Larazotide acetate — compound monograph
Octapeptide tight-junction regulator (zonulin antagonist). Discontinued. The Institute assesses 1 outcome for this compound and grades the strongest at moderate certainty.
§1Identification and status
§1.1Nomenclature
- Preferred name
- Larazotide acetate
- Compound class
- Octapeptide tight-junction regulator (zonulin antagonist)
- Assessment series
- Repair and regeneration
- Synonyms and codes
- AT-1001 · INN-202 · larazotide (INN)
- Route as evaluated
- Oral, before meals
§1.2Chemistry
Chemical identifiers are reproduced where they are public. Where a structure has not been published the monograph records not disclosed rather than constructing one.[1]
- CAS registry number
- 258818-34-7
- Molecular formula
- C33H55N7O11
- Average mass
- 725.83
- Monoisotopic mass
- 725.40
- ATC classification
- not assigned
§1.3Sequence and structural notes
An octapeptide derived from the Vibrio cholerae zonula occludens toxin. It acts locally in the intestinal lumen and is not intended to be systemically absorbed, which makes it pharmacologically unusual and analytically straightforward.
§1.4Assessment status
The Institute assesses Larazotide acetate across 1 indication and grades the strongest of them at moderate certainty. Clinical development was terminated. The Institute treats a discontinued programme as evidence.
Table 1. Assessed outcomes for Larazotide acetate, ordered by certainty. Each row links to the per-indication evidence extract.
| Indication | Effect as recorded | Certainty | Trials |
|---|---|---|---|
| Inflammatory bowel disease and mucosal barrier disorders | 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… | Moderate | 2 |
| Effects are reproduced as the contributing trials reported them. Where a confidence interval is held it appears on the per-indication extract rather than in this summary table. | |||
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.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
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.