Larazotide

What Larazotide does

Larazotide is an experimental oral peptide studied for celiac symptoms and post-COVID illness. Some small trials found symptom benefits, but the celiac phase 3 trial stopped in 2022. The completed long-COVID trial has no posted results. Community use for “leaky gut” remains poorly tested. Online products may differ from trial capsules.

• In a celiac trial, 0.5 mg three times a day eased symptoms on top of a gluten-free diet; a later phase 3 trial was stopped. (Studied in a trial)
• In a small study, people with celiac disease had less gut leak and fewer symptoms after eating gluten. (Studied in a trial)
• In a small trial of 12 children with MIS-C, a post-COVID illness, recovery was faster when it was added to hospital care. (Studied in a trial)
• A few users report fewer food reactions or better food tolerance; another noticed no benefit. (Reported by users)

Uses in the sources

• Studied as an add-on to a gluten-free diet for persistent celiac symptoms. Benefit was inconsistent across doses and trials. (Studied in a trial) (source)
• Studied as an add-on to hospital care for MIS-C. A 12-child trial reported faster recovery; it does not establish routine use. (Studied in a trial) (source)
• Studied for long COVID in 107 participants aged 7–50. The trial is completed; results were not posted by 2026-10-18. (Studied in a trial) (source)
• People report oral use for “leaky gut,” food reactions, MCAS and chronic gut symptoms. These reports do not establish benefit. (Reported by users) (source)

Larazotide dosage

Typical reported dose: 0.25 mg three times a day before meals

• First celiac study: 12 mg: 12 mg per dose; Once daily once daily, by mouth. Studied in a trial. Studied in: Adults with controlled celiac disease. (source)
• Healthy volunteers: 0.25 mg: 0.25 mg per dose; Three times daily three times daily, by mouth. Studied in a trial. Studied in: Healthy adults aged 18–45. (source)
• Healthy volunteers: 1 mg: 1 mg per dose; Three times daily three times daily, by mouth. Studied in a trial. Studied in: Healthy adults aged 18–45. (source)
• Healthy volunteers: 4 mg: 4 mg per dose; Three times daily three times daily, by mouth. Studied in a trial. Studied in: Healthy adults aged 18–45. (source)
• Two-week gluten challenge: 0.25 mg: 0.25 mg per dose; Three times daily three times daily, by mouth. Studied in a trial. Studied in: Adults with celiac disease in remission. (source)
• Two-week gluten challenge: 1 mg: 1 mg per dose; Three times daily three times daily, by mouth. Studied in a trial. Studied in: Adults with celiac disease in remission. (source)

Highest studied: 8 mg orally three times daily in gluten-challenge trials; 24 mg total per day..

These are doses reported in labels, trials or user reports, not a personal plan. Check the source behind each one.

Work out syringe units with the dosing calculator

How to store Larazotide

Comes as: Trial oral gelatin capsules, Trial capsules containing enteric-coated multiparticulate beads.

Mixed with: No human injection diluent or home reconstitution recipe established..

• The studied oral capsule controls where drug is released; loose powder is not established equivalent.
• No human injection diluent, vial size, water volume or post-mixing shelf life was established in these trial sources.

Before mixing: No approved product label or publicly verified storage period was found for home supplies.

After mixing: No validated home-mixed stability or beyond-use period was found.

Larazotide side effects and risks

Reported side effects

• Headache: Six week trial: 1/4/8 mg, 7%/5%/12%; placebo 7%. All cause events, not proven drug effects., mild. Track persistent or worsening symptoms; review other causes. (source)
• Nausea: Six week trial: 1/4/8 mg, 10%/14%/9%; placebo 19%. Gluten challenge can cause the same symptoms., mild. Persistent vomiting or poor fluid intake needs clinical review. (source)
• Diarrhea: Six week trial: 1/4/8 mg, 17%/28%/19%; placebo 28%. These are all cause trial events., moderate. Track fluids and stools; blood, fainting or severe pain needs urgent care. (source)
• Bloating and gas: Six week trial: bloating 14%/12%/14%; gas 17%/14%/12% at 1/4/8 mg. Placebo: 19% and 14%., mild (source)
• Constipation: Six week trial: 1/4/8 mg, 12%/2%/16%; placebo 12%. Drug causation is uncertain., mild (source)
• Urinary infection: 14 day gluten challenge: 16.7%/8.3%/8.3%/8.3% at 0.25/1/4/8 mg; placebo 0%. Very small groups., moderate. Painful urination or fever needs assessment; a causal link is unproven. (source)
• Serious or delayed harm: No serious events in the 86 person trial; no drug related serious events in the 342 person trial. Long term rates are unknown., serious (source)

Stop and get help if

• Sudden severe abdominal pain, blood in vomit, or black or bloody stool: Get emergency assessment. Do not assume this is “gut healing” or a routine peptide effect.
• Throat or tongue swelling, trouble breathing, collapse or fainting after a dose: Call emergency services; use prescribed emergency adrenaline if available.
• Ongoing diarrhea, unexplained weight loss or persistent celiac symptoms: Arrange prompt assessment for gluten exposure, nutrient loss and other bowel disease.

Who should avoid it

• pregnant: No pregnancy safety data; celiac trials excluded pregnancy. This is a precaution, not a demonstrated fetal risk.
• breastfeeding: No milk-transfer or infant-safety data; breastfeeding participants were excluded from celiac trials.
• tryingToConceive: Reproductive safety is unknown. Celiac trials required contraception for participants who could become pregnant.
• under18: No routine pediatric regimen is established. Small MIS-C studies used hospital research or emergency access.
• other: Avoid a known allergy trigger; larazotide-specific allergy rates are unknown.
• kidneyDisease: No dedicated kidney-disease dose study found; oral trial safety does not establish dosing in severe kidney disease.
• liverDisease: No dedicated liver-disease dose study found; clinically important illness was excluded from celiac trials.
• other: Persistent symptoms need a cause-specific workup. Refractory disease and severe celiac complications were excluded from the main trial.
• testedAthlete: S0 inference: an unapproved investigational drug is prohibited at all times under the 2026 list; larazotide is not named individually.

Interactions

• Proton pump inhibitors and other acid-reducing drugs: Drugs changing gut pH were excluded from celiac trials. Effects on capsule release or drug absorption have not been measured.
• NSAID pain relievers: Regular NSAID use was excluded because it can affect gut measures. A harmful interaction with larazotide has not been shown.
• Immunosuppressants, corticosteroids and IVIG: Excluded from celiac trials, but steroids and IVIG were used in small MIS-C studies. Safety of other combinations is unknown.
• Other experimental gut peptides: Reported blends have no verified combination trial. Duplicate larazotide can hide the total daily dose.

Product quality risks

• No independent larazotide-specific market survey of purity, dose or sterility was found.
• FDA cited larazotide acetate among ineligible compounding ingredients in a 2025 supplier warning letter.
• General peptide alerts describe wrong ingredients, too much or too little drug, contamination and nonsterile injections. These are not larazotide-specific rates.
• An HPLC purity percentage does not establish identity, dose, sterility or gut-release performance.

What to expect

13 primary human study records: 10 registries, one additional sponsor-listed phase 1 study and two compassionate-use reports. Several lack results; the celiac phase 3 trial stopped.

Key studies

• First healthy-volunteer study (2005): A sponsor filing documents 24 participants; detailed dose cohorts and results were not recovered. (source)
• First celiac proof-of-concept trial (2007): A small inpatient study found less acute gut leak and fewer symptoms after gluten exposure. (source)
• Healthy volunteers: 10-day dosing: The completed registry describes fixed cohorts; no tabulated results were posted. (source)
• Two-week gluten challenge (2012): The permeability endpoint failed; some lower-dose symptom results favored larazotide. (source)
• Six-week gluten challenge (2013): The 1 mg arm reduced symptoms; none of the three doses improved the primary permeability test. (source)
• Active celiac disease: 8 weeks: This completed 105-person study has no posted results or recovered peer-reviewed report. (source)

Larazotide FAQ

• Is Larazotide FDA-approved? No FDA label or approved indication located. Trial or emergency-use authorization is not marketing approval.
• How do people take it? By mouth, three times daily. One month reported. Source: reported by users, not an established dose.
• What's the difference between Larazotide and KPV? Larazotide: an oral gut-barrier peptide with mixed celiac results and a stopped phase 3 trial. KPV: an alpha-MSH fragment studied for gut inflammation in animals, with no human dosing trial. Why people pair them: people combine it with larazotide hoping to address inflammation and gut-barrier symptoms.
• Can I take it with KPV? People combine it with larazotide hoping to address inflammation and gut-barrier symptoms. No human combination trial found; benefit and added risk are unknown. Source: reported by users. Ask a doctor before combining anything.
• Is it banned in sport? Yes. It is banned in and out of competition (WADA 2026). Inference from the S0 rule for unapproved investigational drugs; larazotide is not named individually. Confirm with the relevant anti-doping body.
• How do I store it once opened? No validated home-mixed stability or beyond-use period was found.