Eluxadoline

Eluxadoline is a pivotal active pharmaceutical ingredient (API) and a certified reference standard in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). As a potent, selective, orally bioavailable μ-opioid receptor agonist and δ-opioid receptor antagonist, Eluxadoline offers a unique therapeutic mechanism that targets local gut receptors to provide symptom relief while minimizing constipation and systemic side effects. In quality control and regulatory contexts, Eluxadoline reference standards are invaluable for pharmaceutical research, supporting product development, ANDA and DMF submissions, quality control (QC), method validation, and stability studies. The rigorous characterization and detailed Certificates of Analysis (COA) provided with Eluxadoline reference materials meet regulatory requirements, making this compound an indispensable tool for generic manufacturers and analytical laboratories. With its demonstrated efficacy and safety profile, Eluxadoline has become a preferred choice for IBS-D management.

Product Parameters

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Parameter	Specification
Product Name	Eluxadoline
CAS Number	864821-90-9
Molecular Formula	C₃₂H₃₅N₅O₅
Molecular Weight	569.6 g/mol
Melting Point	>180°C (dec.)
Boiling Point	834.2±65.0 °C (Predicted)
Density	1.284±0.06 g/cm³ (Predicted)
Appearance	Off-white solid
Solubility	Soluble in DMSO (slightly), methanol (slightly)
Storage Condition	Refrigerator

A new drug for diarrhea-type irritable bowel syndrome – Eluxadoline

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On May 27,2017, the U.S. FDA approved Eluxadoline (brand name Viberzi), a novel drug developed by Furiex Pharmaceuticals for the treatment of diarrhea-type irritable bowel syndrome (IBS-D). Eluxadoline is a mu-opioid receptor agonist that acts on mu-opioid receptors to alleviate symptoms of IBS-D. It represents a pioneering oral therapeutic agent with localized action and a unique mechanism of action, exhibiting mixed opioid receptor activity as both a μ-receptor antagonist and a delta-opioid receptor agonist as well as a kappa-receptor agonist. Administration during meals significantly reduces abdominal pain and diarrhea symptoms in patients with IBS-D. IBS-D is a multifactorial gastrointestinal disorder characterized by persistent abdominal pain, diarrhea, and impaired intestinal function; it affects approximately twice as many women as men, with a current global prevalence of 15 million cases in the United States and 13 million in Europe. Eluxadoline was initially developed by Furiex Pharmaceuticals in the United States; ForestLab acquired the company for $1.47 billion in July 2014, followed by a subsequent acquisition by Swiss pharmaceutical firm Aventis for $25 billion. Notably, Valeant Pharma of Canada has also developed rifaximin (brand name Xifaxan) as a new treatment option for IBS-D. Rifaximine is a drug acquired following the $11.1 billion acquisition of Salix Pharma and has been approved for the treatment of hepatic encephalopathy (HE) and non-invasive diarrhea caused by Escherichia coli.

 

Why Cosperpharm?

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When your IBS-D therapeutic development or ANDA filing requires high-quality API and impurity reference standards, Cosperpharm delivers Eluxadoline with the analytical rigor, documentation depth, and supply flexibility that pharmaceutical customers demand.

 

Rigorous quality control for regulatory confidence. Eluxadoline is a complex peptidomimetic molecule with multiple stereocenters and a demanding synthetic pathway. Any impurity in this API can compromise both efficacy and safety. Our analytical release protocol includes HPLC purity verification, chiral purity analysis, residual solvent testing, and comprehensive identity confirmation—because your final drug product quality depends on the integrity of this active ingredient.

 

Documentation that supports regulatory submission. As a key API for ANDA and DMF submissions, Eluxadoline reference standards require thorough characterization. Every shipment includes a Certificate of Analysis (COA) with batch-specific HPLC purity, chromatographic traceability, and residual solvent data—structured for direct insertion into your method validation package. DMF-ready documentation, stability summaries, and custom quality agreements are available upon request.

 

Flexible supply across all development stages. Cosperpharm supplies Eluxadoline across the full range of applications—from gram-scale reference standard quantities for QC impurity profiling and analytical method development, to bulk quantities for commercial manufacturing. R&D samples ship within 5–7 business days; bulk orders ship within 2–3 weeks.

 

Technical support for the full synthetic cascade. Our process chemistry team can advise on the selection of synthetic routes, impurity profiling strategies, and analytical methods for detecting process-related impurities—because we have worked extensively with this complex molecule across multiple manufacturing campaigns.

 

Global reach with transparent pricing. Cosperpharm ships to pharmaceutical manufacturers, CROs, and analytical laboratories worldwide, with full customs documentation included. Volume discounts apply at larger scales, and we communicate lead times upfront—no hidden fees, no unexpected delays.

 

Storage Conditions

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Store Eluxadoline in a tightly sealed container under recommended storage conditions (refrigerator). Keep the container dry, protected from light, and stored in a clean, well-ventilated area away from strong oxidizing agents and sources of ignition. The compound is stable under recommended storage conditions.

 

Handling precautions: Use only in a fume hood. Wear chemical-resistant gloves, safety goggles, and a lab coat. Avoid generating dust or aerosols. Do not eat, drink or smoke in work areas. After handling, wash hands thoroughly. Refer to the Safety Data Sheet (SDS) for complete safety information.

 

Contact Us

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Securing Eluxadoline for your IBS-D therapeutic development program, impurity profiling initiative, or analytical method validation should be straightforward. Cosperpharm makes it simple.