Secretin is a gastrointestinal peptide hormone that was first identified
by Jorpes and Mutt in 1961. Secretin and other members of the VIP family
of peptides have been studied and reported in the literature. The primary
FDA approved clinical indications for the previous marketed porcine
secretin were: 1) Exocrine Pancreas Function Test; 2) Zollinger-Ellison
Syndrome Test, and 3)Stimulation of pancreatic secretions to facilitate the
identification of the ampulla of Vater and accessory papilla during
endoscopic retrograde cholangio-pancreatography (ERCP).
Synthetic Porcine Secretin
NDA submitted May, 1999; First approvable letter March, 2000; Second
approvable letter November, 2000. NDA Approval April 5, 2002.
ChiRhoClin will continue to be responsible for manufacturing, medical,
regulatory activities, marketing and distribution.
Synthetic Human Secretin
NDA Submitted March, 2000; NDA amendment June, 2001. Approvable letter
received on December 14, 2001.
Human Secretin NDA Approved on April 9th, 2004
ChiRhoStim™(Human Secretin for Injection) is approved, for the diagnostic
indications of exocrine pancreas function test, facilitated cannulation
during ERCP procedures, and Zollinger-Ellison Syndrome test.
Dosing and Reconstitution
Secretin for Injection) is
reconstituted with eight (8) mL of saline for injection.
reconstitution, the resulting solution should be used within 60 minutes.
One ( 1 ) microgram ( mcg ) of Synthetic Human
is approximately equal to five ( 5 ) clinical units ( CU ).
Exocrine Pancreas Function testing:
-Dose 0.2 mcg/kg
Zollinger - Ellison Syndrome testing:
-Dose 0.4 mcg/kg