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KAN-101

Phase 2

Celiac Disease | Small molecule | Gastrointestinal |Pfizer, Inc.|Last Updated: Dec 18, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

KAN-101 · 1 trial · 2 indications

Phase 2 1
NCT06001177A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac DiseaseCeliac Disease
COMPLETED55 Analytics
PHASE2COMPLETED
A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease
Celiac Disease
NCT0600117755
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Study Endpoints

Primary Endpoints

Changes From Baseline in Villous Height to Crypt Depth (Vh:Cd) as Assessed by Esophagogastroduodenoscopy With Biopsy After 2-week Gluten Challenge (GC)
Baseline and Day 29

KAN-101 attenuated GC-induced changes in duodenal histology as measured by the Vh:Cd ratio.

Secondary Endpoints

Change in Magnitude of Interleukin-2 (IL-2) Response From Day 15 (First Day of GC) Pre-GC to Day 15 Post GC
From Day 15 pre-GC to Day 15 post GC
Changes From Baseline in Intraepithelial Lymphocyte (IEL) Density in Duodenum Biopsy After 2-week GC
Baseline and Day 29
Incidence and Severity of Treatment Emergent Adverse Events (TEAE) as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
From the time the participant provided informed consent through Day 42.
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALAll eligible participants will receive 3 intravenous (IV) infusions of KAN-101
Group 2PLACEBO_COMPARATORAll eligible participants will receive 3 intravenous (IV) infusions of placebo

Interventions

NameTypeDescription
KAN-101DRUGDose KAN-101 Intravenous (IV) Infusion
PlaceboDRUGPlacebo Intravenous (IV) Infusion
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Previous diagnosis of celiac disease based on histology and positive celiac serology * HLA-DQ2.5 genotype * Gluten-free diet for at least 12 months * Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening * Screening i...

Countries:United StatesCanadaFinlandGermanyIrelandIsraelNetherlandsPoland
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Competitive Landscape -Celiac Disease 5 trials

CompanyTickerTrialsLead PhaseDrugs
Sanofi SA Sponsored ADRSNY1PHASE2Amlitelimab
Forte Biosciences Inc.FBRX1PHASE2FB102
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA1PHASE2TEV-53408
Barinthus Biotherapeutics plc Sponsored ADRBRNS1EARLY_PHASE1VTP-1000
TScan Therapeutics, Inc.TCRX1 - Undisclosed
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Frequently asked questions about KAN-101

What is KAN-101 used for?

KAN-101 is an investigational small molecule being developed for the treatment of celiac disease, also known as coeliac disease. It is intended for adults with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does KAN-101 target?

The specific molecular target of KAN-101 has not been disclosed. It is a small molecule modality being studied for its efficacy, safety, and tolerability in people with celiac disease. The mechanism of action is not publicly detailed in available information.

Who makes KAN-101?

KAN-101 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this investigational drug for celiac disease.

What phase is KAN-101 in?

KAN-101 is in Phase 2 clinical development. A Phase 2 study has been completed, which was a randomized, double-blind, placebo-controlled trial involving 55 participants. The drug remains investigational and is not yet approved for any use.

What clinical trials is KAN-101 in?

KAN-101 has one completed clinical trial registered as NCT06001177, titled "A Study of Efficacy, Safety, and Tolerability of KAN-101 in People With Celiac Disease." This Phase 2 study enrolled 55 adults with celiac disease across multiple countries, including the United States, Canada, and several European nations.

Is KAN-101 the same as any other drug?

No alternative names for KAN-101 have been identified. It is referred to solely as KAN-101 in clinical trial records and development documentation. No other drug names have been associated with this investigational compound.