Larazotide: peptide identity and research status

Larazotide is a synthetic peptide with eight amino acid residues. Research records also use the names larazotide acetate and AT-1001. The study protocol describes a proposed role in regulating tight junctions, the connections between neighboring cells in the intestinal lining. Study record; Study protocol, sections 1.2, 1.7 and 6.1.

What tight junction research means

Tight junctions regulate movement through the spaces between cells. Researchers call this paracellular movement. The protocol describes larazotide as a locally acting peptide studied in relation to zonulin signaling and intestinal permeability. That description explains the research hypothesis; it does not establish a benefit for someone using a product outside the study. Study protocol, sections 1.2 and 1.7.

The protocol also describes a capsule formulation intended to release the peptide in the small intestine. Formulation is part of the study context. Its description cannot establish that another preparation has the same properties. Study protocol, section 6.1.

What the trial entries show

The phase 3 entry NCT03569007 lists the study as terminated. Its stated reason is that the sponsor terminated the trial. No summary results are posted in that entry. The record does not supply an outcome analysis that would justify calling the peptide effective or ineffective. Phase 3 study record.

A separate phase 2 entry, NCT05747534, lists its study as completed, with an actual completion date of June 18, 2026. No summary results are posted in that entry either. Completed describes the study’s status; it does not say that the study met its objectives. These two records concern separate studies, so the phase 3 termination does not mean that all larazotide research stopped. Phase 2 study record.

Research status and U.S. authorization

The cited protocol identifies larazotide as an investigational product. The trial entries document clinical research and do not establish a U.S. marketing authorization. A claim of FDA approval requires an FDA record for the specific finished product. Study registration, a research name or a completed trial cannot substitute for that record. Study protocol; FDA product review information.

The protocol’s formulation details do not verify the contents or quality of a product offered elsewhere. FDA review considers the finished product’s manufacturing and labeling. An ingredient name alone provides no such verification. FDA product review information.

Related reading

Read what peptides are for an introduction to peptide terminology, or browse the Peptide Guide. Separate profiles cover KPV, BPC-157 and VIP. Those profiles do not establish that the compounds are interchangeable.

Peptide Labs does not sell larazotide. This information is educational and is not medical advice. A licensed healthcare professional can address personal medical questions.

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