Is secretin FDA-approved, and what does the research show?

What is secretin?

Secretin is a hormone the body makes in the duodenum, the first part of the small intestine ¹. The label says it is released when stomach acid, fatty acids and amino acids reach the intestinal lining ¹. Its receptors sit in the pancreas, stomach, liver, colon and other tissues ¹. Its main job is to make the pancreas pour out a large volume of watery fluid rich in bicarbonate, the alkali that neutralizes stomach acid ¹.

The approved human product, ChiRhoStim, is synthetic human secretin, a chain of 27 amino acids with the same sequence as the natural hormone ¹. ChiRhoClin, Inc. supplies it for intravenous injection ¹. Secretin is not a wellness, weight-loss or performance peptide. It is a hospital diagnostic agent, given by a physician, by intravenous injection, as part of a test of how the pancreas or a suspected tumor responds ¹.

Is secretin FDA-approved?

Yes, as a prescription diagnostic agent. FDA approved ChiRhoStim (human secretin) on April 9, 2004, under NDA 021256 ¹, ². Its marketing status is "Prescription" as of November 9, 2026, the date of the Drugs@FDA record's data ².

The label lists three indications, each "for the stimulation of" a secretion ¹. The first is "pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction," the exocrine pancreas being the part that makes digestive juice ¹. The second is "gastrin secretion to aid in the diagnosis of gastrinoma," a tumor that releases gastrin, the hormone that drives stomach acid ¹. The label also calls that condition Zollinger-Ellison syndrome ¹.

The third is "pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP)" ¹. ERCP is an endoscopy of the bile and pancreatic ducts, and the ampulla and the papilla are the small openings the endoscopist must find ¹.

Each use is a test or an aid to a procedure, and the label names no condition that secretin treats ¹. It says stimulation testing "should only be performed by physicians with sufficient expertise," in an institution with its own normal ranges ¹. The label does not list secretin-enhanced MRCP, an MRI scan of the pancreatic duct studied with secretin in a trial published in 2014, among its indications ³, ¹. The imaging use on the label is during ERCP ¹.

Drugs@FDA holds three other secretin applications ⁶, ⁷, ⁸. Porcine secretin, the pig form of the hormone, under NDA 021209 from the same company, was approved April 4, 2002 and is listed as "Prescription" ⁶. SecreFlo, a synthetic porcine secretin under NDA 021136, was approved the same day and is listed as "Discontinued" ⁷. Secretin-Ferring, NDA 018290, is listed as "Discontinued" ⁸. FDA withdrew approval of Secretin-Ferring (NDA 018290) effective September 17, 2003, after its holder told the agency the product was "no longer marketed" ⁹.

See the FDA status of every peptide, updated weekly.

How does secretin work?

The account is the label's, for an approved drug ¹. Its "primary action" is "to stimulate pancreatic ductal cells to secrete pancreas fluid in large volumes that contain bicarbonate" ¹.

When secretin binds its receptors on the duct cells, it opens CFTR channels, and bicarbonate-rich fluid follows ¹. CFTR is named for cystic fibrosis, the disease in which that channel is faulty ¹. The label adds that it may also act through the vagus nerve ¹. Stimulating that nerve raises bicarbonate secretion, and atropine, an anticholinergic drug, blocks the response ¹.

In the gastrinoma test the logic is reversed: a gastrinoma releases gastrin when secretin arrives, while healthy people and people with duodenal ulcers show little or no change ¹. A rise of more than 110 picograms per milliliter over the starting level is the label's threshold for a positive test ¹. In 12 healthy subjects given a single intravenous dose, blood levels of secretin fell back to baseline within 90 to 120 minutes ¹. The elimination half-life, the time for half the hormone to leave the blood, was 45 minutes ¹.

What does the research show?

The evidence is at the top tier for the three approved uses, and the label's clinical studies are small ¹. For the pancreatic function test, three crossover studies, in which every patient receives each product in turn, gave 21 patients with chronic pancreatitis synthetic human secretin and two porcine forms ¹. All 21 had a peak bicarbonate concentration, measured in fluid collected from the duodenum, below 80 milliequivalents per liter ¹. In another study, 35 healthy subjects received the human form, and all 35 reached at least 80, with a mean of 100 ¹. The label calls the values in its figures guidelines from skilled investigators that should not be generalized to other laboratories ¹.

For gastrinoma, a three-way crossover study gave 6 patients with tissue-confirmed tumors each of the three secretin products, and every one tested positive ¹. Twelve healthy subjects tested negative ¹. For ERCP, a randomized crossover study, in which each patient got secretin and a placebo, a dummy injection, in turn, enrolled 24 patients with pancreas divisum ¹. That is a variant of the duct anatomy in which the pancreas drains through the accessory papilla, the smaller opening ¹. Secretin allowed the endoscopist to pass a tube into the smaller duct (cannulation) in 16 of the 24, against 2 of 24 with placebo ¹.

Studied in people for imaging: a phase 3 study, the trial stage that precedes an approval, enrolled 258 patients with acute or acute recurrent pancreatitis scheduled for ERCP ³, ¹⁰. It ran at several centers and was published online in June 2014 ³. Each patient had a baseline MRCP (magnetic resonance cholangiopancreatography), then a dose of synthetic human secretin, RG1068, and a repeat scan, with ERCP within 30 days as the reference test ³.

There was no placebo arm: the study was baseline-controlled, each patient's own unstimulated scan being the comparison, in a single-group design ³, ¹⁰. Of the 258, 251 image sets were assessed and 236 patients had evaluable ERCPs, which showed duct abnormalities in 60.2 percent ³. All three radiologists, reading independently and blinded, found a higher share of the real abnormalities, the sensitivity, on the secretin-stimulated images ³. The difference was too large to be chance (P < .0001), and it came "with minimal loss of specificity," the share of healthy ducts correctly cleared ³. The authors concluded that secretin-stimulated MRCP "could aid in diagnosis and clinical decision making" in pancreatitis; the sponsor was Repligen Corporation ³, ¹⁰.

Studied in people for autism: after secretin was proposed for autism in 1998 on anecdotal evidence, and publicity about one child who improved, thousands of children may have received it ⁴, ⁵. A placebo-controlled trial published in December 1999 randomized 60 children aged 3 to 14 with autism or pervasive developmental disorder, a related developmental diagnosis ⁴. It was double-blind: neither the doctors nor the families knew who received secretin and who received saline, each child getting a single intravenous dose ⁴.

Among the 56 who completed it, 28 in each group, secretin was not associated with significant improvement on any outcome measure ⁴. The Autism Behavior Checklist score fell by 8.9 in the secretin group and 17.8 in the placebo group ⁴. The mean difference was -8.9, with a 95 percent confidence interval of -19.4 to 1.6 ⁴. The authors concluded that a single dose "is not an effective treatment for autism or pervasive developmental disorder" ⁴.

A Cochrane review published in April 2012 found 16 randomized controlled trials of intravenous secretin against placebo in autism spectrum disorders, with over 900 children recruited ⁵. Meta-analysis was not possible, but the authors found "consistency of findings, with RCTs of the efficacy of secretin in autism not showing improvements for core features of ASD" ⁵. Their conclusion: "There is no evidence that single or multiple dose intravenous secretin is effective and as such currently it should not be recommended or administered as a treatment for ASD" ⁵.

The label names no use for weight, metabolism, muscle, aging or performance ¹. The label states that safety and effectiveness in children "have not been established" ¹.

What are the side effects?

The label's side-effect data come from 531 patients in one open-label trial, where everyone knew what was given, aged 1 to 91, 185 male and 346 female ¹. They had known or suspected disease of the exocrine pancreas, including chronic pancreatitis and pancreatic cancer, and most received a single dose ¹. Nausea was reported by 9 of the 531, vomiting by 3, and flushing and upset stomach by 2 each ¹. The label lists no contraindications: the section reads "None" ¹.

In the 258-patient imaging study, adverse events were reported in 38.0 percent of patients after the secretin-enhanced MRCP and 68.1 percent after the ERCP that followed ³. Of 55 patients with a serious adverse event, 3 (1.2 percent) had events that occurred around the time of the MRCP and 52 (20.5 percent) around the ERCP ³. The events most often judged related to secretin were nausea, abdominal pain and flushing, and most were mild ³. In the 1999 autism trial, none of the children had treatment-limiting adverse effects ⁴.

The label's warnings concern results that can mislead rather than harm to the patient ¹. Patients who have had a vagotomy, who have inflammatory bowel disease or who take anticholinergic drugs may show a "hyporesponse," a blunted result ¹. Patients taking H2-receptor antagonists or proton pump inhibitors, two kinds of acid-reducing drug, may show a rise in gastrin "falsely suggesting gastrinoma" ¹. The label tells physicians to stop those drugs before the test ¹.

Patients with alcoholic or other liver disease "may be hyperresponsive," which can mask a coexisting pancreatic disease ¹. There are no data in pregnancy or breastfeeding ¹. Among the 11 percent of the 531 who were 65 or older, the label found no overall difference in safety or response ¹.

In sport

Secretin is not named on WADA's 2026 Prohibited List ¹¹. WADA, the World Anti-Doping Agency, lists peptide hormones, growth factors and related substances in section S2, and secretin appears neither there nor in any other section ¹¹. Because the drug is given by intravenous injection, WADA's method rule M2.2 applies to the route: it prohibits "intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations" ¹¹.

Section S0 of the list reads: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times" ¹¹. FDA's approval of ChiRhoStim is for the stimulation of secretions "to aid in the diagnosis of pancreatic exocrine dysfunction," "to aid in the diagnosis of gastrinoma" and "to facilitate the identification of the ampulla of Vater and accessory papilla" during ERCP ¹.

What JumpstartMD offers

JumpstartMD does not prescribe secretin. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

Ready to talk?

Book FREE Consultation

Share your details and a JumpstartMD team member will reach out shortly. Or call 408.478.3496 for your free, no-obligation consultation.

Share your details and a JumpstartMD team member will reach out when we open.

Disclaimer

Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.