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1. (4s,4as,5ar,12as)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-((pyrrolidin-1-ylacetyl)amino)-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide
2. (4s,4as,5ar,12as)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-((pyrrolidin-1-ylacetyl)amino)-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide Dihydrochloride
3. 7-fluoro-9-pyrrolidinoacetamido-6-demethyl-6-deoxytetracycline
4. Eravacycline Dihydrochloride
5. Tp-434
6. Tp-434-046
7. Tp-434046
8. Tp434
9. Xerava
1. 1207283-85-9
2. Tp-434
3. Xerava
4. Eravacycline [usan]
5. Tp434
6. (4s,4as,5ar,12ar)-4-(dimethylamino)-7-fluoro-1,10,11,12a-tetrahydroxy-3,12-dioxo-9-[(2-pyrrolidin-1-ylacetyl)amino]-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide
7. Eravacycline (usan)
8. 07896928zc
9. 1-pyrrolidineacetamide, N-((5ar,6as,7s,10as)-9-(aminocarbonyl)-7-(dimethylamino)-4-fluoro-5,5a,6,6a,7,10,10a,12-octahydro-1,8,10a,11-tetrahydroxy-10,12-dioxo-2-naphthacenyl)-
10. Eravacycline [usan:inn]
11. Unii-07896928zc
12. Yqm
13. Tp434;eravacycline
14. Eravacycline [mi]
15. Eravacycline [inn]
16. Eravacycline [who-dd]
17. Chembl1951095
18. Chembl4597183
19. Schembl10040430
20. Gtpl10805
21. Ex-a751
22. Chebi:177804
23. Dtxsid401026285
24. Mfcd31010183
25. Zinc200151468
26. Cs-7564
27. Db12329
28. Compound 17j [pmid: 2148514]
29. Hy-16980
30. D10369
31. J-690064
32. Q15410941
33. 7-fluoro-9-pyrrolidinoacetamido-6-demethyl-6-deoxytetracycline
34. (4s,4as,5ar,12ar)-4-(dimethylamino)-7-fluoro-1,10,11,12a-tetrahydroxy-3,12-dioxo-9-[2-(pyrrolidin-1-yl)acetamido]-3,4,4a,5,5a,6,12,12a-octahydrotetracene-2-carboxamide
35. (4s,4as,5ar,12ar)-4-(dimethylamino)-7-luoro-1,10,11,12a-tetrahydroxy-3,12-dioxo-9-[(2-pyrrolidin-1-ylacetyl)amino]-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide
36. (4s,4as,5ar,12as)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-((pyrrolidin-1-ylacetyl)amino)-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide
37. (4s,4as,5ar,12as)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-[(2-pyrrolidin-1-ylacetyl)amino]-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide
38. (4s,4as,5ar,12as)-4-(dimethylamino)-7-fluoro-3,10,12,12atetrahydroxy-1,11-dioxo-9-(2-(pyrrolidin-1-yl)acetamido)-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide
39. 4s,4as,5ar,12as)-4-(dimethylamino)-7-fluoro-3,10,12,12a-tetrahydroxy-1,11-dioxo-9-((pyrrolidin-1-ylacetyl)amino)-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide
40. 7-[6-(2-hydroxy-2-propanyl)-3-pyridinyl]-1-(4-methoxycyclohexyl)-3,4-dihydropyrazino[2,3-b]pyrazin-2(1h)-one
41. N-[(5ar,6as,7s,10as)-9-(aminocarbonyl)-7-(dimethylamino)-4-fluoro-5,5a,6,6a,7,10,10a,12-octahydro-1,8,10a,11-tetrahydroxy-10,12-dioxo-2-naphthacenyl]-1-pyrrolidineacetamide
Molecular Weight | 558.6 g/mol |
---|---|
Molecular Formula | C27H31FN4O8 |
XLogP3 | 1 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 5 |
Exact Mass | 558.21259212 g/mol |
Monoisotopic Mass | 558.21259212 g/mol |
Topological Polar Surface Area | 194 Ų |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 1200 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Eravacycline is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older.
FDA Label
Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Eravacycline is an antibiotic that disrupts bacterial protein synthesis, treating complicated intraabdominal infections.
J01AA
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01A - Tetracyclines
J01AA - Tetracyclines
J01AA13 - Eravacycline
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.
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).
Eravacycline is metabolized primarily by CYP3A4- and FMO-mediated oxidation.
The mean elimination half-life is 20 hours.
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.
Details:
Xerava (eravacycline) is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive, gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates.
Lead Product(s): Eravacycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xerava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 27, 2023
Lead Product(s) : Eravacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Everest Medicines Announces Approval of XERAVA® in Taiwan for the Treatment of Complicated Intra-...
Details : Xerava (eravacycline) is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive, gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates.
Product Name : Xerava
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 27, 2023
Details:
XERAVA® (eravacycline) is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive, gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates.
Lead Product(s): Eravacycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xerava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 27, 2023
Lead Product(s) : Eravacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Everest Medicines Announces Commercial Launch and First Prescription for XERAVA in China
Details : XERAVA® (eravacycline) is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive, gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates.
Product Name : Xerava
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 27, 2023
Details:
Under the partnership, Everest and SPH Kyuan will work closely to promote import and channel distribution of XERAVA (eravacycline), a novel, fully synthetic, fluorocycline intravenous antibiotic, in China.
Lead Product(s): Eravacycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xerava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Everest Medicines
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership April 18, 2023
Lead Product(s) : Eravacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Everest Medicines
Deal Size : Undisclosed
Deal Type : Partnership
Details : Under the partnership, Everest and SPH Kyuan will work closely to promote import and channel distribution of XERAVA (eravacycline), a novel, fully synthetic, fluorocycline intravenous antibiotic, in China.
Product Name : Xerava
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
April 18, 2023
Details:
Xerava (eravacycline) is bacteriostatic which disrupts bacterial protein synthesis by binding to the 30S ribosomal subunit thus preventing the incorporation of amino acid residues into elongating peptide chains.
Lead Product(s): Eravacycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xerava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 16, 2023
Lead Product(s) : Eravacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Xerava (eravacycline) is bacteriostatic which disrupts bacterial protein synthesis by binding to the 30S ribosomal subunit thus preventing the incorporation of amino acid residues into elongating peptide chains.
Product Name : Xerava
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 16, 2023
Details:
Xerava™ (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug resistance.
Lead Product(s): Eravacycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xerava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: TTY BIOPHARM CO LTD
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 08, 2022
Lead Product(s) : Eravacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : TTY BIOPHARM CO LTD
Deal Size : Undisclosed
Deal Type : Partnership
Everest Medicines Announces Regulatory Update and Strategic Partnership for Xerava in Taiwan
Details : Xerava™ (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug res...
Product Name : Xerava
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
November 08, 2022
Details:
XERAVA® (eravacycline) for injection is approved by the U.S. Food and Drug Administration (FDA) as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older.
Lead Product(s): Eravacycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xerava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 14, 2022
Lead Product(s) : Eravacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : XERAVA® (eravacycline) for injection is approved by the U.S. Food and Drug Administration (FDA) as a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older.
Product Name : Xerava
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 14, 2022
Details:
XERAVA® (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired MDR and are prevalent in China.
Lead Product(s): Eravacycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xerava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 10, 2022
Lead Product(s) : Eravacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Everest Medicines Announces Approval of XERAVA® in Hong Kong for the Treatment of Complicated Int...
Details : XERAVA® (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired MDR and are pr...
Product Name : Xerava
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 10, 2022
Details:
Xerava (eravacycline) is a novel, fully synthetic, broad-spectrum parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug resistance (MDR) and are prevalent in China.
Lead Product(s): Eravacycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xerava
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 08, 2021
Lead Product(s) : Eravacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Xerava (eravacycline) is a novel, fully synthetic, broad-spectrum parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug resistance (MDR) and a...
Product Name : Xerava
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 08, 2021
Details:
In vitro experiments confirmed inhibition of the protease with an IC50 in the low micromolar range. Eravacycline inhibits the infection of SARS-CoV-2 in VeroE6 cells and shows no toxicity when applied alone.
Lead Product(s): Eravacycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: TP-434
Study Phase: PreclinicalProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 19, 2020
Lead Product(s) : Eravacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : In vitro experiments confirmed inhibition of the protease with an IC50 in the low micromolar range. Eravacycline inhibits the infection of SARS-CoV-2 in VeroE6 cells and shows no toxicity when applied alone.
Product Name : TP-434
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 19, 2020
Details:
Through this acquisition, Melinta will enhance its commercial portfolio with XERAVATM. Once the transaction closes, Melinta will have a portfolio of five complementary marketed antibiotics: VABOMERE, ORBACTIV, BAXDELA, MINOCIN for Injection, and XERAVATM.
Lead Product(s): Eravacycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xerava
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Melinta Therapeutics
Deal Size: $55.0 million Upfront Cash: $55.0 million
Deal Type: Merger September 06, 2020
Lead Product(s) : Eravacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Melinta Therapeutics
Deal Size : $55.0 million
Deal Type : Merger
Melinta Therapeutics to Acquire Tetraphase Pharmaceuticals
Details : Through this acquisition, Melinta will enhance its commercial portfolio with XERAVATM. Once the transaction closes, Melinta will have a portfolio of five complementary marketed antibiotics: VABOMERE, ORBACTIV, BAXDELA, MINOCIN for Injection, and XERAVATM...
Product Name : Xerava
Product Type : Other Small Molecule
Upfront Cash : $55.0 million
September 06, 2020
Global Sales Information
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ABOUT THIS PAGE
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PharmaCompass offers a list of Eravacycline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Eravacycline manufacturer or Eravacycline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eravacycline manufacturer or Eravacycline supplier.
PharmaCompass also assists you with knowing the Eravacycline API Price utilized in the formulation of products. Eravacycline API Price is not always fixed or binding as the Eravacycline Price is obtained through a variety of data sources. The Eravacycline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eravacycline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eravacycline, including repackagers and relabelers. The FDA regulates Eravacycline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eravacycline API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Eravacycline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eravacycline supplier is an individual or a company that provides Eravacycline active pharmaceutical ingredient (API) or Eravacycline finished formulations upon request. The Eravacycline suppliers may include Eravacycline API manufacturers, exporters, distributors and traders.
click here to find a list of Eravacycline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Eravacycline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eravacycline API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Eravacycline as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Eravacycline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eravacycline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eravacycline suppliers with NDC on PharmaCompass.
Eravacycline Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Eravacycline GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Eravacycline GMP manufacturer or Eravacycline GMP API supplier for your needs.
A Eravacycline CoA (Certificate of Analysis) is a formal document that attests to Eravacycline's compliance with Eravacycline specifications and serves as a tool for batch-level quality control.
Eravacycline CoA mostly includes findings from lab analyses of a specific batch. For each Eravacycline CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Eravacycline may be tested according to a variety of international standards, such as European Pharmacopoeia (Eravacycline EP), Eravacycline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eravacycline USP).