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gedatolisib + darolutamide
- Development stage
- Unknown
- Lead developer
- Celcuity
- Modality
- Small Molecules
- Administration
- Oral, Intravenous
01
Overview
Gedatolisib + darolutamide is an investigational combination therapy for **metastatic castration-resistant prostate cancer (mCRPC)**, currently being studied in clinical trials. - **Gedatolisib** is a small molecule inhibitor targeting all 4 class I PI3K isoforms and both mTOR complexes (mTORC1/2), producing a comprehensive blockade of the PI3K/AKT/mTOR ("PAM") pathway, which is implicated in cancer cell proliferation and survival[1][5][8]. - **Darolutamide** is a potent, next-generation androgen receptor (AR) antagonist that competitively inhibits androgen binding to AR, blocks nuclear translocation, and AR-mediated transcription[2][4][6]. Darolutamide has a distinct chemical structure and is approved for the treatment of prostate cancer as a single agent. The combination is being assessed to improve antitumor efficacy in mCRPC after resistance develops to AR signaling inhibitors, based on preclinical evidence that the PAM pathway and AR signaling have critical interplay in prostate cancer progression[1][7].
- Other names
- gedatolisib plus darolutamidegedatolisib/darolutamide
02
Targets
PIK3CG (Phosphatidylinositol 4,5-bisphosphate 3-kinase gamma)mTOR (Mammalian target of rapamycin kinase)AR (Adrenergic receptors)PIK3CB (Phosphatidylinositol 3-kinase beta subunit)PIK3CD (Phosphatidylinositol 3-kinase delta)PIK3CA (Phosphoinositide 3-kinase alpha)
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