Linerixibat

Linerixibat is a minimally absorbed ileal bile acid transporter (IBAT) inhibitor being developed for the treatment of cholestatic pruritus in primary biliary cholangitis . As an oral therapy, Linerixibat reduces the reabsorption of bile acids in the ileum, lowering systemic bile acid levels and thereby relieving pruritus . In the Phase III GLISTEN trial, Linerixibat demonstrated rapid and statistically significant improvements in worst itch scores and pruritus-related sleep interference compared to placebo . With a low oral bioavailability of 0.05%, Linerixibat is designed to minimize off-target systemic effects while achieving on-target IBAT inhibition . The most frequently reported adverse effects with Linerixibat are gastrointestinal, predominantly diarrhoea and abdominal pain, which are consistent with its mechanism of action . In analytical and quality control contexts, Linerixibat serves as the primary reference standard for analytical method development, method validation, and quality control applications for branded formulations.

 Product Parameters

FAQ

Q1: What is the mechanism of action of Linerixibat?

A: Linerixibat is a highly potent, reversible inhibitor of the ileal bile acid transporter (IBAT) or apical sodium-dependent bile acid transporter (ASBT). It works by reducing the reabsorption of bile acids in the terminal ileum, thereby increasing fecal bile acid excretion and lowering circulating bile acid levels.

Q2: What are the primary therapeutic applications?

A: The primary therapeutic application of Linerixibat is the treatment of cholestatic pruritus (severe itch) associated with primary biliary cholangitis (PBC) in adults. It has also been investigated as a lipid-lowering agent for type 2 diabetes.

Storage Conditions

Store Linerixibat as a powder in a tightly sealed container, protected from light and moisture, at -20°C for long-term storage (3 years) or at 4°C for short-term storage (2 years). For solution storage, aliquot and store at -80°C (2 years) or -20°C (1 year), and avoid repeated freeze-thaw cycles to maintain product integrity.

Handling precautions: Use in a fume hood. Wear appropriate personal protective equipment including gloves, safety goggles, and a lab coat. Avoid generating dust. Refer to the Safety Data Sheet (SDS) for complete safety information. The compound is classified with hazard statements H302 (Harmful if swallowed), H315 (Causes skin irritation), H319 (Causes serious eye irritation), and H335 (May cause respiratory irritation).

 Product Quality Assurance

Cosperpharm has established a comprehensive quality assurance system for Linerixibat that meets the rigorous expectations of pharmaceutical research and development:

Thorough analytical characterization. Each batch undergoes multi-technique analytical release testing: HPLC purity verification (≥95% standard grade; ≥99.98% high purity grade), NMR structural confirmation, mass spectrometry identity verification, and appearance verification. The analytical methods are validated to ensure accuracy, precision, and specificity.

Full batch traceability. From raw material procurement through synthesis, purification, and final packaging, every step is fully documented and traceable. Each batch receives a unique lot number with retention samples maintained in accordance with Cosperpharm quality procedures.

Stability monitoring program. Cosperpharm conducts ongoing stability studies under recommended storage conditions: long-term storage at -20°C under inert atmosphere. Linerixibat powder is stable for 3 years at -20°C and 2 years at 4°C. Stability summaries are available to support customer research and regulatory submissions.

Documentation ready for regulatory submission. Every shipment includes a Certificate of Analysis (COA) with batch-specific purity and characterization data, a Material Safety Data Sheet (SDS), and customs documentation for international delivery. For customers preparing regulatory submissions, DMF-ready documentation packages, method validation reports, stability data, and custom quality agreements are available upon request.

Customer-initiated quality audits. Qualified customers are welcome to audit Cosperpharm's manufacturing, quality control, and documentation facilities. Please contact our regulatory team to schedule an audit or to request ISO compliance documentation.

Contact Us

Looking for Linerixibat for your ASBT inhibitor research, PBC pruritus studies, or bile acid metabolism program? Cosperpharm is your trusted source for high-purity research compounds. Contact us today — let's discuss how we can support your research with quality material and expert service.