X
[{"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":"Small molecule","graph2":"Nabriva Therapeutics"},{"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":"Large molecule","graph2":"Nabriva Therapeutics"},{"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":"Small molecule","graph2":"Nabriva Therapeutics"},{"orgOrder":0,"company":"Inflazome","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Inzomelid completes Phase I studies and shows positive results in the treatment of Cryopyrin-Associated Periodic Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Inflazome"},{"orgOrder":0,"company":"Inflazome","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Orphan Drug Designation for Inflazome\u2019s Inzomelid for the Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"IRELAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Inflazome"},{"orgOrder":0,"company":"Prothena","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prothena Reports Positive 9 Month Results from Phase 1 Long-term Extension Study of PRX004","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Prothena"},{"orgOrder":0,"company":"Prothena","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Prothena Presents Phase 1 Study Results of PRX004 in Oral Presentation at AAN 2021","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Prothena"},{"orgOrder":0,"company":"Prothena","sponsor":"Novo Nordisk","pharmaFlowCategory":"D","amount":"$1,200.0 million","upfrontCash":"$100.0 million","newsHeadline":"Prothena and Novo Nordisk Announce Acquisition Agreement for Prothena\u2019s ATTR Amyloidosis Programme","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"IRELAND","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Prothena"}]
Find Clinical Drug Development Pipelines & Deals | PipelineProspector
Filters
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
Product Name: Xenleta
Highest Development Status: Phase I
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
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
Product Name: Xenleta
Highest Development Status: Phase I
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 11, 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
Product Name: Xenleta
Highest Development Status: Phase I
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 11, 2022
Details:
PRX004 is a phase 2 ready anti-amyloid immunotherapy designed to deplete the amyloid deposits that are associated with the disease pathology of ATTR amyloidosis.
Lead Product(s):
PRX004
Therapeutic Area: Genetic Disease
Product Name: PRX004
Highest Development Status: Phase I
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Novo Nordisk
Deal Size: $1,200.0 million
Upfront Cash: $100.0 million
Deal Type: Acquisition
July 12, 2021
Details:
In this Phase 1 study, PRX004 was found to be generally safe and well tolerated across all dose levels. Positive clinical findings suggest PRX004’s depleter mechanism of action can result in benefits in both neuropathy and cardiac function.
Lead Product(s):
PRX004
Therapeutic Area: Genetic Disease
Product Name: PRX004
Highest Development Status: Phase I
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 18, 2021
Details:
In the first report of clinical results with this depleter mechanism of action, PRX004 showed favorable results as demonstrated by slowing of neuropathy progression for all 7 evaluable patients at 9 months.
Lead Product(s):
PRX004
Therapeutic Area: Genetic Disease
Product Name: PRX004
Highest Development Status: Phase I
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 09, 2020
Details:
Inzomelid is a potent, selective, orally-available, brain-penetrant NLRP3 inflammasome inhibitor intended for treatment of debilitating inflammatory diseases.
Lead Product(s):
Inzomelid
Therapeutic Area: Genetic Disease
Product Name: Undisclosed
Highest Development Status: Phase I
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 14, 2020
Details:
The Phase I study demonstrated Inzomelid has an excellent safety, tolerability and pharmacokinetic profile in healthy subjects, with dose-dependent target engagement.
Lead Product(s):
Inzomelid
Therapeutic Area: Genetic Disease
Product Name: Undisclosed
Highest Development Status: Phase I
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 26, 2020