pp-083.1 Tablets
Dossier type
EU CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Unavailable markets
China
Registered in
China
Comments
Indication: Serious infections caused by multidrug-resistant Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus species, and penicillin-resistant Streptococcus pneumoniae.
Clinical stage: Approved drug (in China/2021 for cSSTI) with additional global multicenter clinical development ongoing for sequential therapy.- Phase III development ( diabetic foot infection).
Modality: Small-molecule antibacterial.
Mechanism / Target: Inhibition of bacterial protein synthesis through binding to the 50S ribosomal subunit, consistent with oxazolidinone pharmacology.
Route / form: Oral formulation.
Differentiation: Next-generation oxazolidinone engineered to reduce hematologic and MAO-related toxicities associated with earlier agents while preserving potent activity against highly resistant Gram-positive organisms; received QIDP and Fast Track designations, priority review, and approval under a national accelerated pathway.
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.