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TEV-53408

Phase 2

Celiac Disease | Small molecule | Gastrointestinal |Teva Pharmaceutical Industries Limited|Trials Updated: Apr 8, 2026

TEV-53408 development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Oct 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment88

FDA Designations

No designations recorded

TEV-53408 clinical trials

TEV-53408 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT06807463A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac DiseaseCeliac Disease
ACTIVE NOT_RECRUITING50 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease
Celiac DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Villous Atrophy as Measured by Villous Height to Crypt Depth Ratio (Vh:Cd)
Baseline, Week 8

Vh:Cd is used to assess the severity of celiac disease. It is calculated by dividing the villous height by the crypt depth. A lower ratio indicates more damage.

Number of Participants With at Least One Treatment-Emergent Adverse Event
Up to Week 28
Number of Participants With at Least One Treatment-Emergent Serious Adverse Event
Up to Week 28
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest (PDAESI)
Up to Week 28
Number of Participants Who Discontinued From the Study Due to an Adverse Event
Up to Week 28
Number of Participants With at Least One Serious Treatment-Emergent Adverse Event
Up to Week 40
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Up to Week 40
Number of Participants With at Least One Treatment-Related Adverse Event
Up to Week 40
Number of Participants who Discontinued Treatment due to an Adverse Event
Up to Week 40

Secondary Endpoints

Change From Baseline in Intraepithelial Lymphocyte (IEL) Density
Baseline, Week 8
Change From Baseline in the VCIEL score
Baseline, Week 8
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Week 40 to Week 80
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TEV-53408EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
TEV-53408DRUGSolution for subcutaneous (sc) injection
PlaceboDRUGSolution for subcutaneous (sc) injection
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Diagnosis of celiac disease at least 12 months prior to screening * On a gluten-free diet for at least 12 months prior to screening * Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the trial period * Male participants (including vasectomized...

Countries:United StatesAustraliaFinland
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Competitive Landscape -Celiac Disease 4 trials

Frequently asked questions about TEV-53408

What is TEV-53408 used for?

TEV-53408 is an investigational small molecule being studied for the treatment of vitiligo and celiac disease. It is currently in clinical development, with trials evaluating its safety and efficacy in both conditions. The drug is not yet approved and remains under investigation.

Who makes TEV-53408?

TEV-53408 is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker TEVA. Teva is conducting clinical trials to evaluate the drug's safety and efficacy in vitiligo and celiac disease.

What phase is TEV-53408 in?

TEV-53408 is in Phase 2 clinical development for celiac disease, with an active trial assessing its efficacy and safety in adults. A separate Phase 1 trial for vitiligo is also active but not recruiting. The drug remains investigational and is not FDA approved.

What clinical trials is TEV-53408 in?

TEV-53408 is being studied in two clinical trials. NCT06625177 is a Phase 1 trial testing safety and efficacy in vitiligo, enrolling 38 participants in the United States. NCT06807463 is a Phase 2 trial for celiac disease, enrolling 50 adults across the United States, Australia, and Finland.

Is TEV-53408 the same as any other drug?

No alternative names for TEV-53408 have been disclosed. The drug is identified solely by its code name TEV-53408 in clinical trial registrations and development communications from Teva Pharmaceutical Industries.