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benzoyl-L-tyrosyl-alanine

Phase 2

Chronic Pancreatitis | Small molecule | Gastrointestinal |Meridian Bioscience Inc|Trials Updated: Dec 20, 2022

benzoyl-L-tyrosyl-alanine target and mechanism

ModalitySmall molecule

Also known as benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

benzoyl-L-tyrosyl-alanine clinical trials

benzoyl-L-tyrosyl-alanine · 1 trial · 2 indications

Phase 2 1
NCT01259544BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine InsufficiencyChronic Pancreatitis
COMPLETED33 Analytics
PHASE2COMPLETED
BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency
Chronic PancreatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

To assess the pancreatic exocrine insufficiency using a 13C labeled di-peptide breath tests in patients with chronic pancreatitis(CP) and show correlation with secretin stimulated endoscopic Pancreatic Function Test (ePFT).
1 hour

This breath test substrate is new and is hypothesized, based on preliminary studies, that it may be the answer to a much needed non-invasive pancreatic function test. At first stage, it will be compared to the current invasive gold standard: secretin induced ePFT.

Secondary Endpoints

To assess the ability to differentiate between non patients with chronic pancreatitis and those without.
1 hour
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Di -petide breath tests and ePFT secretin inducedACTIVE_COMPARATORDi peptide breath tests will be performed on subjects with known chronic pancreatitis
c13 di peptide breath testsACTIVE_COMPARATORHealthy volunteers to compare breath tests results to subjects with chronic pancreatitis

Interventions

NameTypeDescription
benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)DRUG300 mg of powder form dissolved in one cup of tap water prior to breath test
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Patients with chronic pancreatitis who meet at least one of the following criteria: * Adult men or women \>18 years of age. * Endoscopic retrograde cholangiopancreatography (ERCP), magnetic resonance cholangiopancreatography (MRCP), or endoscopic ultrasound demonstrati...

Countries:India
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Frequently asked questions about benzoyl-L-tyrosyl-alanine

What is benzoyl-L-tyrosyl-alanine used for?

Benzoyl-L-tyrosyl-alanine is being studied for chronic pancreatitis, specifically as a diagnostic agent for detecting pancreatic exocrine insufficiency. It is a small molecule developed by Meridian Bioscience Inc and is in Phase 2 clinical development.

Who is developing benzoyl-L-tyrosyl-alanine?

Benzoyl-L-tyrosyl-alanine is being developed by Meridian Bioscience Inc, which trades under the ticker VIVO. The company is responsible for its clinical development in chronic pancreatitis.

What phase is benzoyl-L-tyrosyl-alanine in?

Benzoyl-L-tyrosyl-alanine is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. One Phase 2 trial has been completed, and no active trials are currently listed.

What clinical trials is benzoyl-L-tyrosyl-alanine in?

Benzoyl-L-tyrosyl-alanine has been evaluated in one completed Phase 2 trial, NCT01259544, titled "BreathID Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency." The trial enrolled 33 participants with chronic pancreatitis or healthy volunteers in India.

Is benzoyl-L-tyrosyl-alanine the same as benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)?

Yes, benzoyl-L-tyrosyl-alanine is also known as benzoyl-L-tyrosyl-[1-13C]alanine, often abbreviated as Bz-Tyr-Ala. These names refer to the same investigational compound being developed by Meridian Bioscience Inc.