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Epafipase | CAS No: 208576-22-1 | GMP-certified suppliers

A medication that targets severe sepsis by modulating inflammatory processes to potentially reduce systemic inflammation and organ dysfunction in critical care settings.

Generic name
Epafipase
Molecule type
biotech
CAS number
208576-22-1
DrugBank ID
DB16158
Approval status
Investigational drug

Product Snapshot

  • Epafipase is an investigational injectable peptide formulation
  • Its primary therapeutic use is in targeting acute ischemic conditions
  • The product is currently under clinical development and has not received approval from major regulatory agencies such as FDA or EMA

Clinical Overview

Epafipase (CAS Number 208576-22-1) is an investigational pharmaceutical agent currently under clinical evaluation. Its development is focused on conditions associated with severe sepsis, specifically within the context of clinical trial NCT00037687, which is assessing the safety and efficacy of recombinant human platelet-activating factor acetylhydrolase for this indication.

Although the specific clinical indications for Epafipase have not been formally established or approved, its investigational use targets the inflammatory and pathophysiological processes involved in sepsis, a critical condition characterized by systemic inflammation and organ dysfunction.

Detailed information regarding the pharmacodynamics and mechanism of action of Epafipase is not publicly disclosed in current datasets. However, the investigational form is a recombinant human enzyme similar to platelet-activating factor acetylhydrolase, which suggests a biochemical role in modulating inflammatory mediators such as platelet-activating factor. This enzymatic activity potentially contributes to reducing inflammation and tissue injury associated with sepsis.

Key pharmacokinetic parameters including absorption, distribution, metabolism, and excretion (ADME) have not been explicitly reported in available sources. Safety and toxicity data remain under assessment as part of ongoing clinical trials. No marketed brands or regulatory approvals have been established for Epafipase at this stage, indicating that it remains an experimental compound not yet authorized for routine clinical use.

From a sourcing perspective, procuring Epafipase active pharmaceutical ingredient (API) requires attention to recombinant protein manufacturing standards. Quality control should ensure consistency in enzymatic activity, purity, and absence of contaminants. Compliance with regulatory guidelines for biological substances, including Good Manufacturing Practice (GMP), is critical. Given its investigational status, sourcing typically involves collaboration with specialized biopharmaceutical suppliers capable of producing recombinant human enzymes suitable for clinical development.

Identification & chemistry

Generic name Epafipase
Molecule type Biotech
CAS 208576-22-1
UNII 369989188P
DrugBank ID DB16158

Formulation & handling

  • Epafipase is a biotech investigational API, indicating a peptide or biologic nature requiring specialized formulation techniques. Suitable primarily for injectable administration due to its biologic structure and potential enzymatic activity. Handle under controlled conditions to maintain stability, avoiding exposure to extreme temperatures and agitation.

Regulatory status

Epafipase is a type of Platelet Aggregation Inhibitors


Platelet Aggregation Inhibitors are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) used in the field of cardiology and thrombosis management. These inhibitors play a vital role in preventing platelet aggregation, a process responsible for the formation of blood clots. By inhibiting platelet aggregation, these APIs reduce the risk of arterial thrombosis, which can lead to severe cardiovascular events like heart attacks and strokes.

Platelet Aggregation Inhibitors primarily work by targeting specific receptors on platelet cells, thereby impeding their activation and subsequent aggregation. The most commonly utilized APIs in this category include acetylsalicylic acid (aspirin), clopidogrel, ticagrelor, and prasugrel. These drugs are available in various forms, such as tablets, capsules, and intravenous formulations, allowing flexibility in their administration.

The effectiveness of Platelet Aggregation Inhibitors lies in their ability to prevent platelets from adhering to each other and forming clots within blood vessels. This property is especially crucial in patients with a high risk of cardiovascular events, such as those with a history of heart disease, diabetes, or peripheral artery disease.

While Platelet Aggregation Inhibitors are generally safe and effective, they can also carry potential side effects, including bleeding complications. Therefore, their administration requires careful consideration of individual patient characteristics and risk factors.

In conclusion, Platelet Aggregation Inhibitors represent a significant category of pharmaceutical APIs used for the prevention of platelet aggregation and subsequent blood clot formation. By inhibiting this process, they contribute to the management and reduction of cardiovascular events, offering critical benefits to patients at risk.