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1 products found

pp-081

Injection

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Severe infections caused by multidrug-resistant Gram-negative pathogens, including carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa, Klebsiella pneumoniae, and other carbapenem-resistant Enterobacterales. Clinical stage: U.S. Phase 1 completed (2022); China Phase 1 completed (2024). Modality: Small-molecule antibacterial (novel polymyxin class). Mechanism / Target: Disruption of Gram-negative bacterial outer-membrane integrity through interaction with lipopolysaccharides, consistent with polymyxin-class activity while engineered for improved therapeutic index. Route / form: Intravenous formulation. Differentiation: Designed to overcome toxicity and efficacy limitations of legacy polymyxins; optimized to retain activity against highly drug-resistant Gram-negative organisms; backed by a national strategic new-drug development initiative;
Manufacturer #23854

A global biopharmaceutical company developing innovative antibiotics to treat drug-resistant bacterial infections. It advances multiple clinical programs targeting multidrug-resistant pathogens and unmet infectious-disease needs with strategic global development efforts. The organization emphasizes safe, effective next-generation therapies.
 

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