Company profile
CELCUITY INC.
NASDAQ:CELCMedical Specialities
Drug pipeline (1)
| Asset | Stage | Revenue | Trials | Status |
|---|---|---|---|---|
| REVTORPYK | approved | — | 10 | approved |
Revenue is the latest quarter the company reported for that product, from SEC filings; a fourth quarter is the year less nine months when no filing states one. Trial counts are of the product's ingredients, deduplicated by trial, so products sharing an ingredient share trials.
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 | Approved | Type | Applicant | Products | ||||
|---|---|---|---|---|---|---|---|---|
| NDA 219908 | 2026-07-14 | NDA | CELCUITY INC | |||||
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