gedatolisib

Gedatolisib is a **small-molecule pan-PI3K and mTORC1/2 inhibitor** originally developed by Pfizer and later licensed to Celcuity for global development and commercialization in oncology. It inhibits all class I phosphatidylinositol 3-kinase isoforms together with mTOR complex 1 and mTOR complex 2, thereby suppressing a central growth, survival, and endocrine-resistance signaling network that is frequently activated in solid tumors. Clinically, the program has been led by advanced breast cancer, where gedatolisib was studied in the Phase 3 VIKTORIA-1 trial in combination with fulvestrant with or without palbociclib for HR-positive, HER2-negative locally advanced or metastatic breast cancer after progression on CDK4/6 inhibitor-based therapy, and it has also been evaluated in metastatic castration-resistant prostate cancer and other investigator-sponsored solid tumor studies. Public company disclosures and trial materials identify an intravenous development program, and Celcuity has also publicly announced FDA approval of REVTORPYK for HR-positive, HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer.

Brand names

REVTORPYK

Other names

gedatolisib