Healing & Recovery Protocol
LarazotideComplete Dosing & Administration Guide
Restore your intestinal barrier and protect against gluten damage
Dose Range
250 mcg-1000 mcgmcg
Frequency
Once daily
Route
Oral (capsule or tablet)
Cycle Length
Ongoing/indefinite
Dosing
How much
do I take?
Timing
Best time to take
Take Larazotide at the same time each day for consistent blood levels. Morning dosing with breakfast is often preferred, but follow your healthcare provider's specific instructions.
With food?
Larazotide can typically be taken with or without food. Taking it with a light meal may help reduce any GI discomfort. Avoid taking with grapefruit juice or high-fat meals unless specifically directed.
If stacking
Larazotide should be used as directed by your healthcare provider. If combining with other medications or supplements, discuss potential interactions with your provider. Avoid combining with compounds that have overlapping mechanisms unless specifically guided by a medical professional.
Adjusting Your Dose
Increase if
- +You've tolerated the current dose for the recommended period without significant side effects
- +Therapeutic goals haven't been met at the current dose level
- +Your healthcare provider recommends dose escalation based on your response
- +Lab work or clinical assessments support a higher dose
Decrease if
- -Side effects are bothersome or impacting daily life despite management strategies
- -You experience any signs of an adverse reaction
- -Lab results indicate the need for dose reduction
- -Your healthcare provider recommends a lower dose based on your response
Signs of right dose
- ✓Therapeutic goals being met with minimal side effects
- ✓Stable and consistent response to treatment
- ✓Lab values or clinical markers trending in the right direction
- ✓Good tolerance with manageable or absent side effects
Dosing Calculator
Calculate Your Exact Dose
Step 1: Peptide Weight
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The peptide weight is printed on the label
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Administration
How do I
use it?
Reconstitution
What you need
- •Larazotide in its prescribed form
- •Clean, dry storage container
- •Measuring device if applicable (oral syringe, measuring cup)
- •Calendar or reminder app for dosing schedule
Injection
Route
Larazotide is administered Oral (capsule or tablet)—no injection required
Best sites
- •Not applicable—this is not an injectable formulation
Technique
- 1.Follow the specific administration instructions for your Larazotide formulation
- 2.Take or apply as directed by your healthcare provider
- 3.Store properly between uses according to package instructions
Storage
Signs of degradation
Sample Daily Schedule
Safety
Is it
safe?
Safety Profile
Larazotide (ALX-0061, AT-1001) is a synthetic tight-junction regulator that improved intestinal barrier function in Phase 2 celiac disease trials with favorable safety. The mechanism—zonula occludens-1 modulation—is specific to epithelial tight junctions without broad immunosuppression. Gastrointestinal side effects (nausea, diarrhea, abdominal pain) occur in 10-20% of patients but are typically mild and resolve with dose adjustment or continued exposure. FDA feedback on Phase 3 trials indicated efficacy trends but required additional manufacturing and clinical data before approval consideration.
Larazotide safety derives from two Phase 2b randomized controlled trials (n=316 and n=362 patients) published in Gut and Gastroenterology showing no serious adverse events attributable to larazotide and favorable tolerability compared to placebo. Serum enzyme elevation was minimal and reversible. Phase 3 trial data remain unpublished as of 2025, but regulatory interactions with FDA suggest development is ongoing. The peptide demonstrates selective intestinal barrier modulation without systemic toxicity in evaluated cohorts.
Common Side Effects
Experienced by some users
Headache
Occasional headaches reported in clinical trials, usually mild and transient. Often resolves within a few hours to days.
Management: Stay hydrated, rest in a quiet environment, and monitor frequency. If persistent, discuss with your healthcare provider about dose adjustment.
Nausea
Some patients experience mild nausea, particularly when taking the peptide on an empty stomach. This is typically mild and temporary.
Management: Take larazotide with food or a light meal to minimize nausea. Try ginger tea or small frequent meals throughout the day.
Abdominal Cramping
Occasional mild cramping or discomfort reported during the adjustment period. Usually diminishes after the first week of treatment.
Management: Use a heating pad, practice gentle stretching, and ensure adequate hydration. Contact your doctor if cramping is severe or persistent.
Fatigue
Rare reports of mild fatigue, possibly related to the body's healing response. Energy levels typically normalize quickly.
Management: Ensure adequate sleep, maintain good nutrition, and stay physically active. Supplement with B vitamins if deficient.
Less Common
- •Transient Diarrhea
These typically resolve with continued use or dose adjustment.
Stop and Seek Help If
- ×Severe or worsening side effects that don't improve with dose adjustment or supportive care
- ×Signs of an allergic reaction—rash, hives, swelling, or difficulty breathing
- ×Your healthcare provider recommends discontinuation based on your clinical response
- ×Development of any new medical condition that may be contraindicated with Larazotide
- ×Pregnancy or planning to become pregnant (unless specifically approved for use during pregnancy)
- ×Abnormal lab results or clinical markers that suggest adverse effects
Larazotide should only be started, adjusted, or discontinued under medical supervision. This information is for educational purposes only and does not replace professional medical advice. Never stop a prescribed treatment without consulting your healthcare provider first, as abrupt discontinuation may have consequences.
Interactions
With other peptides
- ✓Synergistic intestinal barrier repair - glutamine feeds enterocytes while larazotide regulates tight junctions
- ✓Supports healthy gut microbiome while larazotide restores barrier function for better probiotic colonization
- ✓Essential for tight junction protein synthesis and intestinal epithelial cell repair
With medications
- !High-dose NSAIDs - Can increase intestinal permeability and may counteract larazotide's barrier-protective effects
- !Excessive Alcohol - Alcohol damages tight junctions and can undermine larazotide's therapeutic benefits
- !Certain Antibiotics - May disrupt beneficial gut microbiota needed for barrier healing synergy
With supplements
- ✓Multivitamins - Generally safe to take alongside Larazotide. Space doses apart if taking oral formulations to ensure optimal absorption.
- ✓Electrolyte supplements - Helpful if experiencing any GI side effects that could lead to dehydration. Safe to combine.
Want the Full Picture?
View the complete Larazotide research profile including mechanism of action, clinical studies, effectiveness timeline, and FAQ.
View Full Larazotide Profile