Overview
Human secretin is a gastrointestinal peptide hormone that regulates secretions in the stomach, pancreas, and liver. The hormone is produced from the enterochromaffin cells in the duodenum in response to the duodenal content with the pH less than 4.5 . The main action of secretin is to stimulate the pancreas to secrete pancreatic juice for pH regulation in the small intestines. Secretin is also responsible in body fluid homeostasis and bile production. Although it is a gastrointestinal hormone, secretin is also considered as a neuropeptide hormone since it is also expressed in the central nervous system . Purified synthetic human secretin, also referred to as RG1068, is available as an intravenous injection under the market name ChiRhoStim ® in the U.S.. It contains an amino acid sequence identical to the naturally occurring hormone consisting of 27 amino acids that supports α-helical formation . The carboxyl-terminal amino acid, valine, is amidated. Synthetic human secretin displays equivalent biological activity and properties as naturally-occurring secretin . It is indicated for the stimulation of the pancreatic and gastric secretions to aid in the diagnosis of pancreatic exocrine dysfunction and the diagnosis of gastrinoma, and facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).
Indication
Indicated for the stimulation of:
Associated Conditions
- Gastrinoma
- Pancreatic exocrine dysfunction
Research Report
Secretin Human (DB09532): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Investigational Horizons
1.0 Executive Summary
[Secretin human (DrugBank ID: DB09532) is a synthetic, 27-amino acid peptide hormone that is chemically and biologically identical to endogenous human secretin. Initially recognized over a century ago as the first-ever described hormone, its modern clinical application has been refined into a highly specific diagnostic tool in gastroenterology. Marketed principally under the brand name ChiRhoStim®, this biotech drug serves an indispensable role in the diagnostic evaluation of pancreatic exocrine function, the provocative testing for gastrin-secreting neuroendocrine tumors (gastrinomas), and the procedural facilitation of complex endoscopic retrograde cholangiopancreatography (ERCP). Its mechanism of action is centered on its binding to G-protein coupled secretin receptors, primarily stimulating the secretion of a large volume of bicarbonate-rich fluid from the pancreas and biliary tree, thereby neutralizing duodenal acid and creating an optimal environment for digestion.]
[The pharmacological profile of Secretin human is characterized by a rapid onset of action following intravenous administration and a short elimination half-life of approximately 45 minutes. This pharmacokinetic profile is ideally suited for its function as a diagnostic agent, enabling a transient, controlled physiological challenge with a swift return to baseline. However, this same characteristic presents the primary barrier to its use as a chronic therapeutic agent. The safety profile is favorable, with most adverse events being mild and transient, such as nausea and flushing. The most significant clinical risks are not related to direct toxicity but to the potential for diagnostic misinterpretation due to critical pharmacodynamic interactions with common medications like anticholinergics and acid-suppressing agents.]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/06/22 | Phase 3 | Recruiting | Fundacion Clinic per a la Recerca Biomédica | ||
2022/12/21 | Phase 4 | ENROLLING_BY_INVITATION | |||
2020/11/03 | Not Applicable | Completed | |||
2020/01/18 | Phase 3 | Terminated | |||
2018/09/27 | Phase 2 | UNKNOWN | |||
2018/08/07 | Phase 1 | Completed | |||
2018/01/19 | N/A | Completed | |||
2017/09/25 | Phase 2 | Completed | |||
2016/08/17 | Not Applicable | Completed | |||
2015/05/29 | Phase 1 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
ChiRhoClin, Inc. | 67066-007 | INTRAVENOUS | 40 ug in 10 mL | 10/14/2021 | |
ChiRhoClin, Inc. | 67066-005 | INTRAVENOUS | 16 ug in 8 mL | 10/14/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SECRETIN INJ 75UNIT/VIAL | Ferring Inc | 00874000 | Powder For Solution - Intravenous | 75 UNIT / VIAL | 12/31/1990 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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