MedPath

Celcuity

🇺🇸United States
Ownership
-
Employees
55
Market Cap
-
Website
Introduction

Celcuity, Inc. is cellular analysis company. The company discovers new cancer sub-types and commercializing diagnostic tests designed to improve the clinical outcomes of cancer patients treated with targeted therapies. Its proprietary CELx diagnostic platform is the commercially ready technology that uses a patient's living tumor cells to identify the specific abnormal cellular process driving a patient's cancer and the targeted therapy that treats it. The company was founded by Brian F. Sullivan and Lance G. Laing in January 2012 and is headquartered in Minneapolis, MN.

Clinical Trials

7

Active:0
Completed:1

Trial Phases

2 Phases

Phase 1:4
Phase 3:2

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (6 trials with phase data)• Click on a phase to view related trials

Phase 1
4 (66.7%)
Phase 3
2 (33.3%)

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

Phase 3
Recruiting
Conditions
Breast Cancer
First Posted Date
2025-01-03
Last Posted Date
2025-06-18
Lead Sponsor
Celcuity Inc
Target Recruit Count
674
Registration Number
NCT06757634
Locations
🇺🇸

Providence Medical Foundation, Fullerton, California, United States

🇺🇸

UCLA Hematology Oncology Ventura, Los Angeles, California, United States

🇺🇸

The University of Kansas Cancer Center, Westwood, Kansas, United States

and more 184 locations

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Phase 1
Recruiting
Conditions
mCRPC (Metastatic Castration-resistant Prostate Cancer)
Genital Diseases, Male
Prostatic Disease
Prostatic Neoplasms, Castration-Resistant
Urogenital Diseases, Male
Prostate Cancer
Interventions
First Posted Date
2024-01-05
Last Posted Date
2025-03-21
Lead Sponsor
Celcuity Inc
Target Recruit Count
54
Registration Number
NCT06190899
Locations
🇺🇸

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

🇫🇷

Centre Jean Perrin, Clermont-Ferrand, France

🇫🇷

Institut Paoli-Calmettes, Marseille, France

and more 10 locations

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)

Phase 3
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2022-08-16
Last Posted Date
2025-06-24
Lead Sponsor
Celcuity Inc
Target Recruit Count
701
Registration Number
NCT05501886
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

Arizona Oncology (US Oncology/McKesson) - Goodyear, Goodyear, Arizona, United States

🇺🇸

St. Bernards Medical Center, Jonesboro, Arkansas, United States

and more 214 locations

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Conditions
Breast Neoplasm Malignant Female
First Posted Date
2021-11-26
Last Posted Date
2025-03-21
Lead Sponsor
Celcuity Inc
Registration Number
NCT05134922
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

and more 2 locations

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

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2016-02-17
Last Posted Date
2022-07-27
Lead Sponsor
Celcuity Inc
Target Recruit Count
141
Registration Number
NCT02684032
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

🇺🇸

Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc., Riverside, California, United States

🇺🇸

Keck Hospital of USC - Norris Healthcare Center (HC3), Los Angeles, California, United States

and more 33 locations

News

Celcuity's Gedatolisib Shows Promising Results in Prostate and Breast Cancer Trials

Celcuity reported a 66% six-month radiographic progression-free survival rate for gedatolisib plus darolutamide in metastatic castration-resistant prostate cancer patients.

Gedatolisib Shows Promising 77-Month Overall Survival in Advanced Breast Cancer Phase 1b Trial

Phase 1b trial demonstrates gedatolisib combination therapy achieved 77.3 months median overall survival in treatment-naïve HR+/HER2- advanced breast cancer patients.

Celcuity's Gedatolisib Projected to Reach $155M Annual Revenue by 2034 for Breast Cancer Treatment

Gedatolisib, a dual PI3K/mTOR inhibitor developed by Celcuity, shows promising market potential with projected annual revenue of $155 million by 2034 in the US market.

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