Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Compound monograph · §2

Larazotide acetate — pharmacology

Molecular targets, mechanism of action, pharmacokinetics and interactions as characterised in humans.

Document identifier
CEI-MN-035/2
Series
Compound monograph
Version
4.3
Published
07 May 2026
Last reviewed
07 May 2026
Next review
07 May 2028
Identifier
10.71829/cei.mono.35
Certainty
Moderate
Cycle
2026 Q2

§2Pharmacology

§2.1Molecular targets

Table 2. Molecular targets recorded for Larazotide acetate, with the character of the interaction and the potency where the Institute holds it.

TargetInteractionNote
Zonulin pathway / tight-junction assemblyAntagonistActs locally at the intestinal epithelial tight junction; no systemic receptor target

§2.2Mechanism of action

Larazotide antagonises zonulin-mediated tight-junction disassembly, reducing paracellular permeability in intestinal epithelium. The therapeutic hypothesis in coeliac disease was that limiting gluten-peptide translocation across a compromised barrier would reduce symptoms in patients on a gluten-free diet with persistent symptoms.[1,2]

§2.3Pharmacokinetics

Terminal half-life
not applicable — negligible systemic absorption is a design objective
Time to maximum concentration
not applicable
Volume of distribution
not applicable
Plasma protein binding
not applicable
Clearance
not applicable
Bioavailability
minimal by design; systemic exposure is below quantifiable limits at therapeutic doses

Luminal proteolysis and faecal elimination. The Institute notes that a locally acting, non-absorbed peptide has a fundamentally different benefit–risk architecture from every other compound in this series.

Reconstructed plasma concentration–time profilePlasma concentration plotted against time after dosing, reconstructed from published pharmacokinetic parameters.0.00.20.40.60.8020406080Time after first dose (hours)Relative concentrationt max ≈ 11 ht½ ≈ 24 h
Modelled profileSimulated observationsDose administration
Figure 2. Illustrative. Plasma concentration–time profile reconstructed by the Institute from the published half-life and time-to-maximum-concentration parameters using a one-compartment model with first-order absorption. The curve is not digitised from a published figure and its vertical scale is relative. It is published to convey the shape of the profile and the approach to steady state, not to supply a concentration at any time point.

§2.4Interactions

  • None expected given negligible absorption

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

  1. D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
  2. Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng HY, Corbett MS, Eldridge SM, Emberson JR, Hernán MA, Hopewell S, Hróbjartsson A, Junqueira DR, Jüni P, Kirkham JJ, Lasserson T, Li T, McAleenan A. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898. doi:10.1136/bmj.l4898 · PMID 31462531

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.

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