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Sivelestat | CAS No: 127373-66-4 | GMP-certified suppliers
A medication that inhibits serine proteases to potentially reduce inflammation and tissue injury in acute lung injury and adult respiratory distress syndrome.
Therapeutic categories
Product Snapshot
- Sivelestat is an injectable small molecule formulation
- It is primarily investigated for use in acute respiratory conditions related to systemic inflammation
- The product is currently in the investigational stage with no approved regulatory status in major markets
Clinical Overview
Clinically, sivelestat has been studied primarily in the context of acute lung injury (ALI) and adult respiratory distress syndrome (ARDS). These conditions involve complex inflammatory pathways that lead to respiratory failure and significant morbidity. While sivelestat's exact pharmacodynamics and mechanism of action have not been fully detailed in publicly available data, its classification as a serine protease inhibitor suggests it functions by modulating protease activity implicated in inflammation and tissue injury within the lung.
Key pharmacokinetic parameters such as absorption, distribution, metabolism, and excretion (ADME) profiles for sivelestat are not comprehensively described in existing literature. However, as an enzyme inhibitor targeting proteases, the compound’s efficacy and safety are closely related to its ability to reach sites of pulmonary inflammation at effective concentrations without causing systemic toxicity.
Safety and toxicity considerations have been evaluated in clinical trials, with particular attention to the potential for adverse effects related to protease inhibition and immune modulation. The overall tolerability profile remains under investigation, consistent with its current investigational status.
Sivelestat has been developed and studied by several pharmaceutical entities in Japan and other regions, typically within clinical trial frameworks rather than approved commercial products. It is important for API sourcing specialists to ensure material compliance with regulatory standards, particularly regarding purity, stability, and batch-to-batch consistency. Rigorous supplier qualification and adherence to Good Manufacturing Practice (GMP) guidelines are critical for successful inclusion of sivelestat in investigational pharmaceutical development programs.
Identification & chemistry
| Generic name | Sivelestat |
|---|---|
| Molecule type | Small molecule |
| CAS | 127373-66-4 |
| UNII | DWI62G0P59 |
| DrugBank ID | DB12863 |
Formulation & handling
- Sivelestat is a small molecule with low water solubility, requiring formulation strategies to enhance bioavailability for oral administration. Its moderate lipophilicity (LogP 2.42) may influence absorption and distribution profiles. Stability and handling do not indicate special sensitivity, but low solubility suggests potential challenges in solution-based formulations.
Regulatory status
Sivelestat is a type of Enzyme Replacements/modifiers
Enzyme replacements/modifiers are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) utilized in the treatment of various enzyme-related disorders. Enzymes play a vital role in the normal functioning of the body by catalyzing specific biochemical reactions. However, in certain medical conditions, the body may lack or produce dysfunctional enzymes, leading to serious health complications.
Enzyme replacement therapy (ERT) involves administering exogenous enzymes to compensate for the enzyme deficiency in patients. These enzymes are typically derived from natural sources or produced using recombinant DNA technology. By introducing these enzymes into the body, they can effectively substitute the missing or defective enzymes, thereby restoring normal metabolic processes.
On the other hand, enzyme modifiers are API substances that regulate the activity of specific enzymes within the body. These modifiers can either enhance or inhibit the enzyme's function, depending on the therapeutic objective. By modulating enzyme activity, these APIs can restore the balance of enzymatic reactions, leading to improved physiological outcomes.
Enzyme replacements/modifiers have shown remarkable success in treating various genetic disorders, such as Gaucher disease, Fabry disease, and lysosomal storage disorders. Additionally, they have demonstrated potential in managing enzyme deficiencies associated with rare diseases and certain types of cancer.
The development and production of enzyme replacements/modifiers involve rigorous research, formulation optimization, and adherence to stringent quality control measures. Pharmaceutical companies invest substantial resources in developing these APIs to ensure their safety, efficacy, and compliance with regulatory standards.
Overall, enzyme replacements/modifiers represent a vital therapeutic category in modern medicine, offering hope and improved quality of life for patients with enzyme-related disorders.
Sivelestat API manufacturers & distributors
Compare qualified Sivelestat API suppliers worldwide. We currently have 1 companies offering Sivelestat API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Guangzhou Green Cross Pha... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 15 products |
When sending a request, specify which Sivelestat API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Sivelestat API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
