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pp-085

Tablets

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Advanced solid tumors and hematologic malignancies characterized by intact (wild-type) p53, including melanoma, liposarcoma, AML, MDS, and other cancers where reactivation of p53-mediated apoptosis is therapeutically relevant. Clinical stage: Phase I/II clinical development across multiple tumor types, including monotherapy and combination studies with checkpoint inhibitors and other standard treatments. Modality: Small-molecule targeted therapy Mechanism / Target: Selective MDM2–p53 interaction antagonist that releases p53 from negative regulation, restoring apoptosis and cell-cycle arrest in p53-wild-type tumors. Route / form: Oral formulation Differentiation: Designed to potentiate p53-dependent antitumor activity with improved tolerability compared with earlier MDM2 inhibitors; supports combination strategies with immunotherapy due to immune-modulating effects; broad activity across several p53-wild-type cancers with potential first-in-class or best-in-class characteristics.
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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