Ficonalkib (CAS 2233574-95-1) is a potent, selective, third-generation inhibitor of anaplastic lymphoma kinase (ALK), a receptor tyrosine kinase implicated in various malignancies, particularly non-small cell lung cancer (NSCLC). The molecular structure of Ficonalkib (SY-3505) features a pyrrolo[2,3-d]pyrimidine core with a dimethylaminopiperidinyl substituent and a propan-2-ylsulfonylphenyl group.
Ficonalkib is a potent antineoplastic agent that inhibits the anaplastic lymphoma kinase (ALK) tyrosine kinase receptor, used as an anticancer agent in the treatment of ALK-driven malignancies. As an orally bioavailable, third-generation inhibitor of ALK, Ficonalkib demonstrates IC₅₀ values of 1.3 nM and 1.5 nM for wild-type ALK and the F1174L mutant, respectively. Ficonalkib binds to and inhibits ALK wild-type tyrosine kinase and numerous ALK mutations, including acquired resistance mutations, leading to the disruption of ALK-mediated signaling and the inhibition of cell growth in ALK-expressing tumor cells. Ficonalkib belongs to the third generation of ALK inhibitors, designed to overcome resistance mechanisms that limit the efficacy of earlier-generation ALK inhibitors such as crizotinib, ceritinib, and alectinib. With its high kinase selectivity profile, Ficonalkib represents a promising therapeutic option for patients with ALK-positive NSCLC who have progressed on prior ALK inhibitor therapies.
Product Parameters
Parameter
Specification
Product Name
Ficonalkib
CAS Number
2233574-95-1
Molecular Formula
C₂₉H₃₉N₇O₃S
Molecular Weight
565.73 g/mol
Appearance
Light yellow to brown solid
Boiling Point
781.1±70.0℃
Density
1.32±0.1 g/cm3
Storage Condition
−20 °C
Product Advantages
Potent Third-Generation ALK Inhibitor
Ficonalkib is a potent, selective, third-generation ALK inhibitor with IC₅₀ values of 1.3 nM for wild-type ALK and 1.5 nM for the F1174L mutant. This exceptional potency makes Ficonalkib a leading candidate for ALK-positive NSCLC and other ALK-driven malignancies.
Broad Coverage of ALK Resistance Mutations
Ficonalkib binds to and inhibits ALK wild-type tyrosine kinase and numerous ALK mutations, including acquired resistance mutations. This broad coverage makes Ficonalkib effective in patients who have progressed on earlier-generation ALK inhibitors.
High Kinase Selectivity
Ficonalkib exhibits high kinase selectivity and has very weak inhibition on tropomyosin receptor kinase (TRK) family members (TRKA-C). This selectivity profile suggests a favorable safety and tolerability profile compared to less selective ALK inhibitors.
Orally Bioavailable
Ficonalkib is orally bioavailable, supporting convenient oral dosing in clinical applications. This pharmacokinetic property is critical for patient adherence and chronic dosing in oncology indications.
Advanced Pyrrolopyrimidine Scaffold
The pyrrolo[2,3-d]pyrimidine core of Ficonalkib represents a sophisticated class of kinase inhibitors. The compound's complex architecture requires advanced synthetic capabilities—expertise that Cosperpharm brings to every batch.
Product Quality Assurance
Cosperpharm has established a comprehensive quality assurance system for Ficonalkib that meets the rigorous expectations of both research compound manufacturing and reference standard applications:
Thorough analytical characterization. Each batch undergoes multi-technique analytical release testing: HPLC purity (≥98%), appearance verification (light yellow to brown solid powder), water content determination (Karl Fischer), residual solvent analysis (GC), and where applicable, ¹H NMR and MS confirmation of molecular identity.
Full batch traceability with retention samples. From raw material procurement through synthesis, purification, drying, and final packaging, every step is fully documented and traceable. Each batch receives a unique lot number with sufficient retention samples maintained in accordance with Cosperpharm quality procedures.
Stability monitoring program. Cosperpharm conducts ongoing stability studies under recommended storage conditions: long-term storage at −20 °C, with accelerated stability studies conducted on representative batches. Stability summaries are updated regularly, with full data packages available to support customer regulatory submissions. Shelf life: 3 years at −20 °C; 2 years at 4 °C.
Documentation ready for regulatory submission. Every shipment includes a Certificate of Analysis (COA) with batch-specific purity and characterization data, a Material Safety Data Sheet (SDS), and customs documentation for international delivery. Custom quality agreements and additional documentation are available upon request.
Customer-initiated quality audits. Qualified customers are welcome to audit Cosperpharm's manufacturing, quality control, and documentation facilities. Please contact our regulatory team to schedule an audit.
FAQ
Q1: What is Ficonalkib?
A: Ficonalkib (CAS 2233574-95-1, SY-3505) is a potent, selective, third-generation inhibitor of anaplastic lymphoma kinase (ALK), a receptor tyrosine kinase implicated in various malignancies, particularly non-small cell lung cancer (NSCLC).
Q2: What is the mechanism of action of Ficonalkib?
A: Ficonalkib binds to and inhibits ALK wild-type tyrosine kinase and numerous ALK mutations, including acquired resistance mutations. This inhibition disrupts ALK-mediated signaling and inhibits cell growth in ALK-expressing tumor cells.
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