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Gedatolisib + Darolutamide

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase 1b/3ActiveNCT06136624

Key Facts

Indication

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Phase

Phase 1b/3

Status

Active

Company

Celcuity

About Celcuity

Celcuity is a clinical-stage biotech focused on developing targeted therapies for cancers driven by the PAM pathway. Its strategic pivot from diagnostics to therapeutics is centered on the late-stage development of gedatolisib, a highly differentiated dual inhibitor. Recent Phase 3 data in HR+/HER2- advanced breast cancer suggests practice-changing potential, positioning the company for a pivotal transition to commercialization if successful.

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Therapeutic Areas

Oncology Breast Cancer Prostate Cancer

Other Metastatic Castration-Resistant Prostate Cancer (mCRPC) Drugs

Drug	Company	Phase	Status
Tomivosertib	eFFECTOR Therapeutics	Phase 2	Terminated
AB001 (²¹²Pb-NG001)	ARTBIO	Phase 1/2	Active - First patient dosed in ARTISAN trial (Jan 2026)
AB-3028	Arsenal Biosciences	IND-Enabling	Active
PRO CAR-201A	PromiCell	Phase 1	Active
PRO CAR-202	PromiCell	Preclinical	Active
FG-3246	Kyntra Bio	Phase 2	Active
PROVENGE (sipuleucel-T)	Dendreon	Approved	Active
RP12146	Rhizen Pharmaceuticals	Phase 1b	Active
Monoclonal Antibody (undisclosed)	MetaCurUm Biotech	Preclinical	Active
ModraDoc006/r	Modra Pharmaceuticals	Phase 2b	Active
SYNC-T	Syncromune	Phase 2	Active
Oncotype DX® AR-V7 Nucleus Detect™	Exact Sciences	Commercial	Active