Company profile

Celcuity Inc.

NASDAQ:CELCMedical Specialities

Drug pipeline (1)

AssetStageRevenueTrialsStatus
Gedatolisibapproved—10approved

Revenue is the latest reported period from SEC filings. A combination product's amount appears on each of its constituent assets, so those rows are not additive.

Clinical trials (4)

NCT IDPhaseStatusStartCompletionSponsor nameTitle
NCT02684032phase1completed2016-06-142022-01-19Celcuity IncA Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer
NCT05501886phase3active_not_recruiting2022-12-082026-06-30Celcuity IncGedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
NCT06190899phase1_2recruiting2024-01-012028-01-01Celcuity IncGedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
NCT06757634phase3recruiting2025-07-242029-03-31Celcuity IncPhase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

FDA applications (1)

ApplicationTypeApplicantProducts
NDA 219908NDACELCUITY INC