STUDresearch · Peptide

Larazotide

Also known as

Larazotide acetate · AT-1001 · AT1001 · AT 1001 · INN-202 · GGVLVQPG · H-Gly-Gly-Val-Leu-Val-Gln-Pro-Gly-OH · zonulin antagonist (discussion shorthand) · tight-junction regulator peptide (discussion)

Community talk. May be wrong. Not medical advice. Not a protocol. Not for human or animal use.

Open in the directory ↗

Peptide Some talk Mixed Oral Gut & inflammation peptides

Gut-local oral — people swallow it before meals for the lining, not a scalp or joint pin. Vendor shot charts exist and are not the trial path.

What people say Larazotide is an investigational eight-amino-acid, gut-restricted oral peptide studied as a tight-junction regulator in celiac disease. It is not approved, is not a digestive enzyme, and trial enteric formulations are not equivalent to gray-market powder. Doses people talk about

Inspected community account250 mcg four times daily, then 500 mcg four times daily

Same author reported about seven days at 500 mcg four times daily, a brief stop and restart; illness and multiple concurrent drugs confounded the experience.

Phase 2b primary-endpoint arm0.5 mg orally three times daily

Twelve-week adult celiac trial arm; the 0.5 mg arm, not the 1 or 2 mg arms, met the primary comparison.

Other Phase 2b arms1 mg or 2 mg orally three times daily

Same 12-week design; neither higher arm beat placebo on the primary endpoint.

These are descriptive exposures, not a progression. Trial enteric formulations, indications and monitoring do not transfer to unverified community products.

Half-life & effect duration

Half-life in the body: Oral · plasma half-lifeNo settled estimate
Felt duration people report: One course / restart accountWorsened over 3 days off; renewed energy after restarting

Timing context & sources

How it may feel There is no established acute buzz. One user reported strength and pain changes during a 250-to-500 mcg four-times-daily course, worsening over three days off and energy improvement on restart, but illness and several concurrent drugs make attribution weak.

Cycles people discuss Celiac trials used weeks-long oral blocks, including 12 weeks in Phase 2b. Community maintenance and stop/restart use are not validated cycles, and one inspected restart story was heavily confounded. Timing Oral timing is usually discussed around meals. Trial writeups describe about 15 minutes before breakfast, lunch and dinner; community charts vary, and bulk powder or plain capsules may not match the trial formulation. Stacks Preserved community notes pair larazotide with BPC-157 or KPV, often in marketed gut blends. These are combination narratives, not evidence that a blend works or that one ingredient caused a reported change. Access talk Not 503A, not the July 2026 PCAC peptide vote. Larazotide is not legally compoundable on the US bulks list as of 2026 trackers. Watch for Not a gluten free pass: Barrier talk does not make unrestricted gluten safe; trials kept GFD or used controlled challenge grams — not restaurant free-for-all.

Tap a line to jump into the full notes. Research only — may be wrong.

Timing context & sources

Half-life in the body

A human parent-plasma half-life is not established by the reviewed larazotide program.

A protocol background reports plasma larazotide and metabolites below a 0.5 ng/mL quantification limit after single 3, 12 and 36 mg oral doses and repeated CLIN1001-003 dosing; its study table says 0.25, 1 or 3 mg three times daily, while its narrative says 0.25, 1 or 4 mg three times daily. A separate delayed-release pig study measured local intestinal exposure around 1–4 hours.

The protocol's internal 3-versus-4 mg discrepancy is unresolved. Below-quantification human plasma observations do not support an elimination estimate, and the 1–4-hour observation is porcine intestinal-tissue/formulation timing that cannot be converted to human half-life.

AT1001 MIS-C 101 Phase 2a clinical research protocol (opens in a new tab)The Phase 2a pediatric MIS-C protocol's background summarizes earlier oral Phase 1 exposure: plasma larazotide and metabolites remained below a 0.5 ng/mL quantification limit after single 3, 12 and 36 mg doses and repeated CLIN1001-003 dosing. Its table says 0.25, 1 or 3 mg three times daily for 10 days, while the narrative says 0.25, 1 or 4 mg three times daily.This is a pediatric MIS-C protocol using background summaries, not the CedLara Phase 3 protocol or a peer-reviewed population-PK model. Its CLIN1001-003 amount is internally inconsistent, and below-quantification plasma values do not yield a human parent half-life.
Pharmacokinetics of larazotide acetate in porcine intestinal tissue after oral delayed-release dosing (opens in a new tab)Fasted pigs received a total 1 mg delayed-release oral dose, about 0.05 mg/kg; intestinal tissue concentrations peaked around 1 hour in duodenum/proximal jejunum and were detected over approximately 2–4 hours.Porcine local-tissue/formulation study, not human plasma pharmacokinetics or a measured subjective-duration study; the direct PMC page presented a browser-check screen, so indexed article content was reviewed.

Felt duration people report

The inspected community evidence does not establish a reliable felt-duration window.

One same-author account described changes during a 250-to-500 mcg four-times-daily course, deterioration over three days off and renewed energy after restart.

Single anonymous account, unverified product, uncontrolled disease fluctuations, exertion and nearby hydrocortisone, Q10, B12 and LDN changes prevent causal timing inference.

Phoenix Rising — Game-Changing Leaky Gut Treatment Larazotide Acetate, page 5 (opens in a new tab)Same author reported starting 250 mcg orally four times daily, then 500 mcg four times daily for about seven days; reported strength and neck/throat pain changes, concurrent hydrocortisone/Q10/B12/LDN and illness, deterioration over three days off, and energy return after restart.Anonymous unblinded self-report with unverified product and strong time-varying confounding from ME/CFS, COVID, hydrocortisone, Q10, B12, LDN and activity. It cannot establish efficacy, prevalence, or causal timing.

Other context in this card

Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet (opens in a new tab)Randomized Phase 2b report: 342 adults with celiac disease on a gluten-free diet; 0.5, 1, or 2 mg orally three times daily for 12 weeks after run-in, with run-out follow-up. Only 0.5 mg met the primary CeD-GSRS comparison.Disease-specific trial with symptom endpoints. It does not establish unrestricted-gluten protection, community-product equivalence, or a plasma half-life; the direct PMC page presented a browser-check screen, so indexed article text and tables were reviewed.
ClinicalTrials.gov — NCT03569007 CeD-LA-3001 (opens in a new tab)Official study record and Study Arms module list larazotide 0.25 mg capsules three times daily, larazotide 0.50 mg capsules three times daily and matching placebo; overall status is Terminated and the stated reason is 'Trial terminated by Sponsor.'Registry record for the planned and enrolled Phase 3 study. It does not itself attribute termination to interim sample-size re-estimation or report efficacy results.

What people say 17

Long-COVID adjacency: Sponsors/investigators and popular science coverage discuss gut permeability and residual viral antigen hypotheses; formal long-COVID trials have been discussed/started in academic networks — outcomes not a settled efficacy claim. forum
Community wellness claims: Less bloating, quieter post-meal reactivity, “accidental gluten buffer,” fewer food-sensitivity days — highly confounded by diet, GFD adherence, and stacks. forum
2026 “gut trifecta” talk: X/peptide blogs name oral larazotide + BPC-157 + KPV as the leaky-gut three. Loud mechanism story; no combo RCT. forum
Phase 2b persistent-symptom CeD (Leffler et al., Gastroenterology 2015): Adults on GFD ≥12 months with ongoing symptoms; larazotide acetate 0.5 mg oral TID for 12 weeks met primary endpoint (improved average on-treatment CeD-GSRS vs placebo); 1 mg and 2 mg TID did not. trial
Symptom-day metrics (0.5 mg TID): ~26% decrease in CeD PRO symptomatic days; ~31% increase in improved/minimal-symptom days vs placebo in the same program. trial
Abdominal domains: Pain, bloating, cramping-type abdominal scores favored the low-dose arm; ≥50% reduction from baseline in weekly average abdominal pain for ≥6 of 12 treatment weeks reported as an exploratory win at 0.5 mg. trial
Non-GI PRO notes: Some 0.5 mg analyses lower headache and tiredness domain scores — still patient-reported, not objective neuro endpoints. trial
Onset in that trial: Symptom separation vs placebo described as evident by treatment week 2 and sustained over the 12-week double-blind window. trial
Gluten-challenge Phase 2 (Kelly et al., ~2.7 g gluten/day × 6 weeks): Larazotide 1 mg TID limited gluten-induced GSRS symptom worsening; 1 mg and 4 mg arms also showed lower anti-tTG IgA rise vs placebo; LAMA permeability primary often failed to separate. trial
Earlier challenge dose-ranging: 0.25–8 mg TID oral ranges with ~2.4–2.5 g gluten/day short challenges — symptom protection most consistent at lower doses; primary LAMA endpoints frequently missed or highly variable. trial
Inverse / flat dose response (key bro talking point): Across programs, lower doses (notably 0.5 mg in real-world GFD residual-symptom study; lower arms in challenges) outperformed higher multi-mg arms on key clinical ends. Authors discuss possible peptide aggregation at higher luminal concentrations reducing activity — not fully settled. trial
Tolerability in controlled CeD work: AE rates often placebo-like overall; no drug-related SAEs highlighted in the large Phase 2b safety summary; vitals/labs/ECGs without notable dose-related red flags in that report. trial
In-vitro / epithelial models: Reduced gliadin-triggered permeability and support for tighter junction assembly / actin reorganization. lab
Animal barrier models: Porcine delayed-release formulation work and ischemia-injury / permeability models show barrier preservation or recovery support under challenge; fragments of the peptide (e.g., VLVQPG) studied for activity/interference at high concentration. animal
MIS-C / post-COVID (early clinical): Open-label and later small randomized pediatric MIS-C work (Mass General Brigham / Yonker et al. line) reported faster GI symptom resolution, faster clearance of circulating SARS-CoV-2 spike antigen in blood, and quicker return toward normal activities vs controls — small N, specialized indication, not consumer “long COVID cure” proof. trial
Yonker 2025 Phase 2a (published): Sci Transl Med; n=12 hospitalized children, oral four times daily × 3 weeks as adjuvant. Faster GI recovery and spike-antigen clearance vs placebo in that tiny trial — hospital MIS-C, not a leaky-gut capsule protocol. trial
What symptom wins are not: Symptom score improvement ≠ proven villous healing, serology cure, or license for unrestricted gluten. Histology/mucosal recovery was not the headline win of the Phase 2b residual-symptom program. trial

Doses people talk about 16

Community “copy the winner” band: ~0.25–0.5 mg oral TID before meals is the most repeated research-chem / clinic chart aiming at the effective low-dose signal. forum
Community wider oral band: ~0.25–1 mg TID (sometimes written 250–1000 mcg per dose) appears in peptide comparison blogs and protocol pages; some once-daily charts exist but conflict with meal-coverage logic and trial TID design. forum
Stack dose etiquette: When combined with BPC-157 and/or KPV, keep each agent in its own usual research band rather than multiplying all three “because barrier.” forum
Same-author community course: One Phoenix Rising user started 250 mcg oral four times daily, moved to 500 mcg four times daily for about seven days, briefly stopped and reported deterioration over three days, then restarted; concurrent drugs and illness confound attribution. forum
Route debate summary: Clinical and serious discussion = oral (often delayed-release/enteric multiparticulate). Inject = outsider vendor culture with no matching Phase 2b/3 celiac program. forum
Peptide-blog wider band (2026): Some gut-stack pages write 0.5–2 mg oral TID 15–30 min before meals for ~12 weeks then a pause — wider than the Phase 2b winner (0.5 mg). Inverse-dose finding still argues against chasing the high end. forumtrial
Gluten-challenge multi-mg TID ranges: Common published arms include 0.25, 1, 4, and 8 mg TID; later challenge work used 1, 4, and 8 mg TID with daily gluten capsules. trial
Early / safety high doses: Single and multi-day oral doses from ~0.25 mg up through 12 mg (and systematic-review mention of ranges extending toward multi-tens of mg in early safety exploration) without a severe drug-related SAE signal in published summaries — still not “more is better” for efficacy. trial
Pre-meal timing (trial-standard): Capsules self-administered ~15 minutes before breakfast, lunch, and dinner so peptide is present with meal antigens. trial
Do not blindly escalate: Inverse dose-response is a repeated finding; community “more peptide = tighter junctions” logic is poorly supported by the human dose-finding pattern. trial
Formulation risk for powder/caps: Trial units used enteric-coated multiparticulate bead capsules designed to release toward mid-duodenum / proximal small bowel; bulk research powder or plain fill may not match luminal delivery. trial
Framing: Figures below are trial arms, protocol writeups, and research-community / vendor-chart discussion — not prescriptions, not approved labeling, not safety clearance for consumer use. forum
Standout Phase 2b dose (residual symptoms on GFD): 0.5 mg oral three times daily — only arm that met the primary CeD-GSRS endpoint vs placebo. trial
Higher Phase 2b arms that did not beat placebo on key ends: 1 mg TID and 2 mg TID in the same Leffler 2015 design. trial
Phase 3 CedLara planned arms: 0.25 mg TID and 0.5 mg TID vs placebo (enteric-coated lower-dose strategy after inverse-dose observations); study discontinued after interim re-estimation. trial
MIS-C early open-label note: Case series described multi-daily oral dosing (four times daily in the early MGH open-label pediatric description) under hospital care — not a consumer wellness schedule. trial

How it may feel 8

No classic “on” rush: Oral barrier peptide; users rarely describe stimulant, cognitive, or systemic “feel” the way injectables do. forum
First week in one report: A user moved from 250 mcg oral four times daily to 500 mcg four times daily and described more strength and less neck/throat pain; hydrocortisone and active illness soon complicated the story. forum
Stop/restart in the same report: The user said symptoms worsened over three days off and energy improved after restarting 500 mcg four times daily, but Q10, B12, LDN, hydrocortisone, exertion and infection all shifted nearby. forum
4–8 weeks wellness talk: Functional-medicine / peptide-clinic blogs often pitch this as the window for “leaky gut” noticeability; evidence quality is far below the celiac RCTs. forum
Beyond 3 months: Continuous “barrier maintenance” while triggers persist is wellness culture, not long-duration RCTs after CedLara stop. forum
No change ~4–12 weeks: Recheck strict GFD/hidden gluten, meal timing of doses, enteric vs plain powder identity, and confounded stacks — inverse-dose lore argues against simple “double it.” forum
Weeks 1–2: Trial narrative and user logs that “work” often cite quieter bloating or less post-exposure anxiety by ~week 2; many notice nothing dramatic. trial
~12 weeks: Main controlled symptom window in the residual-symptom Phase 2b design (plus run-in/run-out context) — not framed as lifetime disease modification. trial

Around the dose 6

Not a pin: SubQ charts for a gut-lumen peptide add injection risk without matching the celiac program. forum
Diet is the other half: Celiac talk still sits on a gluten-free diet. Peptide blogs that skip food are the usual confound. trialforum
After: People treat it as coverage while triggers persist — “it only works while you’re taking it” is the forum line. forum
Stack jobs: Larazotide = tight junctions; BPC = lining-repair lore; KPV = inflammation-calm lore. Three nicknames, still no combo trial. forum
Clock: Oral, ~15 minutes before breakfast, lunch, and dinner in the trial writeups. That is meal coverage, not a morning systemic pin. trial
Don’t double it: Inverse dose-response is the human finding. 0.5 mg TID beat 1–2 mg TID in Phase 2b. trial

Cycles people discuss 8

Wellness continuous use: Forums and clinic blogs often treat TID oral as continuous while dietary triggers, travel, or “leaky gut” goals persist — long-term lifestyle safety/efficacy RCTs are limited after the Phase 3 halt. forum
12-week “trial mirror” cycles: Common research-community habit is to run ~8–12 weeks then reassess diet/labs/symptoms rather than indefinite silent escalation. forum
Pause logic (anecdotal): Stop or pause when symptoms settle and diet is tight, or when no signal by the usual checkpoint; not a guideline. forum
Restart seasons: Restaurant travel, accidental gluten, viral illness, or inflammatory flares — discussed as on-demand restarts without formal on/off protocols. forum
vs classic inject peptide cycles: No standard 5-on/2-off or PCT-style lore dominates; meal-timed continuous oral coverage is the main culture. forum
Phase 2b residual-symptom block: ~4-week placebo run-in → 12 weeks double-blind treatment → ~4-week placebo run-out; mean treatment duration ~80 days in the published cohort. trial
Gluten-challenge blocks: Often ~2 weeks or ~6 weeks of concurrent gluten + drug after GFD run-in — designed to measure acute challenge protection, not long maintenance. trial
Phase 3 CedLara design notes: Multi-week efficacy portion (~12-week primary symptom window) inside a longer (~24-week) study frame; interim analysis on first half of planned enrollment led to stop for futility (impractically large N to show significance). trial

Timing 8

After-dose “feel” duration: User claims of quieter barrier “for a meal window” are anecdotal; no validated consumer wear-off curve. anecdote
NSAIDs / alcohol lore: Community cautions that agents increasing permeability may counteract barrier goals — mechanistic hand-waving, not interaction RCTs. forum
Why TID / meal-linked: Multiple daily pre-meal doses cover repeated luminal antigen windows across the day, not a weekly depot. trial
Porcine delayed-release tissue timing: After a total 1 mg oral dose in fasted pigs, local concentrations peaked around 1 hour in duodenum/proximal jejunum and remained detectable over roughly 2–4 hours; this is animal intestinal exposure, not human plasma half-life. animal
Human plasma half-life: Not established from the reviewed program; protocol summaries report larazotide and metabolites below a 0.5 ng/mL quantification limit after several single and repeated oral regimens. trial
Delayed-release rationale: Enteric multiparticulate designs aim to begin release in mid-duodenum and complete toward proximal small intestine, matching gluten/antigen exposure geography. trial
Brush-border fragments: Larazotide can be cleaved; fragment studies (e.g., VLVQPG) explore residual activity or interference at high local concentrations in injury models — formulation and dose density may matter. animal
Local / gut-restricted PK story: Oral peptide acting at apical epithelium and tight junctions; minimal systemic exposure is the sponsor and review framing — not classic injectable-peptide plasma PK culture. trial

Stacks 10

Barrier + repair (most common): Larazotide + BPC-157 — larazotide for tight-junction / zonulin talk; BPC for mucosal repair / cytoprotection lore. forum
Anti-inflammatory gut: Larazotide + KPV — KPV for NF-κB / cytokine calm; larazotide for junction seal. forum
Triple “leaky gut” stack: Larazotide + BPC-157 + KPV — heavily marketed on clinics, YouTube explainers, and multi-peptide capsules; 2026 X still calls it the “gut trifecta.” Single-agent credit impossible. forum
Quad / blend marketing: Occasional research-chem or formula products list fixed mcg combos (e.g., equal parts BPC + TB-500 + KPV + larazotide in one capsule) — ratios are vendor inventions, not trial designs. forum
Nutrient supports (confounded): L-glutamine, butyrate / tributyrin, zinc carnosine, zinc, collagen, bone broth — standard functional-medicine gut kits. forum
Plant / polyphenol add-ons: Apigenin appears on clinic “gut peptide” menus with larazotide; head-to-head data weak. forum
Microbiome layer: Probiotics / prebiotics discussed as partners once barrier is “quieter”; not proven synergy trials. forum
What people compare it to: Latiglutenase (glutenase enzyme pipeline) vs larazotide (barrier) — different mechanisms, often confused in search. forum
Avoid “counterproductive” lifestyle stacks (lore): High-dose NSAIDs and heavy alcohol flagged in protocol blogs as working against tight-junction goals. forum
Celiac base (non-negotiable in serious discussion): Strict gluten-free diet remains the foundation in all CeD trials — larazotide was studied as add-on for residual symptoms or challenge protection, not a free-gluten license. trial

Access talk 4

Not 503A, not the July 2026 PCAC peptide vote. Larazotide is not legally compoundable on the US bulks list as of 2026 trackers. trialforum
RUO oral vs trial beads: Research powder/caps and N-Ac-Larazotide vendor blends (e.g. gut SKUs next to zinc-L-carnosine) are not the enteric multiparticulate used in CeD trials. forum
Not approved. CedLara stopped 2022 for futility. 9 Meters Biopharma filed Chapter 7 in 2023. No NDA, no celiac label. trial
Hospital MIS-C ≠ Amazon leaky-gut. Yonker 2025 was adjuvant oral in 12 hospitalized children. Not a consumer schedule. trial

Storage notes 2

No mix instructions here: STUDresearch does not list reconstitution, diluent volumes, or syringe unit charts. People reconstitute many different ways and vial labels differ — that content creates more confusion than clarity. forum
Storage (general talk only): Unopened research products are usually kept cool, dry, and away from light per the seller label. Anything after first use is product-specific — follow the label, not a universal forum SOP. forum

Related 8

Watch for 17

Mild nausea / abdominal cramping (community + protocol pages): Usually framed as early, transient, or empty-stomach related. forum
Source / formulation risk: Gray-market orals may lack delayed-release design, correct identity, potency, or impurity control vs trial AT-1001 beads. forum
Inject confusion risk: Following subq charts for a gut-local oral peptide introduces unnecessary injection risk without clinical backing for that route. forum
Indication creep: Autoimmunity, IBS, MCAS, long-COVID, and general inflammation extensions remain largely speculative or early/small clinical outside CeD residual-symptom data. forum
Pregnancy / planning: Not characterized as safe; protocol pages default to avoid unless specialist-directed. forum
Interactions: No rich lifestyle interaction package insert; local action ≠ zero unknowns with concurrent gut-active drugs or permeability-worsening agents. forum
RUO cap ≠ enteric bead. Gray oral powder may miss the delayed-release geography the trials used. forumtrial
Not 503A / not the July 2026 peptide vote. Access is research-chem capsules, not a compounding-pharmacy celiac drug. trialforum
Trial overall AE picture: Safety/tolerability often comparable to placebo across dose levels in Phase 2 residual-symptom and challenge programs. trial
GI events: Abdominal symptoms, diarrhea/loose stool, and related GI TEAEs appear across active and placebo arms — hard to separate from underlying CeD flux. trial
Headache: Among the more frequent TEAEs in dose-ranging/challenge work; weak clear dose-response vs placebo in several summaries. trial
Urinary tract infection signal (some early reports): Listed among >5% events in certain challenge study writeups without driving high dropout — still monitor in source tables. trial
No drug-related SAEs (Phase 2b summary): Published residual-symptom study reported no drug-related serious adverse events and no concerning vitals/lab/ECG pattern by dose. trial
Not a gluten free pass: Barrier talk does not make unrestricted gluten safe; trials kept GFD or used controlled challenge grams — not restaurant free-for-all. trial
Phase 3 futility: CedLara interim (first half of planned ~525-patient, three-arm design) found treatment-effect size would require impractically large additional enrollment; development path for CeD remains uncertain post-2022 stop. trial
Inverse-dose caution: Escalating above the low effective band may waste product or worsen outcomes per human dose-finding pattern — not just “more side effects.” trial
MIS-C / pediatric use: Early promising signals under specialist care — not self-experiment territory; different risk and consent context. trial

Updated: 2026-09-01

Evidence mix More trial/lab tags than forum tags Full: every bullet (trial + community). Use Scan for a faster bro-science read.

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Half-life & effect duration

Timing context & sources⌄

Half-life in the body

Felt duration people report

Other context in this card

What people say 17

Doses people talk about 16

How it may feel 8

Around the dose 6

Cycles people discuss 8

Timing 8

More on what it is 9

Stacks 10

Access talk 4

Storage notes 2

Related 8

Watch for 17

Timing context & sources