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, specifically targeting the ribosomal protein S4. It exhibits bacteriostatic activity against gram-positive organisms and bactericidal effects against certain gram-negative strains. The drug is indicated for the treatment of complicated intra-abdominal infections. |
|---|---|
| Mechanism of action | Eravacycline is a fluorocycline antibacterial of the tetracycline class of antibacterial drugs. Eravacycline disrupts bacterial protein synthesis by binding to the 30S ribosomal subunit, preventing the incorporation of amino acid residues into elongating peptide chains. In general, eravacycline is bacteriostatic against gram-positive bacteria (e.g., Staphylococcus aureus and Enterococcus faecalis); however, in vitro bactericidal activity has been shown against certain strains of Escherichia coli and Klebsiella pneumoniae. |
| Pharmacodynamics | Eravacycline is an antibiotic that disrupts bacterial protein synthesis, treating complicated intraabdominal infections. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 30S ribosomal protein S4 | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Following single-dose intravenous administration, eravacycline AUC (area under the curve) and Cmax (maximum concentration) increase dose-proportionally for doses from 1 mg/kg - 3 mg/kg (3 times the approved dose). There is approximately 45% accumulation following intravenous dosing of 1 mg/kg every 12 hours. |
|---|---|
| Half-life | The mean elimination half-life is 20 hours. |
| Protein binding | Protein binding of eravacycline to human plasma proteins increases with increasing plasma concentrations, with 79% to 90% (bound) at plasma concentrations ranging from 100 to 10,000 ng/mL. |
| Metabolism | Eravacycline is metabolized primarily by CYP3A4- and FMO-mediated oxidation. |
| Route of elimination | Following a single intravenous dose of radiolabeled eravacycline 60 mg, approximately 34% of the dose is excreted in urine and 47% in feces as unchanged eravacycline (20% in urine and 17% in feces) and metabolites. |
| Volume of distribution | The volume of distribution at steady-state is approximately 321 L. |
| Clearance | 17.82 L/min (standard deviation of 3.4) . |
Formulation & handling
- Eravacycline is a small molecule tetracycline antibiotic formulated exclusively for intravenous use as an injection powder for solution.
- The API exhibits moderate water solubility and a low LogP, indicating limited lipophilicity and possible stability considerations during formulation.
- Co-administration with CYP3A inducers such as St. John's Wort should be avoided due to potential reduction in serum drug levels.
Regulatory status
| Lifecycle | The API is currently protected by multiple patents in the United States with expiration dates ranging from 2029 to 2037, indicating a mature market primarily in the US and EU regions. Market entry by generics is expected after the earliest patent expiry in 2029. |
|---|
| Markets | US, EU |
|---|
Supply Chain
| Supply chain summary | Eravacycline is currently marketed primarily in the US and EU regions under the brand name Xerava, indicating a singular originator company presence in these markets. Multiple active patents in the United States extend protection until 2037, suggesting limited generic competition at present. The existing patent landscape supports continued branded product exclusivity across its key markets. |
|---|
Safety
| Toxicity | The most common adverse reactions (incidence ≥ 3%) are infusion site reactions, nausea, and vomiting. Less common (incidence ≥ 1%) adverse effects are palpitations, chest pain, acute pancreatitis, pancreatic necrosis, hypocalcemia, dizziness, dysgeusia, anxiety, insomnia, depression, pleural effusion, dyspnea, rash and hyperhidrosis. The following are various side effects that may occur due to eravacycline use: **Hypersensitivity:** Life-threatening anaphylaxis has been reported with the administration of eravacycline. Antibacterial drugs and should be avoided in patients with known hypersensitivity to tetracycline-class antibacterial drugs. **Tooth Discoloration/enamel hypoplasia**: The use of this drug during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may lead to the permanent discoloration of teeth (yellow-grey-brown). **Inhibition of bone growth:** The use of eravacycline during the second and third trimester of pregnancy, infancy and childhood until the age of 8 years old may cause reversible inhibition of bone growth. All tetracyclines form a stable calcium complex in bone-forming tissue. **Clostridium difficile-Associated diarrhea:** Clostridium difficile associated diarrhea (CDAD) has been reported with use of the majority of antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents changes the normal flora of the colon, leading to an overgrowth of C. difficile. **Tetracycline class adverse reactions:** This drug is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial agents, and may occur with eravacycline. Discontinue eravacycline if any of these adverse reactions are suspected or observed. **Potential for microbial overgrowth:** The use of eravacycline may result in overgrowth of non-susceptible organisms, including fungi. If such infections occur, discontinue eravacycline and manage with appropriate therapy. **Development of drug-resistant bacteria:** Prescribing eravacycline in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. |
|---|
High Level Warnings:
- Handle with care due to the potential for hypersensitivity reactions, including life-threatening anaphylaxis, especially in individuals with known tetracycline-class allergies
- May cause discoloration of developing teeth and reversible inhibition of bone growth
- Exposure during tooth and bone development stages requires precaution
Eravacycline 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.
