Overview
Chidamide is a benzamide-class histone deacetylase (HDAC) inhibitor developed by Shenzhen Chipscreen Biosciences. It received approval from China's NMPA in 2014 as the world's first oral subtype-selective HDAC inhibitor for treating peripheral T-cell lymphoma (PTCL). The drug selectively targets Class I HDACs (HDAC1, 2, 3) and Class IIb (HDAC10), modulating gene expression without the severe side effects of pan-HDAC inhibitors. As a breakthrough in epigenetic therapy, Chidamide represents China's innovative contributions to global oncology drug development. Its mechanism involves restoring normal histone acetylation patterns to reactivate tumor suppressor genes, inducing cell cycle arrest and apoptosis in malignant cells.
Physical and Chemical Properties
Chidamide appears as a white to off-white crystalline powder with a molecular weight of 390.41 g/mol. The compound shows stability under recommended storage conditions (2-8°C) but may degrade when exposed to moisture or light. Its solubility profile favors organic solvents like DMSO, with limited solubility in aqueous solutions—a characteristic that influences formulation strategies. The drug's chemical structure features a fluorinated aromatic ring system that contributes to its selective binding to HDAC isoforms. The melting point of approximately 200-202°C indicates high purity requirements for pharmaceutical use. Analytical methods for quality control typically employ HPLC with UV detection at 260nm.
Main Applications
The primary clinical application of Chidamide is the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL), particularly angioimmunoblastic T-cell lymphoma and PTCL-not otherwise specified. It is administered orally at 30mg twice weekly, showing response rates of 28-40% in pivotal trials. Emerging research explores its potential in combination therapies for other hematological malignancies (e.g., acute myeloid leukemia) and solid tumors. The drug's epigenetic modulation effects are being investigated for overcoming drug resistance in various cancers. Off-label uses in autoimmune diseases are under preclinical evaluation due to HDACs' role in immune regulation.
Safety and Storage
Chidamide requires careful handling as a potent bioactive compound. Standard precautions include using nitrile gloves, safety goggles, and respiratory protection when handling powder formulations. The drug is classified as hazardous if swallowed, with potential side effects including thrombocytopenia, leukopenia, and gastrointestinal disturbances in clinical use. Storage must maintain the product at 2-8°C in original packaging to prevent degradation. Bulk pharmaceutical material should be kept under nitrogen atmosphere when possible. Stability studies indicate a shelf life of 24 months when properly stored, though reconstituted solutions should be used immediately.
B2B Procurement Guide
Bulk procurement of Chidamide requires verification of Good Manufacturing Practice (GMP) certification from suppliers, particularly for active pharmaceutical ingredient (API) sourcing. Key due diligence points include analytical certificates (COA), impurity profiles (<0.5% for any single unknown impurity), and residual solvent testing. International buyers should account for cold chain logistics costs (2-8°C transport) and customs clearance time for controlled substances. MOQs typically start at 100g for API, with lead times of 8-12 weeks for GMP-grade material. Preferred payment terms often involve 30% advance with letter of credit arrangements for new suppliers.
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