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CGT9486
CGT9486 is a selective tyrosine kinase inhibitor that targets FLT3, a receptor implicated in acute myeloid leukemia and other hematologic malignancies.
CGT9486 is a selective tyrosine kinase inhibitor that targets FLT3, a receptor implicated in acute myeloid leukemia and other hematologic malignancies. Used for Acute myeloid leukemia (AML) with FLT3 mutations.
At a glance
| Generic name | CGT9486 |
|---|---|
| Sponsor | Cogent Biosciences, Inc. |
| Drug class | FLT3 inhibitor |
| Target | FLT3 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
CGT9486 selectively inhibits FLT3 (Fms-like tyrosine kinase 3) signaling, which is frequently activated in acute myeloid leukemia (AML) through internal tandem duplications (ITD) or point mutations. By blocking FLT3-mediated proliferation and survival signals, the drug aims to reduce leukemic cell growth and induce apoptosis in FLT3-driven malignancies.
Approved indications
- Acute myeloid leukemia (AML) with FLT3 mutations
Common side effects
- Nausea
- Diarrhea
- Vomiting
- Fatigue
- Thrombocytopenia
Key clinical trials
- Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis
- (Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis (PHASE2)
- (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors (PHASE3)
- (Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis (PHASE2)
- CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CGT9486 CI brief — competitive landscape report
- CGT9486 updates RSS · CI watch RSS
- Cogent Biosciences, Inc. portfolio CI