Gut peptides

Secretin

Synthetic human secretin; ChiRhoStim

US status
FDA-approved
Class
Gut peptides
Approved product
ChiRhoStim (2004); Porcine Secretin (2002)
Route
Intravenous, as an approved diagnostic product

By Diane Walker · Reference Editor · Reviewed September 2026

Regulatory record

3 dated actions on record.
April 2002
FDA approves Porcine Secretin under new drug application 021209; the product remains prescription-only.
April 2004
FDA approves ChiRhoStim, synthetic human secretin, under new drug application 021256, in 16 microgram and 40 microgram vials for intravenous use. Two earlier secretin products, SecreFlo and Secretin-Ferring, are recorded in Drugs@FDA as discontinued.
May 2026
The section 503A bulks list published May 14, 2026 lists Secretin, human 99% in Category 3, the file for substances nominated without adequate support to evaluate. A bulk nomination for a substance that is already the active ingredient of an approved product raises the essentially-a-copy question that section 503A exists to control.

Every entry above is dated; the record is current as of the review date.

Definition

Secretin is a twenty-seven-amino-acid hormone released by the duodenum, which signals the pancreas to secrete bicarbonate-rich fluid. It was the first substance ever called a hormone, and it belongs to the same structural family as vasoactive intestinal peptide and the incretins.

In United States medicine it is a diagnostic agent: given intravenously, it provokes a pancreatic response that can be measured. This index tracks it because it holds two positions at once that are usually reported as mutually exclusive — an approved product, and a bulk nomination the FDA filed as inadequately supported.

Evidence

Across three name variants PubMed returns 9,152 indexed records, of which 4,793 carry the Humans subject heading, 215 the clinical-trial publication type, and 103 the randomized-controlled-trial type [1]. The literature is above this index's itemization ceiling and is reported as a magnitude; the twenty-five most relevant randomized records were read to characterize it [1]. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type; the invalid tag returned zero for that control term; and a deliberately invalid record identifier errored in the same run [1].

The literature divides cleanly in two. The first part supports the approved use: controlled work established that synthetic porcine secretin performs accurately in pancreatic function testing in people with chronic pancreatitis [2]. That is a diagnostic claim, it is narrow, and the approved labeling is built on it.

The second part is a closed question that the marketplace has never fully absorbed, and it is larger than it is usually reported to be. A scoped census run 2026-09-02 returns 19 randomized-type records for secretin in autism; all 19 were opened, and 16 are randomized trials of the peptide in autism or pervasive developmental disorder, the other three being a published Comment, a trial in refractory schizophrenia, and a dietary-intake study [7]. The sequence runs from a 1999 New England Journal of Medicine trial concluding that a single dose of synthetic human secretin is not an effective treatment [8], through single-dose and repeated-dose trials of the porcine and synthetic preparations [3, 4, 5, 9, 10, 11, 12, 13], to a 2005 transdermal trial [6]. One of them tested whether parents could tell the difference under double-blind conditions and reported that they could not [14].

The cluster is unusual in peptide medicine for being large, independent, and consistent. Every one of the 16 reports no benefit on its primary measures; the only positive signals anywhere in the set are a marginal result at three weeks in one trial and a subgroup speech finding in another, both of which their own authors present as provisional [10, 6].

That history is why the substance belongs in this index rather than only in a pharmacology text. A compound with a genuine approval for one narrow diagnostic purpose, and a well-populated negative literature for the purpose it became famous for, is the exact shape a reader is most likely to misread in either direction.

Lawful access

Approved products exist and are marketed. ChiRhoStim, synthetic human secretin, was approved on April 9, 2004 under new drug application 021256, in 16 microgram and 40 microgram vials for intravenous use; Porcine Secretin was approved on April 4, 2002 under application 021209. Two earlier products, SecreFlo and Secretin-Ferring, are recorded in Drugs@FDA as discontinued [15]. All of the marketed presentations are prescription-only.

Separately, and this is the part almost nowhere recorded, the substance is also a nominated bulk drug substance. The section 503A bulks list FDA published May 14, 2026 lists Secretin, human 99% in Category 3 — the file for substances nominated without adequate support to evaluate [16]. Category 3 is not a safety finding and it is not a permission; it records that the submission behind the nomination did not contain enough to review.

The nomination raises a question section 503A exists to control. A pharmacy may not compound a preparation that is essentially a copy of a commercially available approved drug unless a prescriber documents a clinical difference for an individual patient, and human secretin is the active ingredient of an approved product. A bulk nomination for that same substance therefore has to clear a bar that nothing in Category 3 has cleared. The approved page sets out what an approval does and does not settle.

Elsewhere in this index

Filed under

Evidence reviews

Reference tables

Same class

References

  1. PubMed, National Library of Medicine. Census run 2026-09-02 across three name variants — "secretin" OR "synthetic human secretin" OR "porcine secretin" — returning 9,152 indexed records, 4,793 carrying the Humans MeSH term, 215 under "clinical trial"[Publication Type] and 103 under "randomized controlled trial"[Publication Type]. Reported as a magnitude; the 25 most relevant randomized records were retrieved through esummary and read. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. Source
  2. Somogyi L, Cintron M, Toskes PP. Synthetic porcine secretin is highly accurate in pancreatic function testing in individuals with chronic pancreatitis. Pancreas. 2000 Oct;21(3):262-5. PMID 11039470
  3. Dunn-Geier J, Ho HH, Auersperg E, Doyle D, Eaves L, Matsuba C, et al. Effect of secretin on children with autism: a randomized controlled trial. Dev Med Child Neurol. 2000 Dec;42(12):796-802. PMID 11132252
  4. Owley T, McMahon W, Cook EH, Laulhere T, South M, Mays LZ, et al. Multisite, double-blind, placebo-controlled trial of porcine secretin in autism. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1293-9. PMID 11699803
  5. Unis AS, Munson JA, Rogers SJ, Goldson E, Osterling J, Gabriels R, et al. A randomized, double-blind, placebo-controlled trial of porcine versus synthetic secretin for reducing symptoms of autism. J Am Acad Child Adolesc Psychiatry. 2002 Nov;41(11):1315-21. PMID 12410073
  6. Ratliff-Schaub K, Carey T, Reeves GD, Rogers MA. Randomized controlled trial of transdermal secretin on behavior of children with autism. Autism. 2005 Jul;9(3):256-65. PMID 15937041
  7. PubMed, National Library of Medicine. Scoped census run 2026-09-02: the query ("secretin") AND ("autism" OR "autistic" OR "pervasive developmental") returns 132 indexed records, 22 under "clinical trial"[Publication Type] and 19 under "randomized controlled trial"[Publication Type]. All 19 randomized-type records were retrieved and read: 16 are randomized trials of secretin in autism or pervasive developmental disorder, one is a published Comment, one is a trial in refractory schizophrenia, and one is a dietary-intake study. In the same run the control term aspirin returned 6,115 records under the identical randomized filter and 8,906 under the clinical-trial filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. Source
  8. Sandler AD, Sutton KA, DeWeese J, Girardi MA, Sheppard V, Bodfish JW. Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder. N Engl J Med. 1999 Dec 9;341(24):1801-6. PMID 10588965
  9. Roberts W, Weaver L, Brian J, Bryson S, Emelianova S, Griffiths AM, et al. Repeated doses of porcine secretin in the treatment of autism: a randomized, placebo-controlled trial. Pediatrics. 2001 May;107(5):E71. PMID 11331721
  10. Coniglio SJ, Lewis JD, Lang C, Burns TG, Subhani-Siddique R, Weintraub A, et al. A randomized, double-blind, placebo-controlled trial of single-dose intravenous secretin as treatment for children with autism. J Pediatr. 2001 May;138(5):649-55. PMID 11343038
  11. Sponheim E, Oftedal G, Helverschou SB. Multiple doses of secretin in the treatment of autism: a controlled study. Acta Paediatr. 2002;91(5):540-5. PMID 12113323
  12. Molloy CA, Manning-Courtney P, Swayne S, Bean J, Brown JM, Murray DS, et al. Lack of benefit of intravenous synthetic human secretin in the treatment of autism. J Autism Dev Disord. 2002 Dec;32(6):545-51. PMID 12553591
  13. Levy SE, Souders MC, Wray J, Jawad AF, Gallagher PR, Coplan J, et al. Children with autistic spectrum disorders. I: comparison of placebo and single dose of human synthetic secretin. Arch Dis Child. 2003 Aug;88(8):731-6. PMID 12876177
  14. Coplan J, Souders MC, Mulberg AE, Belchic JK, Wray J, Jawad AF, et al. Children with autistic spectrum disorders. II: parents are unable to distinguish secretin from placebo under double-blind conditions. Arch Dis Child. 2003 Aug;88(8):737-9. PMID 12876178
  15. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Read 2026-09-02: four applications name secretin as an active ingredient. NDA 021256 (ChiRhoStim, synthetic human secretin, 16 and 40 microgram vials, intravenous) carries an original approval date of April 9, 2004 and prescription marketing status; NDA 021209 (Porcine Secretin) carries an original approval date of April 4, 2002 and prescription status; NDA 021136 (SecreFlo) and NDA 018290 (Secretin-Ferring) are recorded as discontinued. A deliberately invented ingredient name returned no records in the same run. Source
  16. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full 2026-09-02: the entry "Secretin, human 99%" appears in Category 3 and in neither Category 1 nor Category 2. Source

The editor is not a licensed clinician; this monograph is a regulatory and evidence reference, not medical advice. Statuses are re-verified on the date shown, and every quantitative claim resolves to a numbered reference. Corrections: editor@peptideamerica.org. See how this reference is funded.