Donanemab API Manufacturers
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Looking for Donanemab API 1931944-80-7?
- Description:
- Here you will find a list of producers, manufacturers and distributors of Donanemab. You can filter on certificates such as GMP, FDA, CEP, Written Confirmation and more. Send inquiries for free and get in direct contact with the supplier of your choice.
- API | Excipient name:
- Donanemab
- Synonyms:
- Cas Number:
- 1931944-80-7
- DrugBank number:
- DB16647
- Unique Ingredient Identifier:
- 1ADB65P1KK
General Description:
Donanemab, identified by CAS number 1931944-80-7, is a notable compound with significant therapeutic applications. Donanemab (LY3002813) is a humanized IgG1 monoclonal antibody targeted against an epitope at the N-terminal of a specific type of amyloid beta (Aβ) - pyroglutamate Aβ - which is found only in the brain amyloid plaques associated with Alzheimer's Disease (AD). It works by inducing microglial-mediated clearance of existing Aβ plaques with the intent of slowing the progressive decline in cognitive function associated with AD. A phase II study conducted by Eli Lilly and published in March 2021 (TRAILBLAZER-ALZ), which looked at 257 patients with early symptomatic AD, found that patients receiving donanemab experienced a roughly 30% slower progression in AD as measured by a disease rating scale (iADRS), although results for secondary endpoints were mixed. In March 2021, Eli Lilly announced an expanded trial, named TRAILBLAZER-ALZ 2, which will seek to confirm the results of the first trial with an expanded patient population in order to address some of the deficiencies of the original.
Mechanism of Action:
Donanemab functions by: Donanemab is presumed to exert its therapeutic effects by clearing amyloid beta (Aβ) plaques in the brain, though a clear link between plaque reductions and clinical outcomes was not observed in initial trials. Donanemab is a monoclonal antibody targeted against a specific epitope on a form of post-translationally modified Aβ plaque seen only in the brains of patients with Alzheimer's Disease, namely the N-terminus of pyroglutamate Aβ - after binding, donanemab induces microglial-mediated clearance of these plaques. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.
Classification:
Donanemab belongs to the None, classified under the direct parent group Peptides. This compound is a part of the Organic Compounds, falling under the Organic Acids superclass, and categorized within the Carboxylic Acids and Derivatives class, specifically within the Amino Acids, Peptides, and Analogues subclass.
Categories:
Donanemab is categorized under the following therapeutic classes: Alzheimer Disease, drug therapy. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.
Donanemab 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.
