Filgotinib Maleate

Filgotinib Maleate is a pivotal active pharmaceutical ingredient (API) and pharmaceutical intermediate in the treatment of moderate to severe rheumatoid arthritis, and has been extensively investigated in clinical trials for ulcerative colitis and Crohn's disease . As a JAK1-selective inhibitor, Filgotinib Maleate interferes with the phosphorylation of JAK1 and subsequent STAT-dependent signaling, preventing the cytokine-mediated inflammation and immune cell activation that drives autoimmune pathology . In pharmaceutical formulations, Filgotinib Maleate is the preferred salt form due to its enhanced solubility, crystallinity, and stability characteristics compared to the free base . In quality control and regulatory contexts, Filgotinib Maleate and its related substances serve as essential reference standards for analytical method development, impurity profiling, forced degradation studies, and Abbreviated New Drug Application (ANDA) filings. The selective JAK1 inhibition profile of Filgotinib Maleate continues to be a benchmark in medicinal chemistry programs targeting next-generation JAK inhibitors with improved selectivity and safety profiles.

 Product Parameters

Why Cosperpharm?

When your JAK inhibitor development program, API manufacturing campaign, or regulatory filing requires a reliable supply of Filgotinib Maleate, Cosperpharm delivers with the analytical rigor, documentation depth, and supply chain flexibility that pharmaceutical customers demand.

Salt form consistency starts here. The maleate salt form of Filgotinib Maleate — with its enhanced solubility and crystallinity — is essential for consistent drug product performance . Our analytical release protocol includes HPLC purity verification (≥98.0%), residual solvent analysis, water content determination (Karl Fischer), and identity confirmation by LC-MS. Because your final formulation quality depends on the integrity of this salt form.

Documentation that supports regulatory submission. Every API-grade shipment includes a Certificate of Analysis (COA) with batch-specific HPLC purity, chromatographic traceability, and residual solvent data — structured for direct insertion into your method validation package. Stability summaries, DMF-ready documentation, and custom quality agreements are available upon request.

Flexible supply across all development stages. Cosperpharm supplies Filgotinib Maleate across the full range of applications — from 1g–50g reference standard quantities for QC impurity profiling and analytical method development, to 100g–500g batches for process validation and pilot production, to kilogram-scale batches for commercial manufacturing. R&D samples ship within 5–7 business days; bulk orders ship within 2–3 weeks.

Technical support for the full synthetic cascade. Our process chemistry team can advise on salt formation optimization, polymorph control, and impurity mapping — because we have worked extensively with this triazolopyridine scaffold across multiple manufacturing campaigns.

Global reach with transparent pricing. Cosperpharm ships to pharmaceutical manufacturers, CROs, and analytical laboratories worldwide, with full customs documentation included. Volume discounts apply at kilogram scales, and we communicate lead times upfront — no hidden fees, no unexpected delays.

Product Advantages

 Clinically Validated JAK1-Selective Mechanism

Filgotinib Maleate demonstrates exceptional selectivity for JAK1 over JAK2, JAK3, and TYK2, with IC₅₀ values of 10 nM, 28 nM, 810 nM, and 116 nM, respectively . This selectivity translates to a differentiated safety profile by avoiding JAK2-mediated hematological side effects while maintaining robust anti-inflammatory efficacy .

 Approved Indications with Broad Clinical Investigation

Filgotinib Maleate is recognized for its application in treating moderate to severe rheumatoid arthritis, ulcerative colitis, and Crohn's disease . The drug has demonstrated efficacy in reducing disease activity in patients with inflammatory conditions .

 Enhanced Salt Form for Pharmaceutical Formulation

The maleate salt form of Filgotinib Maleate offers three critical advantages: enhanced aqueous solubility for improved bioavailability; superior crystallinity for consistent manufacturing; and long-term storage stability when stored under recommended conditions .

 Favorable Pharmacokinetic Profile

Filgotinib Maleate is administered orally, offering a convenient alternative to injectable biologics commonly used in autoimmune disease management . Its mechanism of action involves blocking STAT protein phosphorylation, reducing inflammation and immune cell activity .

 Dual-Use: API and Impurity Reference Standard

Cosperpharm supplies Filgotinib Maleate at two quality levels: API-grade (≥98% HPLC) for pharmaceutical manufacturing; and reference standard grade with full characterization data for analytical method validation, impurity profiling, and ANDA filing.

Storage Conditions

Store Filgotinib Maleate in a tightly sealed container at –20°C for long-term storage (up to 3 years) or at 2–8°C for short-term storage . Keep the container dry, protected from light, and stored in a clean, well-ventilated area away from strong oxidizing agents, strong bases, and sources of ignition. For solutions, store at –80°C for up to 1 year . Allow the sealed container to reach ambient temperature before opening to minimize moisture condensation.

Shelf life: 3 years when stored at –20°C as powder; 2 years when stored at 4°C. Stability summaries are available upon request to support regulatory filings.

Handling precautions: Use only in a fume hood. Wear chemical-resistant gloves, safety goggles, and a lab coat. Avoid generating dust or aerosols. Do not eat, drink, or smoke in work areas. After handling, wash hands thoroughly. Refer to the Safety Data Sheet (SDS) for complete safety information.

Contact Us

Securing a reliable Filgotinib Maleate supply partner for API manufacturing, reference standard needs, or drug development should be straightforward — and with Cosperpharm, it is. We combine scientific rigor, regulatory expertise, and supply chain reliability to deliver the quality you need, when you need it. Contact our customer service team today to discuss your requirements, request a quotation, or schedule a technical consultation.