Company profile
Celcuity Inc.
NASDAQ:CELCMedical Specialities
Drug pipeline (1)
| Asset | Stage | Revenue | Trials | Status |
|---|---|---|---|---|
| Gedatolisib | approved | — | 10 | approved |
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 ID | Phase | Status | Start | Completion | Sponsor name | Title |
|---|---|---|---|---|---|---|
| NCT02684032 | phase1 | completed | 2016-06-14 | 2022-01-19 | Celcuity Inc | A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer |
| NCT05501886 | phase3 | active_not_recruiting | 2022-12-08 | 2026-06-30 | Celcuity Inc | Gedatolisib 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) |
| NCT06190899 | phase1_2 | recruiting | 2024-01-01 | 2028-01-01 | Celcuity Inc | Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer |
| NCT06757634 | phase3 | recruiting | 2025-07-24 | 2029-03-31 | Celcuity Inc | Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) |
FDA applications (1)
| Application | Type | Applicant | Products | |||
|---|---|---|---|---|---|---|
| NDA 219908 | NDA | CELCUITY INC | ||||
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