Gastrointestinal · Investigational
Uroguanylin (Dolcanatide)
No lawful US pathway
01 · Overview
Uroguanylin is a 16-amino acid peptide related to guanylin that activates guanylate cyclase-C (GC-C) receptors in the intestinal epithelium (PMID 28255961). Like guanylin, it raises cyclic GMP to regulate intestinal fluid and electrolyte secretion, and it is also found in the kidney, stomach, and other tissues (PMID 11324723).
In mice, a uroguanylin-GC-C signaling axis from gut to hypothalamus helps regulate satiety (PMID 21865642). Dolcanatide is an investigational oral uroguanylin analogue containing selected D-amino acids for greater stability in the intestine (PMID 34632925).
02 · Research summary & key findings
Plecanatide, a synthetic uroguanylin analogue, received FDA approval in January 2017 for chronic idiopathic constipation (PMID 28255961), so a uroguanylin-based drug is already in clinical use. Dolcanatide reduced gut inflammation in mouse colitis models (PMID 26558155). In a phase 1 trial in healthy volunteers, oral dolcanatide for 7 days did not increase cyclic GMP in rectal epithelial cells, indicating it may not be suitable for colorectal cancer prevention (PMID 34632925). Dolcanatide has not achieved regulatory approval.
03 · Regulatory status
Uroguanylin (Dolcanatide) is in the investigational stage. While preclinical and early-phase data exist, it has not received regulatory approval for clinical use in the United States.
No lawful pathway today
Uroguanylin (Dolcanatide) is not FDA-approved and does not currently have a lawful prescription or compounding pathway in the United States, so we do not sell it and will not book a consultation for it. That can change: in 2026 FDA began reviewing several peptides for compounding.
See the 7 FDA-approved compounds in Gastrointestinal
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04 · Administration routes
- Oral
References
- [1]Guanylin family: new intestinal peptides regulating electrolyte and water homeostasis J Gastroenterol, 2001. PMID 11324723
- [2]A uroguanylin-GUCY2C endocrine axis regulates feeding in mice J Clin Invest, 2011. PMID 21865642
- [3]Plecanatide and dolcanatide, novel guanylate cyclase-C agonists, ameliorate gastrointestinal inflammation in experimental models of murine colitis World J Gastrointest Pharmacol Ther, 2015. PMID 26558155
- [4]Plecanatide: First Global Approval Drugs, 2017. PMID 28255961
- [5]Phase I double-blind, placebo-controlled trial of dolcanatide (SP-333) 27 mg to explore colorectal bioactivity in healthy volunteers Cancer Biol Ther, 2021. PMID 34632925
Primary literature
- PubMed: "Uroguanylin"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Uroguanylin"
Registered interventional and observational studies, including status and phase.
- PubChem: "Uroguanylin"
Chemical structure, molecular properties, and bioactivity data.
Related peptides in Gastrointestinal
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