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Celcuity (CELC)
NASDAQ:CELC
Arm A: Gedatolisib + Palbociclib Or Ribociclib + Fulvestrant, Arm B: Palbociclib Or Ribociclib + Fulvestrant
Breast Cancer
Phase III
Recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
Dec 24, 2024
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Darolutamide, Gedatolisib
Prostate Cancer, Prostatic Neoplasms, Castration-Resistant, Mcrpc (Metastatic Castration-Resistant Prostate Cancer), Genital Diseases, Male, Urogenital Diseases, Male, Prostatic Disease
Phase I/II
Recruiting
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
Dec 13, 2023
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Fulvestrant, Palbociclib, Alpelisib, Gedatolisib
Breast Cancer
Phase III
Recruiting
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)
Aug 12, 2022
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Celcuity (CELC) have in its pipeline
CELC is currently developing the following drugs: Arm A: Gedatolisib + Palbociclib Or Ribociclib + Fulvestrant, Arm B: Palbociclib Or Ribociclib + Fulvestrant, Darolutamide, Gedatolisib, Fulvestrant, Palbociclib, Alpelisib, Gedatolisib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.