Larazotide

Also called AT-1001

A gut peptide built for celiac disease that failed its big trial, so its program was shut down.

Updated 03 May 2026Read 3 minBacked by 60 studies

The quick version

What it is: An oral peptide that tightens the gaps between gut cells
Is it FDA-approved?: No, its big trial failed in 2022 and the maker quit
How strong is the proof?: Weak now: early studies looked okay, the final one missed
How you take it: By mouth, as a capsule
Typical result: The deciding trial did not beat placebo
Biggest catch: Development is paused; the science said it did not work well enough

Any word with a dotted underline is a science word — tap it for a plain-English meaning.

In plain words.

Larazotide is a capsule, not a shot. That is unusual for a , since most get torn apart in the stomach. You may see it called AT-1001.

Your gut lining has tiny gaps between its cells. These are called tight junctions. Larazotide is meant to tighten those gaps, like closing little gates. The goal was to keep gluten bits from leaking through in people with celiac disease.

It is not . Its big final trial failed. The company that made it stopped working on it.

What people use it for.

It was built for celiac disease. The idea was to use it on top of a gluten-free diet, to help people who still feel sick from tiny bits of gluten.

It is also sold online as a "leaky gut" fix. That use has zero solid human proof. Do not buy it for that.

Does it actually work?

Early on, it looked hopeful. A mid-stage study in 342 people showed fewer celiac symptoms than placebo.

Then came the deciding test. The , called CeDLara, missed its main goal in 2022. It did not work well enough. The maker, 9 Meters Biopharma, shut the program down.

That failure is the whole story. When the biggest, most careful test misses, that should change your mind. For "leaky gut," there is no controlled human data at all.

what you’ve probably heard.

The claims floating around online, and how true they actually are.

“It's the leaky gut cure that finally fixes your gut.”

It is pushed hard online for "leaky gut," but there is no controlled human data for that use at all. It was built for celiac, not the supplement aisle.

“Take it and you can eat gluten again.”

myth

Never the plan. The most it was ever meant to do is blunt the hit from tiny accidental gluten on top of a strict gluten-free diet. It is not a license to eat bread.

“It works for celiac, the studies showed it.”

not quite

A mid-stage study in 342 people looked promising. Then the deciding phase 3, CeDLara, missed its main goal in 2022 and the maker shut the whole program down.

“It's a pill, so the cheap research powder is easy to take.”

not quite

Larazotide only works if it survives your stomach. The trial capsules had a special acid-proof coating. Raw research powder without that coating gets broken down before it can act, so it is basically useless.

How you take it.

It is taken by mouth as a capsule. In the celiac studies it was used along with a strict gluten-free diet.

There is no version to follow anymore. Note that this is an oral . Your gut juices break peptides down fast. So raw research powder is hard to dose by mouth without a special coating.

What to watch out for.

Larazotide was generally well tolerated in the trials. The bigger issue is not side effects. It is that it did not pass its key test.

The real warning is about how it is sold. It is widely pushed online as a "leaky gut" supplement. That use has no controlled human data behind it.

If you have real celiac disease and still feel sick on a strict diet, talk to a gut doctor (a gastroenterologist). We are not your doctor.

Where people get it.

Here are the lanes, safest to riskiest.

Brand. None. The phase 3 failed in 2022 and the maker exited.
. A few pharmacies still make capsules, about $200–$400 a month. The legal footing is weak, since there is no approved use.
Research-only (). Cheap raw powder, about $60–$150 a month. But it is an oral , so it is hard to dose right without an enteric (acid-proof) coating.
. Overseas raw. Oral powder with no coating is basically useless, so this rarely makes sense.

Our honest take.

For "leaky gut," skip it. There is no controlled human proof for that, full stop.

For biopsy-confirmed celiac with stubborn symptoms on a strict gluten-free diet, it is a maybe. But only with a gut doctor leading, and only with the failed phase 3 result right in front of you.

We would not pay clinic prices for a drug whose big trial missed. That is the honest read.

The studies behind this.

We read the research so you don't have to. Here's where the facts on this page come from.

Learn about these too.

We're not your doctor, and this isn't medical advice. It's a plain-English summary of what the research says, so you can have a smarter conversation with someone who is.

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