Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
benzoyl-L-tyrosyl-alanine · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| Di -petide breath tests and ePFT secretin induced | ACTIVE_COMPARATOR | Di peptide breath tests will be performed on subjects with known chronic pancreatitis |
| c13 di peptide breath tests | ACTIVE_COMPARATOR | Healthy volunteers to compare breath tests results to subjects with chronic pancreatitis |
| Name | Type | Description |
|---|---|---|
| benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala) | DRUG | 300 mg of powder form dissolved in one cup of tap water prior to breath test |
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...
Benzoyl-L-tyrosyl-alanine is an investigational small molecule being developed for chronic pancreatitis, a gastrointestinal condition. It is being studied as a diagnostic agent to detect pancreatic exocrine insufficiency, which is a common complication of chronic pancreatitis. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
Benzoyl-L-tyrosyl-alanine is being developed by Meridian Bioscience Inc, a company traded on the NASDAQ under the ticker symbol VIVO. The company is conducting clinical research to evaluate the drug's potential as a diagnostic tool for pancreatic exocrine insufficiency in patients with chronic pancreatitis.
Benzoyl-L-tyrosyl-alanine is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The drug is being studied for its ability to detect pancreatic exocrine insufficiency in patients with chronic pancreatitis, and it remains in active clinical investigation.
Benzoyl-L-tyrosyl-alanine has one completed Phase 2 clinical trial registered as NCT01259544, titled "BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine Insufficiency." The trial enrolled 33 participants, including patients with chronic pancreatitis and healthy volunteers, and was conducted in India. The study was active-controlled but not randomized or double-blinded.
Benzoyl-L-tyrosyl-alanine is a small molecule designed to detect pancreatic exocrine insufficiency. It is used as a substrate in a breath test, where its metabolism by pancreatic enzymes produces a detectable byproduct in exhaled breath. This allows for non-invasive assessment of pancreatic function in patients with chronic pancreatitis.