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Cogent Biosciences (COGT) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
Cgt6297Endometrial Cancer, Pik3ca Mutations, Advanced Solid Tumors, Adult, Hr Positive/Her-2 Negative Breast Cancer, Her2-Low Breast CancerPhase INot Yet RecruitingA Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid TumorsJan 26, 2026―
Cgt4255Non-small Cell Lung Cancer, Her2, Advanced Solid Tumor, Adult, Erbb2 Altered Breast Cancer, Erbb2 Gene Amplification, Her2 OverexpressionPhase IRecruitingA Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid TumorsDec 03, 2025
Cgt4859Advanced 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 Alterationsphase1AndPhase2RecruitingA Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid TumorsJan 09, 2025
Midazolam, Sunitinib, Cgt9486, Cgt9486 Plus SunitinibMetastatic Cancer, Advanced Gastrointestinal Stromal TumorsPhase IIIActive Not Recruiting(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal TumorsDec 23, 2021―
Bezuclastinib TabletsMastocytosis, Ssm, Mastocytosis, Indolent, Mastocytosis, Systemic, Ism, Bmm, Smoldering Systemic Mastocytosis, Bone Marrow MastocytosisPhase IIActive Not Recruiting(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic MastocytosisNov 19, 2021―
BezuclastinibAdvanced Systemic Mastocytosis (Advsm), Sm With An Associated Hematologic Neoplasm (Sm-Ahn), Mast Cell Leukemia (Mcl), Aggressive Systemic Mastocytosis (Asm)Phase IIRecruiting(Apex) Bezuclastinib in Patients With Advanced Systemic MastocytosisJul 22, 2021
Pexidartinib, Sunitinib, Cgt9486Gastrointestinal Stromal Tumorsphase1AndPhase2CompletedCGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid TumorsMar 19, 2015―

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
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, Inc. (COGT) have in its pipeline
Cogent Biosciences COGT is currently developing the following drugs: Cgt6297, Cgt4255, Cgt4859, Midazolam, Sunitinib, Cgt9486, Cgt9486 Plus Sunitinib, Bezuclastinib Tablets, Bezuclastinib, Pexidartinib, Sunitinib, Cgt9486. These drug candidates are in various stages of clinical development as the company works toward FDA approval.