Inflammatory bowel disease and mucosal barrier disorders — compounds assessed
The 4 compounds the Institute assesses in inflammatory bowel disease and mucosal barrier disorders.
§4Compounds assessed
Compounds the Institute assesses in this indication, with the class of each and its overall certainty. A compound appears here whether or not the evidence supports its use, because recording that a compound has been studied and found wanting is as much part of the assessment as recording that one has not.
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A phase 2b trial met its primary endpoint on symptom scores at the 0.5 mg dose; the subsequent phase 3 trial was discontinued for futility at interim analysis — The Institute rates this moderate certainty for the conclusion that larazotide does not provide…
Moderate -
Response defined as ≥20 % reduction in parenteral support volume in 63 % versus 30 % with placebo at 24 weeks — The indication is short-bowel syndrome with intestinal failure, not inflammatory bowel disease; the Institute maps it to the mucosal-barrier…
Moderate -
Synthetic pentadecapeptide derived from a gastric juice protein sequence1 contributing trialfull monograph
A phase 2 programme in ulcerative colitis was conducted and results were not published in a peer-reviewed journal in a form the Institute could verify — A registered clinical programme existed. The Institute could not locate a peer-reviewed primary…
Very low -
C-terminal tripeptide fragment of alpha-melanocyte-stimulating hormone0 contributing trialsfull monograph
No randomised controlled human trial identified — Preclinical colitis models only, though the mechanistic rationale for a local intestinal effect is among the more coherent in this group.
Very low
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.
- 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
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.