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pp-069.2

Tablets

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Japan
GMP approvals
EU GMP
Comments
Indication: Advanced or metastatic solid tumors with AKT pathway activation, including patients with germline PTEN mutations or tumors demonstrating PTEN loss or PI3K/AKT hyperactivation, particularly after exhaustion of standard therapy options. Clinical stage: Phase II development (global); ongoing precision-oncology studies focused on biomarker-selected populations. Modality: Small molecule (oral) Mechanism / Target: Selective AKT inhibitor that suppresses PI3K/AKT signaling, reducing tumor cell proliferation, survival, and metabolic activity in tumors dependent on this pathway. Route / form: Oral tablets Differentiation: Biomarker-driven, pathway-selective inhibition of AKT with potential for strong activity in PTEN-deficient and PI3K/AKT-activated tumors; offers a targeted approach where standard PI3K/AKT inhibitors show limited tolerability, aiming for a more manageable safety profile and improved precision targeting.
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.

 

 

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