[{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"WEP","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"WEP Clinical Partners With Nabriva Therapeutics for the Named Patient Supply of XENLETA\u00ae (lefamulin)","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"XENLETA\u00ae (lefamulin) Receives Health Canada Approval for Treatment of Community Acquired Pneumonia","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lefamulin Demonstrates Anti-Inflammatory Activity in Pre-Clinical Study","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Nabriva Therapeutics","pharmaFlowCategory":"D","amount":"$101.0 million","upfrontCash":"$5.0 million","newsHeadline":"Nabriva Therapeutics and Sinovant Sciences Restructure License Agreement for XENLETA for Community-Acquired Bacterial Pneumonia in China","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nabriva\u2019s XENLETA Demonstrates High Efficacy in Patients of Advanced Age with Community-Acquired Bacterial Pneumonia (CABP)","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Sinovant Sciences","sponsor":"Nabriva Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sinovant Sciences and Nabriva Therapeutics Announce Positive Topline Results from Phase 3 Trial of Lefamulin in Chinese Adults with CABP","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"CHINA","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Erkim","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Nabriva Therapeutics Expands XENLETA (lefamulin) Presence with Exclusive Agreement with Er-Kim Pharmaceuticals","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nabriva Therapeutics to Present Data at IDWeek 2021","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nabriva Publishes Data Demonstrating the Potent Anti-Inflammatory Properties of XENLETA\u00ae (Lefamulin)","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Preclinical","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lefamulin NDA Filed in Mainland China for Treatment of Community Acquired Pneumonia","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"IND Enabling","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"IND Enabling"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nabriva Therapeutics Announces First Patient Enrolled in Phase 1 Trial of XENLETA (lefamulin) in Adult Patients with Cystic Fibrosis","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nabriva Therapeutics Completes Patient Enrollment in Phase 1 Trial of XENLETA\u00ae (lefamulin) in Adult Patients with Cystic Fibrosis","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"IRELAND","productType":"Large molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I"},{"orgOrder":0,"company":"Nabriva Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nabriva Therapeutics Announces Positive Topline Results from Phase 1 Trial of XENLETA\u00c2\u00ae (lefamulin) in Adult Patients with Cystic Fibrosis","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"IRELAND","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I"}]
Find Clinical Drug Pipeline Developments & Deals for Lefamulin
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.
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.
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.
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.
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.
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.
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.
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.
The restructured agreement provides for additional manufacturing collaboration and regulatory support [to be provided to Sinovant by Nabriva] that is expected to help expedite the delivery of XENLETA to patients in greater China.
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