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CG Oncology, Inc. (CGON)
NASDAQ:CGON
Cretostimogene Grenadenorepvec
High-Risk Non-Muscle-Invasive Bladder Cancer
Phase II
Recruiting
Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC
Aug 14, 2024
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Cretostimogene Grenadenorepvec, N-Dodecyl-B-D-Maltoside
Bladder Cancer, Urothelial Carcinoma, Non Muscle Invasive Bladder Cancer, Urologic Cancer
Phase III
Active Not Recruiting
A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT
Oct 25, 2023
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Cretostimogene Grenadenorepvec, N-Dodecyl-B-D-Maltoside
Non Muscle Invasive Bladder Cancer, High-Grade Ta/ T1 Papillary Disease Bladder Cancer
Phase III
Active Not Recruiting
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
Jun 26, 2020
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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 CG Oncology, Inc. (CGON) have in its pipeline
CGON is currently developing the following drugs: Cretostimogene Grenadenorepvec, Cretostimogene Grenadenorepvec, N-Dodecyl-B-D-Maltoside, Cretostimogene Grenadenorepvec, N-Dodecyl-B-D-Maltoside. These drug candidates are in various stages of clinical development as the company works toward FDA approval.