pp-068.1 Tablets

Dossier type
US CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
FDA
Comments
Indication: Unresectable or metastatic gastrointestinal stromal tumors (GIST) resistant to prior TKIs, with additional evaluation in solid tumors driven by HSP90-client oncogenic pathways. Clinical stage: Marketed in Japan for late-line GIST; further global development ongoing in solid tumors and combination regimens. Modality: Small molecule (oral) Mechanism / Target: Selective HSP90 inhibitor causing degradation of oncogenic client proteins such as KIT and PDGFRA, blocking tumor growth and survival. Route / form: Oral tablets Differentiation: First-in-class HSP90 inhibitor for multi-TKI-resistant GIST; broad activity via simultaneous suppression of multiple HSP90-dependent oncogenic pathways; potential utility across diverse genetically defined tumors.
Manufacturer #38605

A research-driven pharma company developing therapies across oncology and other major diseases. It advances innovative medicines through global R&D and strategic alliances. The organization emphasizes high-quality manufacturing and patient impact.