Gilteritinib API (CAS No. 1254053-43-4) is a synthetic small-molecule kinase inhibitor active pharmaceutical ingredient associated with targeted oncology, acute myeloid leukemia, FLT3-mutated hematologic malignancy, and precision pharmaceutical development.
Gilteritinib is an orally active receptor tyrosine kinase inhibitor with inhibitory activity against multiple kinases, including FMS-like tyrosine kinase 3, commonly abbreviated as FLT3.
FLT3 is a receptor tyrosine kinase involved in hematopoietic cell proliferation, survival, and differentiation.
Mutations involving FLT3 are important molecular abnormalities associated with selected acute myeloid leukemia populations.
Gilteritinib inhibits FLT3 receptor signaling and cellular proliferation in cells expressing FLT3 alterations, including FLT3 internal tandem duplication mutations and selected tyrosine kinase domain mutations.
Inhibition of FLT3 signaling contributes to suppression of leukemic cell proliferation and induction of apoptosis in susceptible FLT3-mutated leukemic cells.
Gilteritinib is associated with targeted oral pharmaceutical treatment strategies for adult patients with relapsed or refractory acute myeloid leukemia containing an FLT3 mutation.
Pharmaceutical companies sourcing Gilteritinib API commonly evaluate assay, HPLC purity, related substances, process-related impurities, degradation products, residual solvents, water content, crystal form, polymorphic characteristics, particle size distribution, and batch-to-batch consistency.
Gilteritinib free base and Gilteritinib Fumarate should be treated as separate pharmaceutical material identities.
The approved oral tablet product uses Gilteritinib Fumarate and provides Gilteritinib active ingredient on a free-base equivalent basis.
Procurement, formulation, quality, and regulatory teams should confirm whether Gilteritinib free base or Gilteritinib Fumarate is required before commercial sourcing.
Swapnroop Drugs and Pharmaceuticals supplies Gilteritinib API for qualified pharmaceutical research, FLT3 inhibitor development, acute myeloid leukemia drug development, targeted oncology research, analytical requirements, generic pharmaceutical development, and regulated pharmaceutical manufacturing requirements with product-specific quality documentation, pharmaceutical-grade packaging, and reliable supply-chain coordination.
Pharmaceutical companies evaluating Gilteritinib API commonly focus on:
Impurity-profile control is an important quality consideration during Gilteritinib API qualification.
Synthesis-related impurities, degradation products, and residual solvents should be evaluated according to the approved product specification and applicable pharmaceutical quality requirements.
Solid-state and particle-size characteristics may also be important during oral solid dosage-form development.
Gilteritinib API is primarily associated with:
Gilteritinib-related pharmaceutical products are associated with targeted treatment of relapsed or refractory FLT3 mutation-positive acute myeloid leukemia in adults.
Gilteritinib represents a targeted pharmaceutical approach to FLT3-mutated acute myeloid leukemia.
FLT3 mutations may contribute to abnormal signaling pathways associated with leukemic cell proliferation and survival.
Gilteritinib inhibits FLT3 receptor signaling and proliferation in susceptible FLT3-mutated cells.
Pharmaceutical companies evaluating Gilteritinib API may review:
Product-specific API specifications should be evaluated according to the exact Gilteritinib material form, intended dosage form, formulation process, target regulatory market, and approved pharmaceutical development requirements.
Gilteritinib is a small-molecule inhibitor of multiple receptor tyrosine kinases, including FLT3.
Gilteritinib inhibits FLT3 receptor signaling.
The compound has demonstrated inhibitory activity in cells expressing FLT3 internal tandem duplication mutations.
It has also demonstrated activity in experimental systems involving selected FLT3 tyrosine kinase domain mutations.
Inhibition of FLT3 signaling suppresses proliferation of susceptible leukemic cells.
Gilteritinib can induce apoptosis in leukemic cells expressing FLT3-ITD.
The targeted kinase-inhibition mechanism supports the use of Gilteritinib-related pharmaceutical products in molecularly selected FLT3-mutated AML populations.
Gilteritinib and Gilteritinib Fumarate should be treated as separate pharmaceutical material identities for website, procurement, quality, and specification purposes.
Gilteritinib free base has CAS No. 1254053-43-4.
Its molecular formula is C29H44N8O3 and its molecular weight is approximately 552.72 g/mol.
The approved oral pharmaceutical product uses Gilteritinib Fumarate.
Gilteritinib Fumarate has the molecular formula (C29H44N8O3)2·C4H4O4 and molecular weight approximately 1221.50 g/mol.
The FDA describes Gilteritinib Fumarate as a light yellow to yellow powder or crystals that is sparingly soluble in water and very slightly soluble in anhydrous ethanol.
Each approved 40 mg Gilteritinib tablet contains Gilteritinib active ingredient as free-base equivalent corresponding to Gilteritinib Fumarate.
Procurement, formulation, quality, and regulatory teams should confirm whether Gilteritinib free base or Gilteritinib Fumarate is required before commercial sourcing.
Gilteritinib-related pharmaceutical products are associated with oral immediate-release tablet dosage forms.
Formulation-development considerations may include:
For development of Gilteritinib oral tablet products, Gilteritinib Fumarate material specifications should be separately evaluated.
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