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1. 1350636-82-6
2. Bc-3781 Acetate
3. Acetic Acid;[(1s,2r,3s,4s,6r,7r,8r,14r)-4-ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl] 2-[(1r,2r,4r)-4-amino-2-hydroxycyclohexyl]sulfanylacetate
4. Bc-3781.ac
5. Lefamulinacetate
6. Xenleta (tn)
7. Lefamulin Acetate (xenleta)
8. Chembl3545309
9. Dtxsid801027897
10. S3496
11. At18250
12. D11632
13. Q27279882
Molecular Weight | 567.8 g/mol |
---|---|
Molecular Formula | C30H49NO7S |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 6 |
Exact Mass | 567.32297408 g/mol |
Monoisotopic Mass | 567.32297408 g/mol |
Topological Polar Surface Area | 172 Ų |
Heavy Atom Count | 39 |
Formal Charge | 0 |
Complexity | 882 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 11 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Xenleta is indicated for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
J01XX
About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...
About the Company : Glixx Laboratories Inc (Glixx) is a global leading company specializing in biological research chemicals, providing services to meet the needs of biomedical research markets. With ...
About the Company : J&H CHEM is one of China's leading providers of integrated fine chemical services including offering, research and development, Custom manufacturing business, as well as other Valu...
About the Company : Sun-shine chemical has over 1,500m² of operation premises. The R&D laboratory is more than 1,000m² and is equipped with a variety of R&D laboratory equipment. The quality control...
Details:
Meitheal secured commercial rights in the U.S. to Xenleta (lefamulin acetate) through an exclusive license agreement with its parent company. It is indicated for the CABP in adults.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xenleta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Meitheal Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement December 11, 2024
Lead Product(s) : Lefamulin Acetate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Meitheal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Meitheal Secures Licensing for XENLETA® to Expand Biopharmaceutical Portfolio
Details : Meitheal secured commercial rights in the U.S. to Xenleta (lefamulin acetate) through an exclusive license agreement with its parent company. It is indicated for the CABP in adults.
Product Name : Xenleta
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
December 11, 2024
Details:
XENLETA (lefamulin) is first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Genetic Disease Brand Name: Xenleta
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 28, 2022
Lead Product(s) : Lefamulin Acetate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Nabriva Therapeutics Announces Positive Topline Results from Phase 1 Trial of XENLETA® (lefamul...
Details : XENLETA (lefamulin) is first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required...
Product Name : Xenleta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 28, 2022
Details:
Xenleta (lefamulin) is a novel, first-in-class, IV and oral pleuromutilin antimicrobial agent that has been demonstrated to be highly potent against S. aureus, including MRSA and strains obtained from patients with CF.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Genetic Disease Brand Name: Xenleta
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 08, 2022
Lead Product(s) : Lefamulin Acetate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Nabriva Therapeutics Completes Patient Enrollment in Phase 1 Trial of XENLETA® (lefamulin) in Adu...
Details : Xenleta (lefamulin) is a novel, first-in-class, IV and oral pleuromutilin antimicrobial agent that has been demonstrated to be highly potent against S. aureus, including MRSA and strains obtained from patients with CF.
Product Name : Xenleta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 08, 2022
Details:
XENLETA has the potential to provide a well-tolerated oral and intravenous anti-MRSA treatment option with a novel mechanism for this difficult to treat patient population. We look forward to sharing the results of this study with the medical community.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Genetic Disease Brand Name: Xenleta
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 04, 2022
Lead Product(s) : Lefamulin Acetate
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : XENLETA has the potential to provide a well-tolerated oral and intravenous anti-MRSA treatment option with a novel mechanism for this difficult to treat patient population. We look forward to sharing the results of this study with the medical community.
Product Name : Xenleta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 04, 2022
Details:
Under the terms of the agreement, Er-Kim gains exclusive rights to distribute XENLETA (lefamulin) in the following countries: Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xenleta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Erkim
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 18, 2022
Lead Product(s) : Lefamulin Acetate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Erkim
Deal Size : Undisclosed
Deal Type : Agreement
Details : Under the terms of the agreement, Er-Kim gains exclusive rights to distribute XENLETA (lefamulin) in the following countries: Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia.
Product Name : Xenleta
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
July 18, 2022
Details:
Sumitomo filed NDA to market oral and IV formulations of lefamulin,first systemic pleuromutilin antibiotic for the treatment of community-acquired pneumonia in adults in mainland China.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xenleta
Study Phase: IND EnablingProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 29, 2021
Lead Product(s) : Lefamulin Acetate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lefamulin NDA Filed in Mainland China for Treatment of Community Acquired Pneumonia
Details : Sumitomo filed NDA to market oral and IV formulations of lefamulin,first systemic pleuromutilin antibiotic for the treatment of community-acquired pneumonia in adults in mainland China.
Product Name : Xenleta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 29, 2021
Details:
XENLETA® (lefamulin) is first-in-class pleuromutilin antibiotic for treatment of community-acquired bacterial pneumonia (CABP). It's in vitro activity of lefamulin against Staphylococcus aureus isolated from lower respiratory tract of children with cystic fibrosis.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Genetic Disease Brand Name: Xenleta
Study Phase: PreclinicalProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 24, 2021
Lead Product(s) : Lefamulin Acetate
Therapeutic Area : Genetic Disease
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Nabriva Therapeutics to Present Data at IDWeek 2021
Details : XENLETA® (lefamulin) is first-in-class pleuromutilin antibiotic for treatment of community-acquired bacterial pneumonia (CABP). It's in vitro activity of lefamulin against Staphylococcus aureus isolated from lower respiratory tract of children with cyst...
Product Name : Xenleta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 24, 2021
Details:
Sinovant’s multi-center, randomized, double-blind trial was designed to evaluate the safety and efficacy of intravenous (IV) to oral lefamulin compared to IV/oral moxifloxacin in 125 subjects with CABP.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xenleta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Nabriva Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 25, 2021
Lead Product(s) : Lefamulin Acetate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Nabriva Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sinovant’s multi-center, randomized, double-blind trial was designed to evaluate the safety and efficacy of intravenous (IV) to oral lefamulin compared to IV/oral moxifloxacin in 125 subjects with CABP.
Product Name : Xenleta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 25, 2021
Details:
XENLETA is the first intravenous and oral pleuromutilin approved for the systemic treatment of community acquired bacterial pneumonia (CABP) in adults, and also reduced pro-inflammatory cytokines comparable to that observed with dexamethasone.
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Xenleta
Study Phase: PreclinicalProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 10, 2021
Lead Product(s) : Lefamulin Acetate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Nabriva Publishes Data Demonstrating the Potent Anti-Inflammatory Properties of XENLETA® (Lefamul...
Details : XENLETA is the first intravenous and oral pleuromutilin approved for the systemic treatment of community acquired bacterial pneumonia (CABP) in adults, and also reduced pro-inflammatory cytokines comparable to that observed with dexamethasone.
Product Name : Xenleta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 10, 2021
Details:
Findings underscore potential of XENLETA as a first-in-class pleuromutilin antibiotic for the IV and oral treatment of CABP in adults, including older patients with comorbidities who are at risk of poor outcomes
Lead Product(s): Lefamulin Acetate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xenleta
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 13, 2020
Lead Product(s) : Lefamulin Acetate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Nabriva’s XENLETA Demonstrates High Efficacy in Patients of Advanced Age with Community-Acquired...
Details : Findings underscore potential of XENLETA as a first-in-class pleuromutilin antibiotic for the IV and oral treatment of CABP in adults, including older patients with comorbidities who are at risk of poor outcomes
Product Name : Xenleta
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 13, 2020
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PharmaCompass offers a list of Lefamulin Acetate 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 Lefamulin Acetate manufacturer or Lefamulin Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lefamulin Acetate manufacturer or Lefamulin Acetate supplier.
PharmaCompass also assists you with knowing the Lefamulin Acetate API Price utilized in the formulation of products. Lefamulin Acetate API Price is not always fixed or binding as the Lefamulin Acetate Price is obtained through a variety of data sources. The Lefamulin Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lefamulin Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lefamulin Acetate, including repackagers and relabelers. The FDA regulates Lefamulin Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lefamulin Acetate 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 Lefamulin Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lefamulin Acetate supplier is an individual or a company that provides Lefamulin Acetate active pharmaceutical ingredient (API) or Lefamulin Acetate finished formulations upon request. The Lefamulin Acetate suppliers may include Lefamulin Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Lefamulin Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
Lefamulin Acetate 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 Lefamulin Acetate 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 Lefamulin Acetate GMP manufacturer or Lefamulin Acetate GMP API supplier for your needs.
A Lefamulin Acetate CoA (Certificate of Analysis) is a formal document that attests to Lefamulin Acetate's compliance with Lefamulin Acetate specifications and serves as a tool for batch-level quality control.
Lefamulin Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Lefamulin Acetate 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.
Lefamulin Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Lefamulin Acetate EP), Lefamulin Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lefamulin Acetate USP).