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Understanding the next-generation lipophilic pancreatic lipase inhibitor engineered for metabolic disease therapy with enhanced gastrointestinal tolerability.
Cetilistat (CAS 282526-98-1) operates locally within the lumen of the stomach and small intestine by covalently binding to the active serine site of gastric and pancreatic lipases. This blocks the hydrolysis of dietary triglycerides into absorbable free fatty acids and monoglycerides, resulting in an unabsorbed fat excretion rate of approximately 30%.
Unlike classical beta-lactone inhibitors like Orlistat, Cetilistat features a unique benzoxazinone core structure (2-(hexadecyloxy)-6-methyl-4H-3,1-benzoxazin-4-one). This molecular modification drastically minimizes adverse gastrointestinal events such as steatorrhea, oily spotting, and fecal urgency, significantly enhancing patient compliance during long-term anti-obesity regimens.
Pharmacokinetic evaluations demonstrate that systemic absorption of Cetilistat is minimal to negligible. The parent molecule acts locally without entering peripheral circulation, preventing central nervous system toxicity or hepatic overload, establishing it as a exceptionally safe oral small-molecule API for metabolic health formulations.
| Chemical Property / Parameter | Cetilistat Specifications (Gentolex Standard) | Comparative Benchmark (Orlistat API) | Analytical Advantage |
|---|---|---|---|
| CAS Registry Number | 282526-98-1 | 96827-07-5 | Distinct Benzoxazinone Class |
| Chemical Structure | 2-(hexadecyloxy)-6-methyl-4H-3,1-benzoxazin-4-one | N-Formyl-L-leucine ester | Higher Hydrophobic Lipase Affinity |
| Purity (HPLC) | ≥ 99.5% | ≥ 98.0% | Ultra-Low Impurity Profile |
| Melting Point Range | 72.0°C – 76.0°C | 43.0°C – 45.0°C | Higher Thermal Stability during Formulation |
| Heavy Metals Content | ≤ 5 ppm | ≤ 10 ppm | Exceeds EP / USP Standard Requirements |
| GI Adverse Event Incidence | Significantly Reduced (< 15%) | Moderate to High (> 40%) | Higher Patient Adherence & Satisfaction |
Strategic analysis of global procurement trends, enterprise demands, and the positioning of Cetilistat alongside GLP-1 peptide therapeutics.
While GLP-1 receptor agonists (such as Tirzepatide and Semaglutide) dominate weight management headline news, oral pancreatic lipase inhibitors remain essential. Cetilistat serves as an ideal combination API or step-down oral maintenance drug, capturing dietary lipids directly without requiring subcutaneous injection or metabolic central signalling adaptation.
Global pharmaceutical brand owners and generic drug developers prioritize supply continuity, complete regulatory audit trails, and consistent batch-to-batch polymorphic stability. Key procurement criteria focus on validating continuous-flow synthesis scalability and non-infringing chemistry routes to safeguard international commercial launch strategies.
Leading buyers require fully structured Drug Master Files (DMF), Certificates of Analysis (CoA) with validated chromatographic purity reports, residual solvent testing (ICH Q3C), and elemental impurity analyses (ICH Q3D) to expedite registration in North America, Europe, Latin America, and Southeast Asia.
Empowering global supply chains through an automated 250,000 square meter standardized production footprint, continuous flow synthesis, and green chemistry systems.
Gentolex's massive production campus operates under rigorous international cGMP standards. Equipped with state-of-the-art reaction vessels from 50L pilot scale to 10,000L commercial reactors, we deliver seamless throughput from research batches to metric-ton scale API orders.
Our Industry 4.0 smart factory implements automated DCS (Distributed Control Systems) and SCADA platforms. Real-time control of temperature, pressure, stoichiometric dosing, and crystallization parameters ensures unparalleled chemical reproducibility and zero batch-loss operational security.
Through solvent recycling units, catalytic synthesis optimizations, and automated zero-discharge wastewater management systems, Gentolex sets the standard for environmentally responsible chemical manufacturing while maintaining maximum cost-competitiveness.
From raw API supply to finished dosage form (FDF) licensing and turn-key chemical engineering support.
We provide full CTD/eCTD dossier licensing out for finished dosage forms (FDF) including hard gel capsules, film-coated tablets, and lipophilic drug delivery matrices, reducing time-to-market for regional pharmaceutical brand owners.
Beyond small molecule lipase inhibitors like Cetilistat, Gentolex specializes in custom peptide synthesis, solid-phase peptide synthesis (SPPS), liquid-phase peptide synthesis (LPPS), and hybrid chemical conjugation for advanced research institutions.
Gentolex engineers deliver technical consultation and complete laboratory setup solutions. We help international clients build in-house analytical testing suites, high-performance liquid chromatography (HPLC) protocols, and pilot processing lines.
Eliminate complex vendor management. Gentolex offers consolidated procurement services connecting you with certified global chemical suppliers, handling customs clearance, cold-chain logistics, and quality assurance auditing.
Gentolex's goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa. Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.
An overall factory construction area of 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions. Gentolex offers an extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Documents and Certificates are supported to customers worldwide.
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Read InsightsComprehensive clarity on sourcing Cetilistat API, quality parameters, regulatory files, and order logistics.
Cetilistat (ATL-962) utilizes a lipophilic benzoxazinone molecular scaffold rather than a beta-lactone structure. Pharmacological trials demonstrate that Cetilistat achieves equivalent enzymatic pancreatic lipase inhibition while causing significantly lower gastrointestinal adverse effects (such as oily stool, steatorrhea, and urgent evacuations). This dramatic improvement in tolerability leads to superior long-term patient compliance.
Gentolex supplies Cetilistat API with a HPLC purity standard of ≥ 99.5%. Every batch is subjected to stringent quality verification, including NMR structural validation, heavy metal limits (≤ 5 ppm), residual solvent analysis via GC-MS according to ICH Q3C, and genotoxic impurity profiling to ensure compliance with European and US Pharmacopeial guidelines.
Yes. Gentolex offers comprehensive technical consultation, custom formulation development (capsules, tablets), and FDF license-out packages complete with stable analytical methods and validation data. Our 250,000 square meter standardized plant supports pilot batches from 1 kg up to multi-ton commercial quantities.
We supply complete technical documentation packages, including Certificate of Analysis (CoA), Safety Data Sheets (SDS), Method of Analysis (MoA), Stability Data under ICH long-term and accelerated conditions, and audit-ready Drug Master File (DMF) support documentation for global health authorities.
Cetilistat API exhibits excellent solid-state stability when stored in tightly sealed, light-resistant containers at controlled room temperature or refrigerated conditions (2°C to 8°C for long-term storage). The standard validated shelf life is 24 to 36 months. We ship globally via temperature-monitored international express or specialized air freight with complete customs declaration clearance.
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