Larazotide
Not approved anywhere; phase 3 celiac trial stopped in 2022.
An oral peptide meant to tighten the seals between gut-lining cells. It was the leading drug candidate for until 2022, and is now marketed online for leaky gut. A , also called AT-1001 and INN-202.
What the evidence shows
Side effects and risks
Who should avoid it: Relying on it in place of a gluten-free diet.
How it works
- Where it acts
- Thought to tighten the junctions between gut-lining cells.
- What it changes
- Less leakage of gluten fragments through the gut wall in lab studies.
- What people notice
- Its phase 3 trial in celiac disease stopped for lack of benefit. It was well tolerated.
How it has been given in studies
Capsules of 0.25 mg to 2 mg three times a day, 15 minutes before meals.
Getting it in the United States
The legal route for Larazotide
Not FDA-approved and not eligible for pharmacy compounding. Vials sold for research use only are unapproved drugs when marketed for people.
Clinical trial only
No approved larazotide product exists in any country. The only supervised route is a registered trial, such as the hospital studies in MIS-C and long COVID.
Source: Mass General Brigham, 2025-07
Routes people use for any peptide in the United States
Telehealth prescribing
Online clinics prescribe after a questionnaire, sometimes with no live doctor visit, and mail the drug. FDA moved in February 2026 to restrict mass-marketed compounded copies and claims that they are generic equivalents.
Risk: Thin medical screening. Compounded versions are not reviewed by FDA for quality.
Covers: Approved GLP-1 drugs, compounded semaglutide and tirzepatide
Source: GZERO Media, Apr 2026
Clinical trial enrolment
The only lawful way to get an unapproved peptide drug with medical monitoring. ClinicalTrials.gov lists eligibility, sites and phone numbers. Researchers note recruitment is hard when people can buy the drug on the gray market instead of risking placebo.
Risk: Possible placebo assignment, strict eligibility and travel to a study site.
Covers: Investigational peptide drugs still in development
Source: NIH, finding a clinical trial
Routes people use for any peptide in the United States
Compounding pharmacy with prescription
A clinician prescribes and a pharmacy compounds. Twelve peptides left the FDA do-not-compound category in April 2026 and a panel backed six in July, but they are not yet formally eligible. Pharmaceutical-grade ingredient is scarce.
Risk: Legal status is unsettled until FDA rulemaking ends. Pharmacies may use research-grade ingredient.
Covers: BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon and similar
Source: Frier Levitt, Apr 2026
Med spas and weight-loss clinics
Very common. Secret shoppers called 75 clinics and med spas in two states after shortages ended. 92 percent offered compounded semaglutide and 87 percent tirzepatide, often mixed with B vitamins to look custom.
Risk: Four of 23 suppliers lacked sterile compounding licenses and four had disciplinary records.
Covers: Compounded semaglutide and tirzepatide
Source: American Med Spa Association on JAMA Health Forum study, Jul 2026
Concierge and longevity doctors
Cash-pay physicians build peptide plans for wealthy clients. Reporting from San Francisco says some source from overseas channels, domestic research-use-only sellers or the few compounding pharmacies that will supply clinicians.
Risk: A doctor's involvement does not guarantee a pharmaceutical-grade product.
Covers: BPC-157, thymosin alpha-1, Selank, Semax, CJC-1295, ipamorelin, retatrutide
Source: San Francisco Standard, Sep 2025
Cross-border purchase or import
FDA says importing drugs for personal use is illegal in most cases but it may not object to small personal quantities in limited situations. Reporting also describes people travelling to Mexico for injections.
Risk: Packages can be seized. Product origin and cold-chain handling are hard to check.
Covers: Approved prescription peptides sold abroad
Source: FDA, personal importation
Routes people use for any peptide in the United States
Research-chemical websites
Sites sell vials marked for research or not for human consumption, with no prescription. FDA says some ship direct to consumers with dosing directions, and it has sent warning letters. Retatrutide exists only through this route or trials.
Risk: Unknown identity, strength and sterility. No pharmacist or prescriber involved.
Covers: Retatrutide, semaglutide, tirzepatide, BPC-157 and most unapproved peptides
Source: FDA, unapproved GLP-1 drugs page
Direct orders from Chinese factories
Buyers message factory sales agents and pay by crypto or payment app. A minimum order of about ten vials pushes people to buy in bulk and share. A blockchain analysis found US buyers were the largest source of funds.
Risk: Many of the same vendors list fentanyl precursors. Lab reports sent by sellers cannot be verified.
Covers: GLP-1 copies, melanotan II, BPC-157, TB-500, GHK-Cu, epitalon
Source: TRM Labs, Oct 2026
Chat groups and social sellers
Dealers are found through Telegram, WhatsApp, Discord and influencer discount codes. In a May 2026 survey of 1,000 US users, 14.5 percent bought this way and three quarters asked an AI chatbot for dosing.
Risk: 45 percent of social media buyers in that survey reported an emergency or urgent care visit for a reaction.
Covers: Retatrutide and other research-use-only peptides
Source: The Ethos, May 2026
This describes what people do. It is not advice. The decision is yours.
What users report
Too few reports to summarize.
More contextCase reports, what public figures say, videos and articles, when options run out and the chemistry
Case reports
From journals, regulators and studies of users. One case proves little.
Benefit reportedtrial result in rare group - 12 people - 2025
Twelve hospitalised children with early MIS-C got larazotide or placebo for 21 days. The drug group cleared gut symptoms and viral spike protein faster and returned to normal activity sooner. No drug-related side effects were reported. Phase 2a only.
Source: Contagion Live, 2025-07
Benefit reportedcase report - 1 person - 2021
One child with MIS-C was given larazotide as a proof of concept. Spike protein in the blood and inflammation markers fell together and the child improved. Single uncontrolled case.
What experts and influencers say
Paraphrased from the linked sources.
Led the 12-child MIS-C trial. Reported that larazotide looked safe and cleared symptoms faster than placebo. Said her team is now testing it in long COVID.
Source: Mass General Brigham, 2025-07
Lael YonkerWebsiteRecommends
Money: Co-inventor on a patent for zonulin blockers in MIS-C
Photo source: utswmed.org
Called the halt of the phase 3 celiac trial a disappointment. Said setbacks are expected and the group still aims for treatments or a cure by 2030.
Source: Beyond Celiac, 2022-06
Alice BastSourceMixed view
When the phase 3 celiac trial was stopped, he pointed to how complex the disease is and how hard it is to measure symptom outcomes.
Source: Beyond Celiac, 2022-06
Patrick GriffinSourceWarns against
Money: Executive at the company developing the drug
Co-author of the MIS-C trial. The hospital release lists his company stake and patent interest next to the positive result.
Source: Mass General Brigham, 2025-07
Alessio FasanoWikipediaRecommends
Money: Co-founder and stockholder of the company that first developed larazotide. Co-inventor on the MIS-C patent
Reported that an independent statistician found the phase 3 trial would need many more patients to give a meaningful answer. The sponsor then ended it.
Celiac Disease FoundationSourceMixed view
Watch and read
Explainers, reporting and podcasts worth your time. Summaries are ours. No sellers.
Disappointing results end 9 Meters' Phase III trial for celiac treatment
Hannah Chudleigh, reporter
Larazotide's Phase III celiac trial was stopped after interim data showed no benefit over placebo, despite promising earlier Phase II results.
Clear account of why this once-promising gut peptide stalled
When options run out
Uses people turn to when standard treatment has failed.
Children with MIS-C after COVID
- Who
- Hospitalised children with the rare post-COVID inflammatory syndrome, alongside standard care.
- Evidence
- One 12-child placebo-controlled phase 2a trial and one earlier single case. Positive but far too small to prove benefit.
- Route
- Hospital-run trial, part funded by NIH
Long COVID
- Who
- People with long COVID, on the theory that a leaky gut lets viral protein keep entering the blood.
- Evidence
- No results yet. The MIS-C team says a long COVID trial is running.
- Route
- Clinical trial at the same hospital group
Source: Mass General Brigham, 2025-07
Celiac symptoms despite gluten-free diet
- Who
- Celiac patients who stay unwell on a strict gluten-free diet and have no approved drug.
- Evidence
- Phase 2 in 342 adults looked promising. Phase 3, planned for 525 patients, was stopped for futility at a 2022 interim look: the number of patients needed to show a difference from placebo was judged too large. No filing followed.
Source: Beyond Celiac, 2022-06
Legal last-resort routes
Expanded access (compassionate use)
For a serious or life-threatening condition with no comparable alternative and no trial you can join. Your physician asks the company for the drug, then files with FDA and an ethics board. The company can refuse. Costs are often not insured.
Right to Try
For a life-threatening condition after approved options are exhausted and no trial is open to you. The drug must have finished Phase 1 and be in active development. Your doctor asks the manufacturer directly. FDA does not review requests.
Source: FDA, Right to Try
Trial finders
Search ClinicalTrials.gov by condition or drug name, check eligibility and call the listed site. ResearchMatch is a free NIH-funded registry that lets researchers find you. Discuss risks with your own clinician before enrolling.
Source: NIH, finding a clinical trial
Personal import for serious conditions
FDA may not object when a US citizen imports up to about three months of a drug for a serious condition with no effective US treatment, with written personal-use confirmation and a US doctor's details. It is discretion, not a right.
Source: FDA, personal importation
Patient-specific compounding
When the approved product cannot meet a specific need of an identified patient, a prescriber can order a compounded version from a licensed pharmacy. Lower price alone does not qualify. Ingredients must be pharmaceutical grade.
Amino-acid sequence
Questions people ask
Does larazotide work for celiac disease?
In phase 2, only the lowest of three doses beat placebo. The phase 3 trial stopped in June 2022 after an interim look showed it would need far more patients to have a chance of success.
Does larazotide help leaky gut?
Leaky gut is not a recognized diagnosis, and larazotide has not been tested for it in a trial.
Is larazotide approved?
No, it is not approved anywhere, and it should not be relied on in place of a gluten-free diet.
Is larazotide safe?
Side effects matched placebo in the trials.
Your notebook
Taking it? A ten-second daily check-in keeps a record of how you feel, to talk through with your clinician.
Sources
- Leffler et al. 2015: larazotide in celiac disease, phase 2b
- 9 Meters Biopharma: phase 3 trial discontinued (21 Jun 2022)
Structure: PubChem