Prevention-First Medicine Starts Here.

Strengthening mucosal defenses across immune-mediated disease.

Protecting Gut Integrity to Prevent Disease.

Building the Future of Barrier-Protective Therapies.

A First-in-Class Therapy for Celiac Disease — and Beyond.

Freedom to Eat. Confidence to Live.

About Us

Interlude Biopharma is pioneering therapies that preserve gut integrity and prevent inflammation at its source. Our lead candidate, Larazotide Acetate, is a Phase 3–ready, first-in-class peptide therapy designed to protect patients with celiac disease from gluten-induced immune activation — a breakthrough for millions living without an approved treatment today.

Our Science — A Prevention‑First Approach

Chronic inflammation begins when the body’s natural defenses break down. When tight junctions in the intestinal lining loosen, gluten fragments and toxins cross into the bloodstream — triggering immune activation and lasting tissue damage.

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Our Lead Candidate — Larazotide Acetate (NCE)

Larazotide Acetate is the first oral peptide designed to reinforce the gut’s natural defense system by blocking zonulin, keeping tight junctions closed, and preventing inflammation before it starts.

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Pipeline — Platform for Preventive Medicine

Interlude Biopharma’s pipeline extends its prevention‑first science into diseases driven by epithelial disruption — from autoimmune and inflammatory to post‑infectious conditions.

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Research & Development

Interlude Biopharma is actively advancing a diversified drug development pipeline aimed at addressing significant unmet medical needs and chronic conditions. The pipeline includes ongoing and planned clinical trials evaluating larazotide acetate, a tight junction modulator, for indications such as celiac disease, Long COVID, multisystem inflammatory syndrome in children (MIS-C), and rheumatoid arthritis.

Additionally, the company has received orphan drug designation in the European Union for the use of oxymetazoline gel in the treatment of neurogenic fecal incontinence associated with spinal cord injury (SCI). In the United States, secretin—designated as an orphan drug—is being developed as a diagnostic agent for magnetic resonance cholangiopancreatography (MRCP).

Interlude Biopharma remains committed to advancing these therapeutic and diagnostic candidates with the goal of addressing critical gaps in care and improving outcomes for underserved patient populations.

Our Pipeline

Our Science

Protecting Gut Integrity to Prevent Disease.

Building the Future of Barrier-Protective Therapies.

Chronic inflammation begins when the body's natural defenses break down. When tight junctions in the intestinal lining loosen, gluten fragments and toxins cross into the bloodstream — triggering immune activation and lasting tissue damage.

Larazotide Acetate acts locally in the gut to help keep these junctions closed, supporting the body's natural defense before inflammation begins.

Targets the zonulin pathway to maintain gut integrity

Locally acting, non-systemic peptide designed for long-term safety

Upstream mechanism halts immune activation at its source

Platform potential across autoimmune, inflammatory, and post-infectious diseases

By preserving gut integrity, we're shifting medicine from treating inflammation to preventing it.

Laboratory research supporting translational development

Gluten exposure

Trigger

Zonulin signaling

Signal cascade

Tight-junction opening

Increased permeability

Larazotide

Pathway modulation

Restored lining

Reduced permeability

Pipeline

Building the Future of Barrier-Protective Therapies.

Interlude Biopharma's pipeline extends its prevention-first science into diseases driven by epithelial disruption — from autoimmune and inflammatory to post-infectious conditions.

Program

Larazotide Acetate

Indication

Celiac Disease

Modality

Oral Tight-Junction Regulator

Stage

Phase 3 Ready Fast Track

Program

Larazotide Next-Gen

Indication

MIS-C, Long COVID

Modality

Oral Peptide

Stage

Phase 2

Program

D‑Larazotide

Indication

Undisclosed

Modality

Oral Peptide

Stage

Pre‑IND

Program

Oxymetazoline Gel

Indication

Neurogenic Fecal Incontinence (SCI)

Modality

Topical Alpha‑Agonist

Stage

Phase 2b EMA Orphan Drug

Program

Secretin (IV)

Indication

Pancreatic Imaging

Modality

Peptide Imaging Agent

Stage

Phase 3 Redesign

One mechanism. Many diseases. Limitless potential.

Our Lead Candidate | Larazotide Acetate

A First-in-Class Therapy for Celiac Disease — and Beyond.

Celiac disease affects millions worldwide, and even trace gluten exposure can cause debilitating symptoms. Despite strict gluten-free diets, most patients remain symptomatic and lack any approved preventive therapy.

Larazotide Acetate is the first oral peptide designed to reinforce the gut’s natural defense system by blocking zonulin, keeping tight junctions closed, and preventing inflammation before it starts.

Prevents flare-ups from hidden gluten exposure

Reduces inflammation and supports mucosal healing

Improves quality of life and confidence around meals

Safe for long-term use alongside a gluten-free diet

Scientific Validation

26%

Overall symptom reduction

50%

Less abdominal pain

31%

More symptom-free days

Excellent safety profile: < 1% systemic absorption, no drug-related serious events.

For Patients & Caregivers

Freedom to Eat.
Confidence to Live.

People with celiac disease live in constant vigilance — every meal a potential risk. Cross-contamination can mean days of pain, fatigue, and anxiety.

Larazotide Acetate is an investigational therapy designed to help strengthen the gut’s natural defense, with the goal of reducing the immune activation that can begin when gluten exposure occurs — giving patients the confidence to share meals, travel, and reconnect socially.

Protecting gut integrity means protecting every meal, every day.

FAQs

How does Larazotide work?

Larazotide Acetate is being studied for its potential to help support the gut barrier. In clinical research, it is designed to help reduce the passage of gluten-related fragments across the intestinal lining that can contribute to immune activation. It remains investigational.

Is it safe for long-term use?

Safety is evaluated continuously in clinical studies. Larazotide Acetate has been assessed across multiple trials, but it is not yet approved for use, and long-term safety continues to be studied. Your trial site team can review known risks and what monitoring is included.

When and where can I join a clinical trial?

Eligibility and locations vary by study. You can review current opportunities on our Clinical Trials page and through ClinicalTrials.gov, then contact the listed study site for screening details.

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Clinical Trials

Turning Scientific Promise
Into Patient Reality.

Each Interlude Biopharma trial represents a step toward making prevention the new standard of care. We design studies with scientific rigor, regulatory alignment, and compassion for the patients we serve.

Launch 1H 2026

Phase 3 Celiac Prevention Trial

U.S./Canada

Co-primary endpoints: symptom improvement and histologic protection

Ongoing

Phase 2 Long COVID Trial

Evaluating barrier restoration in post-infectious inflammation

View on ClinicalTrials.gov

Because protecting the body’s defenses means protecting life itself.

Clinical Development Milestones

Partnerships

Expanding Global Impact Through Collaboration.

Interlude Biopharma welcomes strategic partners to accelerate development and global access to its first-in-class peptide therapies.

We collaborate with organizations that share our mission to protect barrier integrity and make prevention the new standard of care.

Innovative science rooted in the pioneering research of Alessio Fasano, MD
Vice Chair of Research, Massachusetts General for Children
Director of the Mucosal Immunology and Biology Research Center
Professor of Pediatrics and Nutrition, Harvard Medical School

Late-stage programs with Fast Track designation

Strong intellectual property and manufacturing capability

Flexible co-development and regional licensing models

Together, we can make prevention the future of medicine.

Leadership Team

From Innovation to Impact.

Interlude Biopharma's leadership brings together scientific pioneers and industry veterans with decades of experience in drug development, regulatory strategy, and commercialization.

Each shares a commitment to transforming breakthrough science into tangible, life-changing therapies.

Mark Paresky

Chairman

Jay Madan

President

Subbarao Jayanthi

Chief Business Officer