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pp-082

Tablets

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Non-tuberculous mycobacterial (NTM) infections, a group of chronic, treatment-refractory pulmonary and systemic infections requiring prolonged multidrug therapy. Clinical stage: Phase 1 clinical trial completed in Australia in 2024. Modality: Small-molecule antibacterial (novel boron-based compound). Mechanism / Target: Boron-containing pharmacophore engineered to inhibit essential bacterial metabolic pathways involved in growth and persistence of NTM species. Route / form: Oral formulation Differentiation: Represents a new chemical class within antimycobacterial drug development; designed to improve potency, safety, and resistance profile compared with existing multi-drug NTM regimens; addresses a significant unmet need for more effective and tolerable therapies.
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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