Linaclotide Powder

Product Introduction

Product Name: Linaclotide Powder

Source: Synthetic

Specification: ≥98%

CAS No.: 851199-59-2

Molecular Formula: C₅₉H₇₉N₁₅O₂₁S₆

Molecular Weight: 1526.8 g/mol

Assay Method: HPLC

Active Ingredient: Linaclotide

Product Characteristics: White to off-white loose solid powder

Packaging: Typically supplied in well-sealed vials or aluminum foil bags.

Storage Condition: Store at -20℃ ±5℃, sealed, protected from light, and in a dry environment.

Shelf Life: 24 months

Declaration of Use: This product is intended for industrial use or scientific research only.

Products  Description

Our company specialises in supplying high-purity Linaclotide active pharmaceutical ingredient (API). This product employs advanced synthesis techniques and strictly adheres to Good Manufacturing Practice (GMP) standards, ensuring exceptional batch-to-batch consistency and superior quality that fully complies with major global pharmacopoeia requirements.

Our Linaclotide API presents as a uniform, white to off-white powder with excellent stability. It has become the preferred choice for formulation companies developing branded or generic pharmaceuticals. We are committed to providing customers with high-quality, highly competitive products, serving as your reliable and stable supply chain partner.

Pharmacological Action

Linaclotide belongs to a novel class of drugs known as guanylate cyclase-C (GC-C) agonists. It is a locally acting peptide therapeutic agent that works within the gastrointestinal tract to regulate fluid balance and sensory function. Its systemic absorption is minimal, resulting in a low incidence of systemic side effects.

Mechanism of Action

The mechanism of action of Linaclotide is precise and unique, primarily achieved through two key pathways:

Improving Bowel Function: Linaclotide and its active metabolites bind to the guanylate cyclase-C (GC-C) receptors on the luminal surface of the intestinal epithelium intestinal epithelium. This binding stimulates an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). The rise in intracellular cGMP activates the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, leading to secretion of chloride and bicarbonate into the gut lumen. This is followed by the passive secretion of sodium and water. The net result is increased intestinal fluid secretion, stool softening, and accelerated intestinal accelerated intestinal transit.

Relieving Abdominal Pain: The increased extracellular cGMP modulates pain signaling pathways. It acts to reduce the sensitivity of pain-sensing nerves, thereby diminishing visceral hypersensitivity, which is a key factor underlying abdominal pain and discomfort in patients with IBS-C.

The following chart clearly illustrates the dual pathway of Linaclotide's action:

Linaclotide

Binds toinds to GC-C Receptor

Binds toinds to GC-C ReceptorCFTR Channel OpeningCl⁻/HCO₃⁻ Secretion

Passive Na⁺/Water Secretion

Impro>Improves Bowel FunctionSoftens Stool, Promotes Motility

Extracellular cGMP↑

Inhibitshibits Pain Neuron Signaling

Relieves Abdominal PainReduces Visceral Hypersensitivity

Product Efficacy

Based on the above mechanisms, finished pharmaceutical products manufactured from Linaclotide API provide the following dual efficacy:

Significantly increases spontaneous bowel movement frequency.

Effectively relieves abdominal bloating and pain.

Improves stool consistency, making it easier to pass.

Product Application

The Linaclotide Active Pharmaceutical Ingredient (API) is specifically intended for the manufacture of capsule dosage forms for the following prescription medications:

Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.

Treatment of Chronic Idiopathic Constipation (CIC) in adult patients.

Furthermore, it serves as the core active ingredient for the global development, registration, and commercial production of relevant formulations.