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Cogent Biosciences (COGT)
NASDAQ:COGT
Cgt4859
Advanced Solid Tumors, Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma (Icc), Other Solid Tumors, Adult, Fgfr2 Gene Fusion/Rearrangement, Fgfr2 Gene Amplification, Fgfr2 Gene Short Variants, Fgfr3 Gene Fusion/Rearrangement, Fgfr3 Gene Amplification, Fgfr3 Gene Short Variants, Fgfr2 Genetic Alterations, Fgfr3 Genetic Alterations
Phase I/II
Recruiting
A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors
Jan 09, 2025
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Midazolam, Sunitinib, Cgt9486, Cgt9486 Plus Sunitinib
Metastatic Cancer, Advanced Gastrointestinal Stromal Tumors
Phase III
Active Not Recruiting
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
Dec 23, 2021
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Bezuclastinib Tablets (Formulation A), Bezuclastinib Tablets (Formulation B)
Mastocytosis, Ssm, Mastocytosis, Indolent, Mastocytosis, Systemic, Ism, Bmm, Smoldering Systemic Mastocytosis, Bone Marrow Mastocytosis
Phase II
Active Not Recruiting
(Summit) a Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients with Indolent or Smoldering Systemic Mastocytosis
Nov 19, 2021
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Bezuclastinib
Advanced Systemic Mastocytosis (Advsm), Sm With An Associated Hematologic Neoplasm (Sm-Ahn), Mast Cell Leukemia (Mcl), Aggressive Systemic Mastocytosis (Asm)
Phase II
Recruiting
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
Jul 22, 2021
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Pexidartinib, Sunitinib, Cgt9486
Gastrointestinal Stromal Tumors
Phase I/II
Completed
CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors
Mar 19, 2015
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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 Cogent Biosciences (COGT) have in its pipeline
COGT is currently developing the following drugs: Cgt4859, Midazolam, Sunitinib, Cgt9486, Cgt9486 Plus Sunitinib, Bezuclastinib Tablets (Formulation A), Bezuclastinib Tablets (Formulation B). These drug candidates are in various stages of clinical development as the company works toward FDA approval.