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pp-088

Tablets

Dossier type
EU CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Advanced solid tumors and hematologic malignancies harboring wild-type p53, including cancers in which p53 pathway reactivation may overcome therapeutic resistance. Clinical stage: Phase I clinical development, including dose-escalation studies evaluating safety, tolerability, pharmacokinetics, and preliminary antitumor activity. Modality: Small-molecule targeted therapy Mechanism / Target: Next-generation inhibitor of the MDM2–p53 protein–protein interaction designed to stabilize and reactivate p53, inducing apoptosis and cell-cycle arrest in p53-competent tumors. Route / form: Oral formulation Differentiation: Engineered to enhance p53 activation potency with an improved safety and pharmacokinetic profile compared with earlier MDM2 inhibitors; aims to broaden therapeutic applicability and support combination strategies with other anticancer agents.
Manufacturer #38620

A global, clinical-stage biopharmaceutical company discovering, developing and commercializing small-molecule therapies addressing unmet needs in hematological cancers and other serious diseases. It advances programs through international registrational trials with strategic development and partnership goals. The organization integrates R&D and global expansion efforts.
 

 

 

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