- Raw materials
- Other substances
- Ligelizumab
Ligelizumab API Manufacturers & Suppliers
0 verified results
Commercial-scale Suppliers
Join our notification list by following this page.
Click the button below to find out more
Click the button below to switch over to the contract services area of Pharmaoffer.
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Ligelizumab | CAS No: 1322627-61-1 | GMP-certified suppliers
A medication that targets chronic spontaneous urticaria by neutralizing IgE to reduce allergic inflammation and improve symptom control through immunomodulation.
Therapeutic categories
Product Snapshot
- Ligelizumab is a monoclonal antibody formulation designed for injectable administration
- It is primarily intended for the treatment of allergic conditions such as chronic spontaneous urticaria
- The product is currently in the investigational stage and has not received regulatory approval from authorities such as the FDA or EMA
Clinical Overview
The primary clinical focus for ligelizumab is in the treatment of chronic spontaneous urticaria (CSU), an autoimmune-driven inflammatory condition characterized by recurrent hives and itching without identifiable external triggers. While the exact etiopathogenesis of CSU remains incompletely understood, autoantibodies against IgE or its high-affinity receptor FcεRI are implicated in approximately 30-40% of cases. The role of IgE in mediating immediate hypersensitivity reactions involves binding to FcεRI on effector cells such as mast cells and basophils, triggering degranulation and release of inflammatory mediators. IgE also interacts with the low-affinity receptor CD23 (FcεRII), which is involved in antigen presentation and regulation of IgE synthesis.
Ligelizumab neutralizes circulating IgE and inhibits its interaction with FcεRI, thereby reducing activation of allergic effector cells. It also partially inhibits IgE binding to CD23, which may contribute to decreased IgE production. Early clinical trials suggest that ligelizumab may offer superior efficacy compared to omalizumab for CSU, although it remains investigational without regulatory approval for commercial use.
Pharmacokinetic and ADME parameters have not been extensively detailed publicly. Safety considerations focus primarily on potential hypersensitivity reactions and immunogenicity typical of monoclonal antibody therapies. As an immunomodulatory agent, careful monitoring for infection risks and immune-related adverse events is warranted during clinical development.
From a sourcing and quality perspective, ligelizumab must be procured as a highly purified, well-characterized biological API conforming to internationally recognized standards for monoclonal antibodies. Robust manufacturing controls and adherence to Good Manufacturing Practices (GMP) are critical to ensuring batch consistency, potency, and safety for downstream formulation and clinical application.
Identification & chemistry
| Generic name | Ligelizumab |
|---|---|
| Molecule type | Biotech |
| CAS | 1322627-61-1 |
| UNII | L8LE0L691T |
| DrugBank ID | DB11856 |
Pharmacology
| Summary | Ligelizumab is a monoclonal antibody targeting immunoglobulin E (IgE) by binding to its Cε3 domain, leading to neutralization of serum IgE. By inhibiting IgE interaction with high-affinity FcεRI and low-affinity CD23 receptors, it modulates allergic effector cell activation and IgE-mediated hypersensitivity responses. This mechanism aims to reduce immune-mediated hypersensitivity through disruption of IgE-driven signaling pathways. |
|---|---|
| Mechanism of action | Immunoglobulin E (IgE) is a key driver of hypersensitivity reactions, and has thus become an attractive target in the treatment of immune-mediated hypersensitivity disorders. Immediate hypersensitivity reactions are due to IgE binding with FcεRI, which activates allergic effector cells that undergo degranulation to release vasoactive and pro-inflammatory mediators. IgE also binds to CD23/FcεRII, which appears responsible for antigen presentation, antigen transport across airway/epithelial barriers, and the regulation of IgE synthesis. Ligelizumab is a monoclonal antibody directed at IgE, binding specifically to an epitope in the IgE Cε3 domain. It neutralizes serum IgE and also appears to inhibit the production of IgE via inhibition of IgE-FcεRI binding activity and, to a lesser extent, IgE binding to CD23. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Immunoglobulin heavy constant epsilon | Humans | antibody |
Formulation & handling
- Ligelizumab is a biotech investigational drug, indicating a biologic peptide nature requiring specialized formulation techniques.
- Its administration is primarily via injection due to its peptide-based structure and probable poor oral bioavailability.
- Handling requires consideration of cold-chain storage and protection from physical agitation to maintain stability.
Regulatory status
Ligelizumab is a type of Other substances
The pharmaceutical industry encompasses a diverse range of active pharmaceutical ingredients (APIs) that are used in the production of various medications. One category of APIs is known as other substances. This category includes substances that do not fall under the conventional classifications such as antibiotics, analgesics, or antihypertensives.
Other substances in pharmaceutical APIs consist of a broad array of chemical compounds with unique properties and applications. These substances play a crucial role in the formulation and development of specialized medications, catering to specific therapeutic needs. The category encompasses various substances like excipients, solvents, stabilizers, and pH adjusters.
Excipients are inert substances that aid in the manufacturing process and enhance the stability, bioavailability, and patient acceptability of pharmaceutical formulations. Solvents are used to dissolve other ingredients and facilitate their incorporation into the final product. Stabilizers ensure the integrity and shelf life of medications by preventing degradation or chemical changes. pH adjusters help maintain the desired pH level of a formulation, which can influence the drug's efficacy and stability.
Pharmaceutical manufacturers carefully select and incorporate specific other substances into their formulations, adhering to regulatory guidelines and quality standards. These substances undergo rigorous testing and evaluation to ensure their safety, efficacy, and compatibility with the desired pharmaceutical product. By employing other substances in API formulations, pharmaceutical companies can optimize drug delivery, improve patient compliance, and enhance therapeutic outcomes.
In summary, the other substances category of pharmaceutical APIs comprises a diverse range of chemicals, including excipients, solvents, stabilizers, and pH adjusters. These substances contribute to the formulation, stability, and performance of medications, enabling pharmaceutical manufacturers to develop specialized products that meet specific therapeutic requirements.
